星点设计效应面法优化海南霉素钠固体分散体处方

Optimization of Hainanmycin Solid Dispersion by Central Composite Design and Response Surface Method

目的:制备海南霉素钠固体分散体。方法:以PEG4000、PEG6000、PVPK30为分散介质,星点设计效应面法优化处方。结果:以PEG4000、PEG6000、PVPK30和海南霉素钠为自变量,固体分散体分散时间和沉降体积比为因变量的多元二次方程相关系数(R2)是0.8702和0.9076,响应面模型方差分析差异均极显著(P<0.01),对分散时间影响显著的因素是PEG4000和PVPk30,对沉降体积比影响显著的因素是PVPK30、PEG4000、PEG6000、PEG4000^2和PEG6000^2,优化处方海南霉素钠的含量均值是理论含量的99.07%。结论:通过星点设计效应面实现了海南霉素钠固体分散体处方的优化,选用固体分散体分散时间和沉降体积比为因变量提高了试验效率,制备了海南霉素钠新制剂。

Objective：To prepare Hainanmycin solid dispersion. Methods：PEG4000, PEG6000 and PVPK30 were used as mediums. The formulations of Hainanmycin solid dispersion were optimized by central composite design and response surface method. Results：Methods PEG4000, PEG6000, PVPK30 and Hainanmycin were independent variables. Dispersion time and sedimentation ratio were the dependent variables. The coefficient-correlation （R2） of the second-order polynomial equations in terms of actual values demonstrated the empirical relationships between the independent variables and the response were 0.8702 and 0.9076. the ANOVA of the empirical second-order polynomial model were significant （P 〈 0.01 ）.PEG4000 and PVPk30 were significant model terms to dispersion rime. PVPK30,PEG4000,PEG6000,PEG4000^2and PEG6000^2 were significant model terms to sedimentation ratio. The average Hainanmycin content of optimized formulations was 99.07 percent of actual value. Conclusions Hainanmycin solid dispersion was optimized by central composite design and response surface method. The Study was simplified by dispersion time and sedimentation ratio as independent variables. A novel preparation of Hainanmycin was made.