| Phase I clinical trial and experimental trial of Shen fu Kang capsule have obtained gratifying result. The purpose of doing this experiment is to observe the toxicity to gonad and kidney . According to different animal model , observing its Gonad toxicity and renal toxicity and the relationship between therapeutic effect and different dose. Experimental trialThe nephrotic syndrome rat model of this experiment is result in ADR .to divide the 60 vvistar rat into 6 groups by random , normal contrast group , tripterpgium glycosides group, shen fu kang group , shen fu kang and tripterpgium glycosides group, ADR group, dose trial group. When experiment start , all sections inject ADR 6mg/kg weight in a lump through caudal vein . while the normal contrast group's treatment is water for injection .when the model is completed, giving the normal contrast group water for injection to feed them by 2ml/150kg /d, the shen fu kang group, according to the dose one man shoud take a day , to make fitting density liquid , giving them one-tenth for each, giving the tripterpgium glycosides group, dose as the shen fu kang to feed. Giving The shen fu kang and tripterpgium glycosides group 1ml one half, All their feed quantity is eaqual. The dose trial group is divided into two sections , 5 one half for The shen fu kang and tripterpgium glycosides groups, the dose for them both broaden one time. When the experiment go on for 7th Day , 14th day, 28th day, and 56 th day , to collect urine in 24 hours for calculation protein, check serum index. All the experiment last for 60 days.The result show: from the experiment going on for 14 th day, all the urine protein in different groups become to increase, beside normal contrast group. To compare the ADR with other groups, the difference is very notable.(P<0.05) and appeared typical example, such edema and so on. At 28 th day, the urine protein of all the therapy groups began to descend. Then the reducing amount of the tripterpgium glycosides groups gradually reach saturation, while the shen fukang continued to invariablly descend , even above the former. The variance analysis showThe difference has meaning.(P<0.05), and the albumin show, comparing tripterpgium glycosides groups with shen fu kang The former is obviously exceed ADR group,(P<0.05) the latter has no difference between them., but the tripterpgium glycosides groups and shen fu kang is obviously exceed the ADR group(P<0.01). the sex hormone determination show, shen fu kang has no difference between the ADR group, and both them negative to the normal trial group, but the tripterpgium glycosides groups and shen fu kang and the tripterpgium glycosides groups both higher than others.(P<0.05). the cholesterol and creatinine show, only the shen fu kang group is different from the ADR, all the others has no difference.This experiment indicate, compare shen fu kang with tripterpgium glycosides, they have no difference in descending Urine protein in the first time, but when the time is going on they gradually appeared new change, the urine protein of shen fu kang group can be lower than the tripterpgium glycosides group, the sex hormone of them each is apparent. Among them , the tripterpgium glycosides and shen fu kang groups is the highest, it is obvious over the others, the tripterpgium glycosides' LH figure is higher than the ADR group and the shen fu kang group, thus it can be seen, its gonad toxicity exceeded the shen fu kang capsule. Because its high serum LH figure, the feedback regulation of the hypothalamic-piruitary-gonad axis probably misadjustment , so the pituitary gland's producing GnRh cut down, then according to rebound, the serum LH figure became lower. Thus this menoxenia even menoschesis can appear. While the dose trial contrast groupShow , with the therapy dose increasing , the treatment effect improving of the shen fu kang group. To increasethe tripterpgium glycosides group's dose, the effect can't be seen, but the toxcity to gonad became higher than before. All this facts demonstr... |
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