3厂家罗格列酮片的体外溶出度比较研究  

Comparison of External Dissolution of Rosiglitazone Tablets Produced by 3 Manufactures

作　　者：叶金伟[1] 

机构地区：[1]浙江省丽水市中心医院药剂科,浙江丽水323000

出　　处：《中国药业》2007年第9期9-10,共2页China Pharmaceuticals

摘　　要：目的比较3种不同厂家生产的罗格列酮片的体外溶出度。方法以盐酸溶液(9→1000)为溶出介质,采用2005年版《中华人民共和国药典(二部)》中溶出度测定法第3法测定溶出度;用紫外分光光度法测定溶出量,计算累积溶出百分率,并以威布尔公式计算溶出参数T50,Td,m值,并对参数进行t检验。结果3厂家的罗格列酮片在45min内的累积溶出百分率均达70%以上,但其溶出度参数T50及Td值有显著性差异(P<0.05)。结论3厂家的罗格列酮片均符合质量标准,但不同厂家的产品之间有差异。Objective To compare the external dissolution of rosiglitazone tablets produced by 3 pharmaceutical manufacturers, Methods The dissolution test was carried out according to the 3rd method in Chinese Pharmacopoeia （2005 edition） using hydrochloric acid （9→1 000） as a solvent. UV spectrophotometry was used to determined the content of rosiglitazone. The accumulative release was calculated and the Weibull＇s equation was used to model the main dissolution parameters of T50, Td, and m, then which were analyzed by t- test, Results The accumulated release of rosiglitazone tablets produced in 3 pharmaceutical manufacturers at 45 min was over 70% ,but significant differences were found in parameters of T50, Td（ P 〈 0.05）. Conclusion The rosiglitazone tablets produced in 3 pharmaceutical manufacturers are within the quality standards,but there is the quality difference among them.

关 键 词：罗格列酮片 溶出度 紫外分光光度法 溶出参数 

分 类 号：R927.11[医药卫生—药学] R977.15