The Secondary Development Of Diabetes Tablets

Diabetes Tablet is a kind of semi-extract-enteric-coated tablets made of Milkvetch Root extract, Rehmannia Root extract, Solomonseal Rhizome extract, Heterophylly Falsesatarwort Root extract and Trichosanthin extract. It can supplement the center,boost the energy and nourish Yin Regenerate Fluid. It is used to treat diabetes. Diabetes Tablet is the traditional Chinese medicine used to treatⅡ-diabetes,and is the protected species of chinese medicine.The experiments made a second devolopment of Diabetes Tablet, in order to impove the efficacy, safety, stability and homogeneity,shorten production cycle and reduce production costs at the same time. In this experiment, we replace the Ethanol Technology in original process with Adsorption Clarification. We compared ZTC adsorption clarification with Chitosan adsorption clarification, deciding to useⅢ-ZTC 1+1 as Adsorption Clarifier. We examined four factors, they are Solution concentration, ZTC A component usage, A component adding temperature, B component adding temperature, The evaluation is the Composite score of extract yield, content of polysaccharide and content of catalpol. We optimize the adsorption clarification process by L9 (34) orthogonal test. Best process:Liquid concentration of 1:7, ZTC A component addition is 0.3 mL/g, A component adding temperature is 60℃, B components including the temperature is 40℃. Compared to alcohol precipitation, the results show that the effect of ZTC adsorption clarification is superrior to that of alcohol precipitation.In this study, the original Milkvetch Root and Solomonseal Rhizome TLC identification method has been verified, that the original method is feasible. We also increased Rehmannia Root, Heterophylly Falsesatarwort, Trichosanthin TLC identification method, making the Identification of Diabetes Tablets more comprehensive.We established phenol-sulfuric acid method to determine the content of polysaccharide in Diabetes Tablets. The linear range of polysaccharide is 0.02mg/mL-0.08mg/mL, r=0.9986 (n=7), the average recovery rate was 100.01%, RSD 1.56%(n=9). The methods were accurate and reliable. We established HPLC to determine the content of catalpol in Diabetes Tablets, The linear range of catalpol is 0.4μg-2.0μg,r=0.9998(n=5),the average recovery rate was 99.87%, RSD 1.09% (n=9). The methods were accurate and reliable.Preliminary test results showed that the stability of the new technologic Diabetes Tablets is slightly better than the original Diabetes Tablets.Pharmacodynamic results showed that compared to original process, the new technologic Diabetes Tablets had good hypoglycemic effect and were significantly different from model group, positive control group. Original process and new technologic Diabetes Tablets all have a significant recovery effect on the weight decline of STZ diabetic mice, but there is no significent difference.