复方双参口腔崩解片的制备工艺研究

Study on Preparation of Compound Shuangshen Orally Disintegrating Tablets

目的:制备复方双参口腔崩解片,使用星点设计-效应面优化法对处方工艺进行优化筛选。方法:以丹参水提物和人参皂苷为主药,采用粉末直接压片法制备复方双参口腔崩解片,选择MCC/L-HPC(8:2)和PVPP作为联合崩解剂。以MCC/L-HPC的用量及PVPP的用量为考察因素,崩解时限作为评价指标,用线性方程和二次及三次多项式描述崩解时限和两个影响因素之间的数学关系,根据最佳数学模型描绘效应面及等高线图,选择最佳处方,并进行预测分析。结果:当MCC/L-HPC含量25%,PVPP含量8.2%时,片剂的崩解时间最短。各指标的三项式拟合方程均优于多元线形回归方程,建立的数学模型的预测值与实际值符合较好。结论:用星点设计-效应面法优化复方双参口腔崩解片处方工艺预测性良好。

Objective： To prepare the compound Shuangshen orally disintegrating tablets and optimize the formulation by a central composite design/response surface methodology. Method： The compound Shuangshen orally disintegrating tablets were prepared by di- rect powder compression with the water extract of salvia mihiorrhiza and ginsenosides as the mainly effective components. MCC/L-HPC （8： 2） and PVPP were selected as the disintegrants. Independent variables were MCC/L-HPC content and PVPP content, and disintegrating time was dependent variable. Linear or nonlinear mathematic models were used to estimate the relationship between the independent and dependent variables. Response surfaces and contour plot were delineated according to the best-fit mathematic models, and optimum formulations were selected therefore. Prediction was carried out through comparing the observed and predicted values. Result： The disintegrating time was shortest with MCC/L-HPC content of 25% and PVPP content of 8.2%. The trinomial fitting equations of indices were all superior to their multi-linear regression equations, and the predictive values in the established mathematical model were in good conformity with the experimental values. Conclusion： Central composite design/response surface method shows a good predictability in optimizing the formula technology of the compound Shuangshen orally disintegrating tablets.