正交试验优化盐酸特拉唑嗪渗透泵控释片生产工艺  

Preparation of oral osmotic pump tablets of terazosin hydrochloride

作　　者：马廷升[1] 李高[2] 宋思才 刘志华[1] 朱兰寸[1] 

机构地区：[1]怀化医学高等专科学校药学系,湖南怀化418000 [2]华中科技大学同济医学院药学院,武汉430030 [3]怀化正好制药有限公司,湖南怀化418000

出　　处：《中南药学》2011年第4期252-254,共3页Central South Pharmacy

基　　金：湖南省教育厅自然科学基金资助项目(编号:07C058)

摘　　要：目的研究盐酸特拉唑嗪渗透泵控释片生产的最佳工艺。方法采用正交实验设计L9(34),以药物25 h累积释药百分率为评价指标筛选工艺。结果优选实验因素:促渗剂用量为(w/w)20%、促渗透聚合物CMC-Na用量(w/w)为6%、包衣液增重(w/w)为4%、释药孔径为600μm。渗透泵控释片25 h累积释药百分率平均值为82.6%,RSD为2.65%(n=5)。结论由正交试验筛选制备盐酸特拉唑嗪渗透泵控释片的工艺条件是可靠的,为该药的靶向制剂、缓控制剂的药剂学研究奠定基础。Objective To determine the best preparation craft of oral osmotic pump tablets of terazosin hydrochloride.Methods Taking the 25 h cumulative drug delivering percentage as the index,the oral osmotic pump tablets of terazosin hydrochloride were prepared by ultrasonic dispersing method with orthogonal design L9（34）.Results Optimal experiment factors were as follows： the dosage of penetration enhancers agent was 20%（w/w）,the dosage of penetration enhancers polymer CMC-Na was 6%（w/w）,the weight increment of coating liquid was 4%（w/w）,and the aperture of drug delivering was 600 μm.The average cumulative delivering percentage of drug was 82.6%,and RSD was 2.65%（n=5）.Conclusion The preparation of oral osmotic pump tablets of terazosin hydrochloride by ultrasonic dispersing method and orthogonal design is suitable,which lays the foundation for the extended-release preparation study.

关 键 词：盐酸特拉唑嗪 控释片 渗透泵 生产工艺 正交试验 

分 类 号：R944.9[医药卫生—药剂学]