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目的:目的:优化芍甘抗抑郁分散片处方。方法:以分散片崩解时间、甘草总黄酮和白芍总苷30min内累积溶出率为考察指标,以交联聚乙烯吡咯烷酮(PVPP)、羧甲基淀粉钠(CMS-Na)和微晶纤维素(MCC)所在处方百分量为自变量,采用星点设计试验优化处方,并对结果进行多元线性和二项式非线性拟合,通过效应面确定最优处方。结果:最优处方为PVPP,占处方量9.17%,CMS-Na占处方量5.29%,MCC占处方量21.74%,磷酸氢钙为填充剂。预测值与实测值的偏差为2.58%。结论:星点设计-效应面法可用于芍甘抗抑郁分散片的处方工艺,优选的成型工艺稳定可行。
Objective: To optimize the prescription of Shaogan antidepressant dispersible tablet. Methods: The dissolution rate of dispersible tablets, total flavonoids of glycyrrhiza and total glucosides of paeony were measured in 30 min. The effects of PVPP, CMS-Na and microcrystalline cellulose (MCC) where the prescription percentage as an independent variable, using star design experiments to optimize the prescription, and the results of multiple linear and binomial nonlinear fit through the effect of surface to determine the optimal prescription. Results: The optimal prescription was PVPP, accounting for 9.17% of prescription, CMS-Na accounting for 5.29%, MCC accounting for 21.74% of prescription, and DCP as filler. The deviation of the predicted value from the measured value is 2.58%. Conclusion: The star-point design-response surface method can be used for prescription of Shaogan antidepressant dispersible tablet. The optimal forming process is stable and feasible.