摘要
目的建立“浙八味”中药饮片的微生物限度检查方法。方法采集样品24批次,参照《中华人民共和国药典》2020年版四部通则1108,分别设置试验组、菌液或阳性对照组、供试品对照组和阴性对照组。采用平皿法进行微生物计数方法适用性试验,采用直接接种法进行控制菌检查方法适用性试验。结果“浙八味”中药饮片制成1∶10供试液后均能有效检出样品中加入的需氧菌、霉菌和酵母菌,各试验菌回收率为0.5~2.0。控制菌方法适用性试验结果显示,试验组和阳性对照组均能检出试验菌,供试品对照组和阴性对照组均未检出试验菌。因杭白菊粉末质地松泡,易吸水膨胀,不便于后续取样,因此在进行沙门菌检查时将胰酪大豆胨液体培养基增加至200 ml。结论“浙八味”中药饮片微生物计数及控制菌检查均可采用常规法进行检查,方法简便、准确、可靠。
Objective To establish the microbial limit test method for Chinese herbal pieces of “Zhebawei”. Methods Twenty-four batches of samples were collected. According to general rule 1108 of the fourth part of Pharmacopoeia of the People’s Republic of China, 2020 edition, the experimental group, the bacterial suspension or the positive control group, the test sample control group, and the negative control group were set up respectively. The suitability test of microbial count was carried out by plate method, and the suitability test of controlled bacteria was carried out by direct inoculation method. Results The aerobic bacteria, molds and yeasts added to the samples could be effectively detected in the 1∶10 test solution made from Chinese herbal pieces of “Zhebawei”, and the recovery rate of each test bacteria was between 0.5 and 2.0. The results of the suitability test of the controlled bacteria showed that the test bacteria could be detected in both the experimental group and the positive control group, while the test bacteria could not be detected in the test sample control group and the negative control group. Because of the loose and bubbly texture of Chrysanthemum morifolium powder, it was easy to absorb water and expand, which was not convenient for subsequent sampling. Therefore, the trypticase soy broth was increased to 200 ml during Salmonella test. Conclusion The conventional method is simple, accurate and reliable to check the microbial count and the controlled bacteria for “Zhebawei”.
作者
诸夔妞
丁宇琦
储团结
赵岩
梁晶晶
赵超群
袁堃
郑小玲
ZHU Kuiniu;DING Yuqi;CHU Tuanjie;ZHAO Yan;LIANG Jingjing;ZHAO Chaoqun;YUAN Kun;ZHENG Xiaoling(Key Laboratory of Quality and Safety of Functional Food,State Administration for Market Regulation,Zhejiang Institute for Food and Drug Control,Zhejiang Province,Hangzhou310052,China;IntePharma(Zhejiang)Quality&Technology Co.,Ltd,Zhejiang Province,Hangzhou310018,China;National Medical Products Administration Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology,Zhejiang Province,Hangzhou 310052,China)
出处
《中国医药导报》
2025年第2期176-180,共5页
China Medical Herald
基金
浙江省药品监督管理局科技计划项目(2023008)。
关键词
中药饮片
“浙八味”
微生物限度检查
方法适用性试验
常规法
Chinese herbal pieces
“Zhebawei”
Microbial limit test
Method suitability test
Conventional method
作者简介
诸夔妞(1988-),男,硕士,研究方向:药品微生物检验与研究;通讯作者:郑小玲(1983-),女,硕士,副主任药师,研究方向:药品微生物检验与研究。
