摘要
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.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2008年第3期258-259,共2页
China Journal of Traditional Chinese Medicine and Pharmacy
关键词
微生物限度方法验证
回收率
药品质量
Validation of microbial limits method
Recovery rate
Quality of drugs