汉莲牌红曲灵芝丹参胶囊的配方论证及标志性成分和功能学研究
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摘要
目的对汉莲牌红曲灵芝丹参胶囊配方进行论证并对其标志性成分和功能学进行研究。方法依据中医理论和现代健康理念,对其配方进行论证,按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中含洛伐他丁550 mg和丹参酮ⅡA 306 mg;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。结论本品在预防和早期干预血脂异常及相关疾病方面具有显著的优势和较为广阔的市场前景。
Objective To demonstrate the formula of Hanlian brand Monascus Ganoderma Salvia capsule and to study its marker components and efficacy. Methods On the basis of traditional Chinese medicine theory and modern health concept, its formulation was demonstrated; according to the national standard requirements and relevant provisions, its marker components were identified; at the same time, its efficacy was evaluated through the animal and human trial tests. Results The components of this product was classic, scientific and reasonable, of which the effective constituents were clear and had a high content; it contained 550 mg lovastatin and 306 mg tanshinoneⅡA every 100 g. Through animal and human trial tests, it showed that the indexes of experimental group were higher than the control group respectively, and the difference was significant(P<0.01 or P <0.05), which showed that this capsule had a significant function to help reducing the blood lipid. Conclusion This capsule had a prominent advantage and relatively vast market prospect to prevent hyperlipidemia.
Objective To demonstrate the formula of Hanlian brand Monascus Ganoderma Salvia capsule and to study its marker components and efficacy. Methods On the basis of traditional Chinese medicine theory and modern health concept, its formulation was demonstrated; according to the national standard requirements and relevant provisions, its marker components were identified; at the same time, its efficacy was evaluated through the animal and human trial tests. Results The components of this product was classic, scientific and reasonable, of which the effective constituents were clear and had a high content; it contained 550 mg lovastatin and 306 mg tanshinoneⅡA every 100 g. Through animal and human trial tests, it showed that the indexes of experimental group were higher than the control group respectively, and the difference was significant(P<0.01 or P <0.05), which showed that this capsule had a significant function to help reducing the blood lipid. Conclusion This capsule had a prominent advantage and relatively vast market prospect to prevent hyperlipidemia.
引文
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[19]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].Mod Med Health,2013,16:2417?2421.
[2]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.
[3]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 China Med Dig Vers,2011,11(2):70?73.
[4]白毅.制定血脂异常防治策略应考虑各种循证依据[N].中国医药报,2014.6.12(6).Bai Y.To formulate the prevention and cure strategy of dyslipidemia should consider all kinds of evidence-based basis[N].China Pharmaceutical News,2014.6.12(6).
[5]国家药典委员会.中国药典(2010年版一部)[M].北京:中国医药出版社,2010.Chinese Pharmacopoeia Commission.The Chinese pharmacopoeia(2010 Edition)[M].Beijing:Chinese Medicine Press,2010.
[6]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.
[7]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.
[8]陈利明,杨红兵,苑留云,等.富硒灵芝对动脉粥样硬化大鼠血脂代谢及内皮细胞损伤的影响[J].河北中医药学报,2012,01:10?11.Chen LM,Yang HB,Yuan LY,et al.Blood lipid metabolism of atherosclerosis rats and endothelial cell injury under the influence of Se-enriched ganoderma[J].J Hebei Trad Chin Med Pharm,2012,01:10?11.
[9]蒙田秀,龚志强,黄振园,等.白鹤灵芝不同提取部位抗鹌鹑高血脂症及动脉粥样硬化的影响[J].中国实验方剂学杂志,2014,08:166?169.Meng TX,Gong ZQ,Huang ZY,et al.Effect of various extracts of Rhinacanthus nasutus on anti quail hyperlipidemia and atherosclerosis[J].China J Exp Trad Med Form,2014,08:166?169.
[10]国家药典委员会.中国药典2010年版第二增补本[M].北京:中国医药出版社,2010.Chinese Pharmacopoeia Commission.The Chinese pharmacopoeia(2010 Edition of the Second Supplement)[M].Beijing:Chinese Medicine Press,2010.
[11]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,2011,09:1196?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,2011,09:1196?1200.
[12]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 Trad Herbal Drug,2011,11:2296?2299.
[13]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,2013,03:819?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,2013,03:819?822.
[14]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.
[15]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.
[16]李春梅,杨日福,顾取良,等.丹参水提取物对去卵巢大鼠血脂和肝脏的影响[J].华南理工大学学报(自然科学版),2012,12:151?156.Li CM,Yang RF,Gu QL,et al.Effects of aqueous extract from Salvia miltiorrhiza bunge on serum lipid level and liver in ovariectomized rats[J].J South China Univ Technol(Nat Sci Ed),2012,12:151?156.
[17]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,2011,07:62?63.Ma MJ.Clinical observation of Salvia miltiorrhiza in the treatment of cardiovascular diseases[J].Chin Med Mod Dist Edu China,2011,07:62?63.
[18]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].
[19]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].Mod Med Health,2013,16:2417?2421.