丹红注射液醇沉关键工艺参数筛选方法

An approach to determine critical process parameters for ethanol precipitation process of Danhong injection

目的:建立一种多指标综合方法,用于中药生产工艺中关键工艺参数的筛选。方法:以丹红注射液的醇沉工艺为例,通过因素筛选实验设计,建立描述7个工艺参数(浓缩液水含量、乙醇浓度、醇料比、加醇速度、搅拌速度、静置温度、静置时间)对醇沉上清液中羟基红花黄色素A和丹酚酸B的浓度、保留率等10种指标影响的数学模型,并以回归系数的绝对值之和综合评价各工艺参数的重要性。结果:确定了丹红注射液醇沉工艺的关键工艺参数为浓缩液水含量、乙醇浓度和醇料比。结论:建立的多指标综合评价方法能够较全面地对工艺参数的重要程度进行评价。

Objective： To establish a method integrating multi-targets for determining critical process parameters of the manufacturing process of traditional Chinese medicine. Method： The ethanol precipitation process of Danhong injection was taken as an application case of the method established. Fractional factorial design of experiments were conducted. Mathematical models relating seven process parameters to ten targets in the ethanol precipitation process were established. Then the sums of the absolute values of the regression coefficients in the models were used to evaluate the criticality of process parameters. Result： Water content in the concentrate, ethanol concentration and ethanol consumption were identified as the critical process parameters. Conclusion： The method established can integrate multi-targets effectively for the evaluation of critical process parameters.