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本文对康宝褪黑素片进行了致突变性及致畸性测试：小鼠骨髓嗜多染红细胞微核试验，小鼠睾丸染色体畸变试验，Ａｍｅｓ 试验，３０ｄ 喂养和致畸试验。结果表明：小鼠经口一次给予１０ｇ／ｋｇ．ｂｗ 受试物，相当于人体实际摄入量的６００ 倍。最大无作用剂量达３ｇ／ｋｇ．ｂｗ（相当于实际摄入量的１８０ 倍以上），无诱变和致畸作用，说明康宝褪黑素片食用安全。
In this paper, the combo melatonin tablets were mutagenic and teratogenicity tests: mouse bone marrow polychromatic erythrocyte micronucleus test, mouse testicular chromosome aberration test, Ames test, 30d feeding and teratogenicity test. The results showed that the mice were orally given 10g / kg. bw test substance, equivalent to 600 times the actual human intake. The maximum non-acting dose of 3g / kg. bw (equivalent to more than 180 times the actual intake), no mutagenic and teratogenic effects, indicating that combo melatonin tablets food safety.