【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。更多还原

【Abstract】 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.更多还原