安眠胶囊药效、毒理实验研究

【作者】 李坤；

【导师】 张宏；

【作者基本信息】 辽宁中医学院 ， 药理学， 2005， 硕士

【摘要】 一、安眠胶囊急性毒性试验 目的:进行安眠胶囊小鼠灌胃给药急性毒性试验研究。观察受试药物一次给予动物后产生的急性毒性反应和死亡情况。方法:将小鼠按体重随机分成5组,灌胃给药,剂距为1:0.7,进行小鼠灌胃给药半数致死量(LD₅₀)的测定。结果:该药对小鼠灌胃给药的LD₅₀为45.196g/k8（生药）,LD₅₀的95%可信限为36.156～56.496g/kg,死亡动物经解剖肉眼观察心、肝、脾、肺、肾等主要脏器,未见明显异常改变。结论:安眠胶囊小鼠灌胃给药LD₅₀为45.196g/kg（生药）,LD₅₀的95%可信限为36.156～56.496g/kg。 二、安眠胶囊药效学试验 目的:本文对安眠胶囊进行了与功能主治有关的主要药效学试验,为临床应用提供药效学依据。方法:1.安眠胶囊对小白鼠自主活动的影响。2.安眠胶囊对小白鼠戊巴比妥钠阈下剂量催眠作用的影响。3.安眠胶囊对小白鼠戊巴比妥钠阈剂量催眠作用的影响。4.安眠胶囊对小白鼠士的宁惊厥的影响。结果:试验结果表明安眠胶囊低剂量组2.26g/kg（生药）、中剂量组4.52g/kg（生药）、高剂量组9.04g/kg（生药）,能明显抑制小白鼠自主活动次数。安眠胶囊低剂量组2.26g/kg（生药）、中剂量组4.52g/kg（生药）、高剂量组9.04g/kg（生药）,对阈下剂量戊巴比妥钠所致小白鼠催眠作用有显著的协同作用。安眠胶囊低剂量组2.26g/kg（生药）、中剂量组4.52g/kg（生药）、高剂量组9.04g/kg（生药）,可明显缩短阈剂量戊巴比妥钠所致小白鼠睡眠的潜伏期,能延长小白鼠睡眠时间。安眠胶囊中剂量组4.52g/kg（生药）、高剂量组9.04g/kg（生药）,对士的宁引起的小白鼠惊厥有延长强直性惊厥的潜伏期的作用。结论:安眠胶囊可明显抑制小白鼠自主活动,安眠胶囊对阈下剂量戊巴比妥钠所致小白鼠催眠作用有显著的协同作用,安眠胶囊可缩短阈剂量戊巴比妥钠所致小白鼠睡眠的潜伏期,延长小白鼠睡眠时间,安眠胶囊能明显延长士的宁所致的小白鼠惊厥的潜伏期。 三、安眠胶囊长期毒性试验 目的:观察长时间、大剂量连续重复给予受试大鼠安眠胶囊后,大鼠可能产生的毒性反应及其严重程度,并提供毒性反应的靶器官及其损害的可逆性等情况,确定无毒反应的剂量,为临床用药的安全性提供动物长期毒性试验依据,为拟定临床人用安全剂量提供参考。方法:安眠胶囊以10.500g/kg(1/3LD₅₀)（生药）、5.250g/kg(1/6LD₅₀)（生药）和2.625g/kg(1/12LD₅₀)（生药）剂量,每日大鼠灌胃给药一次,连续三个月,观察对大鼠的影响。结果:大鼠连续灌胃安眠胶囊三个月,各组大鼠其一般行为状态及体重增长、摄食量与空白对照组相比无异常改变,高剂量组、中剂量组、低剂量组各组心、肝、脾、肺、肾、肾上腺、胸腺、脑、甲状腺、前列腺、睾丸、子宫、卵巢等脏器指数无明显差异,血液学检查,高剂量血红蛋白与空白对照组相比下降,红细胞与空白对照组相比下降,其它指标与空白对照组相比无异常改变。中剂更多还原

【Abstract】 Somnia is a kind of physiological action and the most important condition of keeping health. Somnipathy is a common disease and some diseases’concomitant symptom.Insomnia is a common and non-specific disorder and maybe reported by 40-50% of people at any given time.Causes of insomnia include medical illness, alcohol or drugs, periodic limb movement disorder, sleep apnoea, and psychiatric illness. Without an obvious underlying cause, it is known as primary or psychophysiological.The chemosynthesis sedative-hypnotic is widely applied in the clinic to treat insomnia but those shorten SWS and REMS resulting in producing some side effects, such as dizziness, somnolence, dependence and addiction for longly taking medicine, rebounding phenomenon and abstinence for suddenly withdra-wing medicine.In view of traditional Chinese medicine, the reason of insomnia of people who suffered from it derives from mang reasons such as kidney deficiency, liver deficiency, spleen deficiency and so on. Traditional Chinese medicine has low side effect and curative effect.In this disquisition, Hypnotic capisule was studied by the method of behavior pharmacology, increasing number of mice by sodium pentobarbital, prolonging sleep time of mice by sodium pentobarbital and inhibiting convulsion.The results showed that Hypnotic capisule could inhibit independence activity, increase the duration of sleep time of mice and increase the number of sleep mice and prolong convulsion delitescence caused by strychnine.The results revealed that Hypnotic capisule has effects on sedation and hyphosis and low side effect.更多还原