论文部分内容阅读
目的:观察天钩降压胶囊的急性毒性和长期毒性,以评估天钩降压胶囊用药的安全性。方法:以最大给药体积的天钩降压胶囊(0.345 g.mL-1)给予小鼠,24 h内分2次灌胃给药,连续观察14 d,记录动物外观、行为活动、精神状态、呼吸变化、中毒反应及死亡情况;存活小鼠每天记录体重及饲料量。用低、中、高剂量(32.4,64.8,129.6 g.kg-1,按生药计)的天钩降压胶囊灌胃给予大鼠,连续给药6个月,停药恢复1个月,分阶段观察大鼠的一般行为、体重增长、食量消耗、血液学及血液生化学指征、尿常规检查、心电图、系统尸解及组织病理学检查。结果:小鼠1 d内2次灌胃给予天钩降压胶囊的最大给药量为534.86 g.kg-1,相当于临床成人拟用日剂量(60 g.d-1)的534.86倍,未见明显的急性毒性反应。长期毒性实验中与同期对照组比较,天钩降压胶囊低、中、高3个剂量组动物行为活动、进食量、心电图等检查均未见异常;血液学指标、血液生化指标和尿液指标及病理组织学检查未发现存在与供试品有关的异常改变。结论:天钩降压胶囊低剂量为相对安全剂量;中、高剂量在6个月给药期内引起体重减少,在临床研究中应予以注意。
Objective: To observe the acute toxicity and long-term toxicity of Tian hook hypotensive capsule in order to evaluate the safety of Tian hook hypotensive capsule. Methods: Mice were administered with Tianxiaojiangya Capsule (0.345 g.mL-1) with the maximum drug volume and intragastrically administrated in 2 groups for 24 days. The animals were observed continuously for 14 days. The appearance, behavior and mental state , Respiratory changes, toxic reactions and death; surviving mice daily record weight and feed volume. Rats in low, medium and high doses (32.4,64.8,129.6 g.kg-1, according to crude drug) were administered intragastrically to rats for 6 months, withdrawal was resumed for 1 month, points The rats were observed for general behavior, weight gain, food intake, hematology and blood biochemical indications, urine routine examination, electrocardiogram, autopsy and histopathological examination. Results: The maximum dosage of Tian hookjiangya capsule was 534.86 g.kg-1, which was equivalent to 534.86 times of the daily dosage of 60 gd-1 Obvious acute toxicity. Long-term toxicity test compared with the same period control group, Tian hookjiangya capsule low, medium and high doses of three groups of animals behavioral activities, food intake, ECG and other tests were no abnormalities; hematological indicators, blood biochemical indicators and urine indicators And histopathological examination found no abnormal changes associated with the test article. Conclusion: Tian hook hypotensive capsule low dose of a relatively safe dose; medium and high doses in the 6-month period of dosing caused weight loss in clinical studies should be noted.