葛根素骨架缓释片的研制及体外释放评价  

Preparation and in vitro Release Evaluation of Puerarin Sustained-Release Tablet

作　　者：周珊珊[1] 谭睿[1] 谢彬[1] 马向华[1] 张娥[2] 顾健[2] 

机构地区：[1]西南交通大学,成都610031 [2]西南民族大学,成都610051

出　　处：《中国实验方剂学杂志》2013年第3期23-26,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(81173594);四川省应用基础项目(2012JY0025);成都市科技局项目(11DXYB263JH-027);中央高校基本科研业务费专项(11NZYTH02)

摘　　要：目的:研制葛根素骨架缓释片,并评价其体外释药机制。方法:以不同型号的羟丙甲基纤维素(HPMC K100M,HPMC E4M)混合物为骨架材料,采用湿法制粒压片制备葛根素骨架缓释片,以葛根素释放度为指标,采用单因素试验法对缓释片的处方进行优化;通过测定释放度,考察葛根素骨架缓释片的体外释放模型。结果:优选的处方为HPMC K100M和HPMC E4M作为复合骨架材料,质量分数分别为片剂总质量的10%,20%;乳糖为填充剂,质量分数为片剂总质量的30%。制备的葛根素骨架缓释片释放规律符合Ritger-Peppas方程曲线,释药过程为药物扩散和骨架溶蚀协同作用。结论:葛根素骨架缓释片处方合理,制备工艺可行,制备的葛根素骨架缓释片具有良好的12 h体外释药特性。Objective： To prepare puerarin sustained-release tablet and investigate its in vitro release mechanism. Method： With mixture of different types of hydroxypropyl methylcellulose （HPMC K100M, HPMC E4M） as skeleton material, puerarin sustained-release tablet was prepared by wet granulation tabletting method, with release of puerarin as index, formulation of sustained-release tablet was optimized by single factor test; In vitro release model of puerarin skeleton sustained-release tablet was investigated by determining release. Result： Optimized prescription was： HPMC K100M and HPMC E4M as compound matrix, the mass fraction of them were 10% , 20% , respectively; Lactose as filler, the mass fraction of it was 30%. Release law of prepared sustained- release tablet complied with Ritger-Peppas equation curve, release process was synergistic reaction of drug diffusion and skeleton dissolution. Conclusion： Prescription of prepared puerarin sustained-release tablet was reasonable, preparation technology was feasible, prepared puerarin sustained-release tablet had good in vitro release characteristics in 12 h.

关 键 词：葛根素 骨架缓释片 制备工艺 释药机制 

分 类 号：R283.6[医药卫生—中药学]