| No.1 Pharmacodynamics experiment of Shengjing Yusi CapsuleObjective: This article undertook main pharmacodynamics experiment connecting with function and indication about Shengjing Yusi Capsule(SYC), which supplied pharmacodynamics proof for clinical application. Method: 60 Kunming mouse were divided into 3 groups: normal group, model group and traditional Chinese medicine group. The mould of dyszoospermia was built by intraperitoneal injecting cyclophosphamide. After completing mould, the mouse in the traditional Chinese medicine group were lavaged SYC 15g/(kg·d), once a day, and the mouse in other groups were lavaged sodium chloride of tales doses, it last 15 days. And then the weight of mouse testis was measured in every group, evaluated follicle stimulating hormone, luteinizing hormone and testosterone of mouse blood serum by radio-immunity way, observed the histomorphology of testis tissue, compared sperm density and activity percentage in every mice-group. Result: Cyclophosphamide made genitical gland and accessory sex gland organ coefficient lower, epididymis sperm count and motility rate descent, the weight of convoluted tubule decreased and calibre shrinked, all ranks of spermatogenic cell lacked in different degrees, in the dyszoospermia mouse. SYC made above-mentioned index better in certain degree, and tend to the level of the normal group. Conclusion:①The way of intraperitoneal injecting cyclophosphamide could copy the dyszoospermia mouse.②SYC could advance testosterone level of the experimental dyszoospermia mouse in effect, also increase the weight of convoluted tubule and accessory sex gland organ coefficient.No.2 Acute toxicity test of SYCObjective: Acute toxicity testing of SYC according to lavaging mouse was undertaken. Observe the acute toxicity reaction and death circumstance when the mouse was given the accepted medicine once. Method:①The all 40 mouse were divided into 5 groups at random by weight, and lavaged medicine, dose spur was 1:0.7, and measured the LD50, but the LD50 could not be measured.②The 60 mouse whose weights were 20g or so were taken, which were absolute diet, not absolute water in 16 hours, then lavaged dosage by maximum concentration 37.8%, maximum administration capacity 0.4ml/10g, twice a day, lasting 7 days, and recorded toxicity reaction of mouse in detail. When the test finished, the whole mouse were put to death, dissected, and macroscopy the main organs, such as heart, liver, spleen, lung and kidney, pathological changes. (Accounting mouse maximum administration dosage and administration multiple: mouse maximum administration multiple= every mice maximum administration dosage /mouse mean weight (20g)×adult mean weight (60kg) / adult dosage per day). Result:①The LD50 could not be measured after lavaged medicine in the all 20 mouse.②The appearances of the main organs such as heart, liver, spleen, lung, kidney and testis were not obviously different in the anatomic mouse which were lavaged medicine of SYC. Conclusion: SYC has no any toxicity reaction in the most prescribed dose when lavaging mouse.NO.3 long-term toxicity test of SYCObjective: According to observe mouse which were successively and repeatly given SYC in long-time, large dose, it was possible that mouse caused toxic reaction and severe degree as well as, and supplied the circumstance about target organ of toxic reaction and reversability of its damage, definited the dose of innocuity reaction, which supply proof of animal long-term toxicity test for safety of clincal medication, and provid the information for safety dose of clinical patient. Method: Due to the LD50 not measured and unobviously toxicity reaction, there were 3 groups: low dose group (0.84g/kg), middle dose group (1.69g/kg), high dose group (3.38g/kg), which corresponded to 12.5, 25, 50 times of adult dosage, and normal control group. 80 mice were taken, which was divided into 4 groups at random, 20 mice every group raised each cage. After seven-day raising in laboratory, and observing the action, eating and excrement and urine of each group mouse no abnormalities, the mice were given dosage by intragastric administration. The mouse in each dose group was given dosage according to isometry, different density 1ml/100g weight, and the mouse in control group was given saline, which last 16 weeks. The mouse was weighed once every week, according to the change of weight, the dosage was adjusted. During the couse of testing, the behavior and action, appearance and sign, weight, pelage, eating, excrement and urine were observed. Result: After given SYC by intragastric administration in 16 weeks:①General behavioral condition, weight, ingestion of mouse in each group had no abnormal change compared to the normal group, the organ index, such as heart, liver, spleen, lung and kidney, in low dose group, middle dose group, high dose group, had not obvious difference.②In the hematology examination, hemoglobin and erythrocyte in high dose group dropped out compared to the normal group (P<0.05), the other index no abnormalities compared to the normal group, the index in low dose group, middle dose group no abnormalities compared to the normal group.③In the biochemical analysis total protein in high dose group obviously degrade compared to the normal group (P<0.05), inosineobviously degrade (P<0.05), GPT advance (P<0.05), blood sugar and cholesterin obviously advance (P<0.05), the index in low dose group, middle dose group no abnormalities compared to the normal group.④In histopathology examination, liver appearance in high dose group was pale purple surface gloss and lubrication, fringe and angularity distincted, soft substance, none hyperemia and haemostasis, under the microscope, the structure of hepatic lobules was still clear, hepatic cell was coincidence, arranged regularly, whose core offer round, situated in the cell centre, hepatic cell and hepatic lobules were not inflammation, degeneration and necrosis, the header was not inflammation as normal liver structure, which had no obvious difference compared to the normal group. In middle dose group, the structure of hepatic lobules was clear, hepatic cell was coincidence, arranged regularly, whose core offer round, situated in the cell centre, hepatic cell and hepatic lobules were not inflammation, degeneration and necrosis, the header was not inflammation as normal liver structure, which had no obvious difference compared to the normal group. In low dose group, liver appearance in high dose group was pale purple surface gloss and lubrication, fringe and angularity distincted, soft substance,none hyperemia and haemostasis, under the microscope, the structure of hepatic lobules was still clear, hepatic cell was coincidence, arranged regularly, whose core offer round, situated in the cell centre, hepatic cell and hepatic lobules were not inflammation, degeneration and necrosis, the header was not inflammation as normal liver structure, which had no obvious difference compared to the normal group. Conclusion: SYC is safe and reliable to be administrated in the prescribed dose, at high-dose may lead to a certain degree of toxicity in long-term use. This experiment for its safety in clinical medicine provides the experimental proof. |
PDF Full Text Request