瑞舒伐他汀钙口腔崩解片的制备工艺优化  

Optimization of the Preparation Technology of Rosuvastatin Calcium Orally Disintegrating Tablets

作　　者：侯娟[1] 王静[2] 张妮妮[2] 谷亚茜 

机构地区：[1]河北医科大学第四医院,石家庄050011 [2]河北医科大学药学院,石家庄050017

出　　处：《中国药房》2013年第45期4270-4272,共3页China Pharmacy

基　　金：河北省2011年医学科学研究重点课题计划(No.20110124)

摘　　要：目的:制备瑞舒伐他汀钙口腔崩解片,优化其处方和制备工艺。方法:采用直接压片法制备瑞舒伐他汀钙口腔崩解片;以5 min溶出度和崩解时限为指标,以交联聚维酮(PVPP)质量百分比(A)、甜味剂总质量比(B)、甘露醇-乳糖质量比(C)为因素,采用正交试验优化处方;再进行验证试验考察最优处方制备的崩解片的5 min溶出度和崩解时限,并考察其30 min内的累积溶出百分率。结果:优化后A为12%,B为4%,C为1∶2;验证试验结果显示5 min溶出度为97.9%,崩解时限为32.28 s,30 min内累积溶出百分率平均为105.93%。结论:该制剂制备简单、处方合理,崩解和溶出均较快。OBJECTIVE： To prepare Rosuvastatin calcium orally disintegrating tablets and to optimize its formulation and prepa- ration technology. METHODS： Rosuvastatin calcium orally disintegrating tablets were prepared by direct compression process. The formulation was optimized by orthogonal design with 5 rain dissolution rate and disintegration time as index using the percentage of PVPP （A）, ratio of edulcorant （B） and ratio of mannitol to lactose （C） as factors. The 5 rain dissolution rate and disintegration time of disintegrating tablets prepared by optimized formulation were investigated by verification test, and the accumulative release percentage of disintegrating tablets was also investigated. RESULTS： The optimal formulation was as follows： A 12%, B 4%, C 1：2; 5 min dissolution rate of 97.9%, disintegration time of 32.28 s, accumulative release percentage of 105.93% within 30 min. CON- CLUSIONS： The preparation is simple in preparation technology and reasonable in formulation, and can disintegrate and dissolute rapidly.

关 键 词：瑞舒伐他汀钙 口腔崩解片 制备 优化 正交试验 溶出度 崩解时限 

分 类 号：R972.6[医药卫生—药品] R943[医药卫生—药学]