Process optimization and evaluation of standard decoction and granule of classical prescription Sanpian Decoction
Objective:To optimize and evaluate the preparation process of Sanpian Decoction standard decoction and granule,and to provide technical support for practical application.Methods:The characteristic chromatogram of Sanpian Decoction was established by HPLC,the chromatographic information was analyzed by principal component analysis,the content of the selected index components was determined,and the preparation process of Sanpian Decoction was optimized by Box-Behnken-response surface method.After that,according to the requirements of granulation difficulty,correlation inspection,cost,and so on,suitable granulation process was screened for pilot test.Results:The optimal extraction process was determined:10 times of water was added,soaked for 0.5 h,and extracted for 2 times,1 h each time.Granulation process:Concentrate to 1.20～1.30 g/mL thick extract,add soluble starch to make soft material,drug to auxiliary ratio of 1:1.6,swing granulating machine sieve dry whole grain.The relevant tests of granules were consistent with the Pharmacopoeia of the People's Republic of China,and the transmission of the index components was above 70％.Conclusion:The quality profile of the characteristic map combined with the relevant index components can be used as the quality control method of Sanpian Decoction preparation process.The preparation process of decoction and granule is simple and feasible,which lays the foundation for further research and development of Sanpian Decoction compound preparation.
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