养胃颗粒对大鼠的长期毒性试验

Experiment of long-term toxicity of Yangwei granules in rats

目的:观察养胃颗粒对大鼠的长期毒性,为临床安全用药提供科学依据,保证用药安全。方法:将SD大鼠分别按体质量随机分为高、中、低剂量(69.0,34.5,6.9 g·kg-1)养胃颗粒组和空白对照组。养胃颗粒组连续灌胃给药90 d,每天给药1次,空白对照组给予等量的0.3%羧甲基纤维素钠,停药后连续观察15 d,分别测定大鼠体质量、进食量、血液学、血液生化学、脏器系数及病理组织学变化。结果:给药期间各组大鼠毛色、活动、摄食量及体质量无异常变化,但部分血液学、血液生化指标和脏器系数有异常变化,停药后,上述异常变化指标均已恢复正常。给药期及恢复期重要脏器病理组织检查均未发现明显异常。结论:养胃颗粒长期用药对大鼠未见明显毒性反应,长期服用安全。

OBJECTIVE To observe the long-term toxicity of Yangwei granules in rats, to provide the sclennhc basis tor its clinical usage and to ensure the safety of drug administration. METHODS SD rats were randomly divided into 4 groups. The drug treatment group was given orally with Yangwei granules at dose of 69. 0, 34. 5 and 6. 9 g·kg^-1 daily for up to 90 d, respectively. Bland control group were given same bulk of CMC-Na. After the withdrawal of drug, the continuous observation of 15 d was done. The rats＇ body weight, food intake, hematology, blood biochemistry analysis, and organ coefficients were measured, and the histo-pathological changes were also observed. RESULTS There was no abnormal change on color pattern, act, cibation and body weight, but part of parameters of hematological, hemato-biochemical and part of coefficient of organs were abnormal during administration period. The rats were examined in 15 days after the cessation of Yangwei granules, the abnormal changes of indexes were completely recovered. After administered repeatedly for 90 days and in 15 days after stopping the drug, there was no obvious abnormality for the important organ pathology examination. CONCLUSION Yangwei granules had no obvious toxicity in rats for long-term administration.