国产盐酸环丙沙星片及胶囊溶出度比较

Comparison of dissolution for domestic-made ciprofloxacin hydrochloride tablets and capsules

目的:比较国内不同药厂盐酸环丙沙星片剂和胶囊的溶出情况。方法:采用中国药典2005年版所述方法,测定了不同厂家盐酸环丙沙星片和胶囊在0.1mol·L-1盐酸溶液中的溶出曲线并采用相似因子法分析结果。同时考察了制剂在pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液和水3种溶出介质中的体外溶出行为。结果:片剂呈现5种溶出过程,胶囊呈现4种溶出过程,制剂在不同溶出介质中溶出行为不同。结论:不同厂家生产的制剂质量存在差异,国产药品的质量有待提高。

Objective：To evaluate the quality of ciprofloxacin hydrochloride tablets and capsules by determining the dissolution of tablets and capsules from different manufactures.Methods：The dissolubility of different ciprofloxacin hydrochloride products was determined with the related standard procedure indexed in China Pharmacopoeia （2005 edition）.The dissolubility was also inspected in the following 3 mediums：pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution and water.Results：The cumulative dissolutions of tablets and capsules were shown 5 and 4 kinds of dissolution process respectively.The dissolution courses were different in different mediums.Conclusion：There are differences among the quality of ciprofloxacin hydrochloride tablets and capsules from different manufactures.The quality of domestic-made preparations needs to be improved.