8个不同厂家盐酸洛美沙星胶囊体外溶出度比较  

Comparison of dissolution in vitro of lomefloxacin capsule of eight pharmaceutical factories

作　　者：李倚云 王威 闻琍毓 

机构地区：[1]江苏省扬州药品检验所,扬州225009

出　　处：《天津药学》2011年第6期14-16,共3页Tianjin Pharmacy

摘　　要：目的:比较8个不同厂家生产的盐酸洛美沙星胶囊的体外溶出情况,以考察产品质量。方法:采用转篮法(转速为100 r/min)进行体外溶出度试验,以紫外分光光度法测定洛美沙星的含量,分别以盐酸溶液(0.1 mol/L)、水、磷酸盐缓冲液(pH 6.8)和醋酸盐缓冲液(pH 4.0)为溶出介质,测定盐酸洛美沙星胶囊的溶出度。结果:8个厂家的盐酸洛美沙星胶囊在盐酸溶液(0.1 mol/L)的溶出介质中30 min溶出量均达到80%以上,在其他不同溶出介质中溶出差异大。结论:不同厂家产品质量和生产工艺存在差异。Objective： To compare the dissolution in vitro of lomefloxaein eapsule of eight pharmaceutical factories so as to in- spect the product quality. Methods ：The dissolution tests were carried out using basket -rotating method at 100 r/min and tested by UV method.. The dissolubility in vitro of lomefloxaein capsule of eight harmaeeutieal faetories was inspected in the following 4 me- diums ： hydrochloric acid solution（ 0.1 mol/L } , water, pH 6.8 phosphate buffer solution and pH 4.0 acetate buffer solution. Re- suits： The cumulative dissolution of all lomefloxaein capsule in 30 min was over 80% when the mediums were regulated in hydrochloric acid solution { 0.1 mol/L）. However, when the mediums were regulated in other mediums, the differences come out. Conclusion ： There are significant differences among the quality and production processes of the lomefloxacin capsule of different pharmaceutical factories.

关 键 词：盐酸洛美沙星胶囊 溶出度 相似因子 

分 类 号：R927.11[医药卫生—药学]