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.
作者
李待军
罗飞
王引弟
刘佳
彭倩
刘铭佩
戴余雯
果茵茵
黄燕
LI Daijun;LUO Fei;WANG Yindi;LIU Jia;PENG Qian;LIU Mingpei;DAI Yuwen;GUO Yinyin;HUANG Yan(Department of Pharmacy,Affiliated Hospital of Gansu University of Chinese Medicine,Lanzhou,Gansu,730020,China;The Second Clinical Medical College,Lanzhou University,Lanzhou,Gansu,730000,China;Department of Pharmacy,the Second Hospital of Lanzhou University,Lanzhou,Gansu,730030,China)
出处
《甘肃中医药大学学报》
2025年第4期52-56,共5页
Journal of Gansu University of Chinese Medicine
基金
甘肃省自然科学基金项目(23JRRA1623,23JRRA1622)。
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
Buguzhi Ding(补骨脂酊)
microbial limit test
membrane filtration
method applicability testing
