摘要
目的:星点设计-效应面法优化阿昔洛韦口腔贴片处方。方法:以羟丙甲纤维素(HPMC)K4M和卡波姆974P NF的用量为因素,以阿昔洛韦在1 h,5 h和12 h的释放度和黏附力为指标,用多元线性方程、双因素模型和二次多项式模型分别描述各指标与因素的关系,根据较优数学模型绘制效应面图;各指标效应面二维等高线图的重叠部分,即为最佳处方区域,选择最佳处方,并进行预测分析。结果:二次多项式模型拟合的相关系数和可信度较高。最佳处方各指标的实测值在预期范围内。结论:星点设计-效应面优化法可以较好地用于阿昔洛韦口腔贴片处方的优化。
Objective： To optimize the formula of acyclovir mucosal adhesive tablets by central composite design and response sur- face methodology. Methods： The amounts of HPMC K4M and Carbopol 974PNF were set as the independent variables; the dissolution of acyclovir mucosal adhesive tablets in 1 h, 5 h and 12 h and the bioadhesion force were used as the four dependent variables. Multi- variate linear equations, 2FI models and quadratic polynomial mathematic models were used to evaluate the relationship between the in- dependent and the dependent variables. According to the best selected mathematic model, the overlaps of the contour graphs were drawn. The optimized formula was chosen from the overlap of the contour graphs of the dependent variables. Prediction and analysis were performed by comparing the observed values with the predicted values. Results： The correlation coefficient oF quadratic polynomi- al mathematic models and reliability were higher. Dissolution and bioadhesion force of the optimized formula Were within the expected values. Conclusion： Central composite design and response surface methodology can be used to optimize the formula of acyclovir muco- sal adhesive tablets successfully.
出处
《中国药师》
CAS
2015年第9期1448-1453,共6页
China Pharmacist
基金
山东省科技发展计划(编号:2013GSF11832)
关键词
阿昔洛韦
口腔贴片
星点设计
效应面法
释放度
黏附力
Acyclovir
Mucosal adhesive tablets
Central composite design
Response surface methodology
Drug release rate
Bioadhesion force
