Study On Chemical Potency And Bioequivalence Evaluation

In this thesis, five ginsenosides including Rg1, Re, Rb1, Rc and Rd were investigated and compare the dissolution of Panax quinquefolium L. micro-powder and common powder, pieces in water and simulated gastric juice in vitro. This is the first compare the difference from intestinal absortion of micro-powder and common powder, extract of Panax quinquefolium L. and investigate the pharmacokinetic parameters of micro-powder and common powder, extract of Panax quinquefolium L. Providing a reference for superfine grinding technology which applying in the field of traditional Chinese medicine. The research results are as follows:1. According to the results, the dissolution rates of ginsenosides from micropowder exceeded 90% of the total content with 5 min, significantly higher than the other two forms in water in vitro, at the same time, the dissolved amount of the micropowder was fourteen percent higher than pieces and eight percent higher than common powder. Under the condition of simulated gastric juice in vitro, the dissolution rates of ginsenosides from micro-powder were little lower than the other two, but the maximum dissolved amount of the former was fourteen percent higher than common powder and five percent higher than extract. Compare the area under curve of dissolved amount, the value of ginsenosides from micro-powder was 1.5 percent higher than common powder and 66.7 percent higher than extract.2. A simple and effective HPLC-QQQ-MS method was established for the quantification of ginsenosides in artificial intestinal juice, the method which was established in line with the guiding principles of the analysis of biological sample, and HPLC-QQQ-MS method could be applied to determine the concerntration of ginsenosides in artificial intestinal juice precisely. The result has said that the absorption effect of ginsenosides from micro-powder were better than ginsenosides from extract. Because the dissolved amount of micro-powder of Panax quinquefolium L. was higher than extract of Panax quinquefolium L. The verdict agree with the former verdict.3. An effective HPLC-QQQ-MS method was established for the quantification of ginsenosides in dog plasma, the method which was established in line with the guiding principles of the analysis of biological sample, and HPLC-QQQ-MS method could be applied to determine the concerntration of ginsenosides in artificial intestinal juice precisely. After oral administration, Tmax was about 8.23 h, showed that ginsenosides from extract rapidly absorbed in dog, Cmax was about 50.95 ng·m L-1 and AUC was about 1670.98 ng·m L-1·h, indicated that ginsenosides from micro-powder have the highest dissolved amount and bioavailability than the other two in dog. In summary,although the Tmax of ginsenosides from micro-powder was slower than the Tmax of ginsenosides from extract,the AUC and Cmax of ginsenosides from micro-powder was more higher than extract and common powder, theoretically the pharmacological function could be more better.