医院制剂微生物限度检查方法的重新验证

eRev Reverification of microbial limit test method in Hospital Preparation

目的对21种医院制剂的微生物限度检查法重新验证和改进。方法按2010年版《中国药典》附录微生物限度检查法及应用指导原则进行方法学验证。结果修改了2个对试验菌的回收率低于70%制剂的检验方法,同时对10个制剂的样品制备及检验方法进行了改进。结论当制剂的组分来源发生改变、检验条件发生改变时,微生物限度检查法重新验证很有必要。

Objective To revalidate the microbial limit test method for 21 kinds of hospital preparation. Methods The methodological validatio was performed according to the china pharmacopeia （2010 edition a microbial limits inspection and application appendix guiding principle）. Results The test method less than the recovery rate of 70% of 2 kinds preparation was revise. The test method and preparation of samples of 10 kinds preparation was improved. Conclusion It was necessary to revatidate the microbial limit test method when the Component source revise of preparation and condition of test was changed.