芯之康牌红曲丹参胶囊动物毒理学安全性评价研究

目的对芯之康牌红曲丹参胶囊的服用安全性进行毒理学研究。方法按照国家标准要求和相关规定,对本品进行小鼠急性毒性实验、遗传毒理实验(含Ames实验、微核实验和小鼠精子畸形实验)和大鼠30 d喂养实验。结果以20.0 g/kg·bw剂量给小鼠灌胃后,14 d动物无中毒症状,无动物死亡;3项遗传毒性实验结果均为阴性;30 d喂养实验的结果与阴性对照组相比无显著差异(P0.05)。结论本品在本实验范围内无急性毒性、无遗传毒性,产品安全,可以作为辅助降血脂类保健食品用于人体。

Toxicological safety evaluation of XinZhiKang brand monascus and Radix Salviae Miltiorrhiae combination capsule

Objective To investigate the safety of XinZhiKang brand monascus and Radix Salviae Miltiorrhiae combination capsule (XYZ/MRSM-CC). Methods In accordance with the standards and relevant regulations of the state, the mouse acute toxicity test, genetic toxicology experiments (including Ames test, micro nuclear test and mouse sperm malformation test) and 30 d feeding experiments in rats were conducted to investigate the safety of the capsule. Results The groups of mice were gavaged with a single dose of 20.0 g/kg?bw in the acute toxicity test, and no mortality or signs of toxicity were noted during the following 14 d. All 3 genetic toxicity tests were negative. The results of the 30 d feeding experiment showed no significant difference compared with the negative control group (P>0.05). Conclusion XYZ/MRSM-CC has no acute toxicity and no genotoxicity, which is a safe product and can be used as a kind of functional food supplement.