正交试验优选洛伐他汀胶囊处方工艺  

Optimization of the Formulation and Technology of Lovastatin Capsule by Orthogonal Test

作　　者：刘会芳[1] 赵燕燕[2] 杜光玲[2] 陈青[3] 薛瑞[3] 

机构地区：[1]河北大学卫生职业技术学院,保定市071000 [2]河北大学医学实验中心,保定市071000 [3]河北大学药学院,保定市071000

出　　处：《中国药房》2008年第31期2435-2437,共3页China Pharmacy

基　　金：河北省科技攻关项目(42761220);河北省中医药管理局资助项目(05015);河北大学人才引进项目(y2004039);河北大学自然科学基金资助项目(2005Y08)

摘　　要：目的:优选洛伐他汀胶囊处方工艺。方法:设计正交试验优选最佳制备条件并进行体外溶出度试验。结果:根据单因素分析及正交试验结果,得最佳处方:以10%聚乙烯吡咯烷酮为黏合剂、羧甲基淀粉钠内外加法(2∶1)为崩解剂,并以颗粒装囊,二次制粒时以75%乙醇为润湿剂。优选工艺所制胶囊30min体外溶出度在92%以上。结论:该制剂工艺稳定,重现性好,体外溶出速率高。OBJECTIVE： To optimize the preparation technology for the lovastatin capsules. METHODS： Orthogonal test was used to optimize the conditions for the technology of preparation meanwhile a dissolution test was conducted. RESULTS： According to the results of the single factor analysis and orthogonal test, the optimal condition for the lovastatin capsules were as follows： agglomerant： 10%PVP; disintegrator： CMS-Na was used by combining exterior and interior addition （2 ： 1）; stuffing capsule by granules; wetting agent of twice granulating： 75% alcohol. The 30 min dissolution rate of the capsules prepared in the optimized technology reached above 92%. CONCLUSION： This preparation is stable in technology, reproducible and with high dissolution rate.

关 键 词：正交设计 洛伐他汀 聚乙烯吡咯烷酮 处方工艺 

分 类 号：R972.6[医药卫生—药品] R943[医药卫生—药学]