论文部分内容阅读
目的:观察急支平喘软胶囊对大鼠的急性毒性和长期毒性,评价急支平喘软胶囊的用药安全性。方法:急支平喘软胶囊灌胃,观察其毒性反应、死亡情况和最大耐受量;SD大鼠随机分为急支平喘软胶囊高、中、低剂量组(20.0 g/kg、6.32 g/kg、2.00 g/kg)和空白对照组,雌雄各半,给药组每天灌胃给药1次,空白对照组给予0.5%CMC-Na溶液,连续给药30 d。停药后恢复期2周,观察大鼠的一般状况、体重、摄食量,测定血液学、血液生化学、脏器系数和病理组织学变化。结果:小鼠最大耐受量为240 g/kg,为临床用药的685倍;给药30 d后大鼠外观、行为、体重、摄食量、血液学、血液生化学、脏器系数与空白对照组比较未见明显差异;病理检查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:急支平喘软胶囊临床应用具有一定的安全性。
OBJECTIVE: To observe the acute toxicity and long-term toxicity of emergency suppository soft capsule in rats, and to evaluate the safety of administration of emergency suppository asthma soft capsules. Methods: The rats were randomly divided into high, middle and low dosage groups (20.0 g / kg, 6.32) of acute relief suppurative asthma soft capsules g / kg, 2.00 g / kg) and blank control group, the male and female were divided into two groups. The treatment group was given gavage once a day, and the blank control group was given 0.5% CMC-Na solution for 30 days. After stopping the recovery period of 2 weeks, observe the general condition, body weight, food intake, determination of hematology, blood biochemistry, organ coefficient and histopathological changes. Results: The maximum tolerated dose was 240 g / kg in mice, which was 685 times of that in clinical medication. The appearance, behavior, body weight, food intake, hematology, blood biochemistry, organ coefficient and the control There was no obvious difference between the two groups. No significant pathological changes were found in the pathological examination. No drug delayed the toxic reaction after stopping the medicine. Conclusion: Emergency relief asthma soft capsule clinical application has a certain safety.