Preparation Process Optimization and Quality Standard of Jiaweiruhe Granules
Objective To optimize the extraction and molding processes of Jiaweiruhe Granules,and to control their quality.Methods With the water addition amount,soaking time,and decoction time as key parameters for the extraction process,with the heating energy consumption and time cost as auxiliary factors for investigation,and with the extract yield as the evaluation index,the L9(34)orthogonal test was used to optimize the extraction process.With particle size,dissolubility,and granulation state as key parameters of the molding process,the appropriate excipients wetting agents and diluents were optimized by the single factor test method.Qualitative identification of Bupleuri Radix,Citri Reticulatae Pericarpium Viride,Corydalis Rhizoma,Paeoniae Radix Rubra,and Scrophulariae Radix in Jiaweiruhe Granules was performed by the thin-layer chromatography(TLC)method.The content of paeoniflorin and salvianolic acid B in the preparation was determined by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Waters XBridge C18 column(250 mm × 4.6 mm,5 µm),the mobile phase was acetonitrile-0.1％phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was set at 230 nm for paeoniflorin and 286 nm for salvianolic acid,the column temperature was 30 ℃,and the injection volume was 10 μL.Results The optimal process was as follows:soaking the Chinese medicinal herbs for 1.0 h,adding 10 times the amount of water and boiling for 1.5 h for the first time,adding 8 times the amount of water and boiling for 1.0 h for the second time,the mass ratio of thick paste to dextrin was 5:(8-9),taking 95％ethanol as a wetting agent with a dosage of 20％of the dextrin content.In the TLC identification,the characteristic spots of Bupleuri Radix,Citri Reticulatae Pericarpium Viride,Corydalis Rhizoma,Paeoniae Radix Rubra,and Scrophulariae Radix were all clearly colored,and the negative control had no interference.The linear ranges of paeoniflorin and salvianolic acid B were 1.05-26.35 µg/mL and 1.04-25.96 μg/mL(r=0.999 8,0.999 9,n=5),respectively.The RSDs of precision,stability,and repeatability test results were all lower than 2.0％.The average recoveries of paeoniflorin and salvianolic acid B were 98.68％and 99.41％,with RSDs of 0.81％and 1.17％(n=6),respectively.The contents of paeoniflorin and salvianolic acid B in the three batches of samples were in the ranges of 1.52-1.58 mg/g,and 1.17-1.23 mg/g,respectively.Conclusion The optimal process was reasonable,simple,stable and reliable,and the established quality standard is easy to operate and accurate in results,which can be used for quality control of Jiaweiruhe Granules.
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