急支平喘软胶囊急性和长期毒性研究  

Observation on Acute and Long-Term Toxicity of Jizhi Pingchuan Soft Capsules

作　　者：王争[1] 侯中华[1] 王曙东[1] 

机构地区：[1]南京军区南京总医院制剂科,江苏南京210002

出　　处：《中华中医药学刊》2014年第6期1487-1490,共4页Chinese Archives of Traditional Chinese Medicine

摘　　要：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 and long- term toxicity of Jizhi Pingchuan soft capsules and to evaluate the safety. Methods：Mice were intragastrically administered with Jizhi Pingchuan soft capsules. Its toxicity,mortality and the maximum tolerated dose were determined. The SD rats were randomly divided into 4 groups with males and females （ 1/ 1 ）. The 3 groups were orally given with Jizhi Pingchuan soft capsules in large, medium, small dosages （respectively 20.0 g/kg ,6.32 g/kg,2.00 g/kg） every day for 30 days. Blank control group was given 0.5% CMC - Na. The physical status （body weight,food intake and appetite）, hematological parameters, blood biochemistry, organ index and tissue pathological changes of rats were checked in 30 days and in two weeks after the stop of medicine. Results ：The maximal tolerated dose was 240 g/kg,which was 685 times as the clinical dosage. The outer appearance and behavior, bodyweights, food intake, hematological parameters, blood biochemistry and organ index in rats of drug taking groups showed no significant difference compared with those of blank control group. Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after the stop of medicine. Conclusion：No toxicity has been found in the observation period. This preparation is relatively safe in clinical application.

关 键 词：急支平喘软胶囊 急性毒性 长期毒性 大鼠 

分 类 号：R284.2[医药卫生—中药学]