李思 易伟 吴晶晶

    [摘要] 目的 建立9种中药制剂的微生物限度检查方法。 方法 按《中国药典》2015年版四部通则1100生物检查法进行微生物限度检查方法的建立和验证。 结果 分别采用常规法、培养基稀释法和薄膜过滤法，各试验菌样品中的回收率均在0.5～2.0，符合《中国药典》要求。 结论 建立的方法准确可靠，可用于9种中药制剂的微生物限度检查。

    [关键词] 中药制剂；微生物限度检查法；方法验证；抑菌作用

    [中图分类号] R917 [文献标识码] A [文章编号] 1673-7210(2018)09(c)-0098-04

    [Abstract] Objective To establish the microbial limit test for 9 kinds of traditional Chinese medicine preparations. Methods According to the Chinese Pharmacopeia 2015 edition 4th part general rule 1100 biological examination method， the microbial limit test method was established and verified. Results By using normal method， medium dilution method and membrane filtration method respectively， the recovery rate of each test bacteria sample was both up to 0.5-2.0， which met the Chinese Pharmacopeia requirements. Conclusion The established method is accurate and reliable， which can be used for the microbial limit test of 9 kinds of traditional Chinese medicine preparations.

    [Key words] Traditional Chinese medicine preparation； Microbial limit test； Method validation； Antibacterial effect

    口服中药制剂的微生物污染情况是其质量控制的重要指标 ......