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目的通过30d给药毒性实验,观察功劳去火片对SD大鼠所产生的各种毒性反应,以评价功劳去火片的安全性。方法 SD大鼠80只,雌雄各半,随机分为四组(空白对照组、功劳去火片高、中、低剂量组),每组各20只。给药组以功劳去火片按27.2g、13.6g、6.8g生药/(kg.d)进行大鼠灌胃(分别相当于临床日用量的80倍,40倍,20倍),空白对照组给予4ml/kg生理盐水溶液,给药30d,于停药次日和停药2周(恢复期)时,各组分别取10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。结果功劳去火片大剂量组对大鼠的体质量增长有一定程度的影响,各剂量组血液学、生化指标和脏器系数,与空白对照组比较,差异均无统计学意义;病理检查,均未见与药物相关的明显病变;停药后,也未见药物延迟毒性反应。结论功劳去火片长期毒性试验未见异常反应,临床上应用是安全的。
OBJECTIVE: To evaluate the toxicity of the detoxification tablets to SD rats by observing the toxicity of detoxification tablets to rats for 30 days. Methods Eighty male and female SD rats were randomly divided into four groups (blank control group, high, medium and low dose group), 20 in each group. The rats in the treatment group were given intragastric administration of 27.2g, 13.6g, 6.8g crude drug / (kg.d) respectively (corresponding to 80 times, 40 times, and 20 times of the daily clinical dosage respectively), and the blank control group Given 4ml / kg saline solution for 30 days. On the next day of withdrawal and 2 weeks after withdrawal (recovery period), 10 rats (half male and female) were taken from each group to detect blood, blood biochemistry, organs Coefficients and Organ Histopathology. Results The results showed that there was no significant difference in hematology, biochemical indexes and organ coefficient between the high dose group and the blank control group in the high dose group. The pathological examination, No obvious drug-related lesions were found; after drug withdrawal, no delayed drug toxicity was observed. Conclusion There is no abnormal reaction in the long-term toxicity test of the credit to fire, and the clinical application is safe.