5种含丹参中成药微生物限度检查方法验证

Validation Method Used for Microbial Limit Test in 5 Kinds of Traditional Chinese Patent Medicine Containing Danshen

目的建立5种含丹参中成药的微生物限度检查方法。方法通过接种阳性菌回收率试验测定冠脉宁片、清脑降压片、脑心通片、睡安胶囊、乙肝宁胶囊5种中成药是否含抑菌成分。结果脑心通片、清脑降压片2种供试品试验菌的回收率均为70%,证明无抑菌现象;冠脉宁片、睡安胶囊、乙肝宁胶囊有一定的抑菌作用,但可通过稀释法消除抑菌作用。结论脑心通片、清脑降压片应按常规方法进行微生物限度检查;冠脉宁片、睡安胶囊、乙肝宁胶囊可按培养基稀释法进行微生物限度检查。

Objective To establish a method of microbial limit test for 5 kinds of traditional Chinese patent medicine containing danshen.Methods The antimicrobial effects of 5 kinds of traditional Chinese patent medicine were determined by the recovery rate of inoculated positive bacteria.Results The recovery rates of Xinnaotong Tablets and Qinnaojiangya Tablets were higher than 70%,which indicated no antimicrobial effect with them;Guanmaining Tablets,Shuian Capsules,Yiganning Capsules had antimicrobial effects to some extend,but the effects could be eliminated by the dilution method.Conclusion The conventional method should be used for the microbial limit test of Xinnaotong Tablets and Qinnaojiangya Tablets,while the dilution method may be used for the microbial limit test of Guanmaining Tablets,Shuian Capsules and Yiganning Capsules.