摘要
目的:建立青翘感冒颗粒微生物限度检查方法。方法:按照《中华人民共和国药典》(简称《中国药典》)2020年版四部通则,分别采用平皿倾注法、稀释法和薄膜过滤法对青翘感冒颗粒进行方法适用性试验。结果:青翘感冒颗粒的需氧菌总数计数采用薄膜过滤法、霉菌和酵母菌总数计数采用平皿倾注法(1:10),各试验菌回收率均在50%~200%的范围内;控制菌检查(大肠埃希菌、耐胆盐革兰阴性菌和沙门菌)采用常规法,试验菌均能检出,且生长良好,阴性对照组无菌落生长。结论:青翘感冒颗粒的微生物限度检查方法经验证,该方法有效可行。
Objective To establish a method for microbial limit test of Qingqiao cold granules.Methods According to the four general rules of Chinese Pharmacopoeia(2020 edition),the applicability test of Qingqiao cold granules was carried out by flat blood pouring method,dilution method and membrane filtration method.Results Green up cold particle counting the total number of aerobe USES film over the franco-german:total number of mold and yeast count method of blood poured(1:10),the recovery rate of each experimental fungus were in the range of 50%to 200%,the control bacteria checking e.coli,bile salt resistant gram-negative bacteria and salmonella using the conventional method,the experimental group were detected test bacteria,and grow well,the negative control group No colony growth.Conclusion The method of microbiological limit test of Qingqiao cold granule is simple and feasible,which can provide reference for the microbiological limit test of Qingqiao cold granule in hospital preparation room and drug testing institutions.
作者
宋增炫
陈媛
米玲
邓映明
SONG Zengxuan;CHEN Yuan;MI Ling;DENG Yingming(Biologic Laboratory,Meizhou Institute for Food and Drug Control,Meizhou,Guangdong 514071,China)
出处
《医药前沿》
2022年第27期37-40,共4页
Journal of Frontiers of Medicine
关键词
青翘感冒颗粒
微生物限度
薄膜过滤法
平皿倾注法
Qingqiao cold Granule
Microbial limit
Membrane method
Blood injection method.
