葛根质量标志物(Q-marker)探讨分析
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摘要
以葛根为主药的中药制剂临床疗效显著,但是葛根素口服吸收差,消除快,生物利用度低,若以葛根素为质量控制指标,无法完全反映葛根为主药的中药制剂疗效。基于刘昌孝院士提出的中药质量标志物(Q-marker)新概念,从成分特有性、传统功效、传统药性、成分可测性、中药配伍环境(药对配伍、复方配伍、经典方配伍)、成分有效性等几个方面对葛根质量标志物(Q-marker)进行探讨分析,为葛根及其制剂质量评价研究提供思路。
The clinical curative effect of formulae mainly with pueraria is remarkable. But puerarin oral absorption is low with fasteliminating and low bioavailability. The curative effect of puerarin can not be completely reflected by puerarin as the quality control and quality evaluation component. Based on the new concept of traditional Chinese medicine quality markers(Q-marker) proposed by LIU Changxiao, from the composition characteristic and traditional function, traditional medicinal properties, ingredients measurability, environmental compatibility of traditional Chinese medicine(medicine for compatibility, compatibility of compound compatibility, classic party), composition of effectiveness of such aspects as quality markers(Q-marker),it carries on the discussion analysis, providing the train of thought for quality assessment of radix puerariae and preparation research.
The clinical curative effect of formulae mainly with pueraria is remarkable. But puerarin oral absorption is low with fasteliminating and low bioavailability. The curative effect of puerarin can not be completely reflected by puerarin as the quality control and quality evaluation component. Based on the new concept of traditional Chinese medicine quality markers(Q-marker) proposed by LIU Changxiao, from the composition characteristic and traditional function, traditional medicinal properties, ingredients measurability, environmental compatibility of traditional Chinese medicine(medicine for compatibility, compatibility of compound compatibility, classic party), composition of effectiveness of such aspects as quality markers(Q-marker),it carries on the discussion analysis, providing the train of thought for quality assessment of radix puerariae and preparation research.
引文
[1] 李国辉,张庆文,王一涛.葛根的化学成分研究[J].中国中药杂志,2010,35(23):3156-3160.
[2] 王翠萍,郭伟星,苏文革,等.愈风宁心冲剂治疗冠心病心绞痛的临床观察[J].中药新药与临床药理,1999(3):15-17,65.
[3] 孙学刚.愈风宁心片治疗冠心病心绞痛的临床观察[J].陕西中医学院学报,2003(4):16.
[4] 张弦,庞浩龙,贡联兵,等.葛根汤颗粒的临床应用评价[J].中国医院用药评价与分析,2013,13(10):869-871.
[5] 姜水红,查圣华,张宏.葛根枳椇子复合制剂对肝损伤保护作用的研究[J].中国中医药科技,2014,21(6):635-636.
[6] 李惠莲,刘斌,杨剑芳.影响中药疗效的化学因素[J].北京中医,2003(4):49-51.
[7] Lu XL, Liu JX. Protective eects of puerarin against A40-induced vascular dysfunction in zebrafsh and human endothelial cells[J].European Journal of Pharmacology,2014,732(1):76-85.
[8] Luo CF, Yuan M, Chen MS, et al. Pharmacokinetics,tissue distribution and relative bioavailability of puerarin solid lipid nanoparticles following oral administration[J].International Journal of Pharmaceutics, 2011,410(1-2): 138-144.
[9] Zhang Y, Wang R, Wu J, et al. Characterization and evaluation of self-microemulsifying sustained-release pellet formulation of puerarin for oral delivery[J].International Journal of Pharmaceutics, 2012,427(2): 337-344.
[10] 白东义,佟春玲,韩慧,等.葛根素的药理作用及其临床应用研究进展[J].江苏中医药,2009,41(3):76-78.
[11] 吴燕红,苏子仁,赖小平,等.愈风宁心片中葛根素在小鼠体内的药动学和生物利用度研究[J].中药新药与临床药理,2004(4):259-261.
[12] 吴燕红,苏子仁,赖小平,等.愈风宁心片中葛根素在Beagle犬体内药动学研究[J].中成药,2006(2):215-218.
[13] 朱秀媛,苏成业,李振华,等.葛根有效成分的代谢研究——Ⅲ葛根素的代谢及其药代动力学分析[J].药学学报,1979(6):349-355.
[14] 宋玮,李艳姣,乔雪,等.中药葛根的化学成分研究进展(英文)[J].中国药学(英文版),2014,23(6):347-360.
[15] 刘昌孝,陈士林,肖小河,等.中药质量标志物(Q-Marker):中药产品质量控制的新概念[J].中草药,2016,47(9):1443-1457.
[16] 董英,徐斌,林琳,等.葛根的化学成分研究[J].食品与机械,2005(6):85-88,100.
[17] 顾志平,陈碧珠,冯瑞芝,等.中药葛根及其同属植物的资源利用和评价[J].药学学报,1996(5):387-393.
[18] 陈兵兵. 葛根多糖的提取分离、理化特性及生物活性研究[D].南京:江苏大学,2016.
[19] 姜程曦,张铁军,陈常青,等.黄精的研究进展及其质量标志物的预测分析[J].中草药,2017,48(1):1-16.
[20] 李冲冲,龚苏晓,许浚,等.车前子化学成分与药理作用研究进展及质量标志物预测分析[J].中草药,2018(6):1233-1246.
[21] 张铁军,白钢,陈常青,等.基于“五原则”的复方中药质量标志物(Q-marker)研究路径[J].中草药,2018,49(1):1-13.
[22] 陶玲,管咏梅,陈丽华,等.雷公藤配伍减毒研究进展[J].中国实验方剂学杂志,2018,24(4):229-234.
[23] 张斌.药对荆芥-桂枝、羌活-葛根和甘草-延胡索化学成分研究[D].长沙:中南大学,2009.
[24] 范颖,李新,刘烨,等.黄芪葛根配伍对糖尿病大鼠肝脏INS、ADPN、LEP、GLUT-4的影响及其交互作用[J].中华中医药杂志,2015(10):3713-3716.
[25] 梁保才.脑脉宁治疗脑梗塞110例[J].陕西中医,2004(7):606-607.
[26] 周云翔,田腊群.抑眩汤治疗眩晕32例[J].陕西中医,2006(7):800-801.
[27] 国家药典委员会.中华人民共和国药典:一部[S].北京:中国医药科技出版社,2015:14.
[2] 王翠萍,郭伟星,苏文革,等.愈风宁心冲剂治疗冠心病心绞痛的临床观察[J].中药新药与临床药理,1999(3):15-17,65.
[3] 孙学刚.愈风宁心片治疗冠心病心绞痛的临床观察[J].陕西中医学院学报,2003(4):16.
[4] 张弦,庞浩龙,贡联兵,等.葛根汤颗粒的临床应用评价[J].中国医院用药评价与分析,2013,13(10):869-871.
[5] 姜水红,查圣华,张宏.葛根枳椇子复合制剂对肝损伤保护作用的研究[J].中国中医药科技,2014,21(6):635-636.
[6] 李惠莲,刘斌,杨剑芳.影响中药疗效的化学因素[J].北京中医,2003(4):49-51.
[7] Lu XL, Liu JX. Protective eects of puerarin against A40-induced vascular dysfunction in zebrafsh and human endothelial cells[J].European Journal of Pharmacology,2014,732(1):76-85.
[8] Luo CF, Yuan M, Chen MS, et al. Pharmacokinetics,tissue distribution and relative bioavailability of puerarin solid lipid nanoparticles following oral administration[J].International Journal of Pharmaceutics, 2011,410(1-2): 138-144.
[9] Zhang Y, Wang R, Wu J, et al. Characterization and evaluation of self-microemulsifying sustained-release pellet formulation of puerarin for oral delivery[J].International Journal of Pharmaceutics, 2012,427(2): 337-344.
[10] 白东义,佟春玲,韩慧,等.葛根素的药理作用及其临床应用研究进展[J].江苏中医药,2009,41(3):76-78.
[11] 吴燕红,苏子仁,赖小平,等.愈风宁心片中葛根素在小鼠体内的药动学和生物利用度研究[J].中药新药与临床药理,2004(4):259-261.
[12] 吴燕红,苏子仁,赖小平,等.愈风宁心片中葛根素在Beagle犬体内药动学研究[J].中成药,2006(2):215-218.
[13] 朱秀媛,苏成业,李振华,等.葛根有效成分的代谢研究——Ⅲ葛根素的代谢及其药代动力学分析[J].药学学报,1979(6):349-355.
[14] 宋玮,李艳姣,乔雪,等.中药葛根的化学成分研究进展(英文)[J].中国药学(英文版),2014,23(6):347-360.
[15] 刘昌孝,陈士林,肖小河,等.中药质量标志物(Q-Marker):中药产品质量控制的新概念[J].中草药,2016,47(9):1443-1457.
[16] 董英,徐斌,林琳,等.葛根的化学成分研究[J].食品与机械,2005(6):85-88,100.
[17] 顾志平,陈碧珠,冯瑞芝,等.中药葛根及其同属植物的资源利用和评价[J].药学学报,1996(5):387-393.
[18] 陈兵兵. 葛根多糖的提取分离、理化特性及生物活性研究[D].南京:江苏大学,2016.
[19] 姜程曦,张铁军,陈常青,等.黄精的研究进展及其质量标志物的预测分析[J].中草药,2017,48(1):1-16.
[20] 李冲冲,龚苏晓,许浚,等.车前子化学成分与药理作用研究进展及质量标志物预测分析[J].中草药,2018(6):1233-1246.
[21] 张铁军,白钢,陈常青,等.基于“五原则”的复方中药质量标志物(Q-marker)研究路径[J].中草药,2018,49(1):1-13.
[22] 陶玲,管咏梅,陈丽华,等.雷公藤配伍减毒研究进展[J].中国实验方剂学杂志,2018,24(4):229-234.
[23] 张斌.药对荆芥-桂枝、羌活-葛根和甘草-延胡索化学成分研究[D].长沙:中南大学,2009.
[24] 范颖,李新,刘烨,等.黄芪葛根配伍对糖尿病大鼠肝脏INS、ADPN、LEP、GLUT-4的影响及其交互作用[J].中华中医药杂志,2015(10):3713-3716.
[25] 梁保才.脑脉宁治疗脑梗塞110例[J].陕西中医,2004(7):606-607.
[26] 周云翔,田腊群.抑眩汤治疗眩晕32例[J].陕西中医,2006(7):800-801.
[27] 国家药典委员会.中华人民共和国药典:一部[S].北京:中国医药科技出版社,2015:14.