复方莨菪碱缓释片的制备及体外释放特性  

Preparation of Compound Hyoscyamine Sustained-release Tablets

作　　者：王雪明[1] 冯端浩[1] 魏荣[1] 曹颖[1] 刘蔚[1] 

机构地区：[1]中国人民解放军总医院第二附属医院药剂科,北京100091

出　　处：《解放军药学学报》2006年第1期38-40,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的制备复方莨菪碱缓释片。方法用正交试验优化处方,以羟丙甲基纤维素为骨架材料,用疏水性阻滞剂乙基纤维素调节药物释放速度,采用湿法制粒压片制备复方莨菪碱缓释片。用紫外分光光度法测定主药氨茶碱的含量,用HPLC法测定其他组分的含量。通过测定氨茶碱的体外释放度,进行释放机制及影响因素的研究。结果所制备的缓释片12h内呈现良好的缓释特性,符合Higuchi方程(Q=24.176t1/2-7.699,r=0.9956)。结论复方莨菪碱缓释片体外释药缓慢、平稳,符合设计要求。Aim To prepare compound hyoscyamine sustained -release tablets and investigate its quality. Methods Orthogonal design was utilized to obtain the best formula. The hydrophilic matrix hydroxypropyl methylcellulose （HPMC） was used to prepare sustained-release tablets by the wet granule compression technique. Ethylcellulose（EC） was used to adjust the releasing rate. The content of the major drug was determined by UV spectrophotometry at 275nm. The other componients were determined by HPLC. The release mechanic and the influence factors were studied by determining the dissolution. Results The drug release curves in-vitro showed that the drug release could be best described by the Higuchi equation（Q = 24.176t^1/2- 7.699, r = 0.995 6）. Conclusion The sustained-release tablets achieved the intendecl goal.

关 键 词：复方莨菪碱 缓释片 体外释放度 

分 类 号：R943[医药卫生—药剂学]