设计空间法优化党参一次醇沉工艺  

Design space approach to optimize first ethanol precipitation process of Dangshen

作　　者：许之麟 黄文华[2] 龚行楚[1] 叶田田[1] 瞿海斌[1] 宋艳刚[2] 刘东来[2] 王国祥[2] 

机构地区：[1]浙江大学药物信息学研究所,浙江杭州310058 [2]丽珠集团利民制药厂,广东韶关512028

出　　处：《中国中药杂志》2015年第22期4411-4416,共6页China Journal of Chinese Materia Medica

基　　金：广东省科技计划项目(2015B090901035)

摘　　要：采用设计空间法优化党参一次醇沉工艺参数操作范围以提升工艺稳健性。首先选取总黄酮保留率、总固体去除率和色素去除率为关键工艺评价指标,然后采用Plackett-Burman设计发现关键工艺参数为浓缩液含固量、乙醇和浓缩液质量比(醇料比)以及乙醇浓度,再采用Box-Behnken设计建立关键工艺参数和关键工艺评价指标间的数学模型,最后通过Monte Carlo法计算获得基于概率的设计空间并验证。验证结果表明,在工艺参数设计空间内操作能够保证党参一次醇沉工艺品质稳定。根据计算结果,党参一次醇沉工艺的推荐操作空间为浓缩液含固量45.0%~48.0%,醇料比2.48~2.80 g·g^(-1),乙醇浓度92.0%~92.7%。Design space approach is applied in this study to enhance the robustness of first ethanol precipitation process of Codonopsis Radix（ Dangshen） by optimizing parameters. Total flavonoid recovery,dry matter removal,and pigment removal were defined as the process critical quality attributes（ CQAs）. Plackett-Burman designed experiments were carried out to find the critical process parameters（ CPPs）. Dry matter content of concentrated extract（ DMCE）,mass ratio of ethanol to concentrated extract（ E / C ratio） and concentration of ethanol（ CEA） were identified as the CPPs. Box-Behnken designed experiments were performed to establish the quantitative models between CPPs and CQAs. Probability based design space was obtained and verified using Monte-Carlo simulation method.According to the verification results,the robustness of first ethanol precipitation process of Dangshen can be guaranteed by operating within the design space parameters. Recommended normal operation space are as follows： dry matter content of concentrated extract of 45. 0%-48. 0%,E / C ratio of 2. 48-2. 80 g·g^（-1）,and the concentration of ethanol of 92. 0%-92. 7%.

关 键 词：党参 醇沉 关键工艺参数 设计空间 

分 类 号：R283.6[医药卫生—中药学]