摘要
基于质量源于设计(quality by design,QbD)理念,优化胆木提取物的醇沉工艺。在单因素试验的基础上选取试验因素水平,以醇沉体积分数、醇沉前药液浓度、醇沉时间为关键工艺参数(critical process parameters,CPPs),以异长春花苷内酰胺转移率与固体去除率的综合评分为关键质量属性(critical quality attributes,CQAs),采用Box-Behnken设计建立CPPs与CQAs之间的数学模型及空间设计,获得最优操作空间并进行验证。实验结果表明最优操作空间为乙醇醇沉体积分数65%~70%,醇沉前药液质量浓度22~27 mg·mL^(-1),醇沉时间12 h。该实验基于QbD理念,将设计空间应用于胆木提取物的醇沉工艺中,为胆木制剂生产过程中的质量控制提供可靠的理论依据,对指导中药工艺研究及工业化生产提供较好的参考价值。
The ethanol precipitation process of Nauclea officinalis extract was optimized based on the concept of quality by design(QbD).Single factor tests were carried out to determine the levels of test factors.The ethanol volume fraction,pre-ethanol precipitation drug concentration,and ethanol precipitation time were taken as critical process parameters(CPPs).With the comprehensive scores of strictosamide transfer rate and solid removal rate as the critical quality attributes(CQAs),Box-Behnken design was employed to establish the mathematical models and space design between CPPs and CQAs,and the obtained optimal operating space was validated.The optimal operating space included ethanol volume fraction of 65%-70%,pre-ethanol precipitation drug concentration of 22-27 mg·mL^(-1),and ethanol precipitation time of 12 h.Based on the concept of QbD,this study adopted the design space to optimize the ethanol precipitation process of N.officinalis extract,which provided a reliable theoretical basis for the quality control in the production process of N.officinalis preparations.Moroever,this study provided a reference value for guiding the research and industrial production of traditional Chinese medicines.
作者
裴晓婷
刘珂
彭雷
尹登科
曾纪锴
陈卫东
PEI Xiao-ting;LIU Ke;PENG Lei;YIN Deng-ke;ZENG Ji-kai;CHEN Wei-dong(College of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China;Yangtze Delta Drug Advanced Research Institute,Nantong 226133,China;He Rong Jia Pharmaceutical Technology(Nantong)Co.,Ltd.,Nantong 226133,China;Hainan Senqi Pharmaceutical Co.,Ltd.,Haikou 570100,China;MOE-Anhui Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials,Hefei 230012,China;Institute of Traditional Chinese Medicine Resources Protection and Development,Hefei 230012,China;Anhui Province Key Laboratory of Chinese Medicinal Formula,Hefei 230012,China;Anhui Province Key Laboratory of Traditional Chinese Medicine Decoction Pieces of New Manufacturing Technology,Hefei 230012,China)
出处
《中国中药杂志》
CSCD
北大核心
2023年第24期6653-6662,共10页
China Journal of Chinese Materia Medica
基金
国家中医药管理局高水平中医药重点学科《药用植物学》建设项目
海南省财政科技计划项目(ZDKJ201805)。
