丹红注射液醇沉关键工艺参数筛选方法(3)
precipitation process of Danhong injection
YAN Bin-jun1， GUO Zheng-tai1， QU Hai-bin1*， ZHAO Bu-chang2， ZHAO Tao2
(1. Pharmaceutical Informatics Institute， Zhejiang University， Hangzhou 310058， China；
2. Heze Buchang Pharma Co.， Ltd.， Heze 274000， China)
[Abstract] 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.
[Key words] critical process parameter； multi-targets integration； Danhong injection； ethanol precipitation
doi：10.4268/cjcmm20131105
[责任编辑 曹阳阳], 百拇医药(严斌俊，郭正泰，瞿海斌，赵步长，赵涛)
YAN Bin-jun1， GUO Zheng-tai1， QU Hai-bin1*， ZHAO Bu-chang2， ZHAO Tao2
(1. Pharmaceutical Informatics Institute， Zhejiang University， Hangzhou 310058， China；
2. Heze Buchang Pharma Co.， Ltd.， Heze 274000， China)
[Abstract] 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.
[Key words] critical process parameter； multi-targets integration； Danhong injection； ethanol precipitation
doi：10.4268/cjcmm20131105
[责任编辑 曹阳阳], 百拇医药(严斌俊，郭正泰，瞿海斌，赵步长，赵涛)