首页|基于QbD理念的经典名方研究:真武汤的提取工艺优化研究

基于QbD理念的经典名方研究:真武汤的提取工艺优化研究

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目的 基于质量源于设计(QbD)理念,优化经典名方真武汤的提取工艺.方法 以芍药苷、6-姜辣素的含量和出膏率作为真武汤提取工艺的关键质量属性,筛选潜在关键工艺参数,在单因素试验结果的基础上采用Box-Behnken设计-响应面法优化提取工艺,建立真武汤提取工艺的设计空间,并进行空间优化,验证得到最佳提取工艺.结果 通过设计空间的优化,得到真武汤的最佳提取工艺:加水倍量10倍、提取时间60 min、提取次数1次.结论 该研究基于质量源于设计理念,开发得到的制剂中间体与基准样品的关键质量属性保持一致,可为后续颗粒剂的制备工艺奠定基础.
Classical prescription based on QbD concept:optimization of extraction for modified Zhenwu decoction
Objective To optimize the extraction of Zhenwu decoction based on the concept of quality by design(QbD).Methods The content of paeoniflorin,6-curcumin and the extraction amount of solid matter were used as critical quality attributes of the extraction technology.Potential critical process parameters were selected.Based on the results of single factor experiment,Box-Behnken design-response surface methodology was used to optimize the extraction technology,and the design space of Zhenwu decoction extraction was established to verify the best extraction technology.Results By optimizing the design space,the optimum extraction of Zhenwu decoction was as follows:10 times of water,60 min extraction and once.Conclusion Based on the concept of quality by design,the developed formulation intermediates are consistent with the critical quality attributes of the bechmark sample,and provide a basis for the preparation of subsequent granules.

Zhenwu decoctionextraction technologyresponse surface methodologybechmark sampledesign space

李明慧、张钰明、卢新颖、李花花、彭紫薇、宋扬、翟晓峰、顾妍、热西旦木·马木江、白洁、杜守颖

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北京中医药大学中药学院,北京 102488

真武汤 提取工艺 响应面法 基准样品 设计空间

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(1)
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