8种中药制剂微生物限度检查方法验证探讨

Validation of microbial limits method for eight kinds of TCM preparations

目的:对8种中药制剂微生物限度采用3种检查方法。方法:按中国药典2005版规定采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果:按供试品制备方法,各试验菌样品中的回收率均达到70%以上。结论:8种中药制剂所采用的检验方法可以消除药品的抑菌作用。测定结果准确,药品质量安全有效,达到验证实验的目的。

Objective： To establish inspection methods of microbial limit for 8 kinds of TCM preparations. Methods： According to the China Pharmacopoeia （published in 2005）, to determine antimicrobial effect by recovery rate test with 5 positive control germs. Results： According to the results, the recovery rates were all more than 70% by preparation of sample. Conclusion： The inspection methods of 8 kinds of TCM preparations can elimination the antiblastic effects, make the determination results are accurate and the drug quality are safe, then accomplish the experiment objective.