Extraction Technology and Quality Standards of Jianpi Xiaoji Granules
Objective:To optimize the extraction process of Jianpi Xiaoji Granules and establish quality standards for Jianpi Xiaoji Granules.Methods:With the content of naringin and neohesperidin as the main evaluation indicators,the optimal extraction process was determined by single-factor investigation method and orthogonal experiment.Aurantii Fructus and Curcumae Rhizoma were used as index components to establish a thin-layer chromatography(TLC)identification method for samples.The moisture,particle size,and solubility of the sample were determined.High-performance liquid chromatography(HPLC)was used to determine the content of naringin and neohesperidin in the sample simultaneously.Results:The optimal extraction process of Jianpi Xiaoji Granules involved decocting with 10 times the amount of water twice,for 2 hours the first time and 1 hour the second time,with a relative density of the dense paste of 1.20-1.25 at 70℃.The TLC spots of Aurantii Fructus and Curcumae Rhizoma were clear and had no interference in the negative controls,which can be used as a thin-layer identification of Jianpi Xiaoji Granules.The moisture content of six batches of samples was 2.80％-3.78％,the particle size was 1.29％-4.97％,and the solubility showed complete dissolution,with no foreign matter or scorched residue.HPLC results indicated that naringin showed good linearity in the range of 9.78-97.80 μg·mL-1 and neohesperidin in the range of 10.34-103.40 μg·mL-1,and the sample recovery rates were 99.31％-100.69％(RSD=0.49％)and 99.69％-100.98％(RSD=0.47％),respectively.The RSDs of precision,stability,and repeatability were less than 2％.The naringin in each bag of samples shall not be less than 20 mg,and the neohesperidin shall not be less than 12 mg.Conclusion:This method has good repeatability and exclusivity and can be used to control the production quality of Jianpi Xiaoji Granules.
万方数据
维普
