摘要
目的建立疏肝通络胶囊的微生物限度检查方法。方法按照《中国药典》2015年版的规定,采用常规法、稀释法进行疏肝通络胶囊微生物限度检查的方法学验证。结果供试品五种试验菌的回收率均达到0.5以上,控制菌能正常检出。结论采用常规法和稀释法进行疏肝通络胶囊的微生物限度检查,能够客观地反映其中微生物的污染状况,以达到检测目的。
OBJECTIVE To establish a method for the microbial limit test of ShuGan TongLuo capsule.METHODS According to the Chinese Pharmacopoeia 2015 edition,the routine method and dilution method were performed for microbial limit test methodology validation of ShuGan TongLuo capsule.RESULTS Five microbe recovery rates of test sample were all above 0.5,control bacteria were performed by routine method.CONCLUSION The routine method and dilution method applied for microbial limit test can objectively reflect the status of microbial contamination in ShuGan TongLuo capsule,so as to meet the destination of examination.
作者
张聪聪
程龙
毛腾霄
ZHANG Cong-cong;CHENG Long;MAO Teng-xiao(Chengdu Institute for Food and Drug Control,Chengdu 610046,China)
出处
《海峡药学》
2020年第2期66-68,共3页
Strait Pharmaceutical Journal
关键词
疏肝通络胶囊
微生物限度检查
方法学验证
ShuGan TongLuo capsule
Microbial limit test
Methodology validation
