2020年版《中华人民共和国药典》中黄芩配方颗粒微生物限度检查方法适用性试验  

Applicability test of microbiological limit method for Huangqin formula granule by ChP 2020

作　　者：张文婷 张春华 章瑛 刘绪平 ZHANG Wen-ting;ZHANG Chun-hua;ZHANG Ying;LIU Xu-ping(Jiangx iInstitute For Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Rsearch Center for Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院、国家药品监督管理局中成药质量评价重点实验室、江西省药品与医疗器械质量工程技术研究中心,南昌330029

出　　处：《药物分析杂志》2023年第8期1418-1422,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：江西省科技厅基金项目(20192BBGL70052)。

摘　　要：目的:建立黄芩配方颗粒微生物限度检查方法,并对方法进行适用性试验。方法:需氧菌计数法采用薄膜过滤法,冲洗量为每筒400 mL;霉菌、酵母菌计数法为平皿法(玫瑰红钠培养基);大肠埃希菌检查为常规法。结果:5种试验菌的回收试验结果均在0.5~2.0,大肠埃希菌检查试验组检出大肠埃希菌。结论:该方法科学可靠,可用于黄芩配方颗粒的微生物限度检查,有效控制该品种质量。Objective:To establish a microbiological limit test method of Huangqin formula granule and test the applicability of the method.Methods:Membrane filtration method was used for aerobic bacteria count,rinse vol⁃ume was 400 mL per cartridge.Plate method was used for mold and yeast count,but the culture was rose bengal agar.And control bacteria was checked by normal method.Results:The recovery rates of 5 bacteria were be⁃tween 0.5-2.0,E.coli ccould be tested in test group.Conclusion:The method is reasonable and reliable,and can effectively control the product quality.

关 键 词：黄芩配方颗粒 微生物限度检查 方法适用性试验 薄膜过滤法 玫瑰红钠琼脂培养基 

分 类 号：R917[医药卫生—药物分析学]