16种中成药微生物限度检查法方法验证

目的:建立16种中成药的微生物限度检查方法.方法: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:根据回收率试验结果,感冒清片、干柏鼻炎片、清开灵口服液、清热解毒口服液、感冒清热颗粒和板兰根颗粒6种供试品试验菌的回收率试验均高于70%,证明无抑菌现象;热炎宁颗粒、黄连上清丸、牛黄上清丸、三七伤药片和双黄连口服液有一定程度的抑菌作用,但可通过稀释法消除抑菌作用;霍香正气滴丸、三黄片、清喉利咽颗粒、复方丹参片和牛黄解毒片的抑菌作用强,必须采用离心集菌加薄膜过滤法才能彻底消除其抑菌作用.结论:感冒清片、干柏鼻炎片、清开灵口服液、清热解毒口服液、感冒清热颗粒和板兰根颗粒按常规方法进行微生物限度检查;热炎宁颗粒、黄连上清丸、牛黄上清丸、三七伤药片和双黄连口服液按培养基稀释法进行微生物限度检查;藿香正气滴丸、三黄片、清喉利咽颗粒、复方丹参片、牛黄解毒片按离心集菌加薄膜过滤法进行微生物限度检查.

Validation Method Used for Microbial Limits of 16 Kinds of Traditional Chinese Medicine

Objective:To establish the method of microbial limit for 16 Traditional Chinese Medicines. Methods:To determine the antimicrobial effect of 16 kinds of Traditional Chinese Medicine by recovery rate with 5 control trains. Results: According to the results,the recovery rates of Ganmaoqing Tablet ,Qianbaibiyan Tablet,Qingkailing Oral Liquid.Qingrejiedu Oral Liquid, Ganmaoqing Granule and Banlangen Granule were higher than 70%,which indicated no antimicrobial effect with them; Reyanning Granule, Huanglian Shangqing Pill, Niuhuang Shangqing Pill,Sanqi Shangyao Tablet and Shuanghuanglian Oral Liquid had antimicrobial effects to some extend,the effect can be eliminated by dilution method ;Huoxiang Zhengqi Pill,San-huang Tablet,Qinghou Liyan Granule,Fufang Dansheng Tablet and Nuihuang Jiedu Tablet had higher antimicrobial effects, which must be eliminated by centrifugation and membrane filtration. Conclusions:The results suggested that common method be used for Ganmaoqing Tablet,Qianbaibiyan Tablet ,Qingkailing Oral Liquid.Qingrejiedu Oral Liquid,Ganmaoqing Granule and Banlangen Granule, dilution method for Reyanning Granule, Huanglian Shangqing Pill,Niuhuang Shangqing Pill,Sanqi Shangyao Tablet and Shuanghuanglian Oral Liquid,centrifugation and membrane filtration method for Huoxiang Zhengqi Pill, Sanhuang Tablet ,Qinghou Liyan Granule,Fufang Dansheng Tablet and Nuihuang Jiedu Tablet,respectively,for examination of microbial limit.