抗疲劳中药复方制剂的安全性毒理学试验

Safety and Toxicology of Antifatigue Compound Chinese Medicinal Herbs Prescriptions

采用小鼠经口急性毒性试验、小鼠骨髓微核试验、精子畸形试验和大鼠30d喂养试验，检测抗疲劳中药复方制荆的急性毒性、致突变性和亚慢性毒性。结果表明：抗疲劳中药复方制荆对小鼠急性经口LD50〉15g/kg；3个剂量组微核率为0．16％～0．20％，精子畸形率2．70％～2．94％，与阴性对照组比均无显著差异。给予中药复方制剂后，各剂量组大鼠生长发育良好。第15d检查，中、高剂量组大鼠平均红细胞体积（MCV）高于对照组，血清球蛋白（GLOB）含量低于对照组，其它指标与对照组比较无显著差异；第30d检查，各剂量组血液葡萄糖（GLU）含量高于对照组，中、高剂量组GLOB和肌酐（CRE）含量也高于对照组，其它指标均在正常范围内，与对照组差异不显著；主要脏器系数及病理组织学检查未见明显异常。以上结果表明抗疲劳中药复方制剂属于实际无毒类，无致突变性，部分检测指标的改变可能与机体代谢状况和抗疲劳机制形成有关。

The acute toxicity, mutagenicity and subchromic toxicity of antifatigue compound Chinese medicinal herbs prescriptions were investigated by acute oral toxicity test, marrow cell micronucleus test, sperm malformation test of mice and 30-day feeding test of rat. The results showed that mice acute oral LD50 of compound Chinese medicinal herbs prescriptions was higher than 15 g/kg. The micronuclear rates （0.16%-0.20%） and sperm malformation rates （2.70%-2.94%） in three doses groups of 3.75, 7.50, 15.00 g/kg have no significant difference compared with that of negative control groups, respectively. Rats growing and developing were normal in feed test. when administratedfor 15 days, larger mean corpuscular vohnne （MCV） and less globoglycoid （GLOB） contents in blood were observed in middle and high dose groups compared to those of control group, when administratedfor 30 days, blood glucose contents in every dose groups were higher than those of control group, and GLOB and creatinine （CRE） contents in middle and high dose groups were also higher. Other hemotological and blood biochemical indexes were similar to those of control group. Main organic coefficients and pathological histology were normal. Conclusion： antifatigne compound Chinese medicinal herbs prescriptions belong to no toxic substance, and have no mutagenicity. Some indexes charged may be concerned with animal metabolic state and formed antifatigue mechanism.