Pharmacodynamic Evaluation And Metabonomics Study Of Tang Shen Kang Pills Based On Quality Control

Objective:Based on the inheritance of famous traditional Chinese medicine clinical classics,a new drug study was made on the formulation of Tangshenkang prescription water pill.The study on pharmacodynamics and metabolomics of guizhenkang water pill can provide a theoretical basis for the clinical treatment and prevention of diabetic nephropathy.Method:1.According to the clinical use of the classic prescription and the characteristics of the prescription composition of the drug flavor,combined with the characteristics of the preparation process of the traditional Chinese medicine water pill,for the prescription of the process of water decoction,Three factors and three levels of L₉（3⁴）orthogonal test were used to investigate the main factors affecting the amount of water,cooking time and cooking times.High performance liquid chromatography（hplc）was used to determine the extraction rate of astragalus glycoside,a representative component of astragalus in the prescription,and the weight of the total solids in water decoction was weighted.Based on the research of extraction technology,the preparation technology of sugar kidney kongshui pill was studied,and the molding preparation technology of sugar kidney kongshui pill was formulated,and the preparation process was verified according to the difference between the amount of raw materials put into the three batches and the acceptance rate of the finished product.Thin layer chromatography was used to identify the specificity of prescription medicine in the preparation and to establish the quality standard of sugar kidney Kangshui Pill,which conforms to the preparation of medical institution.2.In combination with pharmacodynamics research,a metabolomics research method based on UPC-Q-TOF-MS technology was used to scan and test the positive and negative ions of rat urine endogenous metabolites,m/z100¹500;Using PLS-DA（partial least squares method-discriminant analysis）to detect the effect of Guanyenkang pill on the urine and serum potential biomarker content in diabetic nephropathy rats,the mechanism of Guanyenkang pill intervention in the treatment of diabetic nephropathy was discussed from the perspective of metabolic pathway.Result:1.After three batches of test process verification tests,the best molding process of Suizenkang water pill:take half the amount of Astragalus in the prescription marking quantity,and the rest of the prescription taste in the prescription,such as Poria,Ume,Atractylodes,Yam,Chuanxiong,etc..Smash into fine powder,spare;The remaining half amount of Astragalus in the prescription is 10 times the amount of water added to the rest of the prescription,such as Astragalus,Hawthorn,Rehmannia,and Leech.It is decocted twice,each time for 2 hours,and the water is decocted and filtered.The liquid is combined.Concentrate the leachate to the extract with a relative density of 1.25-1.30（60°C）,mix the extract with the aforementioned spare powder,dry,and crush it into fine powder;The preparation of Shuipan Pill preparation,said to take up 14%of the mold powder,starting,pan-water pill,water consumption 45%,made of sugar kidney Kang concentrated water pill,three batches of water pill yield and dosage ratio are within the error range,The process is stable.2.A study on the quality standard of preparations in medical institutions in accordance with the hospital’s own quality control conditions was conducted to identify Astragalus,Chuanxiong,Wumei and Poria in the prescription.The separation Rf values of the specific components of each drug were all in accordance with the shift range,and there was no interference in the negative control preparations3.Compared with the model group and the drug group,the drug group and the model group can significantly reduce the content of fasting blood glucose（FBG）and glycosylated hemoglobin（GHB）,and the dose prevention group in traditional Chinese medicine is the best.;Can significantly reduce the amount of urine microalbumin（U-mAlb）,the best dose prevention group in traditional Chinese medicine;It can reduce creatinine（Cr）and urea nitrogen（BUN）in the serum,with the most significant effect in the medium dose group,and the effect on the content of bloodβ2 microglobulin（β2-MG）was not significant.Through the observation of renal Histopathology,the degree of glomerular sclerosis was reduced in the treatment group（high,medium,and low）,the mesenteric cells and basal hyperplasia were reduced,and GBM and renal tubules had no lesions and were close to the normal group.However,the glomerular membrane matrix was still slightly increased,and the medium dose group was relatively good.4.The 10 endogenous biomarkers in the urine of the DN model rats mainly function through the following pathways:amino acid metabolic pathway,energy metabolic pathway,and nucleotide metabolism（purine metabolic pathway）.The basic content of the markers in the urine of rats in the middle dose group of Tangshenkang was similar to that of the false surgery group.Compared with the model group,the sugar kidney dose group was callback of 8 markers and the Yansuanbeinapuli group was callback of 7 markers.Conclusion:1.Through the process verification,the extraction amount of Astragalus acinosine was used as the measurement index.Compared with the content of the original medicinal materials,the transfer rate of Astragalus acinosine in the water extraction process reached more than 60%.At the same time,the more viscous medicinal materials in the prescription are used as water extraction processes,which can not only serve as adhesives for pan-water pills,but also remove some impurities,and reduce clinical doses to meet the needs of clinical medication.The quality standard method of the preparation is feasible and can ensure the quality control of the formulation of Tangshenkang in the medical institution.2.Tangshenkang can improve and treat the changes of early diabetic nephropathy model rats.3.Tang Shen Kang can improve the metabolic disorders caused by diabetic nephropathy.It may be through the regulation of amino acid metabolic pathways,energy metabolic pathways,nucleotide metabolism and other metabolic disturbances to achieve its therapeutic effect,and can reveal its therapeutic mechanism from the perspective of metabolic pathways.