近六年中成药国家药品评价抽验微生物限度检查结果与分析

Results and Analysis of Microbial Limit Test in National Drug Evaluation and Sampling Inspection of Chinese Patent Medicines in Recent Six Years

目的 基于近六年国家药品抽检微生物限度结果数据,分析评价我国中成药卫生学质量状况.方法 选取2016-2021年间的中成药国家评价性抽验品种微生物限度检验结果,对662批次微生物限度检查数据进行汇总分析.总结了不同剂型中成药的卫生学状况,并结合中成药原料、处方及工艺进行了影响卫生学指标的问题探讨.结果 六年抽样样品总合格率99.5%,各年度合格率均在98%以上.需氧菌总数2批不合格,霉菌和酵母菌总数1批不合格.所有样品的致病菌检测均为阴性,未检出沙门氏菌和大肠埃希菌.结论 近六年间我国中成药质量状况总体乐观,但部分企业的批次稳定性仍不足,提示存在偶发性的污染风险,同时原料是否灭菌、制剂工艺、饮片质量及终产品灭菌方式均直接影响微生物检查结果,为如何有效提升中成药的卫生学质量提供了参考.

Objective To analyze and evaluate the hygienic quality of Chinese patent medicines based on the data of microbial limit results of national drug sampling inspection in recent six years.Methods The results of microbial limit test of Chinese patent medicines from 2016 to 2021 were selected,and the microbial limit data of 662 batches were summarized and analyzed.The microbiological status of Chinese patent medicines with different dosage forms was summarized,while factors affecting microbiological indicators were discussed in combination with Chinese herbal pieces,prescriptions and processes.Results The total qualified rate in 6 years was 99.5%,and more than 98%in each year.There were 3 unqualified batches,2 for total aerobic microbial count(TAMC)and 1 for total molds and yeasts count(TYMC).All samples were negative for pathogenic bacteria,without Salmonella and E.coli detected.Conc lus ion The quality status of Chinese patent medicines in China is generally optimistic in recent 6 years,but the batch stability of some enterprises is stilinsufficient,suggesting an occasional risk of contamination.At the same time,the results of microbial control were affected by sterilization of raw materials,the preparation process,the quality of decoction pieces and the sterilization method of final products,offering a reference for how to effectively improvethe hygienicquality of Chinese patent medicines.