Article(id=1196885349017370844, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1196884515873407615, articleNumber=1001-2494(2024)21-2091-08, orderNo=null, doi=10.11669/cpj.2024.21.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1715184000000, receivedDateStr=2024-05-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1763289304260, onlineDateStr=2025-11-16, pubDate=1730995200000, pubDateStr=2024-11-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763289304260, onlineIssueDateStr=2025-11-16, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763289304260, creator=13701087609, updateTime=1763289304260, updator=13701087609, issue=Issue{id=1196884515873407615, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='21', pageStart='1987', pageEnd='2098', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1763289105623, creator=13701087609, updateTime=1763292131714, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1196897208286097826, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1196884515873407615, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1196897208286097827, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1196884515873407615, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2091, endPage=2098, ext={EN=ArticleExt(id=1196885349290000606, articleId=1196885349017370844, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Textural Study on Fermentum Rubrum (Red Yeast Rice), columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To provide historical evidence for the safety usage of Fermentum Rubrum (red yeast rice) by textural study. METHODS Based on sorting and collating of historical literatures, this article reviewed name, production area, sourcing, fermentation processing, function and contraindication of red yeast rice. RESULTS The mainstream name of red yeast rice had not changed since ancient times, with Fujian, Jiangxi and Zhejiang as the main production area; japonica rice and indica rice were the main raw materials, fermented with red yeast rice mother; the ancient production process of red yeast rice mainly involved soaking rice, steaming rice, mixing red yeast rice mother, fermentation and drying as the key processes. Now, the manufacturing method of red yeast rice have still been used since the Ming Dynasty. Red yeast rice had remarkable medicinal effects and diverse edible functions, and no adverse reactions had been reported in its widespread use for thousands of years. The selected fungi, fermentation process and other aspects of Japanese red yeast rice were different from Chinese red yeast rice, and there might be infection by miscellaneous bacteria, which might cause adverse reactions. CONCLUSION This study provides systematically review on the medicinal history of red yeast rice, which can give historical base and references for the safe and reasonable application, rational development and utilization of red yeast and its products in China.

, correspAuthors=Hui CAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Menghua WU, Liu YANG, Xintong LI, Yi HE, Shuangcheng MA, Puihay BUT Paul, Hui CAO), CN=ArticleExt(id=1196885447864533226, articleId=1196885349017370844, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=红曲的本草考证, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 对红曲进行考证,为红曲的安全用药提供历史依据。方法 基于历代古籍文献挖掘、梳理,从红曲名称、产地、原料与辅料、制法、功能、禁忌等方面开展本草考证。结果 红曲自古主流名称无明显变化,以福建、江西、浙江为主产地;粳米与籼米是主要原料,以曲母发酵而成;古代红曲的生产过程主要含浸米、蒸饭、拌曲母、发酵、干燥等关键工序,在明代已具备成熟的制备工艺,并沿用至今;红曲药用功效显著,食用功能多样,上千年广泛使用中未见不良反应报道;日本红曲在菌种选用、发酵工艺等方面均与中国红曲不同,加之可能存在杂菌侵染,从而造成不良反应事件发生。结论 本研究系统梳理了红曲的药用历史,可为红曲的安全合理使用、更好地开发与利用提供历史依据与文献支撑。

, correspAuthors=曹晖, authorNote=null, correspAuthorsNote=
* 曹晖,男,博士,研究员 研究方向:本草考证、中药鉴定、饮片炮制规范和质量标准研究 Tel:(020)85220010
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吴孟华与杨柳为共同第一作者

吴孟华,女,博士,副教授 研究方向:本草考证与生药鉴定,中药质量标准研究;

杨柳,女,硕士研究生 研究方向:中药学。

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吴孟华,女,博士,副教授 研究方向:本草考证与生药鉴定,中药质量标准研究;

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吴孟华,女,博士,副教授 研究方向:本草考证与生药鉴定,中药质量标准研究;

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杨柳,女,硕士研究生 研究方向:中药学。

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杨柳,女,硕士研究生 研究方向:中药学。

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Beijing: Science Press, 2016: 328-329., articleTitle=null, refAbstract=null), Reference(id=1197225443821662962, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=2011, volume=null, issue=null, pageStart=206, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=LIN R C, journalName=Standards List of Chinese Medicinal Materials (中国药材标准名录), refType=null, unstructuredReference=LIN R C. Standards List of Chinese Medicinal Materials (中国药材标准名录)[M]. Beijing: Science Press, 2011:206-207., articleTitle=null, refAbstract=null), Reference(id=1197225443901354739, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=XU S, journalName=Shuo Wen Jie Zi (说文解字), refType=null, unstructuredReference=XU S. 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Shanghai: Shanghai Ancient Books Publishing House, 2017: 483., articleTitle=null, refAbstract=null), Reference(id=1197225444396282619, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=LI Z Y, journalName=Guxi Ji·Hou Ji(姑溪集·后集), refType=null, unstructuredReference=LI Z Y. Guxi Ji·Hou Ji(姑溪集·后集)[M]. Vol 1. Wu's Yueya Tang Block-Printed Edition at Nanhai in Qing Dynasty Tongzhi Era., articleTitle=null, refAbstract=null), Reference(id=1197225444455002876, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=LIU F, journalName=Youyou Xinshu(幼幼新书), refType=null, unstructuredReference=LIU F. 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Shanghai: Science and Technology Health Press, 1959., articleTitle=null, refAbstract=null), Reference(id=1197225444715049728, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=2013, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=WU X L, journalName=Chinese Medicinal Fungi(中国药用真菌), refType=null, unstructuredReference=WU X L. Chinese Medicinal Fungi(中国药用真菌)[M]. 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Shanghai: Shanghai Scientific & Technical Publisher, 2008., articleTitle=null, refAbstract=null), Reference(id=1197225444874433282, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=HUANG C X, YU Z Y, journalName=Gutian Xianzhi(古田县志), refType=null, unstructuredReference=HUANG C X, YU Z Y. Gutian Xianzhi(古田县志)[M]. Vol 17. Block-Printed Edition in 1942., articleTitle=null, refAbstract=null), Reference(id=1197225444941542147, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=RU Y, journalName=Fuqing Xianzhi Xulue(福清县志), refType=null, unstructuredReference=RU Y. 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Hangu Tang's Block-Printed Edition at Wulin in Qing Dynasty Daoguang Era., articleTitle=null, refAbstract=null), Reference(id=1197225446195639047, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=FANG Y Z, journalName=Wuli Xiaoshi (物理小识), refType=null, unstructuredReference=FANG Y Z. Wuli Xiaoshi (物理小识)[M]. Vol 6. Ningjing Tang's Re-Block-Printed Edition in Qing Dynasty Guangxu Era., articleTitle=null, refAbstract=null), Reference(id=1197225446254359304, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[27], rfOrder=26, authorNames=ZHANG L, journalName=Benjing Fengyuan(本经逢原), refType=null, unstructuredReference=ZHANG L. Benjing Fengyuan(本经逢原)[M]. 2rd ed.ed. Beijing: China Press of Traditional Chinese Medicine,2007:132., articleTitle=null, refAbstract=null), Reference(id=1197225446313079561, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[28], rfOrder=27, authorNames=YANG W S, journalName=Liubi Jiujing(六必酒经), refType=null, unstructuredReference=YANG W S. Liubi Jiujing(六必酒经)[M]. Vol 2. Sizhi Family's Block-Printed Edition in Qing Dynasty Daoguang Era., articleTitle=null, refAbstract=null), Reference(id=1197225446438908682, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[29], rfOrder=28, authorNames=HUANG Z Z, journalName=Bamin Tongzhi(八闽通志), refType=null, unstructuredReference=HUANG Z Z. Bamin Tongzhi(八闽通志)[M]. Vol 25. Block-printed Edition in Ming Dynasty Hongzhi Era., articleTitle=null, refAbstract=null), Reference(id=1197225446510211851, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[30], rfOrder=29, authorNames=XU J X, journalName=Fuzhou Fuzhi(福州府志), refType=null, unstructuredReference=XU J X. Fuzhou Fuzhi(福州府志)[M]. Vol 8. Block-Printed Edition in Ming Dynasty Zhengde Era., articleTitle=null, refAbstract=null), Reference(id=1197225446615069452, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[31], rfOrder=30, authorNames=XIN J K, journalName=Gutian Xianzhi(古田县志), refType=null, unstructuredReference=XIN J K. Gutian Xianzhi(古田县志)[M]. Vol 4. Block-Printed Edition in Ming Dynasty Wanli Era., articleTitle=null, refAbstract=null), Reference(id=1197225446690566925, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[32], rfOrder=31, authorNames=CHEN G F, journalName=Qingliu Xianzhi(清流县志), refType=null, unstructuredReference=CHEN G F. Qingliu Xianzhi(清流县志)[M]. Vol 2. Block-Printed Edition in Ming Dynasty Jiajing Era., articleTitle=null, refAbstract=null), Reference(id=1197225446761870094, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[33], rfOrder=32, authorNames=XU G H, journalName=Jiangle Xianzhi(将乐县志), refType=null, unstructuredReference=XU G H. 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Qian's Block-Printed Edition at Jinshan in Qing Dynasty Daoguang Era., articleTitle=null, refAbstract=null), Reference(id=1197225449366532917, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[72], rfOrder=71, authorNames=CHEN J M, journalName=Bencao Mengquan(本草蒙筌), refType=null, unstructuredReference=CHEN J M. Bencao Mengquan(本草蒙筌)[M]. Beijing: Traditional Chinese Medicine Ancient Books Publishing House,2009:269., articleTitle=null, refAbstract=null), Reference(id=1197225449429447478, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, doi=null, pmid=null, pmcid=null, year=2003, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[73], rfOrder=72, authorNames=WU L Y, journalName=Tianjin:Tianjin Science and Technology Press, refType=null, unstructuredReference=WU L Y. Bencao Congxin(本草从新)[M]. 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A-原料前处理(长流水漂米);B-制备曲母(拌信);C-发酵(凉风吹变)。

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A-“雷公制曲法”图(图中3人,按《雷公炮炙论》法制作红曲:右上1人用石臼舂杵米取末,左下1人在掘地坑,将裹好的米和曲母放入坑中发酵,左上1人在焙红曲);B-“丹溪造曲法”图(图中5人,按《本草衍义补遗》制作红曲:屋外1人从井中汲水,屋内右下1人做饭团,左面2人拌信,上方1人包装成品红曲)。

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名称 朝代(年份) 文献来源
红曲 东汉(213年) 王粲《七释》[12]
红糟 北宋(1038年) 李之仪《姑溪集》[14]
粳红曲 南宋(1227年) 陈衍《宝庆本草折衷》[16]
赤曲 南宋(1150年) 刘昉《幼幼新书》[15]
丹曲 明代(1637年) 宋应星《天工开物》[2]
红米曲 明代(1547年) 《福清县志续略》[22]
红曲米 清代(1842年) 魏源《海国图志》[17]
红米 1959年 《药材资料汇编》[16]
红大米 2013年 《中国药用真菌》[19]
福曲 2008年 《上海市中药饮片炮制规范》[20]
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红曲曾用名及其异名

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名称 朝代(年份) 文献来源
红曲 东汉(213年) 王粲《七释》[12]
红糟 北宋(1038年) 李之仪《姑溪集》[14]
粳红曲 南宋(1227年) 陈衍《宝庆本草折衷》[16]
赤曲 南宋(1150年) 刘昉《幼幼新书》[15]
丹曲 明代(1637年) 宋应星《天工开物》[2]
红米曲 明代(1547年) 《福清县志续略》[22]
红曲米 清代(1842年) 魏源《海国图志》[17]
红米 1959年 《药材资料汇编》[16]
红大米 2013年 《中国药用真菌》[19]
福曲 2008年 《上海市中药饮片炮制规范》[20]
), ArticleFig(id=1197225443091854058, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1196885349017370844, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
省份 地方志 产地(现名)
福建省 明弘治《八闽通志》[29]、明正德《福州府志》[30]、明万历《古田县志》[31]、民国《古田县志》[22] 古田(宁德市古田县)
明嘉靖《清流县志》[32] 嵩溪(三明市清流县嵩溪镇)
明万历《将乐县志》[33] 安仁(三明市将乐县安仁乡)
明崇祯《尤溪县志》[34] 四都、十九都(三明市尤溪县)
明崇祯《寿宁县志》[35] 六甲(宁德市寿宁县)
清乾隆《海澄县志》[36] 海澄(漳州市龙海区)
清乾隆《长泰县志》[37] 长泰(漳州市长泰区)
江西省 明嘉靖《东乡县志》[38] 东乡(抚州市东乡区)
明隆庆《临江府志》[39] 临江(樟树市、新干县和峡江县)
明万历《新修南昌府志》[40] 奉新(宜春市奉新县)
清同治《赣县志》[41] 赣县(赣州市赣县区)
广东省 明崇祯《兴宁县志》[42] 兴宁(梅州市兴宁市)
中国台湾省 清乾隆《台湾县志》[43] 中国台湾(中国台湾省)
清光绪《苗栗县志》[44] 苗栗(苗栗县)
湖南省 清嘉庆《临武县志》[45] 临武(郴州市临武县)
浙江省 民国《诏安县志》[46] 湖州诏安(湖州市)
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地方志中红曲产地历史表

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省份 地方志 产地(现名)
福建省 明弘治《八闽通志》[29]、明正德《福州府志》[30]、明万历《古田县志》[31]、民国《古田县志》[22] 古田(宁德市古田县)
明嘉靖《清流县志》[32] 嵩溪(三明市清流县嵩溪镇)
明万历《将乐县志》[33] 安仁(三明市将乐县安仁乡)
明崇祯《尤溪县志》[34] 四都、十九都(三明市尤溪县)
明崇祯《寿宁县志》[35] 六甲(宁德市寿宁县)
清乾隆《海澄县志》[36] 海澄(漳州市龙海区)
清乾隆《长泰县志》[37] 长泰(漳州市长泰区)
江西省 明嘉靖《东乡县志》[38] 东乡(抚州市东乡区)
明隆庆《临江府志》[39] 临江(樟树市、新干县和峡江县)
明万历《新修南昌府志》[40] 奉新(宜春市奉新县)
清同治《赣县志》[41] 赣县(赣州市赣县区)
广东省 明崇祯《兴宁县志》[42] 兴宁(梅州市兴宁市)
中国台湾省 清乾隆《台湾县志》[43] 中国台湾(中国台湾省)
清光绪《苗栗县志》[44] 苗栗(苗栗县)
湖南省 清嘉庆《临武县志》[45] 临武(郴州市临武县)
浙江省 民国《诏安县志》[46] 湖州诏安(湖州市)
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红曲的本草考证
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吴孟华 1 , 杨柳 1 , 李心潼 1 , 何轶 2 , 马双成 2 , 毕培曦 3 , 曹晖 1, *
中国药学杂志 | 论著 2024,59(21): 2091-2098
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中国药学杂志 | 论著 2024, 59(21): 2091-2098
红曲的本草考证
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吴孟华1, 杨柳1, 李心潼1, 何轶2, 马双成2, 毕培曦3, 曹晖1, *
作者信息
  • 1 暨南大学药学院, 广州 511443
  • 2 国家药典委员会, 北京 100061
  • 3 香港中文大学, 香港特别行政区 999077
  • 吴孟华,女,博士,副教授 研究方向:本草考证与生药鉴定,中药质量标准研究;

    杨柳,女,硕士研究生 研究方向:中药学。

通讯作者:

* 曹晖,男,博士,研究员 研究方向:本草考证、中药鉴定、饮片炮制规范和质量标准研究 Tel:(020)85220010
Textural Study on Fermentum Rubrum (Red Yeast Rice)
Menghua WU1, Liu YANG1, Xintong LI1, Yi HE2, Shuangcheng MA2, Puihay BUT Paul3, Hui CAO1, *
Affiliations
  • 1 College of Pharmacy, Jinan University, Guangzhou 511443, China
  • 2 Chinese Pharmacopoeia Commission, Beijing 100061, China
  • 3 The Chinese University of Hong Kong, Hongkong SAR 999077, China
出版时间: 2024-11-08 doi: 10.11669/cpj.2024.21.013
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目的 对红曲进行考证,为红曲的安全用药提供历史依据。方法 基于历代古籍文献挖掘、梳理,从红曲名称、产地、原料与辅料、制法、功能、禁忌等方面开展本草考证。结果 红曲自古主流名称无明显变化,以福建、江西、浙江为主产地;粳米与籼米是主要原料,以曲母发酵而成;古代红曲的生产过程主要含浸米、蒸饭、拌曲母、发酵、干燥等关键工序,在明代已具备成熟的制备工艺,并沿用至今;红曲药用功效显著,食用功能多样,上千年广泛使用中未见不良反应报道;日本红曲在菌种选用、发酵工艺等方面均与中国红曲不同,加之可能存在杂菌侵染,从而造成不良反应事件发生。结论 本研究系统梳理了红曲的药用历史,可为红曲的安全合理使用、更好地开发与利用提供历史依据与文献支撑。

红曲  /  发酵  /  本草考证  /  制备工艺

OBJECTIVE To provide historical evidence for the safety usage of Fermentum Rubrum (red yeast rice) by textural study. METHODS Based on sorting and collating of historical literatures, this article reviewed name, production area, sourcing, fermentation processing, function and contraindication of red yeast rice. RESULTS The mainstream name of red yeast rice had not changed since ancient times, with Fujian, Jiangxi and Zhejiang as the main production area; japonica rice and indica rice were the main raw materials, fermented with red yeast rice mother; the ancient production process of red yeast rice mainly involved soaking rice, steaming rice, mixing red yeast rice mother, fermentation and drying as the key processes. Now, the manufacturing method of red yeast rice have still been used since the Ming Dynasty. Red yeast rice had remarkable medicinal effects and diverse edible functions, and no adverse reactions had been reported in its widespread use for thousands of years. The selected fungi, fermentation process and other aspects of Japanese red yeast rice were different from Chinese red yeast rice, and there might be infection by miscellaneous bacteria, which might cause adverse reactions. CONCLUSION This study provides systematically review on the medicinal history of red yeast rice, which can give historical base and references for the safe and reasonable application, rational development and utilization of red yeast and its products in China.

Fermentum Rubrum (red yeast rice)  /  fermentation  /  bencao texture  /  preparation process
吴孟华, 杨柳, 李心潼, 何轶, 马双成, 毕培曦, 曹晖. 红曲的本草考证. 中国药学杂志, 2024 , 59 (21) : 2091 -2098 . DOI: 10.11669/cpj.2024.21.013
Menghua WU, Liu YANG, Xintong LI, Yi HE, Shuangcheng MA, Puihay BUT Paul, Hui CAO. Textural Study on Fermentum Rubrum (Red Yeast Rice)[J]. Chinese Pharmaceutical Journal, 2024 , 59 (21) : 2091 -2098 . DOI: 10.11669/cpj.2024.21.013
根据《中国药典》2020年版一部成方制剂“血脂康胶囊”所附红曲质量标准,红曲来源为曲霉科真菌紫色红曲霉(Monascus purpureus Went,菌株号CGMCC No.0272)接种于稻米(去皮种仁)上,经人工培养制成[1]。主要产自福建、江西、浙江等地。红曲自古便是药食两用品种,最早用于酿酒,后逐渐开始药用,明·宋应星《天工开物》有“供用岐黄者神其名,而坚固食羞者丹其色”的说法[2]。红曲味甘、性温,具有活血化瘀、健脾消食的功效,中医临床常用于产后恶露不净,瘀滞腹痛,食积饱胀,赤白下痢,跌打损伤等的治疗[3]。红曲既可作防腐剂,避免鱼及肉类的腐败,又可用于食物如米饭、荤素菜肴(红烧肉、红腐乳、红曲卤等)、调味料的着色剂,还是米醋、红酒、黄酒等传统饮用食品的发酵剂。因此红曲类食品、保健品备受青睐。虽其应用历史悠久,用途广泛,但是作为法定药材却未作为单列品名收录于《中国药典》一部“药材与饮片”项下,而是在部颁标准与各地方中药材标准、炮制规范中收录[4-5]
由于近期日本小林制药的红曲涉事保健品致多人死亡事件持续发酵,已引发全球相关领域的高度关注。红曲保健品导致的安全性事件究竟缘于现代工艺未能传承古代传统手工制作技艺,还是日本红曲与中国红曲在菌种、标准、质量控制、制造过程等方面存在差异,值得进一步探究。因此,本研究基于历代古籍文献挖掘、梳理,从红曲名称、产地、原料与辅料、制法、功能、禁忌等方面进行本草考证,为红曲的安全合理使用、更好地开发与利用提供历史依据与文献支撑。
“曲”最早的写法为“麴”,而后又有 “麹”“麯”“粬”等写法,现代简化为“曲”。《列子·杨朱》:“聚酒千钟,积曲成封。”东汉·许慎《说文解字》:“曲,酒母也。”[6]东汉·刘熙《释名》:“曲,朽也。郁之,使生衣,朽败也。”[7]可见春秋至汉代训诂文献记录的曲,是酿酒工艺的发酵剂,由谷物堆积发酵(即生衣)而得。
在历代本草文献单列“曲”条,最早应该是南北朝刘宋时期《雷公炮炙论》,之后唐代《食疗本草》《本草拾遗》《食性本草》,五代《日华子本草》和《蜀本草》均沿袭记载[8]。处方药味首次采用曲入药者,当为东汉·张仲景《金匮要略》“薯蓣丸”[9]。此后在《肘后方》《千金方》《古今录验》《子母秘录》《伤寒类要》等方书均有含“曲”的各种处方应用[8]
北魏·贾思勰的《齐民要术》因“曲”制作工艺不同,分为神曲、女曲[10]。明·李时珍《本草纲目》在曲条“集解”下以原料命名总结为“曲有麦、面、米造者不一,皆酒、醋所须”,并列有小麦曲、大麦曲、面曲、米曲[11]。随着“曲”在中医临床的逐步运用,最终演变为一种品类繁多的发酵类制剂(曲剂),如半夏曲、沉香曲等。其中以神曲药用最为广泛,并在此基础上,后世创制出六神曲、建神曲、百草神曲等,其名均与药味、辅料、工艺或产地有关。
“红曲”之名首见于东汉·王粲《七释》[12]。而作为本草文献单列“红曲”,首见于元·忽思慧《饮膳正要》[13]。后世本草文献多沿用此名,延续至今。红曲异名众多,如北宋·李之仪《姑溪集》名“红糟”[14],南宋·刘昉《幼幼新书》名“赤曲”(“藿香散”中用之名,是红曲入成方药用首次记载[15]),南宋·陈衍《宝庆本草折衷》名“粳红曲”(首次单列在“曲”的续附中[16],意指原料为粳米),明·宋应星《天工开物》名“丹曲”[2],清· 魏源《海国图志》名“红曲米”[17]。《药材资料汇编》(1959年)名“红米”[18],《中国药用真菌》(2013年)名“红大米”[19]
因红曲主产于福建等地,又有“福曲、福米”之名[20]。据民国《古田县志》(1942年)记载,“福建红曲”商品名称有市曲、色曲、崖曲之分[21]。与现今红曲分库曲、色曲、轻曲等3个商品规格相当,库曲主要用于酿酒;色曲则主要用于菜肴着色;轻曲用于腐乳、酱菜、药酒等着色。
综合以上分析,红曲的主流名称并无明显的变化,即使有异名,也以“红”的同义词“丹”“赤”等出现。历代红曲名称演变见表1
东汉·王粲《七释》曰:“西旅游梁,御宿素粲。瓜州红曲,参糅相半。软滑膏润,入口流散。”[12]记载瓜州地区有用红曲做饭食用的习俗。根据黄祖新的考释,《七释》中瓜州为今甘肃敦煌,因汉武帝时期中原人被发遣到敦煌屯耕戍边,且当时的敦煌降水丰沛、气候偏暖,具备以稻米制备红曲的自然条件和技术条件,极有可能敦煌是当时红曲的产地之一[23]。同时河南新郑裴李岗遗址考古工作中发现距今约8 000年红曲酿酒残迹,足以证明西域、中原具备制备红曲的能力[24]
后世文献记载红曲的产地十分明确,如宋·阮阅有“黄领青腰墟市罢,尽沽红酒夕阳归”诗句,描绘了江西万载县红曲制酒售卖场景。南宋·黄震《黄氏日抄》中也记叙了江西抚州饮红酒的风俗,该红酒由红曲制成,且红曲制酒形成了庞大产业。在抚州地区发生饥荒时期,为了防止曲户大量消耗食用米,官府专门贴出《禁造红曲榜》,明令禁止红曲生产,从侧面说明江西抚州当时是红曲的一个重要产区。至明·缪希雍《先醒斋广笔记》仍认为红曲“出江西”[25];方以智《物理小识》记载“向来瑞金造红曲,福州古田最红”[26],认为江西瑞金一直是红曲主要产地,但是质量较佳的红曲产自福建古田。至清·张璐《本经逢原》也提到红曲“福建制者为良”[27];清·杨万树《六必酒经》甚至认为红曲“江西为第一,福建为第二,我浙台温为第三”[28]。从明代至民国各地方志记载也表明福建、江西是红曲的主产地。福建省三明、漳州、宁德(古田)出产红曲销至全国,明代诗人林春秀曾有“田家多制曲,畲客少租山”之句,说明福建古田红曲在明朝颇负盛名。福建古田至今仍是红曲的主要产地,产量占全国85%以上。江西宜春(万载)、抚州(建昌、东乡)、瑞金、樟树、吉安、赣州,以及浙江、湖南、中国台湾多自产自销。现将代表性地方志记录的红曲产地信息列表如下(表2)。
南宋·陈衍《宝庆本草折衷》“粳红曲”的原料为粳米,辅料为蓼汁[16]。元·陈元靓《事林广记》红曲主要原料为白粳米,白糯米为曲母(糖化发酵剂)的原料[47]。元·朱丹溪《本草衍义补遗》[48]、明·李时珍《本草纲目》[11]等皆沿用《事林广记》原料与辅料。明嘉靖《东乡县志》原料为晚糯[38]。明·方以智《物理小识》曲母为“赤芝、辣蓼遏饭积多次之精者”,辅料用赤芝汁和辣蓼叶[26]。明·宋应星《天工开物》原料为籼稻米(即籼米),曲母为“绝佳红酒糟”,辅料为马蓼自然汁、明矾水[2]。清·张璐《本经逢原》沿用粳米原料[27]。清·杨万树《六必酒经》辅料为酒、醋、蜊灰水[28]
由此可见,历代红曲制造过程使用原料主要有粳米、籼米,辅料有新汲井水、长流水、马蓼(汁)、明矾(水)、蜊灰(水)等。曲母必不可少,造曲母(信)原料有糯米、红酒糟、辣蓼叶、赤芝(汁),拌曲母辅料有酒、醋。
目前,我国16个地方药材标准与炮制规范中的药用红曲半数以上原料指明为粳米,仅陕西用籼米,其余只言稻的种仁,菌种为曲霉科真菌紫色红曲霉(Monascus purpureus)[4,49]。食用红曲及相关食品原料通常为大米,个别用到大豆、小麦麸、小麦等粮谷,或稻米和其他淀粉质,且规定菌种为红曲霉属(Monascus spp.)数种[50]。功能性红曲米之前规定菌种为安卡红曲霉(Monascus anka)[51],自2024年7月1日起,新标准对发酵菌种不作限定要求。可见食用与功能性红曲现行标准更贴近古代传承至今的红曲制法。保健食品规定红曲菌种为紫色红曲霉(Monascus purpureus)和安卡红曲霉(Monascus anka)[52]。以紫色红曲霉(Monascus purpureus)和安卡红曲霉(Monascus anka)为菌种制得的红曲均含莫纳可林类成分[53]
关于红曲起源学术上存在不同观点。笔者同意红曲东汉敦煌起源说观点[23]。尽管东汉已有训诂、诗文出现红曲,但直至元初类书《事林广记》中才有详细的红曲制法记载。究其原因,一方面,可能与红曲繁复考究的制作工艺有关,因此成为曲户秘而不宣的技艺,其制作工艺不见于宋及以前古籍。另一方面,传统制曲技艺是从散曲到块曲的演变发展过程[54],北魏·贾思勰《齐民要术》和北宋·朱翼中《北山酒经》均收录块曲(以麦为主料)制造方法,而散曲(以粳米为主料)制成的红曲未见于宋及以前古籍文献。
另外有人提出福建省古田县起源说,认为唐开元二十八年(740年)为我国红曲史料翔实、证据确凿的最早记载[55]。明弘治《八闽通志》有“以红曲造成者曰老酒”的记载[29],因红曲酒的原料为糯米,“糯”与“老”在福建方言中发音相近,故福建红曲酒又名老酒。目前,古田红曲酒是世界三大古酿之一,也是闽派黄酒的代表。
红曲虽在东汉便已出现于训诂文献和诗句中,就目前所收集的文献资料看,红曲制法在宋末元初才有正式记录。元·陈元靓《事林广记》首载详细的制作工艺(造红曲法和造曲母法):“凡造红曲,皆先造曲母。造曲母:白糯米一斗,用上等好红曲二斗,先将秫米淘浄,蒸熟做饭,用水升合,如造酒法,溲和匀,下瓮,冬七日,春秋五日,夏三日不过,以酒熟为度,入盆中,擂为稠糊相似。每粳米一斗,止用此母二升。此一料母可造上等红曲一石五斗。造红曲:白粳米一石五斗,水淘洗,浸一宿,次日蒸作八分熟饭,分作十五处,每一处入上项曲二斤,用手如法搓揉,要十分匀停,了,共并作一堆。冬天以布帛物盖之,上用厚荐压定,下用草铺作底。全在此时,看冷热,如热则烧坏了。若觉太热,便与去覆盖之物,摊开堆面;微觉温,便当急准起,依原覆盖;如温热得中,勿动。此一夜不可睡,常令照顾。次日,日中时分作三堆,过一时分作五堆,又过一两时辰却,作一堆,又过一两时分,作十五堆。既分之后,稍觉不热,又并作一堆,俟一两时辰觉热,又分开,如此数次。第三日,用大桶盛新汲井水,以竹箩盛曲,作五六分浑,蘸湿便提起,蘸尽又揔作一堆,似稍热,依前散开,作十数处摊开,候三两时,又并作一堆,一两时又撒开。第四日,将曲分作五七处,装入箩,依上用井花水中蘸,其曲自浮不沉。如半沉半浮,再依前法堆起,摊开一日,次日再入新汲水内蘸,自然尽浮,日中晒干,造酒用。”[47]该工艺考究,大体分为浸米、蒸饭、拌曲、发酵、晒干5个步骤,耗时约6日。此后元至明的各著作如朱丹溪《本草衍义补遗》[48]、姚可成《食物本草》[56]、宋诩《竹屿山房杂部》[57]、《墨娥小录》[58]、李时珍《本草纲目》[11]均沿用此法,本草书籍多参照朱丹溪《本草衍义补遗》沿引,并称该法为“丹溪造曲法”。清·杨万树《六必酒经》记述了该造红曲法在浙江台温地区与江西、福建的工艺差异,主要体现在拌曲母时要用酒、醋,以及第5日开始改新汲井水为蜊灰(煅蛤粉)水,目的是发酵过程中利用蛤粉碱性中和醋的酸性[28]
明·宋应星在《天工开物》中创建了一种红曲新制法:“凡造法,用籼、稻米,不拘早晚。舂杵极其精细,水浸七日,其气臭恶不可闻,则取入长流河水漂净(必用山河流水,大江者不可用)。漂后恶臭犹不可解,入甑蒸饭则转成香气,其香芬甚。凡蒸此米成饭,初一蒸半生即止,不及其熟。出离釜中,以冷水一沃,气冷再蒸,则令极熟矣。熟后,数石共积一堆拌信。凡曲信必用绝佳红酒糟为料,每糟一斗入马蓼自然汁三升,明矾水和化。每曲饭一石入信二斤,乘饭热时数人捷手拌匀,初热拌至冷。候视曲信入饭,久复微温,则信至矣。凡饭拌信后,倾入箩内,过矾水一次,然后分散入篾盘,登架乘风。后此风力为政,水火无功。凡曲饭入盘,每盘约载五升。其屋室宜高大,防瓦上暑气侵逼。室面宜向南,防西晒。一个时中翻拌约三次。候视者七日之中,即坐卧盘架之下,眠不敢安,中宵数起。其初时雪白色,经一二日成至黑色。黑转褐,褐转代赭,赭转红,红极复转微黄。目击风中变幻,名曰生黄曲,则其价与入物之力皆倍于凡曲也。凡黑色转褐,褐转红,皆过水一度。红则不复入水。”[2]这是迄今记载最为详尽的红曲制作工艺,并认为此法所得“生黄曲”为商品红曲优等级,其价格与效果较普通红曲高数倍,且配有漂米、拌信、凉风、吹变工艺流程图(图1)。另外明宫廷画师于万历十九年(1591年)在《补遗雷公炮制便览》卷23米谷部有“雷公制曲法”和“丹溪造曲法”2幅工艺流程彩绘图(图2)[3]
与元代造红曲法相比,明代造红曲工艺更为耗时繁杂,大体分为杵米、浸泡、长流水漂米、蒸饭、拌信(即拌曲母)、过矾水、发酵(凉风吹变)、过水、干燥等10个步骤,需时近20日。可能因方法过于繁琐耗时,并未在后世古籍中得以广泛收载。
明·方以智《物理小识》创制一个比较简约的新红曲法:“造红曲,用秔米煮熟烂饭,煎草汁,溲为团,中穿一穴,上下撷辣蓼叶覆藉三五日,如未红,再煎芝草汁常灌之,常浴之,仍以蓼覆,以红为度,晒干收。七八月可造曲母,即赤芝、辣蓼遏饭积多次之精者,此方近世乃出。”[26]该新法似为南宋·陈衍《宝庆本草折衷》“粳红曲法”的升级版。此法也未见后世沿用。相较于北魏《齐民要术》神曲、女曲制法,尽管食用红曲在东汉《七释》红曲饭、五代《清异录》“酒骨糟”[59]、北宋·苏轼“糟红曲”一直记载沿用,南宋·黄震《黄氏日抄》所引《禁造红曲榜》也从侧面反映了江西抚州地方红曲制酒在民间的盛行,但其制作技艺在南宋及以前的传承并未公开,属秘而不宣之事。
上述几种红曲的传统制法均采用自然固态发酵法,因其基质构成一个碳源浓度梯度微环境,利于微生物生长及产物生成。传统工艺尽管复杂而严谨,其实生产过程可概括为浸米、蒸饭、拌曲母、发酵和干燥等关键工序。其特点一是生产过程洁净度要求较高:“凡造此物,曲工盥手与洗净盘簟,皆令极洁。一毫滓秽,则败乃事也”(《天工开物》)[2]。二是发酵生产过程终点、成品优劣判断要求:“其米过心者,谓之生黄,入酒及酢醢中,鲜红可爱;未过心者,不甚佳”(《本草纲目》)[11]。三是造曲母利用酒、醋、明矾、蛤粉等调节酸碱度。四是利用辣蓼等辅料控制杂菌生长。可见,红曲制法到明朝已较为成熟。
上世纪70年代《中药大辞典》记载了一种基于南北朝《雷公炮炙论》红曲传统制法的衍生方法:“择土壤为红色的地方,挖一深坑,在坑之上下周围铺以篾席,将粳米倒入其中,上压以重石,使其发酵,而变为红色。经3~4年后,米粒外皮呈紫红色,内心亦为红色。若内心有白点,表示尚未熟透,品质较差”[3]。湖南、山东等地炮制规范沿用此法[4]。四川、重庆、天津、上海、江苏、浙江、河南等地炮制规范基本在元代红曲制备工艺基础上简化为:取稻米蒸煮,接种紫色红曲霉菌,发酵、干燥,除杂[4]
虽然现代药用红曲生产过程采用优良的纯菌种发酵工艺,但各地方炮制规范对菌种要求并不完全一致,如河南省标准中紫色红曲霉(Monascus purpureus)和安卡红曲霉(Monascus anka)均可作为红曲饮片的发酵菌种,其他地方炮制规范均为紫色红曲霉(M. purpureus)[4]
食用红曲及相关食品原料与药用红曲不同,原料除大米外,还用到大豆、小麦麸、小麦等粮谷或稻米和其他淀粉质,现行食品标准中发酵菌种只作红曲霉属(Monascus spp.)要求[50]。仅功能性红曲米规定菌种为安卡红曲霉(M. anka)[51]。保健食品规定菌种为紫色红曲霉(M. purpureus)和安卡红曲霉(M. anka)[52]。中国红曲发酵产生功能性成分红曲色素量高。
日本红曲的制备工艺在江户时期由中国传入,稻生宣义《炮炙全书》(1702年)基本沿用元·陈元靓《事林广记》“造红曲法”:“白粳米一石五斗,水淘浸一宿,做饭,分作十五处,入曲母三斤,搓揉令匀,并作五堆,再一时合作盛新汲水,以竹箩盛曲作五六分蘸湿,沉半浮,再依前法作一次,又蘸,若尽浮,则成矣。” [60]
上世纪80年代开始,日本未沿用江户时期从中国传入的传统红曲生产工艺,而是应用现代生物技术(紫外诱变、化学诱变)构建丛毛红曲菌(Monascus pilosus)基因工程菌株,采用基于传统固态发酵进行优化的双向发酵工艺[61],在红曲资源开发和健康食品商品化方面取得巨大成功。由于日本红曲制备工艺、菌种较中国传统红曲均发生明显的改变,其莫纳可林 K(洛伐他汀)含量高,这可能是目前报道小林制药生产的红曲保健品中次生代谢产物种类如肝肾毒性的橘青霉素(citrinin)和软毛青霉酸(puberulic acid)含量较高,存在较大安全风险的原因之一。
南宋·刘昉《幼幼新书》在“藿香散”条首次记载红曲与藿香等药味组方用于治疗吐逆[15],南宋·陈衍《宝庆本草折衷》引用南宋·张松《究原方》“红玉散”治腰疼[16],可见其主要发挥活血化瘀的功效。元·忽思慧《饮膳正要》首载红曲药性和功效:“红曲,味甘,平,无毒。健脾益气,温中。腌鱼、肉、内用”[13]。元·吴瑞《日用本草》记载红曲为原料制成红酒的功效:“味苦、甘、辛,大热,有毒。发脚气肠风,下血,痔瘘哮喘,咳嗽痰饮诸疾,主行药势,破血杀毒,辟山岚寒气,及治打扑伤损尤妙”[62]。元·朱丹溪《本草衍义补遗》认为红曲具有“消食、活血、健脾、燥胃,治赤白痢,下水谷”功效[48]。明·姚可成《食物本草》总结:“红曲,味甘,温,无毒。主消食活血,健脾燥胃。治赤白痢,下水谷。酿酒破血,行药势,杀山岚瘴气,治打扑伤损,女人血气痛,及产后恶血不尽。擂酒饮之,良。”[56]清代医家对红曲功效的描述基本沿用前代医家经验。明·缪希雍《神农本草经疏》指出红曲与神曲功效的异同点:“红曲消食、健脾胃,与神曲相同,而活血和伤,惟红曲为能,故治血痢尤为要药”[63]。自明·李时珍《本草纲目》提出药用红曲“陈久者良”说法,后世一直沿用此观点,但是传统的“六陈”中药并未列入红曲。
历代古籍和诗词歌赋中用红曲着色食物(米饭、荤素菜肴、调味料)不胜枚举,如东汉“红曲饭”(《七释》[12]),宋代“红糟炒笋”(李之仪《姑溪居士集》[64])、“玉灌肺”和“罂乳鱼”(林洪《山家清供》[65])、“赐绯羊(又称酒骨糟)”(陶谷《清异录》[59]),明代“红曲芝麻酱”(陈继儒《增补陶朱公致富奇书》[66])、“红熝腊”(黄一正《事物绀珠》[67]),清代“红腐乳”(曾懿《中馈录》[68])。现代美食(红烧肉、红腐乳、红曲卤等)多用红曲着色,已经成为百姓的家常生活。
红曲能抑制杂菌污染而防止鱼及各肉类的腐败,宋元时期有苏轼“剩与故人寻土物,腊糟红曲寄驼蹄”,耶律楚材“春雁旅浇浓鹿尾,腊糟微浸软驼蹄”等诗句,皆是河西地区向中原进贡的驼蹄,用“红曲”防腐使之长途运送不腐臭的描述[69-70]。同时元代创立“造鲊法”,即在腌制食品中普遍使用红曲作为防腐剂,如元·忽思慧《饮膳正要》记载红曲“腌鱼、肉、内用”[13]。又如造鱼鲊、蛏鲊、鹅鲊、红蛤蜊酱等均是古代红曲防腐的例子。
明·宋应星《天工开物》也谓红曲“其义臭腐神奇,其法气精变化。世间鱼肉最朽腐物,而此物薄施涂抹,能固其质,于炎暑之中,经历旬月蛆蝇不敢近,色味不离初,盖奇药也。”[2]显示了红曲极佳的防腐效果,即便是夏日最易变质的鱼肉,也能让其色味如初。
红曲为红酒、米醋等传统食品的发酵剂之一。红曲酿酒历史悠久,也是红曲在古代主要的用途之一。唐代发明红曲酿酒,宋以后兴盛。历代诗词中不乏红曲酒的生动描述,如唐·褚载“有兴欲沽红曲酒”、宋·阮阅 “江南人造红曲酒”“尽沽红酒夕阳归”、宋·苏轼“夜倾闽酒赤如丹”、宋·胡仔“江南人家造红酒”、宋·祖无择“官酤米为曲,酿出成红酒”、元·刘涣“惜别缓斟红曲酒”。
红曲做醋在元·鲁明善《农桑衣食撮要》“老米醋”条记载:“每黄子一斗,用水二斗,入瓮内,又用红曲一合,温水泡下,将瓮口封闭。”[71]说明在米蒸熟后加入红曲生黄衣(发酵)可以制成米醋。
关于红曲药食两用的安全性应用,明·陈嘉谟《本草蒙筌》提到“红曲色赤,滑血须知。”[72]明·缪希雍《神农本草经疏》“(红曲)无积滞者勿用,……无瘀血者禁使。”[63]清·吴仪洛《本草从新》“(红曲)忌同神曲”,即“脾阴虚、胃火盛者勿用,能损胎。”[73]说明红曲有滑血、落胎作用,故孕妇禁用红曲。同时红曲药性较烈,脾阴虚、胃火盛者慎用。
红曲因其色红,具有发酵剂的作用而得名。红曲药食兼用,历代医家经过长期的临床实践,总结出红曲药性和功能主治为味甘、性温,归肝、脾、大肠经,活血化瘀,健脾消食,用于产后恶露不尽、瘀滞腹痛、食积饱胀、赤白下痢、跌打损伤。同时红曲作为天然食品、食用色素与防腐剂,被用于制作红曲饭、红曲卤、红糟、红腐乳、红曲肉以及红酒。与红曲相关的重要节点根据时间总结见图3
中国红曲多采用古代传承的自然发酵法(固体发酵工艺),历经上千年的使用,未见不良反应报道。日本小林制药红曲保健品出现不良反应事件,现已初步认为原料发酵过程受到杂菌侵染,产生软毛青霉酸和橘青霉素,亦不排除其他不明物质的影响。另外日本红曲在菌种选用、发酵工艺均与中国红曲菌种、制造工艺不同,可能也是其中原因之一。
综上,中国药用红曲作为发酵饮片和曲剂之一,多以单独菌种沿用古法或在古法基础上适当优化发酵而成,古法红曲产品以色素成分含量高为特征,并不含或少含洛伐他汀类成分。但是基于现行《中国药典》血脂康产品红曲标准以及江苏、河南等多个地方炮制规范均以洛伐他汀作为红曲质量评价的指标成分,进而影响到红曲以含有更高的洛伐他汀为产业化发展方向,实际上已经背离红曲传统制法守正原则。对比中国红曲药品和食品标准与日韩、欧美等食品补充剂(food supplement)红曲标准,关键是莫纳可林K(洛伐他汀)作为标志性成分的质量控制标准问题。欧盟和美国对莫纳可林类成分做出安全性上限要求,而我国现行标准把莫纳可林类作为药效成分做出有效性下限要求,并未对含有红曲的食品和药品及其原料的标准做出莫纳可林类安全性上限要求。因此,笔者建议在传统制法基础上,修订我国红曲作为药品、食品(保健食品)原料及其相关产品的标准,建立以色素类成分为基础的红曲质量标准,使中国传统瑰宝红曲能更好地在医疗、保健中发挥更大的作用。
  • 全国名老中医药专家传承工作室项目(国中医药人教函[2022]75号)
  • 全国中药特色技术传承人才培训项目(T20234832002)
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2024年第59卷第21期
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doi: 10.11669/cpj.2024.21.013
  • 接收时间:2024-05-09
  • 首发时间:2025-11-16
  • 出版时间:2024-11-08
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  • 收稿日期:2024-05-09
基金
全国名老中医药专家传承工作室项目(国中医药人教函[2022]75号)
全国中药特色技术传承人才培训项目(T20234832002)
作者信息
    1 暨南大学药学院, 广州 511443
    2 国家药典委员会, 北京 100061
    3 香港中文大学, 香港特别行政区 999077

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* 曹晖,男,博士,研究员 研究方向:本草考证、中药鉴定、饮片炮制规范和质量标准研究 Tel:(020)85220010
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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