Study On Preparation Technology And Qu Ality Standards Of Shen Ge Jiang Tang Granules

In recent years,as people living standard rising and the change of the diet,the incidence of diabetes increased with years,which has become the third largest disease after cardiovascular disease and cancer.Shen Ge Jiang Tang granules were based on the classical prescriptions in treating diabetes,coming from "ginseng decoction" in"ShengJiZongLu" and "YuHu pill,in "RenZhaiZhiZhi" in the song dynasty.combined with modem pharmacological experimental research,the effective prescription treating type Ⅱ diabetes was optimized with ginseng,radix pueraridae and radix trichosanthis as the main composition.Based on the extraction and enrichment of effective fractions of prescription in the early stage of the research,the hypoglycemic effect of radix trichosanthis polysaccharide,the optimization of prescription compatibility proportion,the preparation technology and quality standards of granules were researched in the present paper.Using fasting blood glucose in mice as the index,the experiments were arranged by uniform design method to optimize the best ratio of formula in the three herbs.Regression analysis and stepwise regression method was applied to get the optimal compatibility of the formula:ginseng 3g,radix puerariae 6g,and radix trichosanthis 3g.The blood glucose level and glucose tolerance were selected as pharmacodynamics index and alloxan diabetes mice were used as animal models in this article,pharmacodynamics experiments were arranged to explore the anti-diabetic effect of the effective fraction,radix trichosanthis polysaccharide,in the formula.The experimental results showed that radix trichosanthis polysaccharide can significantly reducing blood glucose level of diabetic mice.On the basis of previous study,total saponins of ginseng and total flavanone of pueraria,which were the effective components on lowering blood glucose level in the formula,were extracted and enriched.Moreover,the extraction technology of the polysaccharide in the fornula was optimized and the optimum process was as follows:cellulose enzyme 1.5%,ratio of material to liquid 20:1 and extraction time 4h.By screening the raw materials ratio,alcohol concentration and the amount of alcohol in Shen Ge Jiang Tang granules,the best preparation technology was obtained as follows:raw material,dextrin and lactose ratio was 1:0.5:1,alcohol concentration was 70%,and the alcohol consumption was 16%of the total raw materials,moisture,particle size,solubility,content uniformity and microbial limit examination of the granules were conducted.In the quality standards of preparation,applying thin layer chromatography(TLC),the qualitative identification method of radix puerariae and ginseng in the preparation was established.At the same time,using high performance liquid chromatography(HPLC),content determination method was established to determine puerarinn and ginsenoside Rb1,Re and Rg1 in the preparation.The result were as follows:puerarin 70.86 mg/g,ginsenoside Rbi 4.70 mg/g,Re 2.91 mg/g and Rg 10.446 mg/g,which showed that the preparation process is reasonable and feasible,the quality was controled.