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目的:对医院制剂“降粘胶囊”进行长期毒性实验,以评价其长期用药安全性。方法:将80只大鼠随机分为空白组、大剂量组、中剂量组、小剂量组,给药组灌胃降粘胶囊浸膏水溶液,空白组灌胃等量蒸馏水,连续灌胃90 d,观察空白组与给药各组大鼠一般体征、各器官组织脏器指数、病理切片及血液学各项指标、血液生化各项指标的情况。结果:连续给药90 d及停药15 d期间,各组大鼠体重增加,各组间无明显差异(P>0.05),各组大鼠活动正常,皮毛、眼、耳、口、鼻分泌物及粪便性状未见异常变化;给药组各脏器指数、血液学各指标、血液生化学各指标与空白组比较均无显著性差异(P>0.05);病理学切片:空白组与给药各组各器官组织形态正常,无明显病理变化。结论:连续3个月灌胃降粘胶囊,未见明显毒性反应,说明降粘胶囊较安全。
OBJECTIVE: To carry out long-term toxicity test on hospital preparation “viscosity reducing capsule ” to evaluate its long-term safety. Methods: Eighty rats were randomly divided into blank group, high dose group, middle dose group and low dose group. The rats in the administration group were given gavage solution of Jiangsan Capsule, and the blank group were given the same amount of distilled water. The general signs of the rats in the blank group and the administration group were observed, and the indexes of organ tissues, pathological sections, hematology indexes and blood biochemical indexes were observed. RESULTS: During continuous administration for 90 days and withdrawal for 15 days, the body weight of rats in each group increased and there was no significant difference among the groups (P> 0.05). Rats in each group had normal activity, fur, eyes, ears, mouth and nose There was no significant difference in the indexes of organ, hematology and blood biochemistry in the administration group compared with the blank group (P> 0.05). Pathological sections: The various organs of each group of normal morphology, no significant pathological changes. CONCLUSION: There is no obvious toxic reaction after 3 consecutive months of intragastric administration of viscosity reducing capsule, which shows that the viscosity reducing capsule is safer.