The Pharmacodynamics And Toxicology Studies Of FZTS

Aim: In order to supply the experimental basement of clinical usage, we studied the pharmacodynamics and toxicology of FZTS (Fuzheng Tongshuan Capsules), an assist medicine of cerebral paralysis. Methods: 1 .We choose indexes such as swallow function of macrophage, activity of NK-cell, DTH reflection of mice sole, to research the immunomodulation of the medicine. 2. To study the effect on clotting system, the normal Wistar rats were chosen to ig test drug. 3. The acute toxicity of the test drug was studied on healthy mice. 4. The long-term toxicity of the test drug was studied on healthy rats. Results: 1. The test drug not only can significantly enhance the swallow function of macrophage and the activity of NK-cell, but also can greatly increase the weight of thymus gland and spleen. It is suggested that FZTS can modulate the immunization of the animal. But FZTS have little effect on B. pertissos induced DTH reflection of mice sole. 2. The affection of the indices, such as platelet aggregation rate, clotting system and hemorheology, suggest that FZTS may have some therapeutically effect on thromboembolus disease. 3. Acute toxicity: The maximum tolerance dose of FZTS per day is larger than 40.0g/kg in mice. 4. Long-term toxicity: (l)5g/kg/day Group: Rats' appearance and behavior were normal during the 26 weeks of dosage and 4 weeks withdrawal. During the first two weeks, the rats of 5g/kg/day Group had less weight-increase than the control group and were recovered after three weeks. (2) 15g/kg/day Group: Rats' activity, intake and weight increase were lower than control group during the 26 weeks. In the first four weeks after administration, female rats of 15g/kg/day Group had less weight-increase than the control group and were recovered after the next four weeks. Male rats of 1 5g/kg/day Group had less weight-increase than the control group until twenty-four weeks. There is no significant abnormality inhematology and laboratory test. After thirteen weeks administration, the organ coefficients of male animals' heart, liver, adrenal were greatly increased in high dosage group. After twenty-six weeks administration, the organ coefficients of female animals' liver, womb and male animals' liver, adrenal, brain was higher than those of control group. After administration, the pathologic examination found that some high dosage group' animals whose lung were infiltration with white blood cells. In this experiment, the safe dosage of FZTS is 5g/kg/d, while the poison dosage is 15g/kg/d, which is thirty-three times and one hundred times of clinical usage. Conclusion : 1. This study indicated that FZTS 0.6-1.8g/kg, which administrated for one week, Could enhance the function of immunization of mice. 2. FZTS 0.4-1.2g/kg had anti-coagulate effect, which could lower the platelet maximum aggregation ratio and blood viscosity of healthy rat. 3. There was no obvious abnormality in the acute toxicological test. The maximum tolerance dose of FZTS per day was larger than 40.0g/kg in mice. 4. Long-term toxicological test proved that FZTS had characters as low toxicity, wide safety scope, and good security utilities. The safe dosage of FZTS in rats was 5g/kg/d.