2种医院制剂微生物限度检查方法验证  

Establishment of Microbial Limit Test Methods for 2 Kinds of Hospital Preparations

作　　者：杨晓峰 李惠英[1] 李聃 刘晓宁[1] 秦利芬[1] YANG Xiaofeng;LI Huiyin;LI Dan;LIU Xiaoning;QIN Lifen(Pharmacy Department of Kunming Children's Hospital,Kunming 650000,China)

机构地区：[1]昆明市儿童医院药剂科,云南昆明650000

出　　处：《云南化工》2025年第2期85-89,共5页Yunnan Chemical Technology

基　　金：昆明市科技计划项目,编号2024-1-NS-21。

摘　　要：目的:建立2种医院制剂(新止咳合剂、小儿颠茄溴化钠口服溶液)的微生物限度检查方法。方法:按照2020年版《中国药典》(通则9202),采用平皿法开展微生物计数方法适用性试验;用常规法对控制菌进行检查。需氧菌、霉菌和酵母菌总数计数计算回收率。结果:需氧菌、霉菌和酵母菌总数验证中各试验菌的回收率均在0.5~2之间,按常规法可以检出控制菌。结论:通过方法适用性验证,平皿法操作简单,能真实反映2种制剂微生物检测结果。(Objective)To establish microbial limit test methods for two hospital preparations(Xin zhike mixture and Xiao'er dianqie xiuhuana oral solution).(Methods)According to the 2020 edition of Chinese Pharmacopoeia(General Code 9202),the applicability test of microbiological counting method was carried out by the plate method.The control bacteria were checked by conventional methods.The recovery rate was calculated by counting the total number of aerobic bacteria,mold and yeast.(Results)The recoveries of all tested bacteria were 0.5-2 in the total number verification of aerobic bacteria,mold and yeast.Control bacteria can be detected by conventional methods.(Conclusion)Through the applicability verification of the method,the plate method is simple to operate and can truly reflect the microbial detection results of the 2 preparations.

关 键 词：医院制剂 微生物限度检查 平皿法 方法适用性试验 回收率 口服制剂 

分 类 号：R927[医药卫生—药学]