中心复合设计法优化维生素C阴道生物黏附缓释片处方  

Formulation Optimization of Vitamin C Vaginal Bioadhesive Sustained-release Tablets by Central Composite Design

作　　者：邱黎娜[1] 柯学[1] 田超[1] 陈艺[1] 

机构地区：[1]中国药科大学药剂学教研室,江苏南京210009

出　　处：《药学进展》2011年第11期515-520,共6页Progress in Pharmaceutical Sciences

基　　金：十一五新药重大专项新制剂与新释药系统技术平台项目(No.2009ZX093102-004)

摘　　要：目的:制备维生素C阴道生物黏附缓释片,考察其释放和黏附性能的影响因素,并运用中心复合设计法优化处方。方法:选用羟丙甲纤维素和卡波普分别作为骨架材料及生物黏附材料制备缓释片,采用自制装置测定缓释片的生物黏附力,应用相似因子法评价不同处方工艺制备的缓释片释放行为;以缓释片的生物黏附力和释放度综合评分为评价指标,对羟丙甲纤维素和卡波普的用量进行多元线性回归和二项式拟合,预测最优处方。结果:经预测分析,获得最优处方,且由此优化处方制备的缓释片各评价指标的实验值与预测值很接近。结论:应用中心复合设计法优化维生素C阴道生物黏附缓释片处方,切实可行。Objective：To prepare vitamin C vaginal bioadhesive sustained-release tablets,to investigate the influencing factors on their release and bioadhesive profiles and to apply central composite design to optimize their formulation.Methods：The sustained-release tablets were prepared by using hydroxypropyl methyl cellulose（HPMC） as the matrix material and carbopol as the bioadhesive material.The biohensive force of the tablets was measured by self-made device,and the release profiles of the tablets prepared based on different formulations were evaluated by similarity factor method.The optimal formulation was predicted by using the bioadhesive force and total release score as indicators,and the amounts of HPMC and carbopol as factors via multiple linear regression and binomial fitting.Results：The optimal formulation was obtained by the predictive analysis.The observed and predicted values of the indicators for the tablets prepared with the optimal formulation were closely fitted.Conclusion：The application of central composite design in optimization of the formulation of vitamin C vaginal bioadhesive sustained-release tablets is practicable.

关 键 词：维生素C 生物黏附缓释片 中心复合设计 处方优化 

分 类 号：R944.9[医药卫生—药剂学]