氧氟沙星凝胶微生物限度检查方法研究  

Research on the Method of Microbial Limit Test for Ofloxacin Gel

作　　者：毛腾霄 熊雯 秦玉花[2] 

机构地区：[1]成都市食品药品检验研究院,成都610041 [2]成都中医药大学基础医学院,成都610072

出　　处：《中国药房》2015年第18期2559-2561,共3页China Pharmacy

摘　　要：目的:建立氧氟沙星凝胶的微生物限度检查方法。方法:采用不同浓度的硫酸锰、氯化钙、氯化镁破胶制备供试液,采用薄膜过滤法检查细菌数和控制菌,同时采用常规法检查霉菌和酵母菌数。结果:不以破胶剂处理制备供试液,经常规法检查,白色念珠菌和黑曲霉的回收率均>70%;以5%硫酸锰、3%氯化钙、1%氯化镁处理制备的供试液,经薄膜过滤法检查,大肠埃希菌、金黄色葡萄球菌和枯草芽孢杆菌的回收率均>70%;以破胶剂处理制备的供试液,经薄膜过滤法检查,能正常检出控制菌。结论:加入适当浓度的破胶剂能够有效消除氧氟沙星凝胶的抑菌性。所建立的方法适用于该制剂的微生物限度检查。OBJECTIVE：To establish a method for the identification and content determination of leguminosae in Qizhu bishi granules. METHODS：Thin layer chromatography（TLC） was used to identify the leguminosae. HPLC-ELSD was used to determine the content of astragaloside A in leguminosae. The column was Diamonsil C18 with the mobile phase of acetonitrile-water（32 ∶68,V/V）at the flow rate of 1.0 ml/min,the column temperature was 40 ℃. The sample size was 20 μl. The drift tube temperature was 108 ℃ with the nitrogen gas flow rate of 2.8 ml/min. RESULTS：The TLC features of leguminosae were obvious with clear spots and good specificity. Astragaloside A had a good linear relationship in the range of 0.402 4-4.02 μg（r=0.997 0）. RSDs of precision,stability and reproducibility tests were≤0.8%. The average recovery was 99.00%（RSD=1.29%,n=9）. CONCLUSIONS：The method is simple,accurate and reliable and can be used for the quality control of Qizhu bishi granules.

关 键 词：氧氟沙星凝胶 微生物限度检查 破胶剂 薄膜过滤法 

分 类 号：R927.1[医药卫生—药学]