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目的:优化沙棘黄酮提取物分散片的处方。方法:以崩解时间、混悬系数和抗张强度为指标,交联聚维酮(PVPP)、羟丙基纤维素(HPC)、聚维酮(PVP-K30)用量为自变量,采用星点设计试验优化处方,数据进行多元线性和二项式非线性方程拟合,通过效应面法确定最佳处方。结果:最佳成型工艺为PVPP 50.0 mg/片,HPC 9.2 mg/片,PVP-K30 7.0 mg/片。预测值和测定值非常接近,偏差0.32%。结论:星点设计-效应面法可用于优选沙棘黄酮提取物分散片的处方工艺,优选的成型工艺稳定可行。
Objective: To optimize prescription of dispersible tablets of sea buckthorn flavonoids extract. Methods: Taking the disintegration time, suspension coefficient and tensile strength as indexes, the amount of PVPP, HPC and PVP-K30 as independent variables, Point design and test optimization prescription, the data were multivariate linear and binomial nonlinear equation fitting, determine the best prescription by response surface methodology. Results: The best forming process was PVPP 50.0 mg / tablet, HPC 9.2 mg / tablet and PVP-K30 7.0 mg / tablet. The predicted and measured values are very close, with a deviation of 0.32%. Conclusion: The star-point design-response surface method can be used to optimize the prescription of Seabuckthorn Flavonoid Extractable Dispersible Tablets. The optimal forming process is stable and feasible.