午时茶颗粒微生物限度检查方法的验证  

Verification of Microbial Limit Test Method for Wushicha Granule

作　　者：俞泽帆 杲秀珍 蒋桂娟[1] 王虹蕾 王道芳 李冰[1] 李玉林[1] YU Zefan;GAO Xiuzhen;JIANG Guijuan;WANG Honglei;WANG Daofang;LI Bing;LI Yulin(Northwest Institute of Plateau Biology,Chinese Academy of Sciences,Xining 810001,China)

机构地区：[1]中国科学院西北高原生物研究所,青海西宁810001

出　　处：《分析测试技术与仪器》2024年第3期166-171,共6页Analysis and Testing Technology and Instruments

基　　金：2021年度青海省“昆仑英才·高端创新创业人才”领军人才计划项目。

摘　　要：按照《中华人民共和国药典》(2020年版四部)要求,采用平皿倾注法(1∶10,1∶20,1∶50,1∶100)和常规培养基体积直接接种法对午时茶颗粒进行微生物计数方法和控制菌检查方法适用性试验,通过计算3批次的试验菌回收比值筛选需氧菌总数计数、霉菌和酵母菌总数计数方法.当采用平皿倾注法(1∶10)时,各试验菌回收比值均在0.5~2.0范围内.控制菌阳性对照组生长良好,经革兰氏染色显微镜检查和生化鉴定试验,符合试验菌形态学和生化特性.研究建立的方法准确可行,重现性好,可用于午时茶颗粒的微生物限度检查.According to the requirements of the Pharmacopoeia of the People's Republic of China(Part 4,2020 edition),the applicability of calculation method of microbial and control bacteria examination method for Wushicha granule were tested by the plate pouring method(1∶10,1∶20,1∶50,1∶100)and the routine medium volume direct inoculation method.The total aerobic microbial count,fungi and total saccharomyces cerevisiae count method were screened by calculating the recovery ratio of the test bacteria in three batches.When the plate pouring method(1∶10)was used,the recoveries of each test bacterium were within the range of 0.5~2.0.The positive control group of control bacteria grew well,and through gram staining microscopic examination and biochemical identification tests,it met the morphological and biochemical characteristics of the test bacteria.The method is accurate,feasible,reproducible,and can be used for microbial limit testing of Wushicha granule.

关 键 词：午时茶颗粒 微生物限度检查 平皿倾注法 

分 类 号：R286.0[医药卫生—中药学]