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目的:通过星点设计-效应面法优化香青兰黄酮缓释片处方并探讨释药机制。方法:以HPMC的用量和乳糖/淀粉(1∶1)的用量为考察因素,以2,6,12 h的累积释放度为考察指标,分别用线性和二项式模型描述因素与考察指标之间的数学关系,根据模型绘制等高线图,通过重叠等高线图确定优化处方并进行验证实验,探讨药物释放机制。结果:优化后的处方为HPMC 50 mg,乳糖68 mg,淀粉68 mg,主药150 mg,释放模型符合Higuchi方程。结论:星点设计-效应面法优化香青兰黄酮缓释片的处方具有良好的预测性。
OBJECTIVE: To optimize the prescription of sustained-release flavonoids and explore the mechanism of drug release by the method of star-point design-response surface methodology. Methods: The amount of HPMC and the amount of lactose / starch (1: 1) were used as the investigation factors, and the cumulative release rates at 2, 6, and 12 h were taken as the indexes of investigation. Linear and binomial models were used to describe the factors and indexes According to the model, the contour map was drawn, the optimal prescription was confirmed by overlapping contour maps and the validation experiment was conducted to explore the mechanism of drug release. Results: The optimized prescription was HPMC 50 mg, lactose 68 mg, starch 68 mg and main drug 150 mg. The release model accorded with Higuchi equation. Conclusion: The method of star design - response surface optimization of the formulation of the Cymbidium sustained release tablets has good predictability.