醒脑注射液对大鼠安全性影响的研究

Studies on the Effects of Conscionsness-regaining Injection on the Security of Rats

将醒脑注射液以不同剂量不同方式注射于大鼠体内,研究该药对大鼠的安全性产生的影响。结果,最大耐受量实验中,以临床拟用日剂量(0.0016g/kg体重)的250倍(0.4g/kg体重)给药,未引起毒副反应,亦无动物死亡,LD50>0.4g/kg体重。以临床拟用日剂量的120倍注射于大鼠臀部肌肉,分别于注射6小时、24小时、48小时取注射局部肌肉样本病检,结果表明无明显组织损伤及坏死现象。不同剂量的急性毒性实验中,分别以临床拟用日剂量的30倍、60倍、120倍注射于大鼠腹腔内,在给药后第1、3、7天测其心率、呼吸频率、体温等指标,经t检验均与对照组无显著差异(P>0.05)。在慢性毒性实验中,每天分别以临床拟用日剂量的30倍、45倍、60倍,连续给药20天,持续观察40天以上,在实验的第10天、20天、30天、40天分别测得的心率、呼吸频率、体重、体温等指标,经t检验均与对照组无显著差异(P>0.05)。在实验40天后解剖观察的大鼠,未见内脏器官有异常变化。未解剖的实验大鼠,继续饲养3个月,其生长状况良好,无死亡。这些结果均表明,醒脑注射液具有短期和长期使用的安全性。

The effect on rats' security of consciousness-regaining injection injected into the rats' bodies in the different dosage and different ways was studied. The experiments of maximum endurance showed that it produced no poisoning side effects and didn't cause the rats'deaths after the rats were administered 250 times doses of daily dosage in clinical practice.The local musclur pathological showed that it produced no tissue injury or necrosis at six, twenty-four and forty-eight hours after 120 times medicine was injected into the rats' bottom everyday.The author carried out the acute poisoning experiment of the different dosage after 30, 60 and 120 times doses of clinical daily dosage was injected nito the rats' peritoneal. The indexes as heart rate, respiration, temperature, etc, were examined and t test was done at the first, third and the seventh day after the administration of the medicine.There was no remarkable difference in comparison with the control group(P > 0.05). The author arried out the chronic poisoning experiment after 30, 45 and 60 tunes the doses of clinical daily dosage was administered for twenty days, and had been observing over forty days. The indexes as heart rate, respiration, weight, temperature, etc, were examined and t test was done at the tenth, twentieth, thirtieth and the fortieth day after the administration of the medicine. There was no remarkable difference in comparsion with the control group(P>0.05). The authoranatomized the rats and found no special variety about the organs in the rats after the experiment of forty days.To those rats that didn't anatomise, they lived nomally and no one died after three months raising. All these experiments show, Consciousness-regaining injection has the security both on the long term and the short one.