梗脉通颗粒的毒理学实验研究

Study on Toxicological Experiments of Gengmaitong Granules

目的:研究梗脉通颗粒的急性和长期毒性。方法:急性毒性实验采用小鼠最大耐受量(MTD)实验,长期毒性实验中大鼠给予高、中、低剂量(相当于推荐剂量的100、20、10倍量)的梗脉通颗粒,连续给药90d,进行一般行为、血常规、血液生化、脏器指数、系统解剖检查与可逆性观察。结果:急性毒性实验中未见明显中毒症状,小鼠急性毒性MTD>120.0g(生药)/kg;长期毒性实验中给予高、中、低剂量梗脉通颗粒的大鼠外观体征、行为活动、体重、血常规、血液生化、脏器指数与系统解剖检查均未见异常,可逆性观察表明梗脉通颗粒对大鼠未引起延迟毒性,与对照大鼠比较无显著性差异;但给予高、中、低剂量梗脉通颗粒的大鼠凝血酶时间、凝血酶原时间显著延长,与对照大鼠比较有显著性差异(P<0.05)。结论:梗脉通颗粒对实质性器官无明显毒性作用,但其可明显延长凝血时间,在临床应用中当引起重视。

OBJECTIVE： To study the acute and long-term toxicity of Gengmaitong granules. METHODS： The maximum toler- ance dose （MTD） of mice was used to detect the acute toxicity. 10,20,100 times of recommended dose of Genmaitong granules were given continuously to rats for 90 days to detect the long-term toxicity, and behavior, appearance,body weigh and blood cytolo- gy indexes, blood biochemical indexes, weight coefficient of organs, histopathology examination and reversibility study were all observed. RESULTS： There was no obvious toxic symptom in the acute toxicity trial （the acute toxicity of the different sexual mice, MTD〉 120.0 g·kg^-1 dose of Gengmaitong granules）. The results of long-term toxicity trial indicated that there were no sig- nificant differences in appearance, behavior, body weight, blood cytology indexes, blood biochemical indexes, organ index and histo- pathology examination in the rats of the three dosage groups. The reversibility study demonstrated that there was no delayed toxicity in the rats of the three dosage groups as compared to control group, but there were significant difference among those groups; but there were significant differences in thrombin time and prothrombin time in the rats of three dosage groups as compared to the con- trol group （P〈0.05）. CONCLUSION： Gengmaitong granules have no significant toxic effect on parenchymatous organs, but can prolong coagulation time significantly. Great importance should be attached to the application of it in the clinic.