摘要
目的:建立小儿感冒颗粒微生物限度检查方法。方法:按《中国药典》2010年版一部微生物限度检查方法的要求进行验证试验。结果:小儿感冒颗粒微生物限度检查细菌数、霉菌和酵母菌数测定方法采用常规法进行验证试验,试验组的菌回收率均不低于70%;控制菌(大肠埃希菌、大肠菌群)检查方法用大肠埃希菌采用常规法(100mL/瓶、10mL/支)进行验证试验,试验组、阳性对照组检出大肠埃希菌,阴性对照组无菌生长。结论:小儿感冒颗粒微生物限度检查细菌数、霉菌和酵母菌数测定方法可用常规法(1mL/皿)测定,控制菌(大肠埃希菌、大肠菌群)检查方法可用常规法(100mL/瓶、10mL/支)进行检查。
Objective To establish microbial limit test method for Xiao^r Ganmao Granules. Methods according to microbial limit test method in Chinese Pharmacopoeia （2010 edition, Volume I ） for verification test. Result Bacterial count, Mold count and Yeast count test by microbial limit test method of Xiao^r Ganmao Granules could be verify by conventional method （lmL/vessel）, the re- covery rate （ % ） in trial group are not less than 70% ; escherichia coli for check method of control bacterias （ escherichia coli group, Coliform）, adopt conventional method （ lOOml./flask, lOmL/ flask） to do the verification test, trial group, positive control group detected escherichia coli, negative control group have no bacterium. Conclusion Bacterial count, Mold count and Yeast count test by microbial limit test method of Xiao^r Ganmao Granules can adopt conventional method （ lmL/vessel）, check method of control bacte- rias （escherichia coli group, Coliform） can adopt conventional method （100mL/flask, lOmL/flask） .
出处
《中国民族民间医药》
2013年第16期30-32,34,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
关键词
小儿感冒颗粒
微生物限度检查
Xiaoer Ganmao Granules
microbial limit test method
