为了制定药物有效期的稳定性试验方法和评价方法,首先应考虑以下几方面:(1)质量指标和它的界限的明确化;(2)包装、容器的考虑;(3)要建立妥当的加速试验条件;(4)要掌握贮存条件;(5)为测定药物有效期,要能运用统计学处理方法。在进行稳定性试验及其评价时,必须重视上述五项条件。现重点作如下介绍。 In order to develop a test method and evaluation method for the stability of the drug, the following aspects should be considered first: (1) clarity of the quality indicator and its limits; (2) packaging and container considerations; (3) proper acceleration Test conditions; (4) to master the storage conditions; (5) to determine the validity of drugs, to be able to use statistical methods. In the stability test and its evaluation, we must attach importance to the above five conditions. Now focus on the following introduction.