星点设计-效应面法优选淋必通颗粒的成型工艺

为了优选淋必通颗粒的成型工艺,以成型率、休止角、吸湿率、溶化性4项的总评OD值作为总评价指标,以辅料用量、乙醇体积分数、乙醇使用量作为考察因素,以星点设计-效应面法优选出淋必通颗粒的成型工艺。结果表明,淋必通颗粒的最佳成型工艺条件为m(干膏):m(糊精）为1:1,乙醇体积分数为90.0%,乙醇用量为每10.0 g干膏粉加90.0%的乙醇6.0 g。总评OD值均值为0.740 1,与预测值0.766 3相当。该方法预测性强,稳定性好,制备的淋必通颗粒具有成型率高、流动性好、抗吸湿性强及溶化性好的特点,为该复方制剂的工业化生产提供了理论参考。

Optimization of the molding process for Linbitong granules using centralcomposite design-response surface methodology

This study aims to optimize the molding process of Linbitong granules.The forming process of Linbitong granules was optimized using central composite design-response surface methodology (CCD-RSM), taking the total optical density (OD) value of the molding rate, angle of repose, hygroscopic rate, and solubility as the evaluation indexes and the excipient dosage, ethanol volume fraction, and ethanol dosage as the investigation factors. Results show that the optimum molding process condition includes a mass ratio of dry paste powder to dextrin of 1:1, ethanol volume fraction of 90.0%, and ethanol dosage of 6.0 g of 90.0% ethanol for every 10.0 g of dry paste powder. The total OD value is 0.7401, which is equivalent to the predicted value of 0.7663.The proposed method has high predictability and stability, and the Linbitong granules prepared using this method have high molding rate, good fluidity, strong antihygroscopicity, and good melting property. This method provides a theoretical reference for the industrial production of such compounds.