Study On The Preparation Process And Quality Standard Of Compound Rice-steamed Rehmanniae Radix

Objectives:To develop a compound rice-steamed Rehmanniae Radix granules health food which is helpful to improve bone mineral density by combining rice-steamed Rehmanniae Radix and Epimedium.To conduct a preliminary study on the preparation process and quality standard of the particles,and to establiish the quality standard of rice-steamed Rehmanniae Radix pieces,so as to provide a reference for qualty control of rice-steamed Rehmanniae Radix as health food materials.Methods:1.Collection and optimization of Rehmanniae Radix and Epimedium samples.24 batches of Rehmannia radix samples and 29 batches of different derived Epimedium samples were collected from the main production areas,and the quality of medicinal materials was evaluated according to the relevant items under the item of Rehmannia radix and Epimedium in the 2020 edition of Chinese Pharmacopoeia.HCA and PCA were used to evaluate and analyze the content determination results.To study the effect of different origin on the quality of Epimedium.2.Study on preparation technology of compound rice-steamed Rehmanniae Radix granules.The content of rehmanoside D,verbascoside and icariin in rice-steamed Rehmanniae Radix granules was determined by HPLC segmented wavelength method,and the content of the three index components and the yield of dry paste of the extraction solution were comprehensively scored,and the extraction process and concentration drying process were optimized.(1)The best extraction solvent was screened by the univariate method,and the L9(34)screening water extraction process was carried out,and the intuitive analysis and ANOVA were analyzed together to determine the optimal extraction process.(2)The single-factor test was used to investigate the reduced pressure concentration process and the atmospheric pressure drying,reduced pressure drying,and spray drying processes,and the retention rate of index components and the drying condition of materials were used as indicators to evaluate.(3)Taking soft material properties,particle formability,molding rate and solubility as the investigation indexes,the wet granulation,dry granulation and one-step granulation were investigated,and the proportion and type of auxiliary materials and granulation process parameters were investigated,and the best molding process was optimized.3.The quality standard of rice-steamed Rehmannia Radix was established,and the quality standard of compound rice-steamed Rehmannia Radix granules was established.According to the item of Inspection,identification and content determination under processed Rehmannia Radix in Chinese Pharmacopoeia(2020 edition),the quality standard of rice-steamed Rehmannia was studied.The characteristics,particle size,moisture,solubility and moisture absorption of the particles were examined.The thin layer chromatography and HPLC methods were used to qualitatively and quantitatively identify rice-steamed Rehmannia Radix and Epimedium in compound rice-steamed Rehmannia Radix granules,and the quality standard of compound ricesteamed Rehmannia Radix was established.Results:1.The inspection results showed that the samples of Rehmannia Radix and Epimedium were in line with the provisions of Chinese Pharmacopoeia,and the content determination results showed that the quality of raw Rehmannia Radix in Zhongmou County was better;The results of the content determination method of different Epimedium established in this paper showed that the index components of Epimedium from Xihe of Gansu and producing areas were higher than other epimedium samples from other production areas.Therefore,Rehmanniae Radix from Zhongmou County and Epimedium from Xihe of Gansu Province were selected as raw materials for the follow-up study.2.(1)The optimal extraction process is as follows: add 12 times the amount of water to the decoction slices,reflux extraction twice,2 hours each time.The comprehensive score of the three validation results was 89.77,and the average extract yield was 50.67%.(2)The optimal concentration process was as following: concentration under reduced pressure at 70℃ to a density of 1.05-1.10,and the transfer rates of rehnoside D,verbascoside and icariin were91.49%,78.39% and 101.28%,respectively.(3)The best molding process is: Using dextrin as auxiliary material(material ratio 1:0.6),the concentrated liquid prepared by the best process was sprayed into the fluidized bed for one-step granulation at a pump speed of 10-15 r/min.The air inlet temperature was 75-85℃,the air inlet volume was 20-120 m~3/h,the material temperature was 45-60℃,the drying temperature was 40℃,and the drying time was 1-1.5 h.3.The draft quality standards of rice-steamed Rehmanniae Radix decoction pieces and compound rice-steamed Rehmanniae Radix granules were established.A thin layer identification method for rice-steamed Rehmanniae and Epimedium decoction slices in granules was established,and the contents of rehmanniae D?Verbascoside and Epimedium were determined by HPLC.Conclusions:In this study,the preparation technology of compound rice-steamed Rehmannia Radix granules was studied,and the quality standards of rice-steamed Rehmannia Radix granules and compound rice-steamed Rehmannia Radix granules were initially established,which lay the foundation for the standardization of rice-steamed Rehmannia Radix granules and the research and development of compound rice-steamed Rehmannia Radix granules.