药品微生物限度检查方法适用性的研究进展  

Research progress on applicability of microbial limit test for drugs

作　　者：庞云娟 刘康连 梁晓玲 赖馥茜 周德华 李翔朝 黎强 樊文研 PANG Yun-juan;LIU Kang-lian;LIANG Xiao-ling;LAI Fu-xi;ZHOU De-hua;LI Xiang-chao;LI Qiang;FAN Wen-yan(Yulin Center for Food and Drug Control,Yulin Engineering Technology Research Center for Quality Monitoring and Evaluation of Chinese Medicinal Materials(Including Spices),Yulin 537000,China)

机构地区：[1]玉林市食品药品检验检测中心,玉林市中药材(含香辛料)质量监测与评价工程技术研究中心,玉林537000

出　　处：《药物分析杂志》2024年第8期1285-1292,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：广西重点研发计划(桂科AB24010236);广西科技重大专项(桂科AA23023035);广西科技基地和人才专项(桂科AD22080002)。

摘　　要：本文针对药品微生物限度检查方法适用性研究的关键实验操作,从供试品溶液的制备、微生物计数方法和控制菌检查方法适用性试验的方法设计、加菌回收试验操作、菌液计数、菌液纯度控制等方面进行文献和经验的总结。重点介绍了具有较强抑菌作用的水溶性供试品、不易溶解分散的非油脂类供试品、油脂类供试品的供试品溶液制备方法,详细介绍了需氧菌总数计数、霉菌酵母菌总数计数、控制菌检查方法的循序实验方案;阐述了关于薄膜过滤法加菌操作的4种方式并分析其对方法结果的影响,总结了3种菌液计数的方法;详细分享了关于菌液纯度控制的操作经验,总结了药品微生物限度检查方法适用性研究的现状。提出了关于药品微生物限度检查方法适用性研究未来发展的4点建议:对薄膜过滤法加菌操作进行科学、合理的统一;加强对药品生产企业的监管和对药品微生物限度检查方法的复核;对国抽品种开展统一其微生物限度检查方法的研究并逐步收载成册;加强药用辅料微生物限度检查方法适用性试验的研究。This article focuses on the key experimental operations in the study about the applicability of microbial limit testing methods for drugs,summarizing literature and experience from the preparation of test solution,design of methods for microbial counting and control bacteria inspection,operation of microbial recovery test,bacterial liquid concentration counting,and operational methods for controlling bacterial&fungal purity.Emphasis was placed on the preparation methods of water-soluble test samples with strong antibacterial effects,non-oil and fat test samples that were not easily soluble and dispersed,and the test solution for oil and fat test samples.Detailed introduction of the sequential experimental plan for methods of aerobic bacterial count,mold&yeast count,and control bacterial inspection were introduced.Four operational methods for adding bacteria about membrane filtration were explained,and the impact of different ways of adding bacteria on the results of the method was ana⁃lyzed.Summarized three counting methods for bacterial&fungal concentrations.Detailed sharing of operational experience on controlling the purity of bacterial solution.Summarized the current status about research on the applicability of microbial limit testing methods of drugs.Four suggestions for the future development of research on the applicability of microbial limit testing methods for drugs have been proposed:(1)Unify the operation about bacteria adding method in membrane filtration,scientific and reasonable;(2)Strengthen supervision of pharmaceutical production enterprises and review of microbial limit testing methods for drugs;(3)Unify the microbial limit testing methods for the drugs of the national sampling plan,and gradually collect and bind into a book;(4)Strengthen the research on the applicability of microbial limit testing methods for excipients.

关 键 词：微生物限度 方法适用性 供试品溶液的制备 微生物计数 控制菌检查 菌液计数 菌液纯度控制 平皿倾注法 薄膜过滤法 

分 类 号：R917[医药卫生—药物分析学]