乳洁安缓释片的制备及体外释药  

Preparation of Rujiean sustained-release tablets and its in vitro drug release

作　　者：王燕燕[1] 张怡 屈勇 林宁[4] 

机构地区：[1]三峡大学第一临床医学院宜昌市中心人民医院,湖北宜昌443003 [2]武钢总医院药械中心,湖北武汉430080 [3]马应龙药业集团股份有限公司产品开发中心,湖北武汉430064 [4]湖北中医药大学药学院,湖北武汉430065

出　　处：《中国医院药学杂志》2012年第23期1890-1893,共4页Chinese Journal of Hospital Pharmacy

基　　金：湖北省科技攻关计划项目(编号:2004AA301C49);湖北省卫生厅科研基金项目(编号:JX3B53)

摘　　要：目的:研制乳洁安亲水凝胶缓释骨架片,进行体外释放度考察并解析其释药机制。方法:以羟丙基甲基纤维素(HPMC)为缓释骨架材料,通过正交设计优化处方,并考察释放介质黏度、pH值、溶出方法、转速及制片工艺等因素对缓释片体外释放度的影响。结果:正交设计获最优处方为A3B1C1,即HPMC作为亲水凝胶骨架材料,用量为40%,EC用量为10%,乳糖和MCC用量均为5%。药物体外释放行为符合Higuich方程。结论:该方法制得的缓释片具有良好的缓释效果,且制备工艺简单易行。OBJECTIVE To prepare Rujiean sustained-release tablets and study the release mechanism in vitro. METHODS The formulation of the Rujiean sustained-release tablets was selected by orthogonal design using HPMC as the matrix. Based on the optimized prescription, factors （ such as dissolution media, pH, dissolution method, rotational speeds, preparation technique and so on）affecting the in vitro dissolution were studied. RESULTS The optimized prescription was A3 B1 C1： HPMC as hydro philic gel matrices material,40% dosage; EC 10% dosage; each of lactose and MCC was 5%. The release of Rujiean sustained release tablets in vitro fitted the Higuich equation. CONCLUSION The tablets have desirable sustained-release capability. The formulation and technique are simple and can be applicable in production.

关 键 词：乳洁安 缓释片 制备工艺 释放度 

分 类 号：R944[医药卫生—药剂学]