肝康灵颗粒微生物限度检查方法的验证

目的建立肝康灵颗粒微生物限度检查方法，并对方法进行验证。方法按照中国药典2010版一部方法对3个批号的肝康灵颗粒进行微生物限度检查方法验证，采用平皿记数法，接种5种实验菌验证，分别计算各实验菌的回收率。结果各实验菌的回收率均〉70％。大肠埃希菌可采用常规法检出。结论采用常规法可以进行肝康灵颗粒微生物限度检查。

Validation of microbial limit test of Gankangling granules

Objective To establish a method for microbial limit test of Gankangling Granules and to verify this method. Methods According to CH. P（2010） vol I. a method of three batches of Gankangling parti- cle inspection methods validation of microbial limit, used the method of plate counting to gain the experimental result based on the recovery by vaccinating 5 kinds of the test-strains. Results Reaching more than 70% of re- covery rate of each test-strains. Conventional test method can be used for Escherichia coli. Conclusion Con- ventional method could be used for microbial limit test of Gankangling Grains.