中国中药杂志

2019, v.44(13) 2799-2805

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基于质量源于设计理念的地格达-4味汤提取工艺研究
Research on extraction process of Digeda-4 flavored decoction based on QbD concept

丁瑞雪;何雁;田香;蔡大宇;杨小妹;饶小勇;罗晓健;
DING Rui-xue;HE Yan;TIAN Xiang;CAI Da-yu;YANG Xiao-mei;RAO Xiao-yong;LUO Xiao-jian;Jiangxi University of Traditional Chinese Medicine;Chutian Technology Company Limited;Shenzhen Shekou People's Hospital;the National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine;

摘要(Abstract):

应用质量源于设计(quality by design,Qb D)理念,建立地格达-4味汤(DGD-4D)提取工艺的设计空间并进行验证。以DGD-4D饮片为模型药,秦皮乙素、胡黄连苷Ⅰ、胡黄连苷Ⅱ、栀子苷的转移率和浸膏得率为关键质量属性(critical quality attributes,CQAs),采用单因素实验设计确定各因素的高低水平,Plackett-Burman实验设计筛选出关键工艺参数(critical process parameters,CPPs),运用Box-Behnken实验设计优化提取工艺,建立DGD-4D提取工艺设计空间,最后,选取4个实验点,对已建立模型进行验证。单因素实验确定了各因素的高低水平,分别为浸泡时间60,30 min,加水量12,8倍,提取时间90,30 min,提取次数3,1次,提取温度100,90℃。Plackett-Burman实验确定了加水量、提取时间和提取次数为CPPs,Box-Behnken实验方差分析结果显示回归模型的P小于0. 01,且失拟值大于0. 01,表明所建模型具有较好的预测能力,并确定了DGD-4D提取工艺CPPs的操作空间,即加水量10~12倍,提取时间50~80 min,提取次数3次。基于Qb D理念建立的DGD-4D提取工艺设计空间,有利于提高产品质量的稳定性,为今后的DGD-4D开发奠定了基础。
To establish and validate the design space of the Digeda-4 flavored decoction( DGD-4D) extraction process by using the quality by design( Qb D) concept. With DGD-4D decoction pieces as a model drug,with the transfer rate of aesculin,picroside I,picroside Ⅱ,geniposide and the yield of extract as critical quality attributes( CQAs),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( CPPs);and the Box-Behnken experiment design was used to optimize the extraction process. The design space of the DGD-4D extraction process was established,and finally,four experimental points were selected to verify the established model. The single factor experiment determined the levels of each factor,including soaking time 60 min and 30 min,water adding volume 12 times and 8 times,extraction time 90 min and 30 min,number of extraction times 3 times and 1 time,as well as extraction temperature 100 ℃ and 90 ℃.By Plackett-Burman experimental design,the DGD-4D water addition,extraction time and number of extraction times were determined to be CPPs. The Box-Behnken experimental variance analysis showed that P of the regression model was less than 0. 01 and the misstated value was more than 0. 01,indicating that the model had good predictive ability,and the operation space of CPPs in the DGD-4D extraction process was determined as follows: the amount of water addition was 10-12 times; extraction time 50-80 min; and number of extraction times was 3 times. The design space of DGD-4D extraction process based on the concept of Qb D is conducive to improving the stability of product quality and laying a foundation for the future development of DGD-4D.

关键词(KeyWords): 质量源于设计;地格达-4味汤;提取工艺;关键质量属性;关键工艺参数;设计空间
quality by design;DGD-4D;extraction process;critical quality attributes;critical process parameters;design space

Abstract:

Keywords:

基金项目(Foundation): 中药制剂装备制造绿色关键技术改造项目(工信部节函[2016]562号);; 江西省研究生优质课程和案例建设项目

作者(Author): 丁瑞雪;何雁;田香;蔡大宇;杨小妹;饶小勇;罗晓健;
DING Rui-xue;HE Yan;TIAN Xiang;CAI Da-yu;YANG Xiao-mei;RAO Xiao-yong;LUO Xiao-jian;Jiangxi University of Traditional Chinese Medicine;Chutian Technology Company Limited;Shenzhen Shekou People's Hospital;the National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine;

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DOI: 10.19540/j.cnki.cjcmm.20190410.302

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