3种中药配方颗粒全生产链的污染微生物考察  

Investigation of microorganism contamination in the whole production chain of three kinds of TCM formula granules

作　　者：李文靖[1] 钟燕飞[1] 朱欢敏[1] LI Wenjing;ZHONG Yanfei;ZHU Huanmin(Guangdong Institute for Drug Control,Guangzhou 510000,China)

机构地区：[1]广东省药品检验所,广州510000

出　　处：《中国药品标准》2024年第3期265-272,共8页Drug Standards of China

基　　金：广东省药品监督管理局科技创新项目(2023TDZ03)。

摘　　要：目的:对郁金、桑叶、蝉蜕中药配方颗粒生产全过程污染微生物进行考察,建立数据库,探索中药配方颗粒生产过程微生物关键控制点及控制措施,为企业提供示范性研究,为制定标准、改进生产工艺提供依据,填补质量全过程控制的空白。方法:对3种中药配方颗粒的原材料、中间产品、成品按照《中国药典》2020年版进行分析检测,采用质谱技术对负载微生物进行鉴定,分析研究从药材原料到中药配方颗粒成品的外源性污染微生物的程度及容易污染微生物的种类。结果:3种中药配方颗粒的原材料(中药饮片)微生物污染较严重,原材料的耐热芽孢杆菌即使经过工艺处理后,仍能在中间产品、成品中检出,并造成部分批次需氧菌总数结果超出限度规定;中间产品、成品中还检出来源于人和动物肠道中的屎肠球菌。结论:①加强中药饮片的微生物污染控制,有利于降低终端产品的微生物负载;②3种中药配方颗粒的生产工艺存在芽孢类微生物污染的风险,需优化生产工艺参数来降低微生物负载;③药品生产企业需加强对产品全过程控制,降低微生物污染风险。Objective:The contaminated microorganisms in the whole production process of Yujin,mulberry leaf and cicada were investigated,and a database was established to explore the microbial key control points and control measures in the production process of traditional Chinese medicine(TCM)formula granules,in order to provide demonstration research for enterprises,provide basis for formulating standards and improving production processes,and fill the blank of the whole.Methods:The raw materials,intermediate products and final products of three kinds of TCM formula particles were analyzed according to the Chinese Pharmacopoeia 2020,and the supporting microorganisms were identified by mass spectrometry technology.The degree of exogenous polluting microorganisms from raw materials to finished products of TCM formula particles and the types of microorganisms easily contaminated were analyzed and studied.Results:The raw materials(TCM decoction pieces)of the three TCM formulations granules had serious microbial pollution,and the thermostable bacillus of the raw materials could still be detected in the intermediate products and final products even after the process treatment,and the total number of aerobic bacteria in some batches exceeded the limit.Enterococcus faecium from human and animal intestines was also detected in intermediate products and finished products.Conclusion:①Strengthening the control of microbial contamination of TCM decoction pieces is conducive to reducing the microbial load of final products;②There are risks of spore microorganism contamination in the production technology of 3 kinds of formula granuleshas,and the production process parameters should be optimized to reduce the microbial load;③Pharmaceutical companies need to strengthen the whole process of product control to reduce the risk of microbial contamination.

关 键 词：中药配方颗粒 饮片 污染微生物 郁金 桑叶 蝉蜕 全过程控制 

分 类 号：R921.2[医药卫生—药学]