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笔者对11种中成药通过1年、2年或3年留样观察就质量变化情况进行分析,可以掌握产品在贮存过程中的质量变化规律,为改进生产工艺、包装材料、提高产品质量、减少消费者质量投诉提供依据。现就某中成药厂11种产品在有效期内留样观察情况。列表如下(表1、表2)。按厂规定的时间进行质量检验,其中“外观”项是通过肉眼观察得到结果,其余检测项目均参照中华人民共和国药典[S]．2000年版．一部及《中华人民共和国卫生部药品标准》[S]．中成药制剂．第十一册、第十五册、第十七册、第十九册、第二十册中各品种项下相关项目检测。所有品种均在温度25℃±
The author analyzes 11 kinds of proprietary Chinese medicines through one-, two-, or three-year observations of changes in quality, and can grasp the quality change rules of the products in the storage process, in order to improve the production process, packaging materials, improve product quality, reduce Consumer quality complaints provide the basis. Currently, 11 samples of a certain Chinese patent medicine factory are left for observation within the validity period. The list is as follows (Table 1, Table 2). According to the factory’s time for quality inspection, the “appearance” item is obtained through the naked eye observation results, and the rest of the test items are in accordance with the People’s Republic of China Pharmacopoeia [S]. 2000 edition. One and “The People’s Republic of China Ministry of Health Drug Standards” [S]. Chinese medicine preparations. The relevant items in the eleventh volume, fifteenth volume, seventeenth volume, nineteenth volume, and twenty-fifth volume are tested under related items. All varieties are at the temperature of 25 °C