药物稳定性实验

1150药物稳定性The term ―stability,‖ with respect to a drug dosage form, refers to the chemical and physical integrity of the dosage unit and, when appropriate, the ability of the dosage unit to maintain protection against microbiological contamination. The shelf life of the dosage form is the time lapse from initial preparation to the specified expiration date. The monograph specifications of identity, strength, quality, and purity apply throughout the shelf life of the product.The stability parameters of a drug dosage form can be influenced by environmental conditions of storage (temperature, light, air, and humidity), as well as the package components. Pharmacopeial articles should include required storage conditions on their labeling. These are the conditions under which the expiration date shall apply. The storage requirements specified in the labeling for the article must be observed throughout the distribution of the article (i.e., beyond the time it leaves the manufacturer up to and including its handling by the dispenser or seller of the article to the consumer). Although labeling for the consumer should indicate proper storage conditions, it is recognized that control beyond the dispenser or seller is difficult. The beyond-use date shall be placed on the container label.就药物制剂而言，术语“稳定性”是指单位剂量药物理化性质的完整程度以及在适当情况下对微生物污染的抵抗能力。

制剂的有效期指从生产至失效期的期限。

在有效期内，产品须符合各论中有关鉴别、效价、质量和纯度的规定。

药物制剂的稳定性参数可能受到它所贮存的环境（温度、光照、空气和湿度）的影响，还受到包装材料的影响。

药典收载的药物制剂的标签应标明贮存条件。

在有效期内，药品应在规定的各条件下贮存。

药品在分销过程中（即从药品离开生产商后直到由配药员处理或销售者卖给消费者）必须遵守标签上规定的贮存要求。

尽管对于消费者来说药品标签应标明合适的贮存条件，但是药品在由配药员或销售者到达消费者手中时，对贮存环境的控制是很困难的。

药品的失效期应在容器标签上注明。

Stability ProtocolsStability of manufactured dosage forms must be demonstrated by the manufacturer, using methods adequate for the purpose. Monograph assays may be used for stability testing if t hey are stability-indicating (i.e., if they accurately differentiate between the intact drug mol ecules and their degradation products). Stability considerations should include not only the specific compendial requirements, but also changes in physical appearance of the product that would warn users that the product's continued integrity is questionable.Stability studies on active substances and packaged dosage forms are conducted by means of ―real-time,‖ long-term tests at specific temperatures and relative humidities representing storage conditions experienced in the distribution chain of the climatic zone(s) of the coun try or region of the world concerned. Labeling of the packaged active substance or dosage form should reflect the effects of temperature, relative humidity, air, and light on its stab ility. Label temperature storage warnings will both reflect the results of the real-time stora ge tests and allow for expected seasonal excursions of temperature.稳定性试验生产商必须通过合适的方法证明药物剂型的稳定性。

如果各论中的含量测定法可以指示稳定性，那么它们就可以用于稳定性试验（即含量测定法能准确区分出完整的药物分子和它们的降解产物）。

在考察药物的稳定性时，不仅应包括药典对其的要求，还应包括药物物理性状的改变，这些可以提示使用者药物的完整性是否有问题。

按照规定时间点考察活性成分和药物制剂的稳定性。

长期试验是在特定的温度、相对湿度条件下进行的，此条件代表销售此药品的相关国家或地区所在的气候带。

已包装的活性成分或药物制剂的标签（Labeling）中应标明温度、相对湿度、空气和光照对它们的稳定性的影响。

标签（Label）标识的贮存温度的要求不仅要考虑稳定性试验的结果，还要考虑到预期的季节性的温度偏差。

Controlled Room TemperatureControlled room temperature (see Storage Temperature and Humidity in Preservation, Packa ging, Storage, and Labeling under General Notices and Requirements) delineates the allowa ble tolerance in storage circumstances at any location in the chain of distribution (e.g., ph armacies, hospitals, and warehouses). This terminology also allows patients or consumers t o be counseled as to appropriate storage for the product. Products may be labeled either t o store at ―Controlled room temperature‖ or to store at temperatures ―up to 25°‖ where l abeling is supported by long-term stability studies at the designated storage condition of 25°. Controlled room temperature limits the permissible excursions to those consistent wit h the maintenance of a mean kinetic temperature calculated to be not more than 25°. Se e Mean Kinetic Temperature. The common international guideline for long-term stability st udies specifies 25 ±2°at 60 ±5% relative humidity. Accelerated studies are specified a t 40 ±2°and at 75 ±5% relative humidity. Accelerated studies also allow the interpret ation of data and information on short-term spikes in storage conditions in addition to the excursions allowed by controlled room temperature.The term ―room temperature‖ is used in different ways in different countries, and for prod ucts to be shipped outside the continental U.S. it is usually preferable for product labeling to refer to a maximum storage temperature or temperature range in degrees Celsius.受控的室温受控的室温（见通则和要求中保存，包装、贮存和标签项下的贮存温度和湿度）描述了药品销售地的贮存环境（如药房、医院和仓库）的允许偏差。