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.
关键词
真武汤/提取工艺/响应面法/基准样品/设计空间
Key words
Zhenwu decoction/extraction technology/response surface methodology/bechmark sample/design space
维普
万方数据