| 1.literatureHuangkui Siwu Formula is a traditional Chinese medicine compound used for the treatment of chronic kidney disease.This chapter analyzes the prescription of Huangkui Siwu Formula,including prescription composition and formula,it also analyzes the chemical constituents and pharmacological effects of each single medicine in Huangkui Siwu Formula to provide a certain theoretical basis for subsequent experimental research;this chapter also summarizes and analyzes the current Chinese and Western medicines for the treatment of chronic kidney disease to provide experience for the development of this topic.2.Study on extraction and purification of Huangkui Siwu formulaHuangkui Siwu formula contains four traditional Chinese medicines:Abelmoschus manihot,Polygonum cuspidatum,radix curcumae longae and Astragalus membranaceus,which play a certain role in the treatment of chronic kidney disease.The previous research has confirmed that Huangkui Siwu formula is effective in treating chronic kidney disease,and its crsfts will be optimized next.(1)At present,there are many methods to optimize the extraction process,among which orthogonal design can select representative points from comprehensive experiments,which is efficient,fast and economic.In this chapter,the single factor solvent concentration,solvent multiple and extraction time were investigated,and the orthogonal experiment was designed according to the single factor results.The chemical components were hyperoside,isoquercitrin,quercitrin,myricetin,quercetin,polydatin,resveratrol,emodin,calycosin,calycosin and curcumin as the index components,and the index component content and extract yield are used as the evaluation index to determine the optimal extraction process of Huangkui Siwu Formula.The results showed that the best extraction process of Huangkui Siwu Formula was to use 60%ethanol 10 times the amount of reflux extraction 3 times,each extraction for 1.5 hours.(2)The yield of compound extracts of traditional Chinese medicine is generally high.If it is to be directly made into preparations,the dosage will be large,which will bring certain difficulties to patients and lead to poor compliance of patients.Therefore,it is particularly important to purify the extracts.Macroporous resin is widely used in the purification of traditional Chinese medicine.It can reduce the yield of extract while enriching the effective ingredients.Therefore,on the basis of the best extraction process,we will investigate the macroporous resin model,sample amount,sample concentration,eluent concentration,and eluent volume.The results can be obtained:the best purification process of Huangkui Siwu Formula is to use HP-20 type macroporous resin as the purification resin,and the concentration of the extracted drug solution is 1g/mL for loading,and the loading amount per g of resin is 1.5g(extraction Mass),eluting with 80%ethanol,eluting 4 times the column volume(BV).3.Study on the quality of Huangkui Siwu Formula extractHuangkui Siwu formula is composed of Abelmoschus manihot,Polygonum cuspidatum,radix curcumae longae and Astragalus membranaceus.The quality of the raw materials varies from place to place.The quality of the materials of Huangkui Siwu formula must be controlled before forming.Therefore,this chapter will study the quality of the extracts of Huangkui Siwu formula on the basis of optimization of process,and control the quality of the raw materials of Huangkui Siwu formula,so as to provide reference for the follow-up research for the foundation.This chapter mainly established TLC identification method of Abelmoschus manihot,Polygonum cuspidatum,radix curcumae longae and Astragalus membranaceus in Huangkui Siwu formula;established fingerprint of Huangkui Siwu formula extract and identified chemical components;established HPLC content determination method of chemical components in Huangkui Siwu formula.The results showed that:(1)according to the Pharmacopoeia,TLC was used for qualitative analysis of Huangkui Siwu Formula.It was found that the test product chromatograms of various medicinal materials showed the same spots in the corresponding positions of the control medicinal material chromatogram and the reference substance chromatogram,but the color of the spots was different,that is,there were some differences in the quality of different batches of Huangkui Siwu Formula from different producing areas;(2)the following results were obtained the fingerprint of the compound was established by HPLC.Compared with the standard substance,13 compounds were identified.The content of the compound was determined according to the identified chemical components.It was found that the content of most components in the compound was similar,and the content of some components was quite different,such as curcumin,bisdemethoxycurcumin and demethoxycurcumin in Curcuma longa.Therefore,it is necessary to avoid the production area with less content of components in the selection of Curcuma,and select the best medicine for the preparation of Huangkui Siwu formula.4.Study on the molding technology of Huangkui Siwu FormulaThe extraction process and purification process of Huangkui Siwu Formula have been optimized in the early stage of this article,and a series of studies have been carried out on the quality of the extract.This chapter will investigate the molding process of Huangkui Siwu Formula in accordance with the requirements of new drug research technical specifications.The first is the choice of dosage form.Due to the advantages of large drug loading,convenient carrying,and good patient compliance,we chose to make Huangkui Siwu Formula into granules.Next,the granule molding process of Huangkui Siwu Formula Granules is investigated from the selection of auxiliary materials,the ratio of auxiliary materials,the ratio of materials,the drying time and the drying temperature.Dextrin:starch=1:1:1,drying temperature is 80 dry,drying time is 60 min.The packaging materials were selected in the later stage,and the medicinal composite film(polyester/aluminized polyester/polyethylene medicinal composite film)commonly used in granules was finally determined as the inner packaging material of this product.The determination of the dosage form and technology provides a scientific and reasonable basis for the follow-up quality research of Huangkui Siwu Formula.5.Study on quality of Huangkui Siwu Formula GranuleIn order to control the quality of Huangkui Siwu Formula granules and ensure its quality stability,this chapter establishes the quality standard of Huangkui Siwu Formula Granules and evaluates its quality.Firstly,a TLC identification method was established,and the TLC method was used to identify Abelmoschus manihot,Polygonum cuspidatum,radix curcumae longae and Astragalus membranaceus in the preparation;the fingerprint of Huangkui Siwu Formula granules was established by HPLC and the content of the index components in the preparation was determined.A feasible and effective quality control system has been established for Huangkui Siwu Formula granules.In summary,through this study,we found that the best preparation process of Huangkui Siwu Formula Granules is:weigh the four medicinal materials of Abelmoschus manihot,Polygonum cuspidatum,radix curcumae longae and Astragalus membranaceus,and add 10 times the amount of 60%ethanol to reflux extract three times,each time for 1.5 hours,combine the extracts,and concentrate them to 1.0 g/mL to prepare Huangkui Siwu Formula extract.Then HP-20 was used as the purified resin,and the concentration of the drug solution was 1 g/mL for loading.1.5g of the sample(extract mass)per g of resin was loaded,eluted with 4B V of 80%ethanol,and the purified drug solution was concentrated again.The purified product of Huangkui Siwu Formula was obtained.Add dextrin and starch,mix according to the clear cream:dextrin:starch=1:1:1,make soft material,pass through No.2 sieve to granulate,dry for 60 min in oven 80,take out and let cool,use No.1 sieve and No.5 sieve to sizing,package with medicinal composite film(polyester/aluminized polyester/polyethylene medicinal composite film),sterilize,and get the finished product. |
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