Cai Hong, Jia Danchun, Ke Yuan
Shangluo Institute for Drug Control, Shangluo, China.
Evid Based Complement Alternat Med. 2022 May 18;2022:6382676. doi: 10.1155/2022/6382676. eCollection 2022.
This study attempted to verify the applicability of the microbial limit test (plate culture and membrane filtration) for 10 proprietary Chinese medicines for children.
In this study, we collected 10 proprietary Chinese medicines for children as study objects and performed plate culture and membrane filtration to calculate the colony-forming unit (cfu) of microorganisms in these medicines and verify its applicability in objectionable microorganisms.
It was found that the recovery rate of microorganisms including , , , , and ranged from 70% to 150%. This verification was performed by plate culture or membrane filtration. Inspection for objectionable microorganisms (, B, and bile salt-tolerant Gram-negative bacteria) was applicable for most medicines.
Microbial limit test is feasible for the determination of microorganisms in 10 proprietary Chinese medicines for children.
本研究旨在验证微生物限度检查法（平板培养法和薄膜过滤法）对10种儿童专用中成药的适用性。
本研究收集10种儿童专用中成药作为研究对象，采用平板培养法和薄膜过滤法计算这些药品中微生物的菌落形成单位（cfu），并验证其在控制菌检查中的适用性。
发现包括[此处原文应有具体微生物名称缺失]等微生物的回收率在70%至150%之间。此验证通过平板培养法或薄膜过滤法进行。对控制菌（[此处原文应有具体控制菌名称缺失]、B菌和耐胆盐革兰阴性菌）的检查适用于大多数药品。
微生物限度检查法用于测定10种儿童专用中成药中的微生物是可行的。
