一种中药丸剂生产全链条微生物负载的研究  

Study on the whole chain microbial load in the production of one traditional Chinese medicine pills

作　　者：李趣嫦[1] 江艳芳 赖珊[1] 李文靖[1] 林铁豪[1] LI Qu-chang;JIANG Yan-fang;LAI Shan;LI Wen-jing;LIN Tie-hao(Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《药物分析杂志》2024年第8期1394-1399,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：广东省药品监督管理局科技创新项目(2023TDZ03);广东省药品监督管理局科技项目引导扶持(2023YDZ05)。

摘　　要：目的:研究中药丸剂生产全链条的微生物负载情况。方法:选取一种中药丸剂处方的药材及其净药材、中间体(混合药粉、待内包丸)和成品作为研究对象,按照2020年版《中华人民共和国药典》(简称《中国药典》)微生物限度检查法进行方法建立,对全链条收集的样品进行微生物检测鉴定,分析中药丸剂从药材到成品的微生物负载传递。结果:不同药材的微生物含量差异较大,药材微生物污染风险因子较高的品种为紫苏叶、广藿香和白芷。紫苏叶和广藿香“药材-净药材”的生产工艺需要改进和调整。药材微生物负载与中间体和成品呈现明显的正相关系。结论:对中成药生产全链条微生物负载的研究,了解各环节微生物的传递情况,有助于发现生产过程的薄弱环节和工艺控制的关键点,对中成药生产企业改进和探索生产工艺有着重要的指导意义。Objective:To study the whole chain microbial load in the production of a traditional Chinese medicine pill.Methods:A type of traditional Chinese medicine pills prescription was selected as the research object,including the medicinal materials and their purified medicinal materials,intermediates(mixed powder,waiting for inner packaging pills),and finished products.The microbial limit test method was established according to the 2020 edition of the Chinese Pharmacopoeia(ChP),to detect and analyze the microbial loads of all samples collected throughout the entire chain from medicinal materials to finished products of the traditional Chinese medicine pills.Results:The microbial content of different medicinal materials varies greatly,and the varieties with higer risk factors for microbial contamination in medicinal materials were Perillae Folium,Pogostemonis Herba,and Angelicae Dahuricae Radix.The production process of Perillae Folium and Pogostemonis Herba needed to be improved and adjusted from“medicinal material to pure medicinal material”.There was a positive correlation between the microbial load of medicinal materials and intermediate and finished products.Conclusion:The study on the microbial load throughout the entire production chain of traditional Chinese patent medicines can help us to understand the transmission of microorganisms at each stage.This knowledge is crucial for identifying weak links in the production process and the key areas for process control,and has an important guiding significance for traditional Chinese patent medicines manufacturers to improve and explore their production process.

关 键 词：中药丸剂 药材 微生物 生产链 负载 

分 类 号：R917[医药卫生—药物分析学]