红花黄色素缓释骨架片的研制及其体外释放度的研究  

The Preparation of Safflower Yellow Sustained-release Matrix Tablets and Their Drug Release in Vitro

作　　者：刘中垒[1] 李国玉[1] 谭勇[1] 史彩虹[2] 刘金荣[1] 王金辉[1,2,3] 

机构地区：[1]石河子大学药学院,石河子832002 [2]沈阳药科大学中药学院,沈阳110016 [3]新疆特种植物药资源省部共建重点实验室,石河子832002

出　　处：《石河子大学学报（自然科学版）》2009年第3期328-333,共6页Journal of Shihezi University(Natural Science)

基　　金：国家"十一五"支撑计划项目(2006BAI06A15-14)

摘　　要：制备红花黄色素缓释骨架片,研究其体外药物释放的主要影响因素及其释药机理。以羟丙基甲基纤维素（HPMC）和盐酸壳聚糖为主要骨架材料,采用湿制粒法制备红花黄色素缓释骨架片,并研究HPMC和盐酸壳聚糖含量、片重、片剂硬度、释放介质的pH值和转速等因素对其药物释放性能的影响。最佳制剂工艺条件为HPMC含量（30%）、盐酸壳聚糖含量（3%）、片重（450mg）、片剂硬度（8~10kg）;HPMC和盐酸壳聚糖的含量对药物释放行为影响较大;片重、片剂硬度、溶出介质的pH值和转速对药物释放行为影响较小。按最佳制剂工艺条件制备的红花黄色素缓释骨架片体外药物释放机制为符合R itger-Peppas释药模型的Non-F ick扩散,能维持药物在24h内缓慢释放。To prepare the safflower yellow sustained-release matrix tablets and to study their drug-release main influencing factors and mechanism in vitro. The safflower yellow sustained-release matrix tablets were made of HPMC and chitosan hydroehloride both which were used for gel-matrix material by means of wet granulation, and were investigated on their drug-release main influencing factors such as the content of HPMC and chitosan hydrochloride, tablet weight, tablet hardness, pH value in dissolution medium, rotational speed and so on. Optimal preparing technique consists of HPMC （ 30% ）, chitosan hydrochloride （ 3 % ）, tablet weight （450 mg） and tablet hardness （ 8 - 10 kg）. The content of HPMC and chitosan hydrochloride influence drug-release characteristic most obviously while tablet weight, tablet hardness, pH value in dissolution medium and rotational speed effect not so much. The safflower yellow sustained-release matrix tablets prepared according to optimal preparing technique can get sustained-release conforming to Ritger-Peppas Model within 24 hours, and the drug release mechanism is Non-Fiek diffusion.

关 键 词：红花黄色素 缓释片 骨架片 释药机制 

分 类 号：R969[医药卫生—药理学]