几种医院外用中药制剂微生物限度检查方法的建立

Establishment of Microbial Limit Test for Hospital Topical Preparations of TCM

目的:建立三黄膏等几种医院外用中药制剂微生物限度检查法。方法:测定几种医院外用中药制剂对5种验证菌株的回收率,并对控制菌的检查法进行验证。结果:回收率试验结果表明,硝硼散和养阴生肌散2种供试品试验菌的回收率均高于70%,证明无抑菌现象;湿疹膏、止痛膏和玉红膏有一定程度的抑菌作用,但可通过稀释法消除抑菌作用;三黄膏、青黛膏和铁箍膏的抑菌作用强,需采用离心集菌薄膜过滤法才能彻底消除其抑菌作用。结论:硝硼散和养阴生肌散可按常规方法进行微生物限度检查;湿疹膏、止痛膏和玉红膏按培养基稀释法进行微生物限度检查;三黄膏、青黛膏和铁箍膏则按离心集菌薄膜过滤法进行微生物限度检查。

Objective： To establish microbial limit test（MLT） for hospital topical preparations of TCM such as SanHuangGao and so on.Method： The recovery rates of hospital topical preparations of TCM were detected in treating 5 verified microbial strains respectively and microbial limit test for specified micro-organisms was validated.Result： The results of recovery test suggested that recovery rates of XiaoPengSan and YangYin ShengJiSan were higher than 70%,indicating neither drug had antimicrobial activity;ShiZhenGao,ZhiTongGao and YuHongGao had certain antimicrobial effects,but the effects can be eliminated by dilution;SanHuangGao,QingDaiGao and TieGuGao had the highest antimicrobial effects,the effects must be completely eliminated by centrifugation and membrane filtration method.Conclusion： Microbial limit tests for XiaoPengSan and YangYin ShengJiSan can be conducted with common method;ShiZhenGao,ZhiTongGao and YuHongGao with dilution method;SanHuangGao,QingDaiGao and TieGuGao with centrifugation and membrane filtration method.