星点设计-效应面法优化二甲双胍片的缓释包衣工艺

Optimizing the sustained-release coating preparative technology of Metformin by central composite design and response surface method

目的优化二甲双胍片的缓释包衣工艺。方法以包衣效率为评价指标,以包衣锅的转速、包衣液的流速、喷雾的压力、进风的温度为因素,按星点设计安排实验,对结果进行多元线性和二项式拟合,利用效应面等高线图选取最佳工艺条件范围进行预测分析。结果各项指标的二项式拟合方程均优于多元线性回归方程,根据优化工艺制得的二甲双胍缓释包衣片的包衣效率约70%,释放度可达《中国药典》的要求。结论利用星点设计-效应面优化法可用最少的实验次数筛选出最佳的工艺,经验证,实际包衣效率与预测值非常接近,预测性良好。

OBJECTIVE To optimize the sustained-release coating preparative technology of Metformin tablets.METHODS The coating efficiency was chosen as the evaluation standard.The rotation speed of coating pan,the flow rate of coating liquid,the mist pressure and the temperature of wind were considered as the factors.The experiment was arranged by central composit design.The results were processed by multiple linear and binomial fit.Response surface method was used to choose the optimum technical conditions.RESULTS The binomal equation was better than multi-linear regressive equation in every evaluative standard.The coating efficiency of the metformin sustained-release coated tablets prepared by the optimum technical conditions was about 70%.The release degree could achieve the desired requirements.CONCLUSION Least experiment times was used to find the optimum technics by central composite design and response surface method.In this experiment,the practical coating efficiency was conformed with the resulted prediction.