天然活性化合物松萝胺的毒理学安全性评价

Evaluation of Toxicology and Safety of Natural Active Compound Usenamine

目的探讨天然活性化合物松萝胺[C18H17NO6,6-乙酰基-2-(1-氨基-亚乙基)-7,9-二羟基-8,9b-二甲基-9bH-二苯呋喃-1,3-二酮]的使用安全性。方法选用SPF级小鼠进行小鼠经口毒性试验、体内外染色体畸变试验、骨髓微核试验、精子畸形试验及30 d喂养试验。结果研究条件下,实验小鼠急性经口毒性最大耐受剂量(MTD)大于15 000 mg/kg;体内外染色体畸变试验均为性(P> 0.05);骨髓微核试验结果为阴性(P> 0.05);精子畸形试验结果为阴性(P> 0.05);30 d喂养试验未见实验小鼠出现明显中毒体征,各项指标正常。结论松萝胺安全,无急性、亚急性中毒作用,无遗传毒性。

Objective To investigate the natural active compound Usenamine[C18H17NO6,6-acetyl-2-(1-amino-ethylene)-7,9-dihydroxy-8,9 b-dimethyl-9 bH-diphenylfuran-1,3-dione]is safe to use.Methods SPF mice were selected for oral toxicity test,in vivo and in vitro chromosomal aberration test,bone marrow micronucleus test,sperm abnormality test and 30-day feeding test.Results Under the research conditions,the maximum tolerated dose(MTD)of the test substance for acute oral toxicity was more than 15000 mg/kg;both in vivo and in vitro chromosomal aberration tests were negative(P>0.05);bone marrow micronucleus test results were negative(P>0.05)The result of sperm deformity test was negative(P>0.05);no obvious signs of poisoning were found in the 30-day feeding test,and all the indicators were normal.Conclusion Usenamine is safe and has no acute or subacute toxic effects,and genetic toxicity.