Validation of Microbial Limit Test Method of 11 Kinds of Oral Chinese Patent Medicines
- VernacularTitle:11种口服中成药微生物限度检查方法验证
- Author:
Hong YAN
;
Kun XUE
;
Yuedan ZHANG
- Publication Type:Journal Article
- Keywords:
Chinese patent medicines;
Microbial limit test;
Validation of method
- From:
China Pharmacy
2001;0(11):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the antimicrobial effect of 11 kinds of oral Chinese patent medicines and to establish microbial limit test method for them. METHODS: Common method and culture medium dilution method and sticked filter membrane method were used to do the recovery test in order to validate the scientificity and feasibility of established method. RESULTS: Danqi piantan capsule showed strong inhibition effect on Staphylococcus aureus and Bacillus subtilis. Xinshuning tablet, Fuzheng mixture, Shenkangning mixture, Qingshen xiaodu oral liquid had antimicrobial effect on Staphylococcus aureus to some extent. Banlangen granule had antimicrobial effect on Bacillus subtilis. The effect can be eliminated by culture medium dilution method. CONCLUSION: The common method can be used for the microbial limit test of Jiaoou capsule, Zhike ningsou capsule, Rongdanshi granule, Sanjie mingmu capsule, Jiangzhi ruanmai tablet. Dilution method can be used for the microbial limit test of Xinshuning tablet, Fuzheng mixture, Shenkangning mixture, Qingshen xiaodu oral liquid, Banlangen granule, Danqi piantan capsule. The common method is suitable for all kinds of specified microorganisms.
