药品及相关物质取样(英文)929附录4
© World Health OrganizationWHO Technical Report Series, No. 929, 2005Annex 4WHO guidelines for sampling of pharmaceutical products and related materials1.Introduction611.1General considerations611.2Glossary611.3Purpose of sampling641.4Classes and types of pharmaceutical products and relatedmaterials651.5Sampling facilities651.6Responsibilities for sampling661.7Health and safety672.Sampling process672.1Preparation for sampling672.2Sampling operation and precautions682.3Storage and retention693.Regulatory issues703.1Pharmaceutical inspections713.2Surveillance programmes714.Sampling on receipt (for acceptance)724.1Starting materials724.2Intermediates in the manufacturing process and bulkpharmaceutical products734.3Finished products734.4Packaging materials (primary and secondary)745.Sampling plans for starting materials, packaging materials andfinished products755.1Starting materials765.2Packaging materials775.3Finished products78Bibliography78 Appendix 1Types of sampling tools80 Appendix 2Sample collection form85 Appendix 3Steps to be considered for inclusion in a standard operating procedure87Examples of types of containers used to store samples of startingmaterials and bulk products91 Appendix 5Examples of use of sampling plans n, p and r93These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and police officials, but some of the general principles may also be appro-priate for application by procurement agencies, manufacturers and customers.These guidelines should be useful when surveying the national mar-kets for the quality of drug products in accordance with national drug quality surveillance programmes for marketed products, whether reg-istered for sale or compounded in pharmacies.The choice of a sampling plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan fora given purpose.1.1General considerationsSampling comprises the operations designed to select a portion of a pharmaceutical product (for definition, see glossary) for a defined purpose. The sampling procedure should be appropriate to the pur-pose of sampling, to the type of controls intended to be applied to the samples and to the material to be sampled. The procedure should be described in writing.All operations related to sampling should be performed with care, using proper equipment and tools. Any contamination of the sample by dust or other foreign material is liable to jeopardize the validity of the subsequent analyses.1.2GlossaryThe definitions given below apply to the terms as used in these guide-lines. They may have different meanings in other contexts.Available sampleWhatever total quantity of sample materials is available.BatchA quantity of any drug produced during a given cycle of manufacture.If the manufacturing process is continuous, the batch originates in a defined period of time during which the manufacturing conditions arestable and have not been modified.Sample resulting from combining all or parts of two or more samples of the material.ConsignmentThe quantity of a bulk starting material, or of a drug product, made by one manufacturer or supplied by an agent, and supplied at one time in response to a particular request or order. A consignment may com-prise one or more lot-identified packages or containers and may include material belonging to more than one lot-identified batch. Final sampleSample ready for the application of the test procedure. HomogeneityA material is regarded as homogeneous when it is all of the same origin (e.g. from the same batch) and as non-homogeneous when it is of differing origins.Original sampleSample collected directly from the material.Pharmaceutical productAny material1 or product intended for human or veterinary use pre-sented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state. PrequalificationThe activities undertaken in defining a product or service need, seek-ing expressions of interest from enterprises to supply the product or service, and examining the product or service offered against the specification, and the facility where the product or service is prepared against common standards of good manufacturing practice (GMP). The examination of the product or service and of the facility where it is manufactured is performed by trained and qualified inspectors against common standards. Once the product is approved, and the facility is approved for the delivery of the specified product or service, other procurement agencies are informed of the approval. Pre-qualification is required for all pharmaceutical products regardless of1“Material” is used in the document for “pharmaceutical products and related materials”.their composition and place of manufacture or registration, but the amount and type of information requested from the supplier for use in the assessment by the procurement agency may differ. ProductionAll operations involved in the preparation of a pharmaceutical prod-uct, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.Random sampleSample in which the different fractions of the material have an equal probability of being represented.Representative sampleSample obtained according to a sampling procedure designed to en-sure that the different parts of a batch or the different properties of a non-uniform material are proportionately represented.Retention sampleSample collected as part of the original sampling process and reserved for future testing. The size of a retention sample should be sufficient to allow for at least two confirmatory analyses. In some cases statu-tory regulations may require one or more retention samples, each of which should be separately identified, packaged and sealed. SampleA portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. If the quantity of material available is not sufficient for the intended analyses and for the retention samples, the inspector should record that the sampled material is the available sample (see Sampling record) and the evaluation of the results should take account of the limitations that arise from the insufficient sample size.SamplerPerson responsible for performing the sampling operations. Sampling methodThat part of the sampling procedure dealing with the method pre-scribed for withdrawing samples.Description of the location, number of units and/or quantity of mat-erial that should be collected, and associated acceptance criteria.Sampling procedureThe complete sampling operations to be performed on a defined material for a specific purpose. A detailed written description of the sampling procedure is provided in the sampling protocol.Sampling recordWritten record of the sampling operations carried out on a particular material for a defined purpose. The sampling record should contain the batch number, date and place of sampling, reference to the sam-pling protocol used, a description of the containers and of the materi-als sampled, notes on possible abnormalities, together with any other relevant observations, and the name and signature of the inspector.Sampling unitDiscrete part of a consignment such as an individual package, drum or container.Selected sampleSample obtained according to a sampling procedure designed to se-lect a fraction of the material that is likely to have special properties.A selected sample that is likely to contain deteriorated, contami-nated, adulterated or otherwise unacceptable material is known as an extreme sample.UniformityA starting material may be considered uniform when samples drawnfrom different layers do not show significant differences in the quality control tests which would result in non-conformity with specifications.The following materials may be considered uniform unless there are signs to the contrary: organic and inorganic chemicals; purified natu-ral products; various processed natural products such as fatty oils and essential oils; and plant extracts. The assumption of uniformity is strengthened by homogeneity, i.e. when the consignment is derived from a single batch.1.3Purpose of samplingSampling may be required for different purposes, such as pre-qualification; acceptance of consignments; batch release testing;in-process control; special controls; inspection for customs clearance, deterioration or adulteration; or for obtaining a retention sample.The tests to be applied to the sample may include:—verifying the identity;—performing complete pharmacopoeial or analogous testing; and —performing special or specific tests.1.4Classes and types of pharmaceutical products and relatedmaterialsThe materials to be sampled may belong to the following classes:—starting materials for use in the manufacture of finished pharma-ceutical products;—intermediates in the manufacturing process (e.g. bulk granule);—pharmaceutical products (in-process as well as before and after packaging);—primary and secondary packaging materials; and—cleaning and sanitizing agents, compressed gases and other pro-cessing agents.1.5Sampling facilitiesSampling facilities should be designed to:—prevent contamination of the opened container, the materials and the operator;—prevent cross-contamination by other materials, products and the environment; and—protect the individual who samples (sampler) during the sampling procedure.Where possible, sampling should be performed in an area or booth designed for and dedicated to this purpose, although this will not be possible where samples are required to be taken from a production line (e.g. in-process control samples). The area in which the sample was taken should be recorded in the sampling record and a sequential log should be kept of all materials sampled in each area.Sampling from large containers of starting material or bulk products can present difficulties. Whenever possible, this work should be car-ried out in a separate, closed cubicle within the warehouse, to reduce the risk of contamination (e.g. by dust) of either the sample or the materials remaining in the container, or of cross-contamination.Some materials should be sampled in special or dedicated environ-ments (e.g. when sampling articles for which contamination with dirtGenerally, taking the original sales pack as a sample from outlets such as pharmacies or hospitals does not present problems. However, the inspector should ensure that the quantity of sample taken is sufficient for the intended analyses and for the retention samples, and that all units sampled are derived from the same batch and preferably from the same location.1.6Responsibilities for samplingThose responsible for sampling procedures include:•governmental organizations, such as drug control authorities (in-cluding inspectorates); quality control laboratories; customs and police authorities responsible for the clearance of drug products held in quarantine after manufacture or importation, and for the detection of pharmaceutical products that have deteriorated or have been contaminated, adulterated or counterfeited;•customers such as governmental or nongovernmental agencies in-volved in the acquisition of drug products; and•manufacturers in the context of good manufacturing practices (GMP).The samplers need to be adequately trained in the practical aspects of sampling, qualified to perform the sampling operation, and should have sufficient knowledge of pharmaceutical substances to allow them to execute the work effectively and safely. Given that the sam-pling technique itself can introduce bias, it is important that personnel carrying out the sampling should be suitably trained in the techniques and procedures used. The training should be documented in the individual’s training records. Sampling records should clearly indicate the date of sampling, the sampled container and the identity of the person who sampled the batch.A conscientious approach, with meticulous attention to detail andcleanliness, is essential. The sampler should remain alert to any signs of contamination, deterioration or tampering. Any suspicious signs should be recorded in detail in the sampling record.If a governmental agency needs to sample a sterile or bulk pharma-ceutical product at the manufacturing site, it may be best to have the manufacturer’s personnel collect the sample, using their own pro-cedures. The regulatory inspector would observe the procedure in such a way as not to increase the chance of contamination (e.g. forsterile pharmaceutical products, the inspector would observe througha glass window outside the aseptic sampling area) and to preclude thepossibility of the inspector inadvertently contaminating the remaining bulk pharmaceutical product through poor procedures, for example.1.7Health and safetyIt is the responsibility of the sampler to read the relevant health and safety information (e.g. the safety data sheet for a pharmaceutical product and related materials) before sampling the material. The information should include necessary safety precautions and require-ments for both the operator and the environment.The sampler should wear appropriate protective clothing for the task.If specific safety precautions are required, such as the use of respira-tory equipment, the sampler should be properly trained in its use.The sampler should have safe access to and egress from the place where the sample is taken, and the places where the samples are taken for storage. The sample storage areas should have adequate light and ventilation and should be arranged to satisfy the requirements for safety as well as any special ones arising from the characteristics of the material being sampled.Care should be taken to guard against collapse of stacked containers or solids in bulk.2.Sampling process2.1Preparation for samplingFor the sampling of products, the responsible person should have at his or her disposal all the tools needed to open the containers (e.g.packages, barrels and others). Tools may include knives, pliers, saws, hammers, wrenches, implements to remove dust (preferably a vacuum cleaner), and material to reclose the packages (such as seal-ing tape), as well as self-adhesive labels to indicate that some of the contents have been removed from a package or container. Containers due to be sampled should be cleaned prior to sampling if necessary.Sampling of uniform starting materials does not require complicated tools. A variety of pipettes fitted with suction bulbs, cups or beakers, dippers and funnels are needed for liquids of low viscosity. The use of glass should be avoided. A suitable inert rod can be used for highly viscous liquid, and spatulas or scoops are needed for powdered and granular solids. Sterile pharmaceutical products should be sampled under aseptic conditions, and only when deemed absolutely essential,to avoid the risk of loss of sterility.All sampling tools and implements should be made of inert materials and kept scrupulously clean. After use or before reuse, they should be thoroughly washed, rinsed with water or suitable solvent, and dried.They should be stored in clean conditions. Adequate washing facili-ties should be provided in, or in close proximity to, the sampling area, otherwise samplers will need to bring separate clean sets of imple-ments for sampling each product. The cleaning procedure used for all sampling tools and implements should be documented and recorded.The adequacy of the cleaning procedure for the material from which the sampling tool is made should be demonstrated. The use of dispos-able sampling materials has distinct advantages.Examples of sampling tools suitable for each type of material are given in Appendix 1.2.2Sampling operation and precautionsThere should be a written procedure describing the sampling opera-tion. This should include details of the health and safety aspects of sampling. It should ensure that representative samples are taken in sufficient quantity for testing in accordance with specifications. Clo-sures and labels should preferably be such that unauthorized opening can be detected. Samples should never be returned to the bulk.The sampling process should be appropriately supervised and docu-mented (see Appendix 2 for an example of a sample collection form).The sampling procedure should be such that non-uniformity of the material can be detected. During the sampling procedure, attention should be paid to any signs of nonconformity of the material.Signs of non-uniformity include differences in shape, size or colour of particles in crystalline, granular or powdered solid substances; moist crusts on hygroscopic substances; deposits of solid pharmaceutical product in liquid or semi-liquid products; and stratification of liquid products. Such changes, some of which may be readily reversible, can occur during prolonged storage or exposure to extreme temperatures during transportation. Homogeneous portions of the material or bulk such as those mentioned above should be sampled and tested sepa-rately from the rest of the material that has a normal appearance.Pooling of the samples from the different portions should be avoided, because this can mask contamination, low potency or other quality problems.Labelling of samples should provide appropriate details, including the batch number and, if known, the container number from which the sample was taken, the amount taken and for what purpose. Labels should be applied at the time of sampling. The container used to store the sample should also be properly labelled with appropriate details such as sample type, name of material, identification code, batch/lot number, code, quantity, date of sampling, storage conditions, han-dling precautions and container number.For finished drug products, the sampling procedure should take ac-count of the official and non-official tests required for the individual dosage form (e.g. tablets or parenteral preparations). Non-official tests could include testing for adulteration and counterfeiting.The sampling procedure should also take account of past experience with the pharmaceutical product or related material and with the supplier, and of the number of sampling units in the consignment.Examples of steps for sampling are given in Appendix 3.When a container is sampled outside the control of the consignee of the product, the following precautions should be taken. If the tamper-proof seal is broken to obtain a sample, then the consignee of the product should be informed and the container resealed with an appro-priate tamper-proof seal, and the consignee of the product informed of its type and its identification. If a bag has been punctured to takea sample, then the sampling hole should be appropriately closedand identified as a sampling hole made by an authorized sampler.Sampled containers should be identified, as they may no longer contain the quantity of product stated on the label. In accordance with national legislation there may be exceptions, e.g. during ongoing investigations of cases related to counterfeit pharmaceutical products.2.3Storage and retentionThe container used to store a sample should not interact with the sampled material nor allow contamination. It should also protect the sample from light, air and moisture, as required by the storage direc-tions for the pharmaceutical product or related material sampled.As a general rule the container should be sealed and preferablytamper-evident.Suitable screw-top jars in exceptional cases only should be used for solid or semi-solid pharmaceutical products. The container should be inert. Light-sensitive materials should be protected by using amber glass containers or by wrapping colourless glass containers in foil or dark-coloured paper. H eadspace should be kept to a minimum to minimize any possible degradation. Any special procedures, for ex-ample, nitrogen gassing, should be discussed with the consignee of the material and carried out as appropriate.Solid dosage forms such as tablets or granules should be protected during transit, either by totally filling the container with the product or by filling any residual space with a suitable material. All containers should be sealed and labelled, and all samples should be packaged adequately and transported in such a way as to avoid breakage and contamination during transport.For all containers that come apart (e.g. screw-capped jars or metal tins with separate lids) precautions should be taken to avoid any mix-up when they are opened for examination, such as by labelling all parts of each container whenever possible.If one sample is divided into several sample containers, they should be transported in a suitably sealed box, which should be labelled with the identity of the product, the consignment from which the sample was drawn, the size of the sample, the date and place of sampling, and the name of the inspector.Security and adequate storage conditions should be ensured for the rooms in which samples are stored. Samples should be stored in accordance with the storage conditions as specified for the respective active pharmaceutical ingredient (API), excipient or drug product.Packaging materials similar to those in which the bulk is supplied should be used for long-term storage.Examples of types of containers used to store samples of starting materials and bulk products are given in Appendix 4.3.Regulatory issuesWhen sampling for regulatory purposes, additional samples for regulatory testing and verification purposes should be provided(e.g. for duplicate testing and parallel testing by different regulatorylaboratories and by the consignee of the product). The consignee of the product should be informed that samples have been taken, and should the consignee wish to conduct his/her own testing of the sample taken for regulatory purposes, regulatory authorities should provide a sample to the consignee of the goods.Sampling of products for prequalification purposes may follow similar procedures.3.1Pharmaceutical inspectionsPharmaceutical inspectors may take samples from retail or hospital pharmacies (including samples of preparations manufactured in bulk on the premises), or from industry and wholesalers for a variety of reasons, such as:—routine monitoring and control;—following the suspicion or discovery of products that show signs of possible deterioration, contamination, adulteration or counter-feiting; and—when a particular product is suspected of being either ineffective or responsible for adverse clinical reactions.For deteriorated dosage forms, the sample should consist of one or more retail containers of the product that shows visual signs of deterioration.When a complaint has been received about a drug product, the sample should include the original container and, if possible, one or more unopened containers containing the same product and bearing the same batch number. There should be good communication be-tween the regulatory authority and the consignee of the goods con-cerning the findings and any necessary corrective action.3.2Surveillance programmesNational drug regulatory authorities are responsible for monitoring the quality of all drug products marketed in their country and as defined by legislation. The extent to which routine surveillance should be undertaken, as opposed to assessment of suspect products, will depend upon factors such as:—the capacity of the national quality control laboratory;—the extent to which the quality of the product has been assessed prior to registration;—the extent to which the requirements for GMP are implemented;and—the number of products that are imported from abroad.A systematic programme of drug quality surveillance should be inplace which may include sampling of marketed products, whether registered for sale or compounded in pharmacies, as deemed neces-sary. Each product should be assessed regularly (e.g. every 2–3 years) for inclusion in the surveillance programme, but particular attention should be accorded to products that are of prime importance to public health programmes or that are potentially dangerous, unstable or difficult to formulate properly.The responsible laboratory should draw up the sampling programme, if necessary under the guidance of the drug regulatory authority, on a yearly or half-yearly basis. This programme should not only list the products to be sampled during a given period, but should also specify the sampling procedures and the size of the samples to be collected, taking into account the need for retention samples. The programme should state to what extent each brand of a given product will be sampled and which local authority or inspector will be respon-sible for each sampling operation. It should indicate to which labora-tory (if more than one exists) each sample should be sent. Such a programme enables the facilities of each laboratory to be used to best advantage.4.Sampling on receipt (for acceptance)4.1Starting materialsTesting of starting materials should be undertaken using samples collected in accordance with an appropriate procedure.If the material of a consignment can be regarded as uniform, the sample can be taken from any part of the consignment. If, however, the material is not physically uniform, special sampling tools may be required to withdraw a cross-sectional portion of the material. Alter-natively, where applicable, a validated procedure can be followed to restore the uniformity of the material before sampling, based on information concerning the subsequent handling and manufacturing steps. For example, a stratified liquid may be stirred or a solid deposit in a liquid may be dissolved by gentle warming and stirring. Such interventions should not be attempted without adequate knowledge of the properties of the contents and appropriate discussions with the consignee of the goods.All partially processed natural products, both animal, herbal (dried plants and their parts) and mineral, should be treated as intrinsicallynon-uniform. Special procedures requiring considerable practiceare needed to prepare representative samples from such consign-ments, including coning and quartering and the treatment of fines.Details of appropriate procedures may be found in the relevant Inter-national Organization for Standardization (ISO) documents (see Bibliography). These procedures are not further described in these guidelines.4.2Intermediates in the manufacturing process and bulkpharmaceutical productsPharmaceutical intermediates and products supplied in bulk may need to be examined. These include liquids and semi-solid pharma-ceutical products, powdered solids or granulates transported in large containers and intended either for further processing or for direct packaging into final market containers, and unit dosage forms (tablets, capsules) supplied in bulk which are intended for repackag-ing into smaller containers.There is a risk of segregation of bulk materials during transportation and this should be taken into account when drawing up the sampling plan.Products of this kind may be assumed to be uniform where the transportation process has been validated, provided that they:—are labelled with the name of the manufacturer and a single batch number;—have been produced in accordance with GMP; and—are supplied with a certificate, issued in the country of origin, according to the WH O Certification Scheme on the quality ofpharmaceutical products moving in international commerce.In these circumstances the collection of a single sample, sufficient for the intended analyses, is adequate.4.3Finished productsThe quality of finished pharmaceutical products frequently needs to be verified at the time of their importation or purchase. The necessary sampling should be performed using an appropriate method and with regard to the presumed uniformity. A single consignment of a product from a single manufacturer and labelled with a single batch number may be assumed to be uniform.The minimum size of the samples will be determined by the require-ments of the analytical procedure that will be used to test the product.Tests of unit dosage forms for uniformity of weight, volume or con-tent can require a considerable number of units, as can tests。
药物分析英语词汇
药物分析英语词汇Abbe refractometer 阿贝折射仪absorbance 吸收度absorbance ratio 吸收度比值absorption 吸收absorption curve 吸收曲线absorption spectrum 吸收光谱absorptivity 吸收系数accuracy 准确度acid-dye colorimetry 酸性染料比色法acidimetry 酸量法acid-insoluble ash 酸不溶性灰分acidity 酸度activity 活度additive 添加剂additivity 加和性adjusted retention time 调整保留时间adsorbent 吸附剂adsorption 吸附affinity chromatography 亲和色谱法aliquot （一）份alkalinity 碱度alumina 氧化铝ambient temperature 室温ammonium thiocyanate 硫氰酸铵analytical quality control（AQC）分析质量控制anhydrous substance 干燥品anionic surfactant titration 阴离子表面活性剂滴定法antibiotics-microbial test 抗生素微生物检定法antioxidant 抗氧剂appendix 附录application of sample 点样area normalization method 面积归一化法argentimetry 银量法arsenic 砷arsenic stain 砷斑ascending development 上行展开ash-free filter paper 无灰滤纸（定量滤纸）assay 含量测定assay tolerance 含量限度atmospheric pressure ionization(API) 大气压离子化attenuation 衰减back extraction 反萃取back titration 回滴法bacterial endotoxins test 细菌内毒素检查法band absorption 谱带吸收baseline correction 基线校正baseline drift 基线漂移batch, lot 批batch(lot) number 批号Benttendorff method 白田道夫（检砷）法between day (day to day, inter-day) precision 日间精密度between run (inter-run) precision 批间精密度biotransformation 生物转化bioavailability test 生物利用度试验bioequivalence test 生物等效试验biopharmaceutical analysis 体内药物分析，生物药物分析blank test 空白试验boiling range 沸程British Pharmacopeia (BP) 英国药典bromate titration 溴酸盐滴定法bromimetry 溴量法bromocresol green 溴甲酚绿bromocresol purple 溴甲酚紫bromophenol blue 溴酚蓝bromothymol blue 溴麝香草酚蓝bulk drug, pharmaceutical product 原料药buret 滴定管by-product 副产物calibration curve 校正曲线calomel electrode 甘汞电极calorimetry 量热分析capacity factor 容量因子capillary zone electrophoresis (CZE) 毛细管区带电泳capillary gas chromatography 毛细管气相色谱法carrier gas 载气cation-exchange resin 阳离子交换树脂ceri(o)metry 铈量法characteristics, description 性状check valve 单向阀chemical shift 化学位移chelate compound 鳌合物chemically bonded phase 化学键合相chemical equivalent 化学当量Chinese Pharmacopeia (ChP) 中国药典Chinese material medicine 中成药Chinese materia medica 中药学Chinese materia medica preparation 中药制剂Chinese Pharmaceutical Association (CPA) 中国药学会chiral 手性的chiral stationary phase (CSP) 手性固定相chiral separation 手性分离chirality 手性chiral carbon atom 手性碳原子chromatogram 色谱图chromatography 色谱法chromatographic column 色谱柱chromatographic condition 色谱条件chromatographic data processor 色谱数据处理机chromatographic work station 色谱工作站clarity 澄清度clathrate, inclusion compound 包合物clearance 清除率clinical pharmacy 临床药学coefficient of distribution 分配系数coefficient of variation 变异系数color change interval （指示剂）变色范围color reaction 显色反应colorimetric analysis 比色分析colorimetry 比色法column capacity 柱容量column dead volume 柱死体积column efficiency 柱效column interstitial volume 柱隙体积column outlet pressure 柱出口压column temperature 柱温column pressure 柱压column volume 柱体积column overload 柱超载column switching 柱切换committee of drug evaluation 药品审评委员会comparative test 比较试验completeness of solution 溶液的澄清度compound medicines 复方药computer-aided pharmaceutical analysis 计算机辅助药物分析concentration-time curve 浓度－时间曲线confidence interval 置信区间confidence level 置信水平confidence limit 置信限congealing point 凝点congo red 刚果红（指示剂）content uniformity 装量差异controlled trial 对照试验correlation coefficient 相关系数contrast test 对照试验counter ion 反离子（平衡离子）cresol red 甲酚红（指示剂）crucible 坩埚crude drug 生药crystal violet 结晶紫（指示剂）cuvette, cell 比色池cyanide 氰化物cyclodextrin 环糊精cylinder, graduate cylinder, measuring cylinder 量筒cylinder-plate assay 管碟测定法daughter ion （质谱）子离子dead space 死体积dead-stop titration 永停滴定法dead time 死时间decolorization 脱色decomposition point 分解点deflection 偏差deflection point 拐点degassing 脱气deionized water 去离子水deliquescence 潮解depressor substances test 降压物质检查法derivative spectrophotometry 导数分光光度法derivatization 衍生化descending development 下行展开desiccant 干燥剂detection 检查detector 检测器developer, developing reagent 展开剂developing chamber 展开室deviation 偏差dextrose 右旋糖，葡萄糖diastereoisomer 非对映异构体diazotization 重氮化2,6-dichlorindophenol titration 2,6-二氯靛酚滴定法differential scanning calorimetry (DSC) 差示扫描热量法differential spectrophotometry 差示分光光度法differential thermal analysis (DTA) 差示热分析differentiating solvent 区分性溶剂diffusion 扩散digestion 消化diphastic titration 双相滴定disintegration test 崩解试验dispersion 分散度dissolubility 溶解度dissolution test 溶出度检查distilling range 馏程distribution chromatography 分配色谱distribution coefficient 分配系数dose 剂量drug control institutions 药检机构drug quality control 药品质量控制drug release 药物释放度drug standard 药品标准drying to constant weight 干燥至恒重dual wavelength spectrophotometry 双波长分光光度法duplicate test 重复试验effective constituent 有效成分effective plate number 有效板数efficiency of column 柱效electron capture detector 电子捕获检测器electron impact ionization 电子轰击离子化electrophoresis 电泳electrospray interface 电喷雾接口electromigration injection 电迁移进样elimination 消除eluate 洗脱液elution 洗脱emission spectrochemical analysis 发射光谱分析enantiomer 对映体end absorption 末端吸收end point correction 终点校正endogenous substances 内源性物质enzyme immunoassay(EIA) 酶免疫分析enzyme drug 酶类药物enzyme induction 酶诱导enzyme inhibition 酶抑制eosin sodium 曙红钠（指示剂）epimer 差向异构体equilibrium constant 平衡常数equivalence point 等当点error in volumetric analysis 容量分析误差excitation spectrum 激发光谱exclusion chromatography 排阻色谱法expiration date 失效期external standard method 外标法extract 提取物extraction gravimetry 提取重量法extraction titration 提取容量法extrapolated method 外插法，外推法factor 系数，因数，因子feature 特征Fehling’s reaction 费林反应field disorption ionization 场解吸离子化field ionization 场致离子化filter 过滤，滤光片filtration 过滤fineness of the particles 颗粒细度flame ionization detector(FID) 火焰离子化检测器flame emission spectrum 火焰发射光谱flask 烧瓶flow cell 流通池flow injection analysis 流动注射分析flow rate 流速fluorescamine 荧胺fluorescence immunoassay(FIA) 荧光免疫分析fluorescence polarization immunoassay(FPIA) 荧光偏振免疫分析fluorescent agent 荧光剂fluorescence spectrophotometry 荧光分光光度法fluorescence detection 荧光检测器fluorimetyr 荧光分析法foreign odor 异臭foreign pigment 有色杂质formulary 处方集fraction 馏分freezing test 结冻试验funnel 漏斗fused peaks, overlapped peaks 重叠峰fused silica 熔融石英gas chromatography(GC) 气相色谱法gas-liquid chromatography(GLC) 气液色谱法gas purifier 气体净化器gel filtration chromatography 凝胶过滤色谱法gel permeation chromatography 凝胶渗透色谱法general identification test 一般鉴别试验general notices （药典）凡例general requirements （药典）通则good clinical practices(GCP) 药品临床管理规范good laboratory practices(GLP) 药品实验室管理规范good manufacturing practices(GMP) 药品生产质量管理规范good supply practices(GSP) 药品供应管理规范gradient elution 梯度洗脱grating 光栅gravimetric method 重量法Gutzeit test 古蔡（检砷）法half peak width 半峰宽[halide] disk method, wafer method, pellet method 压片法head-space concentrating injector 顶空浓缩进样器heavy metal 重金属heat conductivity 热导率height equivalent to a theoretical plate 理论塔板高度height of an effective plate 有效塔板高度high-performance liquid chromatography (HPLC) 高效液相色谱法high-performance thin-layer chromatography (HPTLC) 高效薄层色谱法hydrate 水合物hydrolysis 水解hydrophilicity 亲水性hydrophobicity 疏水性hydroscopic 吸湿的hydroxyl value 羟值hyperchromic effect 浓色效应hypochromic effect 淡色效应identification 鉴别ignition to constant weight 灼烧至恒重immobile phase 固定相immunoassay 免疫测定impurity 杂质inactivation 失活index 索引indicator 指示剂indicator electrode 指示电极inhibitor 抑制剂injecting septum 进样隔膜胶垫injection valve 进样阀instrumental analysis 仪器分析insulin assay 胰岛素生物检定法integrator 积分仪intercept 截距interface 接口interference filter 干涉滤光片intermediate 中间体internal standard substance 内标物质international unit(IU) 国际单位in vitro 体外in vivo 体内iodide 碘化物iodoform reaction 碘仿反应iodometry 碘量法ion-exchange cellulose 离子交换纤维素ion pair chromatography 离子对色谱ion suppression 离子抑制ionic strength 离子强度ion-pairing agent 离子对试剂ionization 电离，离子化ionization region 离子化区irreversible indicator 不可逆指示剂irreversible potential 不可逆电位isoabsorptive point 等吸收点isocratic elution 等溶剂组成洗脱isoelectric point 等电点isoosmotic solution 等渗溶液isotherm 等温线Karl Fischer titration 卡尔·费歇尔滴定kinematic viscosity 运动黏度Kjeldahl method for nitrogen 凯氏定氮法Kober reagent 科伯试剂Kovats retention index 科瓦茨保留指数labelled amount 标示量leading peak 前延峰least square method 最小二乘法leveling effect 均化效应licensed pharmacist 执业药师limit control 限量控制limit of detection(LOD) 检测限limit of quantitation(LOQ) 定量限limit test （杂质）限度（或限量）试验limutus amebocyte lysate(LAL) 鲎试验linearity and range 线性及范围linearity scanning 线性扫描liquid chromatograph/mass spectrometer (LC/MS) 液质联用仪litmus paper 石蕊试纸loss on drying 干燥失重low pressure gradient pump 低压梯度泵luminescence 发光lyophilization 冷冻干燥main constituent 主成分make-up gas 尾吹气maltol reaction 麦牙酚试验Marquis test 马奎斯试验mass analyzer detector 质量分析检测器mass spectrometric analysis 质谱分析mass spectrum 质谱图mean deviation 平均偏差measuring flask, volumetric flask 量瓶measuring pipet(te) 刻度吸量管medicinal herb 草药melting point 熔点melting range 熔距metabolite 代谢物metastable ion 亚稳离子methyl orange 甲基橙methyl red 甲基红micellar chromatography 胶束色谱法micellar electrokinetic capillary chromatography(MECC, MEKC) 胶束电动毛细管色谱法micelle 胶束microanalysis 微量分析microcrystal 微晶microdialysis 微透析micropacked column 微型填充柱microsome 微粒体microsyringe 微量注射器migration time 迁移时间millipore filtration 微孔过滤minimum fill 最低装量mobile phase 流动相modifier 改性剂，调节剂molecular formula 分子式monitor 检测，监测monochromator 单色器monographs 正文mortar 研钵moving belt interface 传送带接口multidimensional detection 多维检测multiple linear regression 多元线性回归multivariate calibration 多元校正natural product 天然产物Nessler glasses(tube) 奈斯勒比色管Nessler’s reagent 碱性碘化汞钾试液neutralization 中和nitrogen content 总氮量nonaqueous acid-base titration 非水酸碱滴定nonprescription drug, over the counter drugs (OTC drugs) 非处方药nonproprietary name, generic name 非专有名nonspecific impurity 一般杂质non-volatile matter 不挥发物normal phase 正相normalization 归一化法notice 凡例nujol mull method 石蜡糊法octadecylsilane chemically bonded silica 十八烷基硅烷键合硅胶octylsilane 辛（烷）基硅烷odorless 无臭official name 法定名official specifications 法定标准official test 法定试验on-column detector 柱上检测器on-column injection 柱头进样on-line degasser 在线脱气设备on the dried basis 按干燥品计opalescence 乳浊open tubular column 开管色谱柱optical activity 光学活性optical isomerism 旋光异构optical purity 光学纯度optimization function 优化函数organic volatile impurities 有机挥发性杂质orthogonal function spectrophotometry 正交函数分光光度法orthogonal test 正交试验orthophenanthroline 邻二氮菲outlier 可疑数据，逸出值overtones 倍频峰，泛频峰oxidation-reduction titration 氧化还原滴定oxygen flask combustion 氧瓶燃烧packed column 填充柱packing material 色谱柱填料palladium ion colorimetry 钯离子比色法parallel analysis 平行分析parent ion 母离子particulate matter 不溶性微粒partition coefficient 分配系数parts per million (ppm) 百万分之几pattern recognition 模式识别peak symmetry 峰不对称性peak valley 峰谷peak width at half height 半峰宽percent transmittance 透光百分率pH indicator absorbance ratio method pH指示剂吸光度比值法pharmaceutical analysis 药物分析pharmacopeia 药典pharmacy 药学phenolphthalein 酚酞photodiode array detector(DAD) 光电二极管阵列检测器photometer 光度计pipeclay triangle 泥三角pipet(te) 吸移管，精密量取planar chromatography 平板色谱法plate storage rack 薄层板贮箱polarimeter 旋光计polarimetry 旋光测定法polarity 极性polyacrylamide gel 聚丙酰胺凝胶polydextran gel 葡聚糖凝胶polystyrene gel 聚苯乙烯凝胶polystyrene film 聚苯乙烯薄膜porous polymer beads 高分子多孔小球post-column derivatization 柱后衍生化potentiometer 电位计potentiometric titration 电位滴定法precipitation form 沉淀形式precision 精密度pre-column derivatization 柱前衍生化preparation 制剂prescription drug 处方药pretreatment 预处理primary standard 基准物质principal component analysis 主成分分析programmed temperature gas chromatography 程序升温气相色谱法prototype drug 原型药物provisions for new drug approval 新药审批办法purification 纯化purity 纯度pyrogen 热原pycnometric method 比重瓶法quality control(QC) 质量控制quality evaluation 质量评价quality standard 质量标准quantitative determination 定量测定quantitative analysis 定量分析quasi-molecular ion 准分子离子racemization 消旋化radioimmunoassay 放射免疫分析法random sampling 随机抽样rational use of drug 合理用药readily carbonizable substance 易炭化物reagent sprayer 试剂喷雾器recovery 回收率reference electrode 参比电极refractive index 折光指数related substance 有关物质relative density 相对密度relative intensity 相对强度repeatability 重复性replicate determination 平行测定reproducibility 重现性residual basic hydrolysis method 剩余碱水解法residual liquid junction potential 残余液接电位residual titration 剩余滴定residue on ignition 炽灼残渣resolution 分辨率，分离度response time 响应时间retention 保留reversed phase chromatography 反相色谱法reverse osmosis 反渗透rider peak 驼峰rinse 清洗，淋洗robustness 可靠性，稳定性routine analysis 常规分析round 修约（数字）ruggedness 耐用性safety 安全性Sakaguchi test 坂口试验salt bridge 盐桥salting out 盐析sample applicator 点样器sample application 点样sample on-line pretreatment 试样在线预处理sampling 取样saponification value 皂化值saturated calomel electrode(SCE) 饱和甘汞电极selectivity 选择性separatory funnel 分液漏斗shoulder peak 肩峰signal to noise ratio 信噪比significant difference 显著性差异significant figure 有效数字significant level 显著性水平significant testing 显著性检验silanophilic interaction 亲硅羟基作用silica gel 硅胶silver chloride electrode 氯化银电极similarity 相似性simultaneous equations method 解线性方程组法size exclusion chromatography(SEC) 空间排阻色谱法sodium dodecylsulfate, SDS 十二烷基硫酸钠sodium hexanesulfonate 己烷磺酸钠sodium taurocholate 牛璜胆酸钠sodium tetraphenylborate 四苯硼钠sodium thiosulphate 硫代硫酸钠solid-phase extraction 固相萃取solubility 溶解度solvent front 溶剂前沿solvophobic interaction 疏溶剂作用specific absorbance 吸收系数specification 规格specificity 专属性specific rotation 比旋度specific weight 比重spiked 加入标准的split injection 分流进样splitless injection 无分流进样spray reagent （平板色谱中的）显色剂spreader 铺板机stability 稳定性standard color solution 标准比色液standard deviation 标准差standardization 标定standard operating procedure(SOP) 标准操作规程standard substance 标准品stationary phase coating 固定相涂布starch indicator 淀粉指示剂statistical error 统计误差sterility test 无菌试验stirring bar 搅拌棒stock solution 储备液stoichiometric point 化学计量点storage 贮藏stray light 杂散光substituent 取代基substrate 底物sulfate 硫酸盐sulphated ash 硫酸盐灰分supercritical fluid chromatography(SFC) 超临界流体色谱法support 载体（担体）suspension 悬浊液swelling degree 膨胀度symmetry factor 对称因子syringe pump 注射泵systematic error 系统误差system model 系统模型system suitability 系统适用性tablet 片剂tailing factor 拖尾因子tailing peak 拖尾峰tailing-suppressing reagent 扫尾剂test of hypothesis 假设检验test solution(TS) 试液tetrazolium colorimetry 四氮唑比色法therapeutic drug monitoring(TDM) 治疗药物监测thermal analysis 热分析法thermal conductivity detector 热导检测器thermocouple detector 热电偶检测器thermogravimetric analysis(TGA) 热重分析法thermospray interface 热喷雾接口The United States Pharmacopoeia(USP) 美国药典The Pharmacopoeia of Japan(JP) 日本药局方thin layer chromatography(TLC) 薄层色谱法thiochrome reaction 硫色素反应three-dimensional chromatogram 三维色谱图thymol 百里酚（麝香草酚）（指示剂）thymolphthalein 百里酚酞（麝香草酚酞）（指示剂）thymolsulfonphthalein ( thymol blue) 百里酚蓝（麝香草酚蓝）（指示剂）titer, titre 滴定度time-resolved fluoroimmunoassay 时间分辨荧光免疫法titrant 滴定剂titration error 滴定误差titrimetric analysis 滴定分析法tolerance 容许限toluene distillation method 甲苯蒸馏法toluidine blue 甲苯胺蓝（指示剂）total ash 总灰分total quality control(TQC) 全面质量控制traditional drugs 传统药traditional Chinese medicine 中药transfer pipet 移液管turbidance 混浊turbidimetric assay 浊度测定法turbidimetry 比浊法turbidity 浊度ultracentrifugation 超速离心ultrasonic mixer 超生混合器ultraviolet irradiation 紫外线照射undue toxicity 异常毒性uniform design 均匀设计uniformity of dosage units 含量均匀度uniformity of volume 装量均匀性（装量差异）uniformity of weight 重量均匀性（片重差异）validity 可靠性variance 方差versus …对…，…与…的关系曲线viscosity 粘度volatile oil determination apparatus 挥发油测定器volatilization 挥发法volumetric analysis 容量分析volumetric solution(VS) 滴定液vortex mixer 涡旋混合器watch glass 表面皿wave length 波长wave number 波数weighing bottle 称量瓶weighing form 称量形式weights 砝码well-closed container 密闭容器xylene cyanol blue FF 二甲苯蓝FF（指示剂）xylenol orange 二甲酚橙（指示剂）zigzag scanning 锯齿扫描zone electrophoresis 区带电泳zwitterions 两性离子zymolysis 酶解作用。
中国药典附录Ⅰ(A-Z)中英文对照
（附录Ⅰ制剂通则）Appendix ⅠGeneral Requirements for Prearations（丸剂）ⅠA Pills丸剂系指药材细粉或药材提取物加适宜的黏合剂或其他辅料制成的珠形或类球形制剂，分为蜜丸、水蜜九、水丸、糊丸、蜡丸和浓缩丸等类型。
Pills are spherical or spherical-like solid dosage forms made of finely powdered crude drugs or crude drug extracts, proper binders or other excipients. They are classified into honeyed pills, water-honeyed pills, watered pills, pasted pills, concentrated pills waxed pills and concentrated pills etc.蜜丸系指药材细粉以蜂蜜为黏合剂制成的丸剂。
其中每丸重量在0.5g( 含0.5g)以上的称大蜜丸，每丸重量在0.5以下的称小蜜丸。
Honeyed pills are made of fine powder of crude drugs, using honey as binder. Among them, pills weighing more than 0.5g (including 0.5g) per pill are big honeyed pills, pills weighing less than 0.5g per pill are small honeyed pills.水蜜丸系指药材细粉以蜂蜜和水为黏合剂制成的丸剂。
Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders.水丸系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸剂。
EP 2034 药用物质中英文
04/2013:2034EP 7.5SUBSTANCES FOR PHARMACEUTICAL USE药用物质DEFINITION 定义Substances for pharmaceutical use are any organic or inorganic substances that are used as active substances or excipients for the production of medicinal products for human or veterinary use. They may be obtained from natural sources or produced by extraction from raw materials, fermentation or synthesis.药用物质是指人用或兽用医疗产品生产中所使用的活性物质或辅料，其可能是有机的或无机的物质。
这些物质可能是从自然途径获取，或从原料中萃取、发酵或合成得到。
This general monograph does not apply to herbal drugs, herbal drugs for homoeopathic preparations, herbal drug preparations, extracts, or mother tinctures for homoeopathic preparations, which are the subject of separate general monographs (Herbal drugs (1433), Herbal drugs for homoegopathic preparations (2045), Herbal drug preparations (1434), Extracts (0765), Mother tinctures for homoeopathic preparations (2029)). It does not apply to raw materials for homoeopathic preparations, except where there is an individual monograph for the substance in the non-homoeopathic part of the Pharmacopoeia.本通论不适用于草药制品、顺势疗法制剂用草药、草药制剂、提取物、或顺势闻法制剂的药酒母体，这些品种应参照各自的各论（草药制品（1433）、顺势疗法制剂用草药（2045）、草药制剂（1434）、提取物（0765）、或顺势闻法制剂的药酒母体（2029））。
药物分析常用英语词汇
药物分析专业英语词汇表Aabsorbance 吸收度absorbance ratio 吸收度比值absorption 吸收absorption curve 吸收曲线absorption coefficient 吸收系数accurate value 准确值Acid—dye colormcty 酸性染料比色法acidimcty 酸量法acidity 酸度activity 活度adjusted retention time 调整保留时间absorbent 吸收剂absorption吸附alkalinity 碱度alumina 氧化铝，矾土ambient temperature 室温ammonium thiocyanate 硫氰酸铵analytical quality control 分析质量控制anhydrous substance 干燥品antioxidant 抗氧剂application of sample 点样area normalization method 面积归一法arsenic砷arsenic sport 砷斑assay 含量测定assay tolerance 含量限度attenuation 衰减acid burette 酸式滴定管alkali burette 碱式滴定管a mortar 研钵Bback extraction 反萃取band absorption 谱带吸收batch 批batch number 批号Benttendorlf method 白田道夫法between day precision 日间密度精biotransformation 生物转化blank test 空白试验boiling range 沸程British Pharmacopeia 英国药典bromate titration 溴酸盐滴定法bromine method 溴量法bromothymol blue 溴麝香酚蓝bulk drug 原料药by-product 副产物breaker 烧杯burette glass bead nozzle 滴定管brown acid burette 棕色酸式滴定管Ccalibration curve 校正曲线calomel electrode 甘汞电极calorimetry 量热分析capacity factor 容量因子capillary gas chromatography 毛细管气相色谱法carrier gas 载气characteristics description 性状chelate compound 螯合物chemical equivalent 化学当量Chinese pharmacopeia 中国药典Chinese material medicine 中成药Chinese material midical preparation 中药制剂chiral 手性的chiral carbon atom 手性碳原子chromatogram 色谱图chromatography 色谱法chromatographic column 色谱柱chromatographic condition 色谱条件clarity 澄清度coefficient of distribution 分配系数coefficient of variation 变异系数color change interval 变色范围color reaction 显色反应colormetry 比色法column efficiency 柱效column temperature 柱温comparative test 比较试验completeness of solution 溶液的澄清度conjugate 缀合物concentration—time curve 浓度时间曲线confidence interval 置信区间confidence level 置信水平controlled trial 对照试验correlation coefficient 相关系数contrast test 对照试验congealing point 凝点content unifarmity装量差异controlled trial 对照试验correlation coefficient 相关系数contrast test 对照试验counter ion 反离子cresal red 甲酚红cuvette cell 比色池cyanide氰化物casserole small 勺皿Ddead—stop titration 永定滴定法dead time 死时间deflection 偏差deflection point 拐点degassing 脱气deionized water 去离子水deliquescence 潮解depressor substances test 降压物质检查法desiccant 干燥剂detection 检查developing reagent 展开剂developing chamber 展开室deviation 偏差dextrose 右旋糖diastereoisomer 非对映异构体diazotization 重氮化differential thermal analysis 差示热分析法differential scanning calorimetry 差示扫描热法Gutzeit 古蔡day to day precision 日间精密度dissolution 溶出度direct injection 直接进样2，6—dichlorindophenol titration 2,6—二氯靛酚滴定法digestion 消化diphastic titration 双向滴定disintegration test 崩解试验dispersion 分散度dissolubility 溶解度dissolution test 溶解度检查distilling range 滴程distribution chromatography 分配色谱dose 剂量drug quality control 药品质量控制drying to constant weight 干燥至恒重duplicate test 重复试验disk method water method 压片法Eeffective constituent 有效成分effective plate number 有效板数effective of column 柱效electrophoresis 电泳elimination 消除eluate 洗脱液elution 洗脱enamtiomer 对映体end absorption 末端吸收endogenous substances 内源性物质enzyme drug 酶类药物enzyme induction 酶诱导enzyme inhibition 酶抑制epimer 差向异构体equilibrium constant 平衡常数error in volumetric analysis 容量分析误差exclusion chromatography 排阻色谱法expiration date 失效期external standard method 外标法extract 提取物extration gravimetry 提取重量法extraction titration 提取容量法extrapolated method外插法Erlenmeyer flask 锥形瓶evaporating dish small 蒸发皿elongated bulb 胖肚electronic balance MettlerAL204 MettlerAL204电子天平Ffactor 系数fehling’s reaction 斐林实验filter 过滤fineness of the particles 颗粒细度flow rate 流速fluorescent agent 荧光剂fluorescence spectrophotometry 荧光分光光度法fluorescence detection 荧光检测器fluorescence analysis 荧光分析法foreign pigment 有色杂质formulary 处方集free 游离freezing test 冻结试验fused silica 熔融石英filter paper 滤纸Ggas chromatography 气相色谱法gas—liquid chromatography 气液色谱法gas purifier 气体净化器General identification test 一般鉴别试验general notices 凡例General requirements (药典）通则good clinical practices 药品临床管理规范good laboratory practices 药品实验室管理规范good manufacturing practices(GMP) 药品生产质量管理规范good supply practices(GSP) 药品供应管理规范gradient elution 梯度洗脱grating 光栅gravimetric method 重量法Gutzeit test 古蔡(检砷)法glass funnel long stem 玻璃漏斗grad cylinder 量筒glass rod 玻棒graduated pipettes 刻度吸管GC 气相色谱Hheavy metal 重金属half peak width 平峰宽heat conductivity 热导率height equivalent to a theoretical plate 理论塔板高度height of an effective plate 有效塔板高度high—performance liquid chromatography (HPLC)高效液相色谱法high—performance thin—layer chromatography (HPTLC）高效薄层色谱法hydrate 水合物hydrolysis 水解hydrophilicity 亲水性hydrophobicity 疏水性hydroxyl value 羟值hyperchromic effect 浓色效应hypochromic effect 淡色效应HHS—type constant temperature water bath HHS型恒温水锅HPLC 高效液相色谱法Iidentification 鉴别ignition to constant weight 灼烧至恒重immobile phase 固定相immunoassay 免疫测定impurity 杂质inactivation 失活index 索引indicator electrode 指示电极indicator 指示剂inhibitor 抑制剂injecting septum 进样隔膜胶垫instrumental analysis 仪器分析injection value 进样阀insulin assay 胰岛素生物检测法integrator 积分仪intercept 截距interface 接口internal standard substance 内标物质International unit 国际单位in vitro 体外in vivo 体内iodide 碘化物iodoform reation 碘仿反应iodometry 碘量法ion pair chromatography 离子对色谱ion suppression 离子抑制ion suppression 离子抑制ionic strength 离子强度ion-pairing agent 离子对试剂ionization 电离isoabsorptive point 等吸收点isocratic elution 等溶剂组成洗脱isoelectric point 等电点isoosmotic solution 等渗溶液irreversible indicator 不可逆指示剂irreversible potential 不可逆电位KKarl Fischer titration 卡尔-费舍尔滴定Kjeldahl method for nitrogen 凯氏定氮法Kober reagent 科伯试剂Kovats retention index 科瓦茨保留指数Llabelled amount 标示量leading peak 前延峰leveling effect 均化效应licensed pharmacist 执业药师limit control 限量控制limit of detection 检测限limit of quantitation 定量限limit test 杂质限度试验loss on drying 干燥失重low pressure gradient pump 氧压梯度泵linearity and range 线性及范围linearity scanning 线性扫描luminescence 发光litmus paper 石蕊试纸lyophilization 冷冻干燥Mmain constituent 主成分make—up gas 尾吹气maltol reaction 麦芽酚试验Marquis test 马奎斯试验mass analyzer detector 质量分析检测器mass spectrometric analysis 质谱分析mass spectrum 质谱图mean deviation 平均偏差melting point 熔点melting range 熔距metabolite 代谢物metastable ion 亚稳离子micellar chromatography 胶束色谱法microanalysis 微量分析microcrystal 微晶microdialysis 微透析migration time 迁移时间Millipore filtration 微孔过滤mobile phase 流动相molecular formula 分子式monitor 检测monochromator 单色器monographs 正文Nnatural product 天然产物Nessler’s reagent 碱性碘化汞试液neutralization 中和nitrogen content 总氮量nonaqueous acid-base titration 非水酸碱滴定nonprescription drug ，over the counter drugs 非处方药nonspecific impurity 一般杂质non-volatile matter 不挥发物normal phase 正相normalization 归一化法Nessler color comparison tube 纳氏比色管Onotice 凡例octadecyl silane bonded silicagel 十八烷基硅烷键合硅胶odorless 辛基硅烷odorless 无臭official name 法定名official test 法定试验on—column detector 柱上检测器on—column injection 柱头进样on the dried basis 按干燥品计opalescence 乳浊optical activity 光学活性optical isomerism 旋光异构optical purity 光学纯度organic volatile impurities 有机挥发性杂质orthogonal test 正交试验orthophenanthroline 邻二氮菲outlier 可疑数据overtones 倍频封oxidation—reduction titration 氧化还原滴定oxygen flask combustion 氧瓶燃烧Ppacked column 填充柱packing material 色谱柱填料palladium ion colorimetry 钯离子比色法parent ion 母离子particulate matter 不溶性微粒partition coefficient 分配系数pattern recognition（ppm)百万分之几peak symmetry 峰不对称性peak valley 峰谷peak width at half height 半峰宽percent transmittance 透光百分率pH indicator absorbance ratio method pH指示剂吸光度比值法pharmaceutical analysis 药物分析pharmacopeia 药典pharmacy 药学photometer 光度计polarimetry 旋光测定法polarity 极性polydextran gel 葡聚糖凝胶potentiometer 电位计potentiometric titration 电位滴定法precipitation form 沉淀形式precision 精密度preparation 制剂prescription drug 处方药pretreatment 预处理primary standard 基准物质principal component analysis 主成分分析prototype drug 原型药物purification 纯化purity 纯度pyrogen 热原pycnometer method 比重瓶法plastic wash bottle 洗瓶platform balance 天平pipette 移液管pyknowmeter flasks 容量瓶Qquality control 质量控制quality evaluation 质量评价quality standard 质量标准quantitative determination 定量测定quantitative analysis 定量分析quasi-molecular ion 准分子离子Rracemization 消旋化random sampling 随机抽样rational use of drug 合理用药readily carbonizable substance 易炭化物质reagent sprayer 试剂喷雾剂recovery 回收率reference electrode 参比电极related substance 相关物质relative density 相对密度relative intensity 相对强度repeatability 重复性replicate determination 平行测定reproducibility 重现性residual basic hydrolysis method 剩余碱水解法residual liquid junction potential 残余液接电位residual titration 剩余滴定residuce on ignition 炽灼残渣resolution 分辨率response time 响应时间retention 保留reversed phase chromatography 反相色谱法reverse osmosis 反渗透rinse 淋洗robustness 可靠性round 修约reagent bottles 试剂瓶round bottom flask 圆底烧瓶rubber suction bulb 洗耳球Ssafety 安全性Sakaguchi test 坂口试验salt bridge 盐桥salting out 盐析sample applicator 点样器sample application 点样sampling 取样saponification value 皂化值saturated calomel electrode 饱和甘汞电极selectivity 选择性significant difference 显著性水平significant testing 显著性检验silica get 硅胶silver chloride electrode 氯化银电极similarity 相似性sodium dodecylsulfate 十二基酸钠solid-phase extraction 固相萃取solubility 溶解度specific absorbance 吸收系数specification 规格specificity 专属性specific rotation 比旋度specific weight 比重spiked 加入标准的split injection 分流进样spray reagent 显色剂stability 稳定性standard color solution 标准比色液standard deviation 标准差standardization 标定standard substance 标准品statistical error 统计误差sterility test 无菌试验stock solution 储备液stoichiometric point 化学计量点storage 贮藏stray light 杂散光substrate 底物substituent 取代基sulfate 硫酸盐sulphated ash 硫酸盐灰分support 载体suspension 旋浊度swelling degree 膨胀度symmetry factor 对称因子systematic error 系统误差separating funnel 分液漏斗stopcock 玻璃活塞scissors 剪刀spirit lamp 酒精灯silica gel G thin layer 硅胶G薄层板Ttable 片剂tailing factor 拖尾因子tailing peak 拖尾峰test solution 试液thermal analysis 热分析法thermal conductivity detector 热导检测器thermogravimetric analysis 热重分析法The United States Pharmacopoeia 美国药典The Pharmacopoeia of Japan 日本药局方thin layer chromatography 薄层色谱thiochrome reaction 硫色素反应thymol 百里酚thymolphthalein 百里酚酞titer 滴定度three—dimensional chromatogram 三维色谱图titrant 滴定剂titration error 滴定误差titrimetric analysis 滴定分析法tolerance 容许限total ash 总灰分total quality control 全面质量控制traditional drugs 传统药traditional Chinese medicine 中药turbidance 浑浊turbidimetric assay 浊度测定法turbidimetry 比浊度turbidity 浊度Uultracentrifugation 超速离心ultraviolet irradiation 紫外线照射undue toxicity 异常毒性uniform design 均匀设计uniformity of dosage units 含量均匀度uniformity of volume 装量均匀性uniformity of weight 重量均匀性Vvalidity 可靠性variance 方差viscosity 粘度volatile oil determination apparatus 挥发油测定器volatilization 挥发性volumetric analysis 容量分析volumetric solution 滴定液volumetric flasks 比重瓶Wwave length 波长wave number 波数weighing bottle 称量瓶weighing form 称量形式well—closed container 密闭容器white board 白瓷板Xxylene cyanol blue FF 二甲苯蓝FF xylenol orange 二甲酚橙ZZigzag scanning 锯齿扫描zwitterions 两性离子Zymolysis 酶解作用zone electrophoresis 区带电泳。
国际药物注册英语词汇
国际药物注册英语词汇互译FDA（food and drug administration）：（美国）食品药品监督管理局NDA（new drug application）：新药申请ANDA（abbreviated new drug application）：简化新药申请EP（export application）：出口药申请（申请出口不被批准在美国销售的药品）tr eatment IND：研究中的新药用于治疗abbreviated（new）drug：简化申请的新药DMF（drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）holder：DMF持有者CFR（c ode of federal regulation）：（美国）联邦法规PANEL：专家小组bat ch production：批量生产；分批生产bat ch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U.S.public health service：美国卫生福利部NIH（national institute of health）：（美国）全国卫生研究所animal trail：动物试验accelerated approval：加速批准standar d drug：标准药物investigator：研究人员；调研人员preparing and submitting：起草和申报submission：申报；递交benefit(s)：受益risk（s）：受害drug pr oduct：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称narrative summary:记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典（主要指USP、NF）．USP（the united state pharmacopeia）：美国药典（现已和NF合并一起出版）NF（national formulary）：（美国）国家药品集official＝pharmacopeial=compendial：药典的；法定的；官方的agency：审理部门（指FDA）sponsor：主办者（指负责并着手临床研究者）identity：真伪；鉴别；特性strength：规格；规格含量（每一剂量单位所含有效成分的量）labeled amount：标示量regulatory specification：质量管理规格标准（NDA提供）regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品ICH（International Conference on Harmonization of T echnical R equirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2):Stability T esting of New Drug Substances and Products(SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B:Photostability T esting of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C:Stability T esting for New Dosage Forms新制剂的稳定性试验Q1D:Bracketing and Matrixing Designs for Stability T esting of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E:Evaluation of Stability Data对稳定性数据的评估处理Q1F:Stability Data P ackage for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A:T ext on V alidation of Analytical Procedures分析程序的验证Q2B:V alidation of Analytical Procedures:Methodology分析程序的验证：方法学Q3A(R):Impurities in New Drug Substances(Revised Guideline)新原料药中的杂质（修订版）Q3B(R):Impurities in New Drug Products(Revised Guideline)新制剂中的杂质（修订版）Q3C:Impurities:Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M):Impurities:Guideline for Residual Solvents(Maintenance)杂质：残留溶剂指南（修改内容）Q4:Pharmacopoeias药典Q4A:Pharmacopoeial Harmonisation药典的协调Q4B:Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A:Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B:Quality of Biotechnological Products:Analysis of the ExpressionConstruct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C:Quality of Biotechnological Products:Stability T esting ofBiotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D:Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E:Comparability of Biotechnological/Biological Products Subject t oChanges in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6:Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A:Specifications:T est Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products:Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B:Specifications:T est Procedures and Acceptance Criteria forBiotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7:Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A:Good Manufacturing Practice Guide for Active PharmaceuticalIngredients活性药物成份的GMP指南Q8:Pharmaceutical Development药物研发Q9:Quality Risk Ma n a g emen t质量风险管理ICH：Safety-安全S1A:Guideline on the N eed for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B:T esting for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C:Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R):Addendum:Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A:Guidance on Specific Aspects of Regulatory Genotoxicity T ests forPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B:Genotoxicity:A S tandard Battery for Genotoxicity T esting forPharmaceuticals基因毒性：药物基因毒性检验的标准S3A:No t e for Guidance on T oxicokinetics:The Assessment of SystemicExposure in T oxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B:Pharmacokinetics:Guidance for R epeated Dose Tissue DistributionStudies药物代谢动力学：重复剂量的组织分布研究指南S4:Single Dose T oxicity T ests单剂量毒性检验S4A:Duration of Chronic T oxicity T esting in Animals(Rodent andNon-R odent T oxicity T esting)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A:Detection of T oxicity to R eproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M):Maintenance of the ICH Guideline on T oxicity to Male Fertility:An Addendu m to the Guideline on Detection of T oxicity to Reproduction forMedicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6:Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A:Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B:The Nonclinical Evaluation of the Potential for Delayed V entricularRepolarization(QT Interval Prolongation)By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8:Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M):Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical T rials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1:The Extent of P opulation Exposure t o Assess Clinical Safety for DrugsIntended for Long-T erm T reatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A:Clinical Safety Data Management:Definitions and S tandards forExpedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R):Revision of the E2B(M)ICH Guideline on Clinical Safety DataMan ag e me n t Data Elements for T ransmission of Individual Case SafetyR eports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B(M):Maintenance of the Clinical Safety Data Ma n a ge me n t including:Data Elements for T ransmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M):Maintenance of the Clinical Safety Data Ma n a g emen t includingQuestions and Answers临床安全数据管理的变动，包括问答E2C:Clinical Safety Data Management:Periodic Safety Update Reports for Marketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Adden du m to E2C:Periodic Safety Update R eports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D:Post-Approval Safety Data Management:Definitions and S tandards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E:Pharmacovigilance Planning药物警戒计划E3:Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4:Dose-R esponse Information t o Support Drug Registration支持药品注册的剂量－效应资料E5:Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6:Good Clinical Practice:Consolidated GuidelineGCP：良好的临床规范：统一的指南E7:Studies in Support of Special Populations:Geriatrics对特定族群的支持的研究：老人病学E8:General Considerations for Clinical T rials对临床试验的总的考虑E9:Statistical Principles for Clinical T rials临床试验的统计原则E10:Choice of Control Group and Related Issues in Clinical T rials临床试验中控制组和有关课题的选择E11:Clinical Investigation of Medicinal Products in the PediatricP opulation小儿科药物的临床调查E12A:Principles for Clinical Evaluation of New Antihypertensive Drugs 新抗高血压药物的临床评价原则E14:The Clinical Evaluation of QT/QT c Interval Prolongation andProarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QT c间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines多学科兼容的指南M1:Medical T erminology医学术语M2:Electronic S tandards for T ransmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3:Timing of Pre-clinical Studies in Relation t o Clinical T rials(SeeSafety T opics)有关临床试验的临床前研究的时间安排M4:The C o mm o n T echnical Document(See CTD section for complete Status ofthe guidelines)通用技术文件（见有关CTD章节）M5:Data Elements and S tandards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to-progression疾病进展时间SAE：severity Adverse Event严重不良事件AE：Adverse Event不良事件SOP：S tandard Operating Procedure标准操作规程CRF：Case R eport form病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS：Karnofsky P erformance Status行为状态评分CR：complete r esponse完全缓解PR：partial r esponse部分缓解SD：病情稳定PD：progressive disease病情进展CTC：常用药物毒性标准IEC：independent ethics committee独立伦理委员会IRB：institutional review bo a r d伦理委员会CRA：临床研究助理CRO：Contract Research Organization合同研究组织DFS：Disease Free Survival无病生存期OS：（Overall Survival）总生存时间IC：Informed consent知情同意ADR：Adverse Drug Reaction不良反应GAP：Good Agricultural Practice中药材种植管理规范GCP：Good Clinical Practice药物临床试验质量管理规范GLP：Good Laboratory Practice药品实验室管理规范GMP：Good Manufacturing Practice药品生产质量管理规范GSP：Good Supply Practice药品经营质量管理规范GUP：Good Use Practice药品使用质量管理规范PI：Principal investigator主要研究者CI：Co-inveatigator合作研究者SI：Sub-investigator助理研究者COI：Coordinating investigtor协调研究者DGMP：医疗器械生产质量管理规范ICF：Informed consent form知情同意书RCT：randomized controlled trial,随机对照试验NRCCT：non-randomized concurrent controlled trial,非随机同期对照试验EBM：evidence-based medicine循证医学RCD：randomized cross-over disgn随机交叉对照试验HCT：historial control trial,历史对照研究RECIST：R esponse Evaluation Criteria In Solid T umors.实体瘤疗效反应的评价标准QC：Quality Control质量控制UADR：Unexpected Adverse Drug Reaction，非预期药物不良反应11/11。
欧洲药典7.0-凡例(全)
07/2010:10000 1. 凡例1.1. 概述凡例的内容适用于各论和欧洲药典中的其它章节。
欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。
在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写Ph. Eur.也指欧洲药典。
文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
文章参考药典中各论内容时，以斜体的各论题目或相关数字表示。
制剂在有效期内必须性质稳定，明确的有效期或说明书应由权力机构批准。
任何各论的物质也必须服从其使用期限。
任何药品的有效期和有效期的计算由权力机构经稳定性研究的试验结果决定。
除凡例和各论中另有说明，各论中的说明为强制要求；除了特定的引用信息，如果各论引用总论中内容时，该总论要求为法定要求。
各论中描述的活性物质，赋形剂，药物制剂和其它项目都是人用和兽用的（除非明确限制不可使用）。
药品项目必须符合各论的要求，否则不符合药典质量。
但并不要求产品放行前，生产商要做各论中的每项试验以满足药典要求。
生产商可通过原始数据，例如生产过程验证，和中间体控制，确保药品是否符合药典要求。
公布的环境参数，权力机构可适当采信，但不排除故意满足药典要求的可能。
检测和试验方法应基于药典标准的官方方法。
经权利机构允许可采用其它替代的分析方法以达到控制目的，并证明该方法是否能达到各论各标准。
若出现争论或异议，应以药典方法为准。
药典各论中的某些物质有多个等级可满足各种需要，除各论中另有说明，要求适用于各等级。
在一些各论中，特别是赋形剂，一系列相关的功能特性都有介绍，其中给出了一些特性的检测方法。
质量体系：在适宜的质量体系架构下，产生有疑问的项目时，应以各论中的质量标准为法定标准。
通则：各论中介绍的药物和制剂也应符合通则中的相关要求。
交叉引用的通则在各论中不特别指出。
除非限定了适用条件，如规定适用于药典各论中的物质，通则的内容适用于各论定义范围内的所有药物和制剂。
英国药典AppendixXVIC翻译
英国药典AppendixXVIC翻译第一部分Appendix XVI C. Efficacy of Antimicrobial Preservation (Ph. Eur. general text 5.1.3)如果药物制剂本身没有足够的抗菌活性，那么就应该加抗菌防腐剂。
在药品正常的储存和使用过程中，液体制剂特别是多剂量液体制剂，尤其需要添加防腐剂。
这样不仅可以阻止细菌繁殖、限制微生物污染；还可以防止细菌污染给患者身体带来的危害和对药品本身的污染。
抗菌防腐剂在GMP中不能被替代。
抗菌防腐剂的效果根据药物制剂的组成成分的不同、防腐剂加入的形式的不同、或使用容器或封口的不同而增强或减弱。
在最终的包装容器内的制剂，我们需要验证它在整个有效期内的抗菌活性。
这样才能保证在贮存过程中抗菌活性不会减弱。
样品从最终容器中取出时就需要立即进行验证了。
在药物制剂发展期间（注：研发Research & Development，D 就是发展期间，将活性分子变成处方制剂的过程），应该需要证明药物制剂本身的抗菌活性。
如果没有就需要添加合适的防腐剂、或防腐剂能够保护制剂免于遭受微生物污染的不良效果和在贮存和使用过程中细菌的繁殖。
抗菌活性应该通过以下一系列测试来证实。
这些测试并不用于常规的对照目的。
测试抗菌防腐剂的有效性测试包括三方面内容：一、不论最后的包装容器是什么，都需要用规定的接种物，也就是合适的微生物对制剂进行攻击。
二、在规定的温度下贮存已接种制剂。
三、在一段时间间隔内抑制容器内的样本生长，然后计数这样被除去的样本中的菌数。
在测试条件下，如果在规定时间和温度下，接种后制剂中的菌落数有重大的下降或没有增加，那么药物制剂中防腐剂的作用就是可以接受的。
接受标准（即在规定时间内减少微生物的数量）随着制剂类型的不同而不同。
因为制剂类型的不同所达到的保护的程度也不同。
（见表5.1.3-1/2/3）。
微生物检测（见附录二）绿脓假单胞杆菌A TCC 9027; NCIMB 8626; CIP 82.118.金黄色酿脓葡萄球菌ATCC 6538; NCTC 10788; NCIMB 9518; CIP 4.83.白色念珠菌A TCC 10231; NCPF 3179; IP 48.72.黑曲霉A TCC 16404; IMI 149007; IP 1431.83.使用单菌株攻击而且设计微生物可以在合适的地方补充其他菌株或品种，这样就能代表可能的制剂污染。
药品检验英语词汇对照
phase solubility analysis
content uniformity
minimum fill
assay
uniformity of dosage units
dissolution
disintegration
drug release
relative density
multi-wavelength linear regression method
K-ratio method, signal multiplier method
least square method
adaptive least square
partial least square method
nonlinear iterative partial least square
analytical quality control
characteristics
odorless
foreign odor
melting point
melting range
capillary melting point determi-nation
hot stage melting point determi-nation
variate calibration
multivariate calibration
back propagation
optimization method
window diagram technique
chromatographic response function, CRF
chromtographic optimization
Q4B附录4A、B、C(R1)
Q4B附录4A、 在第二阶段获指导委员会批准，并公开征 B、C 求意见
Q4B附录4A、 在第四阶段获指导委员会批准，并推荐给 B、C ICH三方管理机构采纳
现行第四阶段版本
Q4B附录4A、 获指导委员会批准后，在4.5项中加入加拿 B、C （R1） 大卫生部可互换使用的声明 2010年9月27日
实施需考虑的事项
• MHLW的考虑 根据本附录的相关规定，附录2.1节所提及的药典文本可互换使用。
当本附录实施时，MHLW将在通告中提供具体实施细则。
• 加拿大卫生部的考虑 在加拿大，本附录2.1项引用的和依据本附录规定使用的任何药典文 本都认为可互换使用
Ch.P附录Ⅺ J微生物限度检查法 概述
• 一般考虑
当申办者或生产商将其现有方法修订为已实施的经Q4B评价的药典文本的方法时
，任何变更的告知，变动和（或）已批准的方法均应与当地已建立的简要变更管 理程序相一致。 • FDA的考虑 基于上述推荐，并结合附录的相关规定，附录2.1节所提及的药典文本可互换使用 。但是，FDA可能会要求企业不论采取何种方法，均应证明其所选方法对于特定 的原料或制剂是可接受和适用的。 • EU的考虑 对于欧盟，欧洲药典各论具有强制性。基于上述可互换使用的声明，按照本附录 的相关规定，在满足欧洲药典相关要求的情况下，管理机构可以接受在上市许可 申请、再注册申请或变更申请时引用附录2.1节所述其他药典方法。
创造生命的奇迹
ICHQ4B 附录4A、附录4B、附录4C
目录
• 文件历史 • 分析方法 • 实施需考虑的事项 • ChP微生物限度检查法概述
• 检验量和供试液的制备
• 计数培养基的适用性检查 • 微生物计数法 • 控制菌检查 • 非无菌制剂微生物可接受标准
药物分析报告常用英语词汇
药物分析专业英语词汇表Aabsorbance 吸收度 absorbance ratio 吸收度比值absorption 吸收 absorption curve 吸收曲线absorption coefficient 吸收系数 accurate value 准确值Acid—dye colormcty 酸性染料比色法 acidimcty 酸量法acidity 酸度 activity 活度adjusted retention time 调整保留时间 absorbent 吸收剂absorption吸附 alkalinity 碱度alumina 氧化铝，矾土 ambient temperature 室温ammonium thiocyanate 硫氰酸铵 analytical quality control 分析质量控制 anhydrous substance 干燥品antioxidant 抗氧剂 application of sample 点样area normalization method 面积归一法 arsenic 砷arsenic sport 砷斑 assay 含量测定assay tolerance 含量限度 attenuation 衰减acid burette 酸式滴定管 alkali burette 碱式滴定管a mortar 研钵Bback extraction 反萃取 band absorption 谱带吸收batch 批 batch number 批号Benttendorlf method 白田道夫法 between day precision 日间密度精biotransformation 生物转化 blank test 空白试验boiling range 沸程 British Pharmacopeia 英国药典bromate titration 溴酸盐滴定法 bromine method 溴量法bromothymol blue 溴麝香酚蓝bulk drug 原料药by—product 副产物breaker 烧杯burette glass bead nozzle 滴定管 brown acid burette 棕色酸式滴定管Ccalibration curve 校正曲线 calomel electrode 甘汞电极calorimetry 量热分析 capacity factor 容量因子capillary gas chromatography 毛细管气相色谱法carrier gas 载气characteristics description 性状chelate compound 螯合物 chemical equivalent 化学当量Chinese pharmacopeia 中国药典 Chinese material medicine 中成药Chinese material midical preparation 中药制剂 chiral 手性的chiral carbon atom 手性碳原子 chromatogram 色谱图chromatography 色谱法 chromatographic column 色谱柱chromatographic condition 色谱条件 clarity 澄清度coefficient of distribution 分配系数 coefficient of variation 变异系数color change interval 变色范围 color reaction 显色反应colormetry 比色法 column efficiency 柱效column temperature 柱温 comparative test 比较试验completeness of solution 溶液的澄清度 conjugate 缀合物concentration—time curve 浓度时间曲线 confidence interval 置信区间confidence level 置信水平 controlled trial 对照试验correlation coefficient 相关系数 contrast test 对照试验congealing point 凝点 content unifarmity装量差异controlled trial 对照试验 correlation coefficient 相关系数contrast test 对照试验 counter ion 反离子cresal red 甲酚红 cuvette cell 比色池cyanide氰化物 casserole small 勺皿Ddead—stop titration 永定滴定法 dead time 死时间deflection 偏差 deflection point 拐点degassing 脱气 deionized water 去离子水deliquescence 潮解 depressor substances test 降压物质检查法 desiccant 干燥剂detection 检查 developing reagent 展开剂developing chamber 展开室 deviation 偏差dextrose 右旋糖 diastereoisomer 非对映异构体diazotization 重氮化 differential thermal analysis 差示热分析法 differential scanning calorimetry 差示扫描热法Gutzeit 古蔡 day to day precision 日间精密度dissolution 溶出度direct injection 直接进样 2,6-dichlorindophenol titration 2,6-二氯靛酚滴定法 digestion 消化diphastic titration 双向滴定 disintegration test 崩解试验dispersion 分散度 dissolubility 溶解度dissolution test 溶解度检查 distilling range 滴程distribution chromatography 分配色谱 dose 剂量drug quality control 药品质量控制 drying to constant weight 干燥至恒重duplicate test 重复试验disk method water method 压片法Eeffective constituent 有效成分 effective plate number 有效板数 effective of column 柱效electrophoresis 电泳 elimination消除eluate 洗脱液 elution 洗脱enamtiomer 对映体 end absorption 末端吸收endogenous substances 内源性物质 enzyme drug 酶类药物enzyme induction 酶诱导 enzyme inhibition 酶抑制epimer 差向异构体 equilibrium constant 平衡常数error in volumetric analysis 容量分析误差exclusion chromatography 排阻色谱法 expiration date 失效期external standard method 外标法 extract 提取物extration gravimetry 提取重量法 extraction titration 提取容量法 extrapolated method外插法Erlenmeyer flask 锥形瓶 evaporating dish small 蒸发皿elongated bulb 胖肚 electronic balance MettlerAL204 MettlerAL204电子天平Ffactor 系数 fehling’s reaction 斐林实验filter 过滤 fineness of the particles 颗粒细度flow rate 流速fluorescent agent 荧光剂 fluorescence spectrophotometry 荧光分光光度法fluorescence detection 荧光检测器fluorescence analysis 荧光分析法foreign pigment 有色杂质formulary 处方集 free 游离freezing test 冻结试验 fused silica 熔融石英filter paper 滤纸Ggas chromatography 气相色谱法 gas-liquid chromatography 气液色谱法 gas purifier 气体净化器General identification test 一般鉴别试验 general notices凡例General requirements (药典) 通则 good clinical practices 药品临床管理规范 good laboratory practices 药品实验室管理规范 good manufacturing practices(GMP) 药品生产质量管理规范good supply practices(GSP) 药品供应管理规范 gradient elution 梯度洗脱grating 光栅 gravimetric method 重量法Gutzeit test 古蔡(检砷)法 glass funnel long stem 玻璃漏斗grad cylinder 量筒 glass rod 玻棒graduated pipettes 刻度吸管 GC 气相色谱Hheavy metal 重金属 half peak width 平峰宽heat conductivity 热导率height equivalent to atheoretical plate 理论塔板高度 height of an effective plate有效塔板高度high-performance liquid chromatography (HPLC)高效液相色谱法high-performance thin-layer chromatography (HPTLC)高效薄层色谱法hydrate 水合物 hydrolysis 水解hydrophilicity 亲水性 hydrophobicity 疏水性hydroxyl value 羟值 hyperchromic effect 浓色效应hypochromic effect 淡色效应 HHS-type constant temperature waterbath HHS型恒温水锅 HPLC 高效液相色谱法Iidentification 鉴别 ignition to constant weight 灼烧至恒重 immobile phase 固定相immunoassay 免疫测定 impurity 杂质inactivation 失活 index 索引indicator electrode 指示电极 indicator 指示剂inhibitor 抑制剂 injecting septum 进样隔膜胶垫instrumental analysis 仪器分析 injection value 进样阀insulin assay 胰岛素生物检测法 integrator 积分仪intercept 截距 interface 接口internal standard substance 内标物质 International unit 国际单位in vitro 体外 in vivo 体内iodide 碘化物 iodoform reation 碘仿反应iodometry 碘量法ion pair chromatography 离子对色谱 ion suppression 离子抑制ion suppression 离子抑制 ionic strength 离子强度ion-pairing agent 离子对试剂 ionization 电离isoabsorptive point 等吸收点 isocratic elution 等溶剂组成洗脱 isoelectric point 等电点isoosmotic solution 等渗溶液irreversible indicator 不可逆指示剂irreversible potential 不可逆电位KKarl Fischer titration 卡尔-费舍尔滴定Kjeldahl method for nitrogen 凯氏定氮法 Kober reagent 科伯试剂Kovats retention index 科瓦茨保留指数Llabelled amount 标示量 leading peak 前延峰leveling effect 均化效应 licensed pharmacist 执业药师 limit control 限量控制limit of detection 检测限 limit of quantitation 定量限 limit test 杂质限度试验loss on drying 干燥失重 low pressure gradient pump 氧压梯度泵 linearity and range 线性及范围linearity scanning 线性扫描 luminescence 发光litmus paper 石蕊试纸 lyophilization 冷冻干燥Mmain constituent 主成分 make-up gas 尾吹气maltol reaction 麦芽酚试验 Marquis test 马奎斯试验mass analyzer detector 质量分析检测器 mass spectrometric analysis 质谱分析 mass spectrum 质谱图mean deviation 平均偏差 melting point 熔点melting range 熔距 metabolite 代谢物metastable ion 亚稳离子 micellar chromatography 胶束色谱法 microanalysis 微量分析microcrystal 微晶 microdialysis 微透析migration time 迁移时间 Millipore filtration 微孔过滤 mobile phase 流动相molecular formula 分子式 monitor 检测monochromator 单色器 monographs 正文Nnatural product 天然产物 Nessler’s reagent 碱性碘化汞试液 neutralization 中和nitrogen content 总氮量nonaqueous acid-base titration 非水酸碱滴定 nonprescription drug ,over the counter drugs 非处方药 nonspecific impurity 一般杂质non-volatile matter 不挥发物 normal phase 正相normalization 归一化法 Nessler color comparison tube 纳氏比色管Onotice 凡例 octadecyl silane bonded silicagel 十八烷基硅烷键合硅胶 odorless 辛基硅烷odorless 无臭 official name 法定名official test 法定试验 on-column detector 柱上检测器on-column injection 柱头进样 on the dried basis 按干燥品计opalescence 乳浊 optical activity 光学活性optical isomerism 旋光异构 optical purity 光学纯度organic volatile impurities 有机挥发性杂质 orthogonal test 正交试验orthophenanthroline 邻二氮菲 outlier 可疑数据overtones 倍频封 oxidation-reduction titration 氧化还原滴定oxygen flask combustion 氧瓶燃烧Ppacked column 填充柱 packing material 色谱柱填料palladium ion colorimetry 钯离子比色法 parent ion 母离子particulate matter 不溶性微粒 partition coefficient 分配系数pattern recognition(ppm)百万分之几 peak symmetry 峰不对称性peak valley 峰谷 peak width at half height 半峰宽percent transmittance 透光百分率pH indicator absorbance ratio method pH指示剂吸光度比值法pharmaceutical analysis 药物分析 pharmacopeia 药典pharmacy 药学 photometer 光度计polarimetry 旋光测定法 polarity 极性polydextran gel 葡聚糖凝胶 potentiometer 电位计potentiometric titration 电位滴定法 precipitation form 沉淀形式precision 精密度 preparation 制剂prescription drug 处方药 pretreatment 预处理primary standard 基准物质 principal component analysis 主成分分析prototype drug 原型药物 purification 纯化purity 纯度 pyrogen 热原pycnometer method 比重瓶法 plastic wash bottle 洗瓶platform balance 天平 pipette 移液管pyknowmeter flasks 容量瓶Qquality control 质量控制 quality evaluation 质量评价quality standard 质量标准 quantitative determination 定量测定quantitative analysis 定量分析 quasi-molecular ion 准分子离子Rracemization 消旋化 random sampling 随机抽样rational use of drug 合理用药 readily carbonizable substance 易炭化物质 reagent sprayer 试剂喷雾剂recovery 回收率 reference electrode 参比电极related substance 相关物质 relative density 相对密度relative intensity 相对强度 repeatability 重复性replicate determination 平行测定 reproducibility 重现性residual basic hydrolysis method 剩余碱水解法residual liquid junction potential 残余液接电位residual titration 剩余滴定 residuce on ignition 炽灼残渣resolution 分辨率 response time 响应时间retention 保留 reversed phase chromatography 反相色谱法reverse osmosis 反渗透 rinse 淋洗robustness 可靠性 round 修约reagent bottles 试剂瓶 round bottom flask 圆底烧瓶rubber suction bulb 洗耳球Ssafety 安全性 Sakaguchi test 坂口试验salt bridge 盐桥 salting out 盐析sample applicator 点样器 sample application 点样sampling 取样 saponification value 皂化值saturated calomel electrode 饱和甘汞电极 selectivity 选择性significant difference 显著性水平 significant testing 显著性检验silica get 硅胶 silver chloride electrode 氯化银电极similarity 相似性 sodium dodecylsulfate 十二基酸钠solid-phase extraction 固相萃取 solubility 溶解度specific absorbance 吸收系数 specification 规格specificity 专属性 specific rotation 比旋度specific weight 比重 spiked 加入标准的split injection 分流进样 spray reagent 显色剂stability 稳定性 standard color solution 标准比色液standard deviation 标准差 standardization 标定standard substance 标准品 statistical error 统计误差sterility test 无菌试验 stock solution 储备液stoichiometric point 化学计量点 storage 贮藏stray light 杂散光 substrate 底物substituent 取代基 sulfate 硫酸盐sulphated ash 硫酸盐灰分 support 载体suspension 旋浊度 swelling degree 膨胀度symmetry factor 对称因子 systematic error 系统误差separating funnel 分液漏斗 stopcock 玻璃活塞scissors 剪刀 spirit lamp 酒精灯silica gel G thin layer 硅胶G薄层板Ttable 片剂 tailing factor 拖尾因子tailing peak 拖尾峰 test solution 试液thermal analysis 热分析法 thermal conductivity detector 热导检测器thermogravimetric analysis 热重分析法The United States Pharmacopoeia 美国药典The Pharmacopoeia of Japan 日本药局方thin layer chromatography 薄层色谱thiochrome reaction 硫色素反应thymol 百里酚 thymolphthalein 百里酚酞实用标准文案titer 滴定度 three-dimensional chromatogram 三维色谱图titrant 滴定剂 titration error 滴定误差titrimetric analysis 滴定分析法 tolerance 容许限total ash 总灰分 total quality control 全面质量控制traditional drugs 传统药 traditional Chinese medicine 中药turbidance 浑浊 turbidimetric assay 浊度测定法turbidimetry 比浊度 turbidity 浊度Uultracentrifugation 超速离心 ultraviolet irradiation 紫外线照射undue toxicity 异常毒性 uniform design 均匀设计uniformity of dosage units 含量均匀度 uniformity of volume 装量均匀性uniformity of weight 重量均匀性Vvalidity 可靠性 variance 方差viscosity 粘度 volatile oil determination apparatus 挥发油测定器 volatilization 挥发性volumetric analysis 容量分析 volumetric solution 滴定液volumetric flasks 比重瓶Wwave length 波长 wave number 波数weighing bottle 称量瓶 weighing form 称量形式well-closed container 密闭容器 white board 白瓷板Xxylene cyanol blue FF 二甲苯蓝FF xylenol orange 二甲酚橙ZZigzag scanning 锯齿扫描 zwitterions 两性离子Zymolysis 酶解作用 zone electrophoresis 区带电泳文档大全。