加味四逆散长期毒性实验及安全性评价

目的通过长期毒性试验，观察加味四逆散对SD大鼠所发生的各种毒性反应，以评价加味四逆散的安全性。方法SD大鼠80只，雌雄各半，随机分为4组（空白对照组、加味四逆散高、中、低剂量组）每组各20只，三个用药组灌胃18w及停药2w后分别检测体重、血象、肝功、肾功、脏器系数及脏器组织病理。结果各给药组大鼠的血象、肝功、肾功、脏器系数分别与对照组相比差异无显著性意义（P〉0．05）。光镜下高剂量组大鼠心肌见嗜碱性变，心肌轻度充血，其余各组大鼠心脏结构清楚，肌纤维未见变性、坏死、断裂、心内外膜以及间质未见明显变化；停药2w后，各组动物脏器组织均正常，各给药组大鼠的血象、肝功、肾功、脏器系数分别与对照组相比差异无显著性意义（P〉0．05）。结论加味四逆散口服给药对正常大鼠的一般行为无明显影响，对大鼠肝脏、脾脏、肾脏、肺脏、子宫、卵巢、睾丸及肾上腺等组织无明显影响；长期高剂量口服给药对大鼠心脏有轻度的可逆性损伤；本实验表明加味四逆散停药后对大鼠无延迟毒性作用；对正常大鼠总体是基本安全的。

Modified Si Ni Powder: Its Long-term Toxicity Test and Safety Evaluation

Objective： To evaluate the safety of modified Si Ni powder through long-term toxicity test to observe various kinds of toxic reaction of modified Si Ni powder on SD rats. Methods： 80 SD rats were （40 males and 40 females） randomly divided into 4 groups （blank control group, high, middle and low dosage of modified Si Ni powder groups）, 20 mice in each group. The weight, hemogram, liver function, kidney function, organ coefficient and histopathologic of organs of the three groups given with medicine were measured after 18W of administration and 2 weeks after stopping the medicine respectively. Results： The hemogram, liver function, kidney function and organ coefficient of each medicine group had no significant difference compared to the control group （ P 〉 0.05 ）. Under microscope, the myocardium of the rats in high dosage group appeared basophilic change, and was slightly congestive. The cardiac structures of the rats in other groups were clear; no degeneration, neerosis, or rupture was seen in muscle fibers, no obvious changes were seen in endocardium, epicardium or mesenchyma. Two weeks after stopping the medicine, the organs and tissues of the rats in each group were normal. The hemogram, liver function, kidney function and organ coefficient of the medicine group had no significant difference compared with the control group （ P 〉 0.05 ）. Conclusion： Oral administration of modified Si Ni powder has no obvious effects on normal rats＇general behaviors, and has no obvious effects on rats＇liver, spleen, kidney, lung, uterus, ovary, testicle or adrenal gland; long-term of high dosage oral administration has mild reversible injury on rat＇s heart; the experiment shows that modified Si Ni powder has no delayed toxicity on rats after stopping the medicine, and is safe for rats in general.