国产盐酸左氧氟沙星片的溶出度比较  

Comparison of dissolution for domestic-made Levofloxacin hydrochloride tablets

作　　者：刘琦[1] 陆益红[2] 杭太俊[1] 

机构地区：[1]中国药科大学,南京210009 [2]江苏省食品药品检验所,南京210008

出　　处：《北方药学》2011年第1期9-10,共2页Journal of North Pharmacy

摘　　要：目的:对25批国产盐酸左氧氟沙星片的溶出情况进行比较。方法:采用《中国药典》2010年版方法,对25批不同厂家的片剂在水、pH6.8磷酸盐缓冲液、pH4.5磷酸盐缓冲液、0.1mol/l盐酸溶液中的溶出行为进行测定,并比较相似因子。结果:盐酸左氧氟沙星片剂在不同溶剂中的溶出行为不同。结论:不同厂家生产的制剂质量存在差异,水作为溶剂可较好的分辨。部分企业的生产工艺有待改进以提高产品质量。Objective：To compare the dissolution of domestic-made levofloxacin hydroehloride tablets. Method： By using the method 2 in appendix X C of China Pharmacopoeia （2005 edition）, the dissolution profiles of levofloxacin hydrochloride tablets from different pharmaceutical manufacturers were detemined in the following 4 mediums： 0.1 tool· L-1 hydrochloric acid solution, pH 4.5 phosphate buffer solution, pH 6.8 phosphate buffer solution and water. And the similar faetor was eompared. Results： The dissolution courses of levofloxacin hydroehloride tablets were different in different mediums. Conelusion： There are differences among the quality of levofloxacin hydroehloride tablets from different manufactures. Water is more suitable to distinguish the differences as compared to other dissolution mediums. Some manufactures need to improve the product quality by changing the formulation and process.

关 键 词：盐酸左氧氟沙星 片剂 溶出度 相似因子 

分 类 号：R927.1[医药卫生—药学]