15种中药制剂微生物限度检查方法验证

Verifying method used for microbial limits of 15 kinds of preparation of traditional Chinese medicine

[目的]建立15种中药制剂的微生物限度检查方法。[方法]采用5种阳性对照菌回收率实验测定其是否含抑菌成分。[结果]根据回收率实验结果,补肾强身丸、补肾抗衰片、通脉三号胶囊、肾消颗粒、白庇丸、清肺化痰胶囊6种供试品各试验菌的回收率均高于70%,证明无抑菌现象;通脉合剂、调脾生血合剂、消渴脂黏胶囊、心舒宁片、振萎胶囊、健胃合剂、小儿通便合剂、清热利湿合剂8个品种有一定程度的抑菌作用,可通过培养基稀释法消除抑菌作用;而针灸外洗液抑菌作用强,必须采用离心集菌薄膜过滤法才能彻底消除其抑菌作用。[结论]补肾强身丸、补肾抗衰片、通脉三号胶囊、肾消颗粒、白庇丸、清肺化痰胶囊按常规法进行微生物限度检查;通脉合剂、调脾生血合剂、消渴脂黏胶囊、心舒宁片、振萎胶囊、健胃合剂、小儿通便合剂、清热利湿合剂按培养基稀释法进行微生物限度检查;针灸外洗液按离心集菌薄膜过滤法进行微生物限度检查。

[Objective] To establish the test method of microbial limit for 15 preparations of traditional Chinese medicines. [Methods] The antimicrobial effect of 15 kinds of traditional Chinese medicine was determined by recovery rate with 5 control trains. [Results] According to the results, the recovery rates of Bushen Qiangshen Pill, Bushen Kangshuai Tablet, Tongmai Capsule Ⅲ, Shenxiao Granule, Baibi Pill and Qingfei Huatan Capsule were higher than 70%, indicating no antimicrobial effect; Tongmai Mixture, Tiaopi Shengxue Mixture, Xiaoke Zhinian Capsule, Xinshuning Tablet, Zhenwei Capsule, Jianwei Mixture, Xiaoer TongDian Mixture and Qingre Lishi Mixture had antimicrobial effects to some extend. The inhibiting effect can be eliminated by dilution method. Zhenjiu Waixi Liquid had higher antimicrobial effects, which could be eliminated by centrifugation and membrane filtration. [Conclusions] The results suggests that commonly method used for Bushen Qiangshen Pill, Bushen Kangshuai Tablet, Tongmai Ⅲ, Shenxiao Granule, Baibi Pill and Qingfei Huatan capsule, can be examined for microbial limit with routine method and Tongmai Miture, Tiaopi Shengxue mixute, Xiaoke Zhinian capsule, Xinshuning Tablet, Zhenwei capsule, Jianwei Mixture, Xiaoer Tongbian Mixtrure and Qingre Lishi Mixture can be determined with dilution method of incubation medium. For Zhenjiu Waixi Liquid, the centrifugation and membrane filtration method should be used.