黄芩苷微乳凝胶的微生物限度检测方法

Microbial limit test method for baicalin-loaded in microemulsion-based gel

目的:建立黄芩苷微乳凝胶的微生物限度检查方法。方法:按照《中华人民共和国药典》2020版四部通则,分别采用中和剂法及薄膜过滤法,以金黄色葡萄球菌、铜绿假单胞菌和枯草芽孢杆菌3种菌作为测试菌,进行计数法适应性实验;接种金黄色葡萄球菌及铜绿假单胞菌进行控制菌适用性试验。结果:薄膜过滤法中各试验菌回收比值均在0.5~2.0,中和剂法的回收比值不符合要求,控制菌适用性试验结果符合规定。结论:薄膜过滤法的微生物计数法可有效去除黄芩苷微乳凝胶的抑菌作用,控制菌检查合格,适用于其微生物限度检查。

Objective:To establish a microbial limit test method for baicalin-loaded in microemulsion-based gel.Methods:Neutralizing agent method and membrane filtration method were used according to the relevant provisions of Chinese Pharmacopoeia 2020 on the inspection.Staphylococcus aureus,Pseudomonas aeruginosa,and Bacillus subtilis were used as the test bacteria to carry out the adaptability experiments of counting method.Staphylococcus aureus and pseudomonas aeruginosa were inoculated to carry out applicability experiments of control bacteria.Results:The recovery ratio of each test bacteria in the membrane filtration method was in the range of 0.5~2.0 and fit the requirements,but the recovery ratio of the neutralizer method did not fit the requirements,and the test results of the control bacteria inspection method met the requirements.Conclusion:The microbial counting method of membrane filtration method can effectively remove the antibacterial effect of microemulsion-based gel,and the control bacteria inspection result is qualified,which is suitable for microbial limit inspection of microemulsion-based gel.