| The serial prescription named Xiaokeping(wasting-thirst) has already been used for clinical application up to more than 10 years,mainly for preventing and treating various complicating diseases caused by the diabetes.And according to the experimental requirements from "guidance principle about medicine research(2005)",the project has accomplished the study on clinical pharmacology and toxicology data through two years' fundamental research.And now,the following is the summary of the research production from the experiment.â… Main research on pharmacodynamicsFor Observing and validating the pharmacological action of Xiaokeping(wasting-thirst) to the complicating diseases of 2-type diabetesMethod:for experimental observation,it adopts small dose of streptozocin to mate with the high fat fodder for feeding large mouse to make diabetes model of 2-type and adopting tetraoxypyrimidine to mate with the high fat fodder for feeding rabbit to make diabetes model of 2-type.Result:for the animals under experiment of 2-type diabetes,the Xiaokeping has the following effect:â‘ enhancing sugar metabolism,lowering fasting blood glucose of the animals under experiment with sugar tolerance strengthened.â‘¡improving ester metabolism,lowering blood fat level of the animals under experiment,the level of free fatty acid and abicin dialdehyde and maintaining enzymatic activity of red blood cell film Na+-K+-ATP,have the content and activity of superoxide dismutase heightened with the trypsin level lowered and the trypsin sensitivity to the organism enhanced.â‘¢have the animals' immunity heightened with fatigue state enhanced,the integral quality of the 2-type diabetes animals under experiment integrated and disease resistant ability improved.â‘£for preventing and treating complicating diseases of 2-type diabetes,the Xiaokeping(wasting-thirst) is possessed with dose-effect relationship.Conclusion:â‘ the Xiaokeping(wasting-thirst) has the action in treating and preventing the chronic complicating diseases caused by experimental diabetes of 2-type.â‘¡It is planned to recommend that the oral taking method should be used for medicine clinical application.â‘¢according to posologic conversion method by Chenqi, daily dosage of Xiaokeping(wasting-thirst) planned for the adults should be 3.64/day [(3.56+3.72)÷2=3.64].â‘£the administer drugs period of treatment planned for clinical application is 24 weeks.â…¡Acute toxicity experiment for the small miceBecause the medicine under experiment is difficult in calculating LD50,have the small white mice used for assaying the biggest tolerance quantity of Xiaokeping(wasting-thirst) (MTD) according to the rules concerned.And the result has been that:the oral MTD of Xiaokeping for the small mice should be 16g/kg(equivalent to 160times of daily administer drugs dosage for adults).â…¢long term toxicity experiment for the large micemethod:The experiment adopts 160 of SD large mice consisting of male and female in half,with contrast group randomly divided by sex and body weight and by dosage of 1.0 g/ kg,2.5g/kg,5.0 g/kg(respectively being 10,25,50 times of the recommended clinical dosage),feeding medicine through filling stomach every week for six days and continuing the process up to six months.When administer drugs up to three months,six months and after administer drugs is stopped up to four weeks,have the inspection on hematology,blood biochemistry and hestopathology finished,result:from the result of every detection for dosage groups of low,medium and high,it may be seen that:There has not happened abnormal variation to the large mice in the general physical signs of large mice(including shit and urine,hair color and diet,etc.),body weight and blood biochemistry index including alanine amino converzyme(ALT),aspartic acid amino converzyme(AST),alkaline phosphatase(ALP),total bilirubin(T-BIL),total protein(TP),albumen(ALB),blood sugar (GLU),total cholesterol(T-CHO),urea nitrogen(BUN).creatinine(Crea),triglyceride (TG),r-glutamic acid transferase(GGT).concha ion concentration(K),sodium ion concentration(Na) and chlorine ion,etc.and in viscera weight and its coefficient and electrocardiogram,etc.,without significant difference when comparing with the contrast groups(P＞0.05).Histology inspection:when observing the viscera of the animals under medicine feeding with macroscopic observation and having it compared with the contrast groups,significant abnormity has not been found.For histology inspection under microscope, the viscera of high dosage group and contrast group is not found significant and pathological variation.Conclusion:continually feeding the large mice with the medicine Xiaokeping (wasting-thirst) for six months,the toxic reaction caused by the medicine to the large mice has not been found.The above results have shown that:the medicine Xiaokeping(wasting-thirst) has significant effect in preventing and treating the complicating diseases of 2-type diabetes, not finding the intoxicating action to the large and small mice.And from this,it may be seen that the medicine has its value for further development. |
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