【摘要】 目的 对食用色素红曲红开展关键组分分析和毒理学评价，为进一步利用提供基础数据。方法 通过GB 1886.181—2016对红曲红样品进行鉴别试验和理化指标检测，并采用高效液相色谱（HPLC）测定样品中桔青霉素（CIT）和莫拉可林（Monacolin K）含量水平。采用超高效液相色谱-静电场轨道阱-质谱（UPLC-Orbitrap-MS2），对红曲红的组分及其含量进行分析，并对分子结构进行表征。采用限量法开展红曲红小鼠急性经口毒性实验，在此基础上，开展SD大鼠经口14 d毒性实验。结果 受试样品红曲红的质量规格符合食品安全国家标准要求，其中CIT和Monacolin K的含量分别为0.030 8 mg/kg（单位色价计）和0.166 mg/g；受试样品检测出20种组分，其中红色素、橙色素、黄色素比例分别为88.38%、2.04%、5.96%。小鼠急性经口毒性实验结果红曲红半数致死量（LD50）>20 g/kg·BW；大鼠14 d经口毒性实验，5 g/kg·BW剂量组与对照组比较，一般临床观察、血液学、血清生化、尿液常规、病理学检查等指标差异均无统计学意义（P>0.05）。结论 受试样品红曲红由红色素为主要特征成分的多组分构成，初步安全性评价未见明显的毒性作用和靶器官，可为进一步长期安全性研究提供参考。更多还原

【Abstract】 Objective To provide scientific basis for the development and utilization of edible pigment Monascus red, the analysis of its key components and toxicological evaluation were carried out.Methods Identification test and physicochemical indexes test were carried out based on the samples according to the method in National food safety standard GB 1886. 181—2016. The content of citrinin(CIT) and Monacolin K were detected through high performance liquid chromatography(HPLC). UPLC-Orbitrap-MS~2 were used for chemical composition and content determination, in which the molecular structure was also characterized. The 14-day oral toxicity test of SD rats was carried out, based on the acute oral toxicity test of Monascus red by the limited method.Results The quality and specification of test samples conformed to the provisions of China National Food Safety Standard. The content of CIT and Monacolin K was 0. 030 8 mg/kg(converted as one color value) and 0. 166 mg/g. Twenty compounds were separated in Monascus red by UPLC-Orbitrap MS~2, red pigment, orange pigment and yellow pigment of it accounted for 88. 38%, 2. 04% and 5. 96%, respectively. The results of acute oral toxicity showed that Monascus red was innocuous(LD50>20 g/kg·BW). In the 14-day repeated oral dose toxicity test, compared with the control group, rats in 5 g/kg·BW dose group exhibited no significant differences in the general clinical observation, growth and development, hematology, blood biochemistry, routine urine detection, gross anatomy,organ weight,organ-to-body ratio, and histopathological examinations.Conclusion Monascus red is composed of multiple components characterized by red pigments. There is no obvious toxic effects found in the preliminary safety evaluation, which can provide reference for further long-term research.更多还原