蜂珍膏微生物限度检查方法适用性研究

Study on Applicability of Microbial Limit Test for Honeyzheng Ointment

目的:建立蜂珍膏的微生物限度检查方法。方法:按照《中国药典》2015年版四部通则进行蜂珍膏微生物限度检查方法适用性试验。以试验菌株的回收率为指标,考察需氧菌总数、霉菌和酵母菌总数计数方法;建立控制菌金黄色葡萄球菌和铜绿假单胞菌的检查方法。结果:采用平皿法通过增加供试品稀释液法(1∶100)检查需氧菌数;采用平皿法通过增加供试品稀释液法(1∶50)检查霉菌、酵母菌计数;采用培养基稀释法检查金黄色葡萄球菌,控制菌检查常规法检查铜绿假单胞菌。结论:所建立的方法适用于蜂珍膏的质量控制。

Objective:To establish a microbial limit test method for Honeyzheng ointment. Methods: According to the general principles on the Chinese Pharmacopoeia 2015 edition volume IV, the applicability of microbial limit test method for honeyzheng ointment was established. The total aerobic bacteria, mold and yeast counting methods were investigated with the recovery rate of the tested strains as the index, and the detection methods for controlling bacteria Staphylococcus aureus and Pseudomonas aeruginosa were established. Results: The number of aerobic bacteria, mold and yeast, Pseudomonas aeruginosa and Staphylococcus aureus were detected by increasing diluent method(1∶100),(1∶50), medium dilution method and routine method, respectively. Conclusion: The established method is suitable for the quality control of Honeyzheng ointment.