盐酸小檗碱缓释片的研制  

Study on Preparation of Berberine Hydrochloride Sustained-release Tablets

作　　者：初明[1] 刘彦辰[2] 张明波[2] 初正云[2] 徐兰[1] 周鹏[1] 杨柯[1] 马小龙[1] 陈晓芹[3] 梁秀军[4] 王月丹[1] 

机构地区：[1]北京大学医学部基础医学院,北京100191 [2]辽宁中医药大学,辽宁大连116600 [3]首都医科大学,北京100069 [4]承德医学院,河北承德067000

出　　处：《现代生物医学进展》2016年第23期4415-4418,共4页Progress in Modern Biomedicine

基　　金：北京市重点学科基础医学学科建设项目(BMU20110254);国家基础科学人才培养基金(J1030831/J0108);北京大学创新人才培养计划

摘　　要：目的:研究盐酸小檗碱缓释片的配方与制备方法,考察其释放度。方法:以盐酸小檗碱释放度为考察指标,采用单因素试验法,考察了羟丙基甲基纤维素(HPMC)和乳糖的用量对药物体外释放行为的影响,并采用正交设计实验对处方进行优化,确定最佳处方。结果:最佳配方为HPMC-K4M的用量为10%,乳糖用量为20%,PVP的用量为3%,微晶纤维素的用量为20%。2 h累积释药量为30%,6 h累积释药量为60%,12 h累积释药量为90%。结论:按最佳配方制备的盐酸小檗碱缓释片有较好的缓释行为,基本上能满足缓释片的释放要求。Objective： Study the formulation and preparation methods of Berberine hydrochloride sustained-release tablets, and investigate its release rate. Methods： With the release rate of Berberine hydrochloride as investigation index, using single factor test method, studied the impact of the amount of hydroxypropyl methyl cellulose（HPMC,） and lactose on release behavior in vitro drug, and determined the best prescription by orthogonal design to the optimize prescription. Results： Best formula is： HPMC-K4 M in an amount of10 %, the amount of lactose 20 %, PVP in an amount of 3 %, microcrystalline cellulose in an amount of 20 %. 2 h accumulated release amount is 30 %, 6 h cumulative release amount of 60 %, and 12 h accumulated release amount is 90 %. Conclusion： Berberine hydrochloride sustained-release tablets prepared according to the best recipes have better release behavior, can basically meet the requirements of sustained-release tablets.

关 键 词：盐酸小檗碱 缓释片 释放度 体外释放 

分 类 号：R-332[医药卫生] R285