摘要
红曲是发源于我国的历史悠久的药食两用发酵产物,具有降脂功效且含有大量的天然可食用色素,在东南亚及欧美等地均有广泛应用。近年来,随着红曲中他汀类成分和真菌毒素不良反应的相继报道,引起了公众对红曲及其制品食用安全性的担忧。该文通过全面整理红曲的化学成分、生源途径、生物活性、安全性等研究进展,梳理了红曲的主要药效成分和不良反应成分,通过系统对比国内外红曲及其制品的质量标准,指出我国现行药品、食品、保健食品质量标准中,将洛伐他汀作为药效成分/功效成分是需要斟酌的;我国国家和地方食用/药用标准对桔霉素和黄曲霉毒素的限量标准需要统一等问题。对我国现行标准提出如下建议:所有标准均应对莫纳可林K(monacolin K)、桔霉素和黄曲霉毒素进行严格限定。含红曲药品应控制莫纳可林K酸式和酯式总量限定范围,并限定酯式的含量或比例,同时增加降脂药效成分红曲素(monascin)和红曲黄素(ankaflavin)的含量要求;以红曲为原料的食品、保健食品、食品添加剂,应对莫纳可林类成分总量进行限定,红曲原料以干品计莫纳可林总量不高于0.20μg·g^(-1)。药用/食用标准均应限定桔霉素量不高于0.050μg·g^(-1),黄曲霉毒素(G_(1)+G_(2)+B_(1)+B_(2))总量不高于0.0050μg·g^(-1),同时要加强红曲固体发酵生产过程的质量控制体系建设。以上建议为我国有关部门修订和提高红曲相关质量标准提供了切实可行的参考依据,以期助力提升我国红曲制品的质量,保障人民食品药品健康安全。
Red yeast rice(RYR)is fermented rice with a long history of medicinal and edible purposes in China.RYR has gained global popularity,particularly in South and Southeast Asia,Europe,and America,due to its blood lipid-lowering effect and abundant edible natural pigments.However,concerns have been aroused regarding the safety of RYR due to increasing reports on the side effects and toxicity associated with statins and mycotoxins in RYR.This review summarizes the chemical composition,bioactivity,and toxicity of RYR while discussing its safety concerns.Additionally,this review systematically analyzes the quality control standards for RYR in China as well as internationally.Several key issues have been identified in the quality standards in China.Specifically,taking lovastatin as the active component needs to be reconsidered,and the limits of citrinin and aflatoxin in the national and local standards remain to be unified.In view of these issues,it is suggested that all the standards should specify the limits of monacolin K,citrinin and aflatoxin.The medicines containing RYR should have limits about the total content of monacolin K(acid and ester forms)and the content or proportion of the ester form.In addition,the limits about the content of monascin and ankaflavin should be established for the lipid-lowering medicines.For all the food,healthcare products,and food additives with RYR as the raw material,limits about the total content of monacolins should be developed.Specifically,the content in the RYR raw material should be no more than O.20μg:g'.The highest limits of citrinin at 0.050μg·g'and aflatoxin(G_(1)+G_(2)+B_(1)+B_(2))at 0.005 Oμg g'should be established in the quality standards of RYR for medicinal and edible purposes.In addition,addition,efforts should be made to improve the quality control system for solid-state fermentation of RYR.The suggestions above provide a basis for relevant departments to revise the quality standards of RYR,aiming to improve the quality of RYR and safeguarding the public health a
作者
马悦
高慧敏
张玉波
李乐园
刘晓谦
王智民
MA Yue;GAO Hui-min;ZHANG Yu-bo;LI Le-yuan;LIU Xiao-qian;WANG Zhi-min(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Artemisinin Research Center,China Academy of Chinese Medical Sciences,Beijing 100700,China;Liaoning University of Traditional Chinese Medicine,Dalian 116600,China;Henan University of Chinese Medicine,Zhengzhou 450046,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第20期5659-5673,共15页
China Journal of Chinese Materia Medica
基金
国家重点研发计划项目(2023YFC3504000)
中国中医科学院使命担当改革专项(CI2023E001TS03)。
关键词
红曲
化学成分
安全性
质量控制标准
生物活性
red yeast rice
chemical ingredients
safety
quality control standard
bioactivity
