文献类型：期刊文献

中文题名：补骨脂酊微生物限度检查方法适用性试验研究

英文题名：Study on the applicability test methodology for microbial limit testing of Buguzhi Ding(补骨脂酊)

作者：李待军[1];罗飞[2];王引弟[2];刘佳[2];彭倩[3];刘铭佩[3];戴余雯[3];果茵茵[3];黄燕[3]

第一作者：李待军

机构：[1]甘肃中医药大学附属医院药学部,甘肃兰州730020;[2]兰州大学第二临床医学院,甘肃兰州730000;[3]兰州大学第二医院药剂科,甘肃兰州730030

第一机构：甘肃中医药大学第二附属医院

年份：2025

卷号：42

期号：4

起止页码：52

中文期刊名：甘肃中医药大学学报

外文期刊名：Journal of Gansu University of Chinese Medicine

基金：甘肃省自然科学基金项目(23JRRA1623,23JRRA1622)。

语种：中文

中文关键词：补骨脂酊;微生物限度检查;薄膜过滤;方法适用性试验

外文关键词：Buguzhi Ding(补骨脂酊);microbial limit test;membrane filtration;method applicability testing

摘要：目的建立补骨脂酊的微生物限度检查方法。方法依据《中华人民共和国药典(四部)》2020年版通则项下规定,应用常规法、培养基稀释法及薄膜过滤法进行补骨脂酊微生物限度检查适用性试验。结果在建立的补骨脂酊微生物限度检查方法中,5种试验菌株的回收比值均在0.5~2.0范围内,控制菌(金黄色葡萄球菌、铜绿假单胞菌)能够正常检出,阴性对照组未检出。结论可采用薄膜过滤法进行补骨脂酊微生物限度检查方法适用性试验。该方法操作简单、结果准确可靠,适用于补骨脂酊的质量控制。
Objective To establish a microbial limit testing method for Buguzhi Ding(补骨脂酊).Methods In accordance with the 2020 edition of the Pharmacopoeia of the People's Republic of China(Part IV),applicability tests were conducted using conventional methods,medium dilution methods,and membrane filtration methods.Results Under the established microbial limit testing protocol,recovery ratios of all five tested microbial strains fell within the range of 0.5-2.0.Controlled strains(Staphylococcus aureus and Pseudomonas aeruginosa)were effectively detected,with no positive results observed in the negative control group.Conclusion The membrane filtration method is suitable for microbial limit testing of Buguzhi Ding.This method demonstrates operational simplicity,accuracy,and reliability,and is applicable for quality control purposes.