洛索洛芬钠缓释片的制备与体外释放度研究  

Preparation and in vitro release of loxoprofen sodium sustained-release tablets

作　　者：陈志龙[1] 柳萌萌[1] 苏晓丹[1] 廖翔茹 谢向阳[1] 刘辉[1] CHEN Zhi-long LIU Meng-meng SU Xiao-dan LIAO Xiang-ru XIE Xiang-yang LIU Hui(Department of Pharmacy, Wuhan General Hospital of Guangzhou Military Command, Wuhan 43007)

机构地区：[1]广州军区武汉总医院药剂科,武汉430070

出　　处：《中南药学》2016年第11期1219-1223,共5页Central South Pharmacy

摘　　要：目的制备洛索洛芬钠缓释片并优化处方。方法采用高剪切湿法制粒工艺制备洛索洛芬钠缓释片,以HPMC K15M和HPMC K100M的用量为考察因素,以2、6、10 h的累积释放度为评价指标,利用中心复合设计-效应面法优化处方,并考察了洛索洛芬钠缓释片在4种释放介质中的体外释药行为。结果洛索洛芬钠缓释片中HPMC K15M和HPMC K100M的用量各占片重的15.0%和45.0%时,制备的洛索洛芬钠缓释片在12 h内能够平稳释药且释药完全。结论采用中心复合设计-效应面法优化的洛索洛芬钠缓释片处方释放度符合要求,有望应用于工业生产。Objective To prepare and optimize the formulation of loxoprofen sodium sustained-release tablets. Methods Loxoprofen sodium sustained-release tablets were prepared with high shear wet granulation tabletting process. The formulation variables were optimized by central composite design-response surface methodology of HPMC K15 M and HPMC K100 M as the independent variables and the accumulative release percentages at 2, 6, and 10 h as the dependent variables. The in vitro drug release behaviors of loxoprofen sodium sustainedrelease tablets were studied. Results The optimized formulation contained 15.0% of HPMC K15 M and 45.0% of HPMC K100 M of the total tablet weight, and in vitro release data proved that the loxoprofen sodium from sustained-release tablets was steady and complete within 12 h. Conclusion Central composite design-response surface methodology is successfully used to optimize the formulation of loxoprofen sodium sustained-release tablets, and this preparation technology may be used in industrial production.

关 键 词：洛索洛芬钠 缓释片 高剪切湿法制粒 中心复合设计-效应面法 释放度 

分 类 号：R94[医药卫生—药剂学]