Studies On The Preparation Process And Quality Standard Of Compound Huanggen Granules

Objective:The research is to optimize the preparation technology of Compound Huanggen Granules,establish its content determination method,study the effect of its decomposed recipes on rat liver fibrosis caused by carbon tetrachloride,and provide experimental research basis for it.Methods:?1?The study on extraction technology:Taking the weighted total evaluation normalized value?OD value?of total anthraquinone and oleanolic acid extraction as an indicator,the orthogonal test method is used to investigate the ethanol concentration,solid-liquid ratio,extraction time,and the number of extractions,to optimize the alcohol extraction process of Huanggen and Sanjiemei;taking the weighted total evaluation normalized value?OD value?of ginsenoside rb₁and dry cream rate as an index,the orthogonal test method is used to investigate the amount of water added,the extraction time,and the number of extractions,to optimize water extraction process of Gynostemma pentaphyllum,Phyllanthus urinaria,Rhizoma Atractylodis Macrocephalae,Astragalus mongholicus and Panax notoginseng,and to optimize alcohol precipitation density,alcohol content and alcohol precipitation time of Compound Huanggen.?2?The study on preparation:Wet granulation is used to investigate the ethanol concentration,particle size,hygroscopicity,solubility,suspending agents,and flavoring agents,to optimize the best preparation process.?3?The study on quality standard:Thin layer chromatography?TLC?is used in qualitative identification of Huanggen,Sanjiemei,and Panax notoginseng in Compound Huanggen Granules;and HPLC is used to determine the content of Rubiadin and Calycosin in it.?4?The study on decomposed recipes and process screening:Taking ALT,AST,PC?in serum of liver fibrosis rats and SOD,GSH-Px,GSH activities in liver as indicators,whether Compound Huanggen has anti-fibrosis effect is studied.Results:?1?The best alcohol extraction process of Compound Huanggen Granules is 8 times 60%ethanol extraction twice,2 hours each time;the best water extraction process is 10 times water extraction twice for 2 hours each time;the best alcohol precipitation process is to concentrate the concentrated solution to a relative density of 1.10,let it cool,add ethanol to the alcohol content to 60%,and let it stand for 24 hours.?2?The best molding technology of Compound Huanggen Granules is to mix the one-day dosage of dry powder of herbal medicine with the auxiliary material dextrin evenly and stevioside,45g in total;then add 85%ethanol to make soft material,quickly pass through 14 mesh sieve to make granules,and then dry and pack them.?3?A TLC method for the identification of Huanggen,Sanjiemei and Panax notoginseng in Compound Huanggen Granules is established.The chromatogram of the test sample and the control drug or the control sample have spots in the same position,and the separation is good.The spots are clear and negative without interference.A method for the determination of methylisorubicin and maorui isoflavone in Compound Huanggen Granules and the content limit of rubiadin and calycosin in it are established,in which the content of rubiadin and calycosin should not be less than 0.0155mg/g and 0.134mg/g respectively.?4?The decomposed recipes experimental results shows that the high-dose group with the improved technology of alcohol extracted Huanggen and Sanjiemei has the best therapeutic effect,which can significantly reduce the levels of ALT,AST and PC?in serum of liver fibrosis rats,increase the activities of SOD,GSH-PX and GSH in liver,and reduce the activities of HYP,which shows it has a good anti-fibrosis effect.Conclusion:The preparation technology of Compound Huanggen is improved,the content determination method of Compound Huanggen Granules is established,and the improved Compound Huanggen Granules having more anti-fibrosis effect is proven.Moreover,the research provides a theoretical basis for further development of Compound Huanggen Granules.