胃炎灵颗粒剂微生物限度检查方法验证  

Validation of microbial limit test method for Weiyanling granules

作　　者：马海玲 张咏梅 沈花 钱伟[1] MA Hailing;ZHANG Yongmei;SHEN Hua;QIAN Wei(Department of Pharmacy,Zhangjiagang Hospital Affiliated to Nanjing University of TCM,Zhangjiagang,Jiangsu 215600,China)

机构地区：[1]南京中医药大学附属张家港医院药学部

出　　处：《安徽医药》2019年第12期2531-2534,共4页Anhui Medical and Pharmaceutical Journal

基　　金：苏州市科技计划发展项目(SYSD2016161)

摘　　要：目的建立胃炎灵颗粒剂的微生物限度检查方法,并对该检查方法进行验证。方法参照2015版《中华人民共和国药典》四部通则,采用薄膜过滤法、培养基稀释法、常规法对胃炎灵颗粒剂分别进行微生物计数检查方法的验证。采用常规法对胃炎灵颗粒剂进行控制菌检查方法的验证。结果培养基稀释法、常规法不能消除胃炎灵颗粒剂对枯草芽孢杆菌、金黄色葡萄球菌的抑制作用,测得回收率低于0.50。薄膜过滤法可消除对枯草芽孢杆菌、金黄色葡萄球菌的抑制作用,测得回收率在0.50~2.00范围内。控制菌检查结果显示,培养基用量为100 mL时,试验组、阳性对照组检出大肠埃希菌;供试品对照组、阴性对照组无菌落生长。结论胃炎灵颗粒剂的需氧菌总数检查采用薄膜过滤法,霉菌及酵母菌总数检查和控制菌检查采用常规法。Objective To establish a microbial limit test method for Weiyanling granules and to test its validation.Methods Ac cording to the four general principles of the Chinese Pharmacopoeia(edition 2015),membrane filtration method,culture medium di lution method and routine method were used to verify the microbial count of Weiyanling granules.The routine method was used to verify the method of bacteria control.Results The inhibitory effect of Weiyanling granules on Bacillus subtilis and Staphylococcus aureus could not be eliminated by culture medium dilution method and routine method,and the recovery rate was less than 0.50.Membrane filtration method can eliminate the inhibition of Bacillus subtilis and Staphylococcus aureus,and the recovery rate was in the range of 0.50 2.00.The results of bacteria control test showed that Escherichia coli was detected in experimental group and positive control group when the amount of culture medium was 100 mL.There was no colony growth in the control group and nega tive control group.Conclusion The method of membrane filtration can be used for the total number of aerobic bacteria in Weiyan ling granules.The routine method can be used for the bacteria control and the total number of mould and yeast.

关 键 词：中草药 集落计数 微生物 微生物限度 薄膜过滤法 胃炎灵颗粒剂 

分 类 号：R57[医药卫生—消化系统]