摘要
目的优选山参饮提取工艺。方法以山参饮的饮片为模型药,以有机酸、苦杏仁苷的含量和浸膏得率为质量控制指标,采用单因素试验设计确定各因素水平,采用Plackett-Burman试验设计筛选关键工艺参数,通过Box-Behnken试验设计建立数学模型,考察关键工艺参数与关键质量属性的交互作用,建立山参饮提取工艺设计空间并进行优化。结果回归模型的P<0.01,且失拟值不显著,表明所建模型具有较好的预测能力;山参饮的最佳提取工艺为提取次数2次,提取60 min,加10倍量水。结论基于质量源于设计理念的山参饮提取工艺稳定、可靠,有利于提高制剂质量的稳定性,可为实际生产提供参考。
Objective To optimize the extraction process of Shanshenyin by using the quality by design(QbD)concept.Methods With Shanshenyin pieces as a model drug,with the content of organic acids,laetrile and extract yield as critical quality attributes,the single factor experiment design was used to determine the level of each factor;the Plackett-Burman experiment design was used to select the critical process parameters;and the mathematical model was established to investigate the interaction between key process parameters and key quality attributes by Box-Behnken experiment design,and the process design space for the extraction of mountain Shanshenyin was established and optimized.Results The P value of the regression model was less than 0.01 and the lack-of-fit was not significant,which indicated that the model had good predictive ability.The optimal extraction process was determined as follows:the number of extraction were 2 times,the extraction time was 60 min,and the amount of water addition was 10 times.Conclusion The extraction process of Shanshenyin based on Qb D concept is stable and reliable,which is conducive to improving the quality stability of the preparation and providing a basis for production.
作者
何云华
石红霞
刁本恕
杨林
HE Yunhua;SHI Hongxia;DIAO Benshu;YANG Lin(Department of Clinical Pharmacy,West China Hospital of Sichuan University,Chengdu,Sichuan,China 610041;The Studio of Famous TCM Doctor Diao Benshu,Chengdu No.7 People′s Hospital,Chengdu,Sichuan,China 610072)
出处
《中国药业》
CAS
2020年第15期28-32,共5页
China Pharmaceuticals
基金
四川省中医药管理局中医药科研专项[2018KF014]。
关键词
质量源于设计
山参饮
有机酸
苦杏仁
提取工艺
quality by design
Shanshenyin
organic acid
bitter apricot seed
extraction process
