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

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.