盐酸左氧氟沙星凝胶微生物限度检查方法验证

Validation of Microbial Limit Test for Levofloxacin Hydrochloride Gel

目的建立盐酸左氧氟沙星凝胶的微生物限度检查方法。方法加入钙离子(Ca2+)中和喹诺酮类抗菌药物的抗菌活性,并与凝胶中的卡波姆形成不溶性沉淀,从而破坏凝胶的大分子溶液稳定性,结合薄膜过滤、平皿法等方法对盐酸左氧氟沙星凝胶的微生物限度检查方法进行验证实验。结果盐酸左氧氟沙星凝胶的真菌及酵母菌数测定采用平皿法,其回收率>70%;细菌数测定需采用中和、离心及薄膜过滤法,其回收率<70%,而控制菌检查采用中和、离心及薄膜过滤法。结论盐酸左氧氟沙星凝胶的真菌及酵母菌计数和控制菌检查采用上述不同方法准确可行。细菌计数采用该方法存在一定风险,需进一步进行风险评估。

Objective To establish a microbial limit test for levofloxacin hydrochloride gel. Methods Ca^2＋ was added to neutralize the antibacterial activity of quinolone,and to form the insoluble precipitate by binding with carbomer, therefore destroying the stability of macromolecules in the gel. The microbial limit test for levofloxacin hydrochloride gel was confirmed combining with membrane filtration and plate methods. Results The normal plate counting was used in detecting the mold and yeast colony in the gel, the recovery was more than 70%.Simultaneously neutralization centrifugation and membrane filtration were used in bacterial count,with recovery less than 70%,and controlling bacteria test. Conclusion The method is accurate and practical for microbial limit test of levofloxacin hydrochloride gel, but is risky for bacterial counting and needs further risk assessment.