红曲丹参胶囊的配方论证及标志性成分和功效学研究
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摘要
目的对红曲丹参胶囊的配方进行论证并对其标志性成分和功效学进行研究。方法根据中医理论和现代健康理念,对其配方进行论证,依照国家标准要求和相关规定,对其标志性成分进行鉴定,同时通过动物和人体试食试验来评价其功效。结果本品组分经典、科学合理,有效成分清楚、含量较高,每100 g中含洛伐他汀140 mg和黄酮(以芦丁计)1.14 g;动物和人体试食试验证明,各项指标均高于实验对照组,且差异显著(P<0.01或P<0.05),具有较为显著的辅助降血脂功能。结论本品通过辅助降血脂,可以改善和提高血脂偏高人群的健康状况和生活质量,具有较为广阔的市场前景。
Objective To demonstrate the formula of monascus and Radix Salviae Miltiorrhiae combination capsule and study its characteristic components and efficacy. Methods The formula was demonstrated according to the theory of traditional Chinese medicine and the concepts in modern health theory. The symbolic ingredients were identified according to the requirements of national standards and relevant regulations, and its efficacy was evaluated by animal and human food test. Results The components of this product were classic, scientific and reasonable, the effective components were clear and the content was high. The contents of lovastatin and flavonoids(in terms of rutin) were 140 mg and 1.14 g per 100 g, respectively. Animal and human food test showed that all the indexes were significantly higher than the experimental control group(P<0.01 or P<0.05), with a relatively significant function of reducing blood lipid. Conclusion This product can improve and enhance the health status and life quality of people with high blood lipids by assisting blood fat reduction, and has a broad market prospect.
Objective To demonstrate the formula of monascus and Radix Salviae Miltiorrhiae combination capsule and study its characteristic components and efficacy. Methods The formula was demonstrated according to the theory of traditional Chinese medicine and the concepts in modern health theory. The symbolic ingredients were identified according to the requirements of national standards and relevant regulations, and its efficacy was evaluated by animal and human food test. Results The components of this product were classic, scientific and reasonable, the effective components were clear and the content was high. The contents of lovastatin and flavonoids(in terms of rutin) were 140 mg and 1.14 g per 100 g, respectively. Animal and human food test showed that all the indexes were significantly higher than the experimental control group(P<0.01 or P<0.05), with a relatively significant function of reducing blood lipid. Conclusion This product can improve and enhance the health status and life quality of people with high blood lipids by assisting blood fat reduction, and has a broad market prospect.
引文
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[2]居锡萍.血脂异常的药物治疗[J].中国医药指南,2011,11(2):70-73.Ju XP.The drug treatment of dyslipidemia[J].Guid Chin Med,2011,11(2):70-73.
[3]刘迎利,李建科.高血脂的病因及治疗[J].现代医疗卫生,2013,20(7):108-112.Liu YL,Li JK.Etiology and treatment of hyperlipidemia[J].Mod Med Health,2013,20(7):108-112.
[4]廖丰.国际高血脂治疗的回顾和动向[J].中华全科医生杂志,2012,10(4):218-220.Liao F.Review and trends of international hyperlipidemia treatment[J].Chin J General Pract,2012,10(4):218-220.
[5]Liao F.Review and the trend of international hyperlipidemia treatment[J].Chin J General Pract,2012,10(4):218-220.
[6]国家药典委员会.中国药典(2015年版一部)[M].北京:中国医药出版社,2015.Chinese Pharmacopoeia Commission.The Chinese pharmacopoeia(2015Ed)[M].Beijing:Chinese Medicine Press,2015.
[7]南京中医药大学.中药大辞典(上册)[M].上海:上海科学技术出版社,2001.Nanjing University of Chinese Medicine.Chinese medicine dictionary(I)[M].Shanghai:Shanghai Science and Technology Press,2001.
[8]肖培根主编.新编中药志(三)[M].北京:化学工业出版社,2002.Xiao PG Ed.Modern Chinese materia medica(Ⅲ)[M].Beijing:Chemical Industry Press,2002.
[9]刘龙涛,吴敏,王红霞,等.降脂红曲微粉治疗血脂异常合并颈动脉粥样硬化的随机对照研究[J].中国中西医结合杂志,2011,9:1196-1200.Liu LT,Wu M,Wang HX,et al.Clinical study on the treatment of abnormal blood lipids complicated with carotid atherosclerosis with lipid-reducing red rice minute powder:a randomized controlled trial[J].Chin J Integr Trad West Med,2011,9:1196-1200.
[10]赵珺彦,刘小杰.红曲-植物甾醇酯复方制剂调血脂作用研究[J].中草药,2011,11:2296-2299.Zhao JY,Liu XJ.Blood lipid regulation of semen oryzae cum monasco and phytosterol esters compound preparation[J].Chin Tradit Herb Drug,2011,11:2296-2299.
[11]刘臻,来伟旗,刘冬英,等.复合红曲胶囊辅助大鼠降血脂作用研究[J].食品安全质量检测学报,2013,4(3):819-822.Liu Z,Lai WQ,Liu DY,et al.Study of auxiliary hypolipidemic function of monascus pigment compound capsule in rats[J].J Food Saf Qual,2013,4(3):819-822.
[12]南京中医药大学.中药大辞典(上册)[M].上海:上海科学技术出版社,2001.Nanjing University of Chinese Medicine.Chinese medicine dictionary(I)[M].Shanghai:Shanghai Science and Technology Press,2001.
[13]肖培根主编.新编中药志(一)[M].北京:化学工业出版社,2002.Xiao PG Ed.Modern Chinese materia medica(Ⅰ)[M].Beijing:Chemical Industry Press,2002.
[14]马美菊.丹参治疗心血管疾病的临床观察[J].中国中医药现代远程教育,2011,7:62-63..Ma MJ.Clinical observation of Salvia miltiorrhiza in the treatment of cardiovascular diseases[J].Chin Med Mod Dist Edu China,2011,7:62-63.
[15]卫生部.保健食品检验与评价技术规范(2003年版)[Z].Ministry of Health.Technical standards for testing&assessment of health food(The 2003 Edition)[Z].
[16]范雯.高效液相色谱法测定红曲药材中洛伐他汀的含量[J].现代医药卫生,2013,16:2417-2421.Fan W.Determination of content lovastatin in the monascouruar by HPLC[J].J Mod Med Health,2013,16:2417-2421.
[17]国家药典委员会.中国药典(2015年版二部)[M].北京:中国医药出版社,2015.Chinese Pharmacopoeia Commission.The Chinese pharmacopoeia(2015 Ed)[M].Beijing:Chinese Medicine Press,2015.