| Objective:Geqin-Gushen tablet were prepared from the effective component of "Qianjin Wenwu decoction" as raw material.First,optimizing the purification process of effective components.Second,Screening excipients for formulation and optimizing the preparations.Third,optimizing the preparation process parameters and establishing the quality standard of Geqin-Gushen Tablet Finally,investigating the main pharmacodynamic effects on diabetic kidney disease model rats.Method:1.Determining the content and retention rate of the index components after extraction and purification of Geqin-Gushen tablets by using total polysaccharides,total flavonoids and total saponins as indexes.2.Purification process of Macroporous adsorption Resin(MAR),the best concentration,flow rate of the sample and flow rate of eluent was screened by using the enrichment rate of total flavonoids as the index.3.Wet granulation and pressing tablets,selection of fillers based on dry particle formability,angle of repose,bulk density and wettability.Select disintegrant,binder and lubricant to determine the prescription of final preparation according to the appearance of tablet,time limit of disintegrtion and formability.4.The appearance,disintegration time and formability of tablets were used as indexes to screen the process parameters and to determine the optimum process conditions.5.The appearance,hardness,disintegration time and dissolution of tablets were checked.By means of thin-layer chromatography to identify the 9 herbs in the tablet What’s more,through UV spectrophotometry to determine the contents of total flavonoids,total saponins and total polysaccharides in tablets.The contents of puerarin and baicalin in the tablets were determined by high performance liquid chromatography.As a result,the quality standards of Geqin-Gushen tablets were established.6.The rat model of streptozotocin DKD was established.The different concentrations of Geqin-Gushen tablets were administered to model animals,to observe body weight,blood glucose,drinking water,urine volume and the occurrence of cataract Urine microalbumin,urea nitrogen(BUN),and N-acetylation were measured.The main effiacy of(3-D-glucosaminidase(NAG),retinol-binding protein(RBP),homocysteine(Hcy)and urinary protein quantification were also evaluated.Results:1.The results of the determination of the effective components of the extraction and refining liquids of Geqin Gushen tablets show that the extraction and refining process was feasible,and there was no significant change in the content of effective components before and after refining.2.The purification process was as follows:the static adsorption amount of the purified liquid was 1.20 mg·g-1,the static resolution was 84%,the sample concentration was 0.05 g·mL-1,the sample flow rate was 1 BV·h-1,the sample volume was 125 mL and the eluent volume was 100 mL.With a flow rate of 1 BV·h-1,there was no significant change in the content of effective components after purification,and the yield of the extract was significantly decreased.3.The prescription of Geqin Gushen tablets preparation was:extract powder 70.5%,lactose 14.1%,MCC 9.4%,CMS-Na 5%,magnesium stearate 1%,and 70%ethanol.4.The preparation was a yellow-brown ordinary tablet which was smooth and no pockmark.The average piece weight was 0.5 g,the hardness was 50N and the cumulative dissolution was up to 97%at 15 min;5.Thin layer chromatography determine the test sample and the reference product It showed that the chromatogram at the corresponding position had the same color spots or fluorescent streak,negative control was no corresponding spot.6.Via UV spectrophotometry determination of three batches of different batches Geqin Gushen tablets in the effective component of the average content of each component and the total flavonoids,polysaccharides and saponins were 2.14 mg·g-1,0.314 mg·g-1,0.416 mg·g-1,respectively.7.The average content of puerarin in three batches of different batches was 3.25 mg·g-1 by HPLC and baicalin 0.434.mg·g-1.8.After 30 days of intragastric administration,the general indicators of the rats in the treatment group(MDL group,MDH group)compared to the course of the model group was improved including body weight,blood glucose,water intake and urine output Among them,the body weight and the blood glucose values were statistically significant(P<0.05).The biochemical indexes(urinary microal-bumin,NAG,RBP,Hcy,BUN,and urine protein quantification)showed that the content of the treatment group was lower than that of the model control group.The data were statistically significant(P<0.05).Conclusion:The prescription and preparation technology of Geqin Gushen tablets preparation are reasonable and feasible.The established quality standard has good repeatability and specificity and can be used for the quality control of Geqin Gushen tablets.Geqi Gushen tablets can reduce blood glucose in DKD rats,increasing body weight,reducing the effect of diseased rats albumin,NAG,BUN,RBP,urinary protein,Hcy content,which can reduce or inhibit the course of DKD rat retinopathy at the same time. |
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