红他丁牌红曲胶囊的毒理学安全性评价研究
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摘要
通过毒理学研究对红他丁牌红曲胶囊的服用安全性进行评价.首先,以最大耐受量(Maximal Tolerable Dose,MTD)为指标进行小鼠急性毒性实验,然后对其进行遗传毒性实验,主要包括小鼠精子畸形实验、Ames实验和小鼠骨髓嗜多染红细胞微核实验,最后进行大鼠30d喂养实验来评价其毒理学安全性.实验结果显示:以18.75g/kg.bw的样品给小鼠灌胃,未见明显中毒症状,也未出现死亡现象;3项遗传毒性实验结果均为阴性;喂养实验结果显示相较于阴性对照组,各剂量大鼠在体重、进食量、血液学指标以及食物利用率等方面都没有统计学意义(P>0.05).以上结果说明,在本实验范围内,红他丁牌红曲胶囊无毒、无遗传性,其安全性可用于人体.
In this paper,we aimed to evaluate the safety performance of Hongtading brand Monascus capsule by toxicology study.The whole research included the following three parts.The acute toxicity test in mice was first carried out with maximal tolerable dose(MTD)as indicators.Then we tried to proceed some genotoxicity test,including mouse sperm abnormality test,Ames test and polychromatic erythrocyte micronuclear test in mouse bone marrow.At last,a 30-day rat feeding experiment was conducted to assess its safety in the meaning of toxicology.The results reveal that there are no obvious symptom of poisoning,and no death of mice appears when they were administrated by intragastrical gavage with a sample of 18.75 g/kg.bw.The results of all the three genotoxicity tests are all negative.Furthermore,the consequence of feeding experiment shows that compared with the negative control group,the doses with different volume have no statistically significant difference(P>0.05)in terms of body weight,food intake,hematology and food utilization.Therefore,we conclude that,within the scope of this research,this product is non-toxic,non-hereditary,which can be generalized to human securely.
In this paper,we aimed to evaluate the safety performance of Hongtading brand Monascus capsule by toxicology study.The whole research included the following three parts.The acute toxicity test in mice was first carried out with maximal tolerable dose(MTD)as indicators.Then we tried to proceed some genotoxicity test,including mouse sperm abnormality test,Ames test and polychromatic erythrocyte micronuclear test in mouse bone marrow.At last,a 30-day rat feeding experiment was conducted to assess its safety in the meaning of toxicology.The results reveal that there are no obvious symptom of poisoning,and no death of mice appears when they were administrated by intragastrical gavage with a sample of 18.75 g/kg.bw.The results of all the three genotoxicity tests are all negative.Furthermore,the consequence of feeding experiment shows that compared with the negative control group,the doses with different volume have no statistically significant difference(P>0.05)in terms of body weight,food intake,hematology and food utilization.Therefore,we conclude that,within the scope of this research,this product is non-toxic,non-hereditary,which can be generalized to human securely.
引文
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[15]栾霞,王瑛瑶,郭咪咪.菜籽油和辛酸酶法合成结构脂质的毒理学评价研究[J].粮油食品科技,2015(2):35-39.LUAN X,WANG Y Y,GUO M M.Study on the toxicological evaluation of structured lipids synthesized from rapeseed oil and octanoic acid by enzymic method[J].Science and Technology of Cereals,Oils and Foods,2015(2):35-39.
[16]王华晶,秦华炎,李怀宇,等.三七多糖的安全性评价[J].云南中医中药杂志,2017(12):56-60.WANG H J,QIN H Y,LI H Y,et al.Safety assessment of panaxnotoginseng polysaccharides[J].Yunnan Journal of Traditional Chinese Medicine and Materia Medica,2017(12):56-60.
[17]姚玉婷.血清妊娠相关蛋白A:一个新的动脉粥样硬化斑块标记物[J].疾病监测与控制,2016,10(3):199-201.YAO Y T.Pregnancy-associated plasma protein A:An new artery harden sign[J].Journal of Diseases Monitor&Control,2016,10(3):199-201.
[18]陈志蓉,王超,罗飞亚,等.对辅助降血糖、降血脂保健食品双功能评价模式的探讨[J].食品安全质量检测学报,2016,7(4):1456-1461.CHEN Z R,WANG C,LUO F Y,et al.Exploration of dual-function evaluation model of health food for auxiliary glycemia-lowering and auxiliary cholesterol-lowering[J].Journal of Food Safety&Quality,2016,7(4):1456-1461.
[2]傅剑云,夏勇,孟佳.红曲对实验性高脂血症大鼠体重及血脂水平的影响[J].中国组织工程研究,2002,6(1):57-59.FU J Y,XIA Y,MENG J.Effect of monascin on serum lipid and body weight of experimental rats with hyperlipemia[J].Chinese Journal of Tissue Engineering Research,2002,6(1):57-59.
[3]侯敏.金华及其周边地区红曲中红曲菌种类和红曲色素的研究[D].金华:浙江师范大学,2015.HOU M.Study on monascus species and the pigment in red yeast rice in Jinhua and the surrounding areas[D].Jinhua:Zhejiang Normal University,2015.
[4]袁国兴.红曲米中蛋白酶、酯化酶的活性研究[D].济南:山东轻工业学院,2012.YUAN G X.Study on the activity of esterified enzyme and protease in red rice[D].Jinan:QILU University of Technology,2012.
[5]邢旺兴,张梅,方琅,等.中药红曲的药理作用研究进展[J].药学实践杂志,2006,24(1):1-3.XING W X,ZHANG M,FANG L,et al.Research on pharmacological action of red yeast rice in Chinese medicine[J].Journal of Pharmaceutical Practice,2006,24(1):1-3.
[6]戴伟.红曲的降血脂和免疫调节作用的研究[D].北京:中国疾病预防控制中心,1996.DAI W.Study on the hypolipidemic and immune regulation of red yeast rice[D].Beijing:Chinese Center for Disease Control and Prevention,1996.
[7]周文斌,贾瑞博,李燕,等.红曲色素组分、功效活性及其应用研究进展[J].中国酿造,2016,35(7):6-10.ZHOU W B,JIA R B,LI Y,et al.Research progress of components,biological activity and application of monascus pigment[J].China Brewing,2016,35(7):6-10.
[8]逯慎杰,刘秀河.功能性红曲中功能成分的研究进展[J].江苏调味副食品,2011,28(1):17-21.LU S J,LIU X H.Research progress of the functional ingredients in monascus red rice[J].Jiangsu Condiment and Subsidiary Food,2011,28(1):17-21.
[9]陈伟成.新型降血脂药:洛伐他丁[J].药学实践杂志,1992(1):25-27.CHEN W C.New hypolipidemic drug:Lovastatin[J].Journal of Pharmaceutical Practice,1992(1):25-27.
[10]刘怀珠.阿托伐他汀钙口服亚微乳剂的初步研究[D].郑州:郑州大学,2015.LIU H Z.Preliminary study of submicron semulsion on atorvastatin calcium for oral[D].Zhengzhou:Zhengzhou University,2015.
[11]高雅娟.红曲中非他汀物质降血脂机理的初步研究[D].天津:天津科技大学,2016.GAO Y J.Study on the mechanism of non-statin substances in red yeast rice[D].Tianjin:Tianjin University of Science and Technology,2016.
[12]沈珺珺,曾柏全,王卫,等.红曲米的代谢功能及其应用研究进展[J].食品与机械,2014,30(5):294-298.SHEN J J,ZENG B Q,WANG W,et al.Review of active metabolites of red mold rice[J].Food&Machinery,2014,30(5):294-298.
[13]谢玮,郭婕,卢连华,等.某种蜂胶软胶囊的毒理学安全性评价[J].预防医学论坛,2011(3):237-240.XIE W,GUO J,LU L H,et al.Some propolis soft capsule toxicological safety evaluation[J].Preventive Medicine Tribune,2011(3):237-240.
[14]曲琳,尹幸念,樊树理,等.马铃薯提取液毒理学安全性评价[J].毒理学杂志,2016(2):166-168.QU L,YIN X N,FAN S L,et al.Toxicological safety evaluation of potato extract[J].Journal of Toxicology,2016(2):166-168.
[15]栾霞,王瑛瑶,郭咪咪.菜籽油和辛酸酶法合成结构脂质的毒理学评价研究[J].粮油食品科技,2015(2):35-39.LUAN X,WANG Y Y,GUO M M.Study on the toxicological evaluation of structured lipids synthesized from rapeseed oil and octanoic acid by enzymic method[J].Science and Technology of Cereals,Oils and Foods,2015(2):35-39.
[16]王华晶,秦华炎,李怀宇,等.三七多糖的安全性评价[J].云南中医中药杂志,2017(12):56-60.WANG H J,QIN H Y,LI H Y,et al.Safety assessment of panaxnotoginseng polysaccharides[J].Yunnan Journal of Traditional Chinese Medicine and Materia Medica,2017(12):56-60.
[17]姚玉婷.血清妊娠相关蛋白A:一个新的动脉粥样硬化斑块标记物[J].疾病监测与控制,2016,10(3):199-201.YAO Y T.Pregnancy-associated plasma protein A:An new artery harden sign[J].Journal of Diseases Monitor&Control,2016,10(3):199-201.
[18]陈志蓉,王超,罗飞亚,等.对辅助降血糖、降血脂保健食品双功能评价模式的探讨[J].食品安全质量检测学报,2016,7(4):1456-1461.CHEN Z R,WANG C,LUO F Y,et al.Exploration of dual-function evaluation model of health food for auxiliary glycemia-lowering and auxiliary cholesterol-lowering[J].Journal of Food Safety&Quality,2016,7(4):1456-1461.