基于质量源于设计理念的智脑胶囊醇提工艺研究  

Study on Alcohol Extraction Technology of Zhinao Capsule Based on Quality by Design

作　　者：张艳艳 刘睿 杨文明[1,3] 刘晓闯[1,4] 韩燕全[1,4] ZHANG Yan-yan;LIU Rui;YANG Wen-ming;LIU Xiao-chuang;HAN Yan-quan(Department of Pharmacy,the First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China;School of Pharmacy,Anhui University of Traditional Chinese Medicine,Hefei 230012,China;Key Laboratory of Xin’An Medicine,Minsitry of Education,Anhui University of Traditional Chinese Medicine,Hefei 230012,China;The Third Level Laboratory of Traditional Chinese Medicine Preparations of State Administration of Chinese Medicine,Anhui Engineering Technology Center of Modern Pharmaceutical Preparations,Anhui Key Laboratory of Chinese Herbal Compound,the First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China)

机构地区：[1]安徽中医药大学第一附属医院药学部,安徽合肥230031 [2]安徽中医药大学药学院,安徽合肥230012 [3]安徽中医药大学新安医学教育部重点实验室,安徽合肥230012 [4]安徽中医药大学第一附属医院国家中医药管理局中药制剂三级实验室中药复方安徽省重点实验室现代药物制剂安徽省工程技术中心,安徽合肥230031

出　　处：《现代中药研究与实践》2022年第3期67-73,共7页Research and Practice on Chinese Medicines

基　　金：安徽省科技重大专项项目(201903a07020016)。

摘　　要：目的优化智脑胶囊醇提工艺。方法基于质量源于设计(QbD)理念,采用鱼骨图失效模型结合风险优先系数确定关键工艺参数,通过网络药理学、文献调研相结合的方法确定关键质量属性,通过Box-Behnken建立数学模型考察关键工艺参数与关键质量属性的相互关系,建立智脑胶囊提取工艺空间设计。结果结合实际工艺生产情况,最终确定智脑胶囊最佳醇提工艺:提取次数为2次、乙醇浓度为75%、提取时间为60 min、液料比为10。结论提取工艺研究结果可靠,为智脑胶囊的工业生产和质量控制提供参考。Objective To optimize the extraction process of Zhinao capsules.Methods Based on the theory of Quality by Design(QbD),Critical Process Parameters(CPPs)are determined by fishbone diagram failure model combined with risk priority coefficient,and Critical Quality Attributes(CQAs)are determined by network pharmacology and literature research.The relationship between the key process parameters and the key quality attributes is investigated by Box-Behnken mathematical model,and the space design of the extraction process of Zhinao capsule is established.Results Combined with the actual process production conditions,the optimal ethanol extraction process of Zhinao capsule is finally determined to be 2 times of extraction,75%ethanol concentration,60 min extraction time and 10 liquid-solid ratio.Conclusion The results of the extraction process are reliable,which provide a reference for the process production and quality control of Zhinao capsules.

关 键 词：智脑胶囊 QBD 网络药理学 BOX-BEHNKEN设计 醇提工艺 

分 类 号：R283.3[医药卫生—中药学]