中药新药试行标准转正的稳定性试验问题探讨

本文从企业申请中药新药试行标准转为正式标准的材料中整理出一些具有代表性的、对药品稳定性考察不规范的实例进行了分析,指出了企业在稳定性试验中主要存在的问题;通过与规范实例的对照,强调了规范稳定性试验考察的重要性;最后,就企业进行药品有效期的预测试验提出了一些建议.

Investigation of Stability Test before Tentative Standard of New Drug of Chinese Medicine becoming Official Standard

The examples of unture examining methods which refer to the stability of drugs are selected from the declared data concerning the tentative standard of new drug of Chinese medicine becoming the official standard. The main problems existed in the stability tests of new drugs are indicated by the analysis of these examples. Based on the importance of correct examining process the proposals on the forecast of the shelf life of drugs are presented by a correct performing example.