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目的:连续观察6周给大鼠芎桃二乌止痛酊样品导致大鼠长期毒性损伤程度及恢复情况。方法:以芎桃二乌止痛酊的高、中、低剂量分别经大鼠完整皮肤和破损皮肤每天给药1次连续6周(每周停药1 d),按生药量计算,分别为180、90、45μL·cm~(-2)。观察大鼠一般性状,记录给药前后大鼠体重变化,检测血常规、血清肝功能、肾功能、脂质代谢、糖代谢相关指标,处死大鼠,称取心、肝、脾、肺、肾、脑质量,计算大鼠脏器系数,并对脏器进行病理学检查。剩余大鼠停止给药,恢复3周,观察大鼠恢复情况,并进行上述相同指标的检测。结果:完整皮肤高、中、低,破损皮肤高、中、低剂量组在连续给药6周后大鼠外观、行为体征、活动、精神状态均无明显异常;无大鼠死亡情况发生,亦无中毒反应。体重正常增加,脏器系数比较差异均无统计学意义(P>0.05);血中血小板(PLT)、淋巴细胞百分比(LY%)均升高,白蛋白(ALB)下降,与空白对照组比较有差异(P<0.05)。病理学检查无病理学改变;恢复期大鼠上述异常指标均正常,与空白组比较无差异(P>0.05)。结论:长时间给予一定剂量的芎桃二乌止痛酊经皮肤给药对实验大鼠无毒性反应,可以在临床安全使用。
OBJECTIVE: To observe the long-term toxicity of Xiong Tao Er Wu Zhitong tincture in rats for 6 weeks and the recovery. Methods: The high, medium and low doses of Xiong Tao Er Wu Zhitong Tincture were administered once a day for 6 consecutive weeks (once a week for 1 week) via intact skin and damaged skin of rats, respectively, , 90,45 μL · cm ~ (-2). The general traits of rats were observed. The body weight of the rats was recorded before and after the administration. Blood samples were collected and the blood and liver function, renal function, lipid metabolism and glucose metabolism were measured. The rats were sacrificed and hearts, liver, spleen, lung and kidney , Brain mass, calculate the rat organ coefficient, and pathological examination of organs. The rest of the rats were stopped and the rats were resumed for 3 weeks to observe the recovery of the rats, and the same indexes as above were tested. Results: There was no obvious abnormalities in the appearance, behavior, activity and mental state of rats in high, medium and low-dose group with high, medium, low and complete skin of 6 weeks after continuous administration; No toxic reaction. (P> 0.05). PLT, LY%, albumin (ALB) in blood were increased in normal weight group compared with those in blank control group There are differences (P <0.05). Pathological examination without pathological changes; convalescent rats above abnormal indicators were normal, no difference with the blank group (P> 0.05). Conclusion: The long-term given a dose of Xiong Tao Er Wu Zhitong tincture of non-toxic experimental rats on skin toxicity, can be safely used in clinical.