头孢羟氨苄原料兽药质量标准

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头孢氨苄系列制剂质量评价分析

中国药事２０１５年８月第２９卷第８期
Hale Waihona Puke ８４５头孢氨苄系列制剂质量评价分析
巩丽萍，谢元超，杨娜，李玉杰，徐晓洁（山东省食品药品检验研究院，济南２５０１０１）
摘要目的：对头孢氨苄系列制剂质量及其质量标准进行评价和分析，为头孢氨苄系列制剂安全监管和
Ｃｏｎｔｒｏｌ，Ｊｉｎａｎ２５０１０１，Ｃｈｉｎａ）
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头孢氨苄胶囊的制备及质量控制

头孢氨苄胶囊的制备及质量控制作者：王涛来源：《科学与财富》2017年第17期（哈药集团制药总厂）摘要：本实验对头孢氨苄胶囊的制备方法以及头孢氨苄胶囊的质量控制进行研究。

测定方法：采用安捷伦十八烷基硅烷键合硅胶色谱柱（218mm×4.6mm，5μm），水-甲醇-3.85%醋酸钠溶液-4%醋酸（720：240：15：3），检测波长为254nm，流速为1.0ml/min，柱温为30℃。

头孢氨苄在0.12～1.92mg·mL-1范围内呈良好的线性关系。

头孢氨苄平均回收率为99.3%。

结论：本制剂稳定、可靠，测定方法简便、准确。

关键词：头孢氨苄；制备；控制头孢氨苄（Cefalexin）能抑制细胞壁的合成，使细胞内容物膨胀至破裂溶解，杀死细菌。

头孢氨苄（先锋霉素IV）化学名为（6R，7R）-3-甲基-7-[（R）-2-苯乙酰氨基]-8-氧代-5-硫杂-1-氮杂双环[4，2，0]辛-2-烯-2-甲酸一水化合物。

头孢羟氨苄常用于呼吸道、消化道、泌尿系、口腔及耳鼻喉科细菌性感染[1]。

胶囊常用于对食道和胃粘膜有刺激性的粉末或颗粒，或口感不好、易于挥发、在口腔中易被唾液分解，以及易吸入气管的药。

本实验对头孢氨苄胶囊的制备方法以及头孢氨苄胶囊的质量控制进行研究。

1 仪器与试药1.1 仪器：pHS-2C型精密酸度计（上海精科雷磁厂）；智能溶出实验仪（北京卓川电子科技有限公司）；FA200-4D万分之一天平（上海凯朗仪器设备厂）；LC1600 液相色谱系统（美国科诺工业有限公司）；SP-1900双光束紫外可见分光光度计（上海光谱仪器有限公司）；YN-ZD-5 5升普通型不锈钢电热蒸馏水器（上海添时科学仪器有限公司）；Q720实验室全自动洗瓶机（上海添时科学仪器有限公司）；SS/KQ-700VDB台式双频数控超声波清洗器（北京恒奥德仪器仪表有限公司）；UV-1800紫外分光光度计（上海美谱达仪器有限公司）；大连依利特 ZW230Ⅱ色谱柱温箱（北京德世科技有限公司）；ZB-1C型智能崩解仪（青岛胜方分析仪器有限公司）。

农业农村部制订8种宠物用药质量标准和说明书样稿

据了解，非洲猪瘟是由非洲猪瘟病毒引起的猪的一种急性、热性、高度接触性动物传染病，猪主要通过接触病毒或者污染物或被感染的蜱叮咬后而感染，潜伏期为１５天，世界动物卫生组织（ＯＩＥ）将其列为法定报告动物疫病，我同将其列为一类动物疫病，是重点防控的外来病。非洲猪瘟不是人畜共患病，不感染人。
说明书样稿，发布农业农村部第５６弓·公告，并自发布之日起执行。
这８种宠物用药中有３种抗生素类药物，分别是注射用头孢噻呋钠（宠物用）、硫酸阿米卡星注射液（宠物用）和头孢羟氨苄片（宠物用），注射用头孢噻呋钠（宠物用）用于犬大肠杆菌与奇异变形菌引起的泌尿道感染，硫酸阿米卡星注射液（宠物用）用于犬由大肠杆菌、变形杆菌敏感菌引起的泌尿生殖道感染（膀胱炎）和Ｆｌ＝Ｉ假单胞菌、大肠杆菌敏感菌引起的皮肤和软组织感染。头孢羟氨苄片（宠物用）用于犬猫南敏感的葡萄球菌、链球菌、巴氏杆菌和范雷伯菌等引起的呼吸道、泌尿道、皮肤和软组织感染。需要注意的是，已知对青霉素或头孢菌素敏感的人应避免接触注射用头孢噻呋钠和头孢羟氨苄片等。

不同厂家及批次的头孢氨苄质量考察研究

不同厂家及批次的头孢氨苄质量考察研究【摘要】目的比较不同厂家头孢氨苄片及胶囊的含量差异。

方法采用HPLC 法，色谱条件为：十八烷基硅烷键合硅胶柱；水甲醇3.86%醋酸钠溶液4%醋酸溶液(742∶240∶15∶3)为流动相；流速为1.0 ml/min；于254nm处检测。

结果18个厂家的产品均符合2010版药典的含量规定，其中E及H厂家的头孢氨苄片含量较高，N及O厂家的头孢氨苄胶囊含量较高。

结论不同厂家样品含量差异较大，不同批次间亦存在含量差异。

【关键词】头孢氨苄；片剂；胶囊；质量1材料与仪器岛津高效液相色谱仪：LC10AD泵，PD10A检测器，CR6Ae；AE24O型电子天平。

2方法与结果2.1色谱条件色谱柱：十八烷基硅烷键合硅胶柱(4.6 mm×250 mm)；流动相：水甲醇3.86%醋酸钠溶液4%醋酸溶液(742∶240∶15∶3)；流速： 1.0 ml/min；检测波长：254 nm；柱温：25℃；理论塔板数按头孢氨苄峰计算为1900。

2.2对照品储备液的制备精密称取头孢氨苄对照品50.03 mg，置50 ml容量瓶，加流动相溶解并稀释至刻度，即得1.0006 mg/ml对照品储备液。

2.3线性关系考察分别精密量取对照品储备液0.5、3.0、5.5、8.0、10.5、13.0 ml置50 ml量瓶中，加流动相稀释至刻度，摇匀，制成浓度为10、60、110、160、210、260 μg/ml的对照品溶液，分别进样。

结果表明，头孢氨苄浓度在60~210 μg/ml 范围内与峰面积有良好的线性关系。

以峰面积对浓度作标准曲线，其回归方程为：Y=1.684×105X+4582，r=0.9997。

2.4精密度试验分别精密量取浓度为10、160、260 μg/ml的头孢氨苄对照品，重复进样5次，记录色谱图。

2.5回收率试验精密量取头孢氨苄对照品储备液0.2，0.4，0.6，0.8，1.0 ml，分别置10 ml容量瓶内，再分别精密量取1 mg/ml的供试品溶液1.8，1.6，1.4，1.2，1.0 ml置对应容量瓶中，加入流动相混匀，至刻度，依次进样，记录色谱图，计算平均回收率为99.47%，RSD为0.8%。

头孢羟氨苄干混悬质量标准USP

Cefadroxil for Oral Suspension USP 250 mg/5 mL and 500 mg/5 mLRx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil for oral suspension and other antibacterial drugs, cefadroxil for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1-azabicyclo[4.2.O]oct-2-ene2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6R-[6α,7β(R*)]]-. It has the formula C16H17N3O5S•H2O and the molecular weight of 381.40. It has the following structural formula:COOH HHOONCH3 SC NH2CONH H H. H2OCefadroxil for oral suspension contains cefadroxil monohydrate. After reconstitution, each 5 mL contains cefadroxil monohydrate equivalent to 250 mg or 500 mg of cefadroxil. In addition, cefadroxil for oral suspension contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6, powder flavor orange, powder flavor pineapple, sodium benzoate, sucrose, and xanthan gum. Cefadroxil for oral suspension is a light orange colored powder, forming orange colored suspension on constitution. CLINICAL PHARMACOLOGY Cefadroxil monohydrate is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500-mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil monohydrate urinary concentration. The urine antibiotic concentration, following a 1-g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours. Microbiology In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE): Beta-hemolytic streptococci Staphylococci, including penicillinase-producing strains Streptococcus (Diplococcus) pneumoniae Escherichia coliPage 1 of 8Proteus mirabilis Klebsiella species Moraxella (Branhamella) catarrhalis Note: Most strains of Enterococcus faecalis (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium) are resistant to cefadroxil monohydrate. It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species). Susceptibility tests: Diffusion techniques The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility. One such standard procedure1 which has been recommended for use with disks to test susceptibility of organisms to cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefadroxil. Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg cephalothin disk should be interpreted according to the following criteria: Zone diameter (mm) ≥ 18 15-17 ≤ 14 Interpretation (S) Susceptible (I) Intermediate (R) ResistantA report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “intermediate susceptible” suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of “Resistant’’ indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected. Standardized procedures require the use of laboratory control organisms. The 30 mcg cephalothin disk should give the following zone diameters: Organism Staphylococcus aureus ATCC 25923 Escherichia coli ATCC 25922 Zone Diameter (mm) 29–37 17–22Dilution Techniques When using the NCCLS agar dilution or broth dilution (including microdilution) method² or equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 mcg/mL or less. Organisms are considered resistant if the MIC is 32 mcg/mL or greater. Organisms with an MIC value of less than 32 mcg/mL but greater than 8 mcg/mL are intermediate. As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 mcg/mL and 0.5 mcg/mL for Staphylococcus aureus ATCC 29213. For Escherichia coli ATCC 25922, the MIC range should be between 4 mcg/mL and 16 mcg/mL. ForPage 2 of 8Streptococcus faecalis ATCC 29212, the MIC range should be between 8 and 32 mcg/mL. INDICATIONS AND USAGE Cefadroxil for oral suspension is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A betahemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil for oral suspension and other antibacterial drugs, cefadroxil for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. CONTRAINDICATIONS Cefadroxil monohydrate is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. WARNINGS BEFORE THERAPY WITH CEFADROXIL MONOHYDRATE IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFADROXIL MONOHYDRATE OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefadroxil monohydrate, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.Page 3 of 8CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Cefadroxil monohydrate should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 M²). (See DOSAGE AND ADMINISTRATION.) In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy. Prescribing cefadroxil monohydrate in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cefadroxil monohydrate may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Cefadroxil monohydrate should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis. Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefadroxil for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefadroxil for oral suspension or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug/Laboratory Test Interactions Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug. Carcinogenesis, Mutagenesis and Impairment of Fertility No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.Page 4 of 8Pregnancy: Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil monohydrate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery Cefadroxil monohydrate has not been studied for use during labor and delivery. Treatment should only be given if clearly needed. Nursing Mothers Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother. Pediatric Use (See DOSAGE AND ADMINISTRATION.) Geriatric Use Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of cefadroxil for the treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION: Renal Impairment). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred. Hypersensitivity Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported. Other Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported. In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:Page 5 of 8Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. OVERDOSAGE A study of children under six years of age suggested that ingestion of less than 250 mg/ kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying. In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6–8 hour hemodialysis session. DOSAGE AND ADMINISTRATION Cefadroxil for oral suspension is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy. Adults Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.). For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.). Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.). Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis— 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days. Children For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil monohydrate should be administered for at least 10 days.See chart for total daily dosage for children.Page 6 of 8DAILY DOSAGE OF CEFADROXIL FOR ORAL SUSPENSION Child’s Weight 250 mg/5 mL 500 mg/5 mL Lbs kg 10 4.5 ½ tsp 20 9.1 1 tsp 30 13.6 1½ tsp 40 18.2 2 tsp 1 tsp 50 22.7 2½ tsp 1¼ tsp 60 27.3 3 tsp 1½ tsp 70 & above 31.8 + -2 tsp Renal Impairment In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M²]) is 500 mg at the time intervals listed below. Creatinine Clearance 0-10 mL/min 10-25 mL/min 25-50 mL/min Dosage Interval 36 hours 24 hours 12 hoursPatients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function. Bottle Size 100 mL Reconstitution Directions for Oral Suspension Reconstitution Directions Suspend in a total of 67 mL water. Method: Tap bottle lightly to loosen powder. Add 67 mL of water in two portions. Shake well after each addition. Suspend in a total of 51 mL water. Method: Tap bottle lightly to loosen powder. Add 51 mL of water in two portions. Shake well after each addition. Suspend in a total of 34 mL water. Method: Tap bottle lightly to loosen powder. Add 34 mL of water in two portions. Shake well after each addition.75 mL50 mLAfter reconstitution, store in refrigerator. Shake well before using. Keep container tightly closed. Discard unused portion after 14 days.Page 7 of 8HOW SUPPLIED Cefadroxil for oral suspension is orange-pineapple flavored, and is supplied as follows: 250 mg/5 mL NDC 68180-181-01 50 mL Bottle NDC 68180-181-02 100 mL Bottle 500 mg/5 mL NDC 68180-182-01 50 mL Bottle NDC 68180-182-02 75 mL Bottle NDC 68180-182-03 100 mL Bottle Prior to reconstitution: Store at 25°C (77°F); excursions permitted to 15°–30° C (59°– 86° F). [See USP Controlled Room Temperature]. After reconstitution: Store in refrigerator. Shake well before using. Keep containertightly closed. Discard unused portion after 14 days.REFERENCES 1. National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test, 4th Edition, Vol. 10 (7): M2-A4, Villanova, PA, April, 1990. 2. National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990. Manufactured by: Lupin Limited Mumbai 400 098 INDIA Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United StatesNovember 2007ID#:213270Page 8 of 8。

农业部公告第2513号――《兽药质量标准》(2017年版)

农业部公告第2513号――《兽药质量标准》(2017年版)
【法规类别】兽医兽药
【发文字号】农业部公告第2513号
【发布部门】农业部
【发布日期】2017.04.07
【实施日期】2017.11.01
【时效性】现行有效
【效力级别】部门规范性文件
农业部公告
（第2513号）
为加强兽药国家标准管理，我部对2010年12月31日前发布的、未列入《中国兽药典》（2015年版）的兽药质量标准进行了修订，编纂为《兽药质量标准》（2017年版），并制定了配套的说明书范本，现予发布，自2017年11月1日起施行。

现就有关事宜公告如下。

一、《兽药质量标准》（2017年版）包括化学药品卷、中药卷和生物制品卷等三个部分。

二、自2017年11月1日起，除《中国兽药典》（2015年版）和《兽药质量标准》（2017年版）收载品种的兽药质量标准外，2010年12月31日前（含31日）各版《中
国兽药典》《兽药国家标准》《兽用生物制品质量标准》《兽用生物制品规程》以及农业部公告发布的同品种兽药质量标准同时废止。

凡《兽药质量标准》（2017年版）品种项下未收载的制剂规格（已明令废止的除外），其质量标准按《兽药质量标准》（2017年版）同品种相关要求执行，规格项按原批准证明文件执行。

三、自2017年11月1日起，申报《兽药质量标准》（20。

兽药的标准

兽药的标准
兽药的标准是指对兽药的质量、安全性、疗效和使用规范所进行的规定和要求。

以下是兽药的一般标准：
1.质量标准：兽药的质量标准包括纯度、含量、相对分子质量、外观、理化性质、稳定性等指标，确保兽药的成分和性质符合要求。

2.安全性标准：兽药的安全性标准包括对毒性、副作用、残留物等进行评价，确保兽药使用不会对动物的健康和环境造成不良影响。

3.疗效标准：兽药的疗效标准包括对药效、治疗效果、药代动力学等进行评价，确保兽药在动物疾病治疗方面具有一定的疗效。

4.标签标识标准：兽药的标签和标识应包含兽药的名称、成分、用途、用法、剂量、存储条件、生产厂家等信息，确保兽药使用者能够正确理解和使用兽药。

兽药还需要符合国家相关法律法规的规定，如药品管理法、兽药管理法等文件中对兽药的标准和要求进行了详细规定。

兽药的标准是为了保护动物的健康和人类的食品安全，确保兽药的质量和使用符合科学、安全、可靠的原则。

头孢羟氨苄兽药质量标准

头孢羟氨苄兽药质量标准
一、外观
头孢羟氨苄兽药应呈现为白色或类白色结晶性粉末。

颜色不得深于标准品，不得含有肉眼可见的杂质。

二、理化性质
1.溶解度：在水中易溶，在甲醇中微溶，在乙醇中不溶。

2.熔点：该药物的熔点应不低于140℃，并随着温度的升高，熔点逐渐升高。

3.含量：头孢羟氨苄兽药的含量应不低于98.0%。

4.酸碱度：该药物的pH值应在
5.0-7.0之间。

三、其他指标
其他指标应符合相关法规和标准的规定。

例如，应进行无菌、细菌内毒素、异常毒性、降压物质等项目的检查，以保证药物的安全性和有效性。

四、注意事项
1.头孢羟氨苄兽药应按照规定的方法和剂量使用，不得随意超量和延长疗程。

2.在使用过程中，应注意观察动物的反应情况，如出现不良反应或过敏反应，
应立即停止使用并采取相应的治疗措施。

3.该药物应存放在阴凉干燥处，避免阳光直射和潮湿环境。

过期药物不得使
用。

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头孢羟氨苄原料兽药质量标准
一、质量指标
1. 外观：应为白色或类白色结晶性粉末。

2. 理化性质：
(1) 溶解度：在水中易溶，溶解度应大于20g/100mL。

(2) 熔点：熔点应在140℃以上。

(3) 红外吸收：符合相应的红外吸收谱图。

(4) 纯度：应不含其他杂质，纯度不低于98.0%。

(5) pH值：在醋酸溶液中的pH值应在5.0-7.0之间。

二、检验方法
1. 外观：使用合适的颜色盖板，观察样品颜色与标准颜色是否相符。

2. 溶解度：取适量头孢羟氨苄原料兽药样品，加入适量的水中，并迅速搅拌，观察是否完全溶解。

3. 熔点：使用熔点仪进行测试，记录熔点范围。

4. 红外吸收：使用红外光谱仪进行测试，参照标准红外吸收谱图进行比对。

5. 纯度：采用高效液相色谱仪测定纯度，并计算百分含量。

6. pH值：使用pH计进行测试，将头孢羟氨苄原料兽药样品溶解于醋酸溶液中，测定其pH值。

三、包装和标识
1. 包装：头孢羟氨苄原料兽药应采用密封和遮光性好的包装材料进行包装，以避免湿气、阳光和其他有害因素的影响。

2. 标识：标签上应注明产品名称、规格型号、生产日期、有效期、生产批号以及生产厂家的相关信息。

四、存储和运输
1. 存储：头孢羟氨苄原料兽药应存放在干燥、清洁、阴凉通风的地方，避免潮湿和高温环境。

2. 运输：运输时应轻拿轻放，禁止与有毒、有害物质混装混载，防止包装破损和溢漏。

以上质量标准仅供参考，具体的质量标准应根据实际生产情况和法规要求进行制定。