关节解痛膏微生物限度检查方法学验证

Validation of Microbial Limit Test Method of Joint Pain Relieving Ointment

目的:建立适用于关节解痛膏微生物限度的检测方法。方法:根据《中国药典》2020年版微生物限度检查法的相关规定,采用薄膜过滤法对该品种控制菌铜绿假单胞菌和金黄色葡萄球菌进行微生物限度方法适用性试验。结果:铜绿假单胞菌和金黄色葡萄球菌检查采用薄膜过滤法,冲洗量300 mL,方法可行。结论:该方法适用于关节解痛膏微生物限度检查,方法可操作性强、准确性高。

Objective:To establish a microbial limit test method for Joint pain relieving ointment.Methods:According to the provisions of microbial limit test method of Chinese Pharmacopoeia 2020 edition,membrane filtration method was used to test the applicability of microbial limit method for pseudomonas aeruginosa and staphylococcus aureus.Results:Pseudomonas aeruginosa and staphylococcus aureus were examined by membrane filtration method with a washing volume of 300 mL,which was feasible.Conclusion:This method is workable and veracity for microbial limit examination of Joint pain relieving ointment.