椒枝软胶囊大鼠长期毒性实验研究

Chronic Toxicity Testing In Rats For Jiaozhi Soft Capsules

目的:通过30天给药毒性试验,观察椒枝软胶囊对SD大鼠所产生的各种毒性反应,以评价椒枝软胶囊的安全性。方法:SD大鼠96只,雌雄各半,随机分为4组(空白对照组、椒枝软胶囊高、中、低剂量组),每组各24只。给药组以椒枝软胶囊内容物按4、2、1mL/kg进行大鼠灌胃(相当于3.6、1.8、0.9g内容物/kg),空白对照组给予4mL/kg纯化水,给药30天,于停药次日和停药2周(恢复期)时,各组分别取12只大鼠(雌雄各半)检测血常规、血液生化、脏器系数和脏器组织病理。结果:椒枝软胶囊内容物剂量为4mL/kg、2mL/kg时,对大鼠的肝肾功能及血液系统有一定程度的损伤,但均未造成器官的器质性病变,停药后,损伤情况有所恢复。剂量为1mL/kg时,各方面均未见明显异常。结论:椒枝软胶囊内容物剂量为1mL/kg时,可安全用于临床。

Objective： Toxicity Study of 30 days dutation in SD rats provides toxicological findings and evaluates the safety of Jiaozhi soft capsules. Methods ： 80 SD rats were randomly divided into 4 groups with males and females（ 1/1 ）, 24 fitters per group. The 3 groups were administrated with contents of Jiaozhi soft capsules by 4mL/kg, 2mlJkg and lmL/kg（ eaqual to 3.6g/kg, 1.8g/kg,0.9g/kg） respectively, the control group was adminitrated by purified water 4mL/ kg. The length of administration period was 30 days. 12 rats（6 litters per sex） were executed after the cessation of adminitration and the left rats were executed after the recovery period. Blood cell and blood biology were examinated. The coefficient of organ weight and organ histopathology were checked. Results ： 4mL/kg or 2mL/kg of contents of Jiaozhi soR capsules to rats resulted in renal, liver and blood picture injury. The injury of renal,liver and blood picture recovered af- ter the cessation of adminitration. No significant difference between 1mL/kg of contents of Jiaozhi soft capsules group and the control in all aspects. No abnormal changes were found in the histopathological examination. Conclusion： 1mL/kg of contents of Jiaoztfi soft capsules is a safety dose for clinical application.