淫羊藿组分缓释制剂的研究  

Study on sustained release preparations of Epimedium component

作　　者：严红梅[1,2,3] 丁冬梅[2,3] 张振海[2,3] 孙娥[2,3] 宋捷[2,3] 贾晓斌[1,2,3] 

机构地区：[1]南京中医药大学,江苏南京210046 [2]南京中医药大学附属中西医结合医院 [3]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028

出　　处：《中国中药杂志》2015年第8期1484-1488,共5页China Journal of Chinese Materia Medica

基　　金：江苏省中医药领军人才基金项目(2006);苏州2013年科技发展计划医疗器械与新医药专项(ZXY2013022)

摘　　要：筛选淫羊藿组分缓释片的处方,建立体外释放评价方程。采用胶态二氧化硅辅助喷雾干燥淫羊藿组分,并以其为主药制备缓释片。以主要成分宝藿苷Ⅰ的溶出度为评价指标考察骨架材料类型、填充剂、致孔剂、润滑剂等辅料对缓释片质量的影响,并采用干法压片工艺制备出淫羊藿组分缓释片。所筛选的缓释片处方为主药35%,羧甲基纤维素HPMC K_(4M)20%和HPMC K_(15M)10%为骨架材料,微晶纤维素31%,PEG6000 2%,硬脂酸镁2%。该处方条件下制备的淫羊藿组分缓释片体外持续8 h释药达80%。零级方程、一级方程及Higuchi方程等都能较好模拟缓释片体外释放特征,其相关系数r均大于0.96。其中一级方程与体外释放特征最相似,其相关系数r为0.995 0。该制备方法操作简单,处方筛选结果真实可靠,可为淫羊藿组分缓释制剂的生产制备提供思路和方法指导。The formulation for sustained release tablet of Epimedium component was selected and the evaluation equation of in vitro release was established. The liquidity of component was improved with the help of colloidal silica aided by spray drying, which would be the main drug in the sustained release tablets. Dissolution was selected as an evaluation index to investigate skeletal material type, fillers, impact porogen, lubricants and other materials on the quality of sustained release tablet. The sustained release tablets were pre- pared by dry compression. Formulation of sustained release preparations was main drug 35%, HPMC K4M 20% and HPMC KlsM 10% as skeleton material, MCC 31% as filler, PEG6000 2% as porogen and magnesium stearate 2% as lubricant. The sustained release tablets released up to 80% in 8 h. The zero order equation, primary equation and Higuchi equation could simulate the release charac- teristics of sustained release tablets in vitro, the correlation coefficients r were larger than 0. 96. The primary equation was most similar in vitro release characteristics and its correlation coefficient r was 0. 995 0. The preparation method is simple and the results of formula- tion selection are reliable. It can be used to guide the production of Epimedium component sustained release preparations.

关 键 词：淫羊藿组分 缓释片 体外释放 胶态二氧化硅 

分 类 号：R283.6[医药卫生—中药学]