傣药柚木枝叶乙醇提取物的毒理安全性研究

Study on the Toxicology and Safety of Ethanol Extracts from Branches and Leaves of Tectona grandis

【目的】研究傣药柚木(Tectona grandis)枝叶乙醇提取物(ethanol extracts from the branches and leaves,EBLTG)的安全性,为其进一步开发应用提供参考依据。【方法】根据最大耐受量试验结果,通过灌胃给予5~7周龄SPF级SD大鼠高、中、低剂量(2500、1250和625 mg/kg)EBLTG,28 d后测定大鼠的血液毒理学指标,并进行大体解剖观察、脏器称量和组织病理学检查。【结果】EBLTG对昆明小鼠的半数致死量(median lethal dose,LD_(50))大于5.0 g/kg,根据WHO有关外源性化学物急性毒性分级标准评价为实际无毒级。28 d经口毒性试验中各组大鼠体质量、摄食量和食物利用率与对照组相比差异不显著(P>0.05)。血清生化及凝血指标、血常规及电解质指标中各剂量组有个别指标高或低于对照组,但大部分有差异的指标没有同时出现在雌雄大鼠中,且均在本实验室正常值范围内,缺乏毒理学意义。大体解剖未发现与EBLTG相关的病理组织学变化和特异性损伤表现。【结论】EBLTG对SD大鼠血液生理生化指标及脏器组织病理等不呈现与剂量相关的影响,在本试验剂量范围内对SD大鼠无毒性作用,其在SD大鼠体内的无毒性反应剂量为2.5 g/kg。

[Purpose]To study the toxicology and safety of ethanol extracts from the branches and leaves of Tectona grandis(EBLTG),a Dai medicine,providing scientific references for its further development and utilization.[Methods]According to the result of maximum tolerance test,the SPF SD rats aged 5-7 weeks were given high(2500 mg/kg),medium(1250 mg/kg)and low(625 mg/kg)dose of EBTLG for 28 days,biochemical and hematological indexes were determined.After euthanas-ia,general anatomy observation,organ extraction and weighing,and histopathological examination were performed.[Results]The median lethal dose(LD_(50))of EBLTG to Kunming mice was over 5.0 g/kg.According to the WHO classification standard of acute toxicity of exogenous chemicals,EBLTG was actually non-toxic.Compared with the control group,the body weight,food consump-tion and food utilization rate of the SD rats in each group didn’t show significant differences in the 28-day oral toxicity test(P>0.05).The serum biochemical and coagulation indexes,blood routine and electrolyte indexes showed no toxicological significance,although some indexes were higher or lower than those of the control group.Most of these differences did not appear in male and female rats at the same time,and all the indexes were within the normal range in our laboratory.No abnormality was observed in gross anatomy,and no histopathological changes and specific lesions associated with EBLTG.[Conclusion]EBLTG has no dose-dependent effect on blood physiological and biochem-ical indexes and organ tissue pathology,no toxic effect on SD rats at all doses used in this study,and the no observed adverse effect level in SD rats is 2.5 g/kg.