Preparation and Physical Fingerprint of Bupleurum chinense Granules Based on QbD Concept and Subcritical Water Extraction Technology
Based on the quality by design(QbD)concept and subcritical water extraction technology,the preparation process of Bupleurum chinense granules was optimized,and the physical quality consistency of different batches of Bupleurum chinense granules was evaluated using the physical fingerprint method.The Box-Behnken design-response surface method was adopted to optimize the subcritical hot water extraction technology.Multi-index comprehensive weighting method was used to determine the process parameters of molding.The physical fingerprint of granules was established with repose angle,Hausner ratio,moisture,hygroscopicity,relative homogeneity index,bulk density and tap density as the indexes.The optimized process parameters of Bupleurum chinense guanules were determined to be a solid-liquid ratio of 1∶14,extraction time of 40 min,and extraction temperature of 131 ℃.The final granules were prepared by wet granulation with microcrystalline cellulose as the filler,a drug to auxiliary ratio of 1∶1,and 90％ethanol as the humectant.The physical fingerprint similarity of different batches of the granules was higher than 0.99.The results indicated that the optimized preparation process of Bupleurum chinense guanules was stable and feasible,with high extraction efficiency,and the physical quality of the prepared granules was stable,which could provide new ideas for the research and development of traditional Chinese medicine preparations.
Bupleurum chinense granulequality by designsubcritical water extraction technologyphysical fingerprint
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