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考察HPMC/果胶/氯化钙骨架片中两个自变量果胶/氯化钙重量比和骨架总重量对吲哚美辛释放的影响。采用二因素五水平星点设计,效应面法优化Peppas方程拟合参数n、K和T_(0.1)(10%释放时间)。自变量对双相释放参数n和K值有显著影响,n、K和T_(0.1)值可用二次多项式拟合,线性拟合效果不佳。数学模型拟合和效应面结果表明果胶/氯化钙重量比和骨架总重量两个因素间有显著交互作用。在具有较大n和T_(0.1)值和较小K值的优化处方中,其果胶/氯化钙的比例约为1.0,骨架总重量处于中间值,约200 mg。优化处方具有很好的预测性,n、K和T_(0.1)值的预测偏差介于-7.33%和6.26%之间。星点设计可用于优化和预测药物从HPMC/果胶/氯化钙骨架片的释放。
The effect of pectin / calcium chloride weight ratio and total framework weight on indomethacin release in HPMC / pectin / calcium chloride matrix tablets was investigated. The two-factor and five-level star design was adopted and the response surface method was used to optimize the Peppas equation to fit the parameters n, K and T 0.1 (10% release time). Independent variables have a significant effect on the two-phase release parameters n and K values, n, K and T_ (0.1) values can be fitted by quadratic polynomial, the linear fitting effect is not good. Mathematical model fitting and effect surface results showed that there was a significant interaction between pectin / calcium chloride weight ratio and the total weight of the skeleton. In optimized formulations with larger values of n and T_ (0.1) and smaller K values, the pectin / calcium chloride ratio was about 1.0 and the total backbone weight was at an intermediate value of about 200 mg. The optimized prescription has good predictability, and the predicted deviation of n, K and T_ (0.1) values is between -7.33% and 6.26%. The star point design can be used to optimize and predict drug release from HPMC / pectin / calcium chloride matrix tablets.