高山红景天质量标准的建立及指纹图谱研究
摘要
本文选题为《高山红景天质量标准的建立及指纹图谱研究》。在研究过程中,采用现代科学技术及分析方法对不同产地高山红景天药材进行了较全面的分析和研究。
本实验采用成熟传统的HPLC法对该药材进行质量标准的建立和指纹图谱研究。在研究质量标准过程中,确定以红景天苷和甙元酪醇为定量指标,用定量方法进行了HPLC的方法学考察;在建立指纹图谱过程中,通过严格控制药材供试品的制备、参照峰的选择、色谱条件的优化等因素,最终建立了该药材的指纹图谱。
目前,已有几种高山红景天制剂应用于临床,如红景天口服液等,考虑到其药用效果、质量控制以及用药的安全性等多方面因素,本文制定了高山红景天的质量标准和指纹图谱,为全面、科学、有效地控制其质量奠定了理论基础。
Our country has joined WTO, For making the Chinese medicine industry integrate a big market of international medicine, the quality of its drugs controls very importance. The quality criterion of the drugs is the technique provision that the quality of drugs and the test method of a nation or territory,it is the legal basis that the drugs produce,supply, use and control section to follow together, it is the importance compositive part that the drugs modernization produces and quality control.
The our country Chinese herbal resources is very abundant, Add up to 12,807 kinds up to now, but different kinds of herbals have different quality criterions because they have different component, pharmacology and pharmic quality properties. Until now Rhodiola sachalinensis has been applied in clinic, For raising its medicine to use the result,the exaltation quality control,in this disquisition Establishing the Quality Criterion About Rhodiola sachalinensis,For overall, science, availably its quality to establish theories foundation.
In this thesis includes two parts that establishing the quality criterion and researching fingerprints atlas:
一、Establish the quality criterion:We make some physics and chemistry experimentize on Rhodiola sachalinensis from different habitat. For example moisture、ash component、heavy metal etc. Make sure with Salidroside and P-T-yrosol is index of quantitative analysis , obtain many data by other methods and technologies to determine both qualitative analysis and quantitative analysis. Thereby establish the Quality Criterion About Rhodiola sachalinensis.
二、Research Fingerprints Atlas : During the Research Fingerprints Atlas,via choose chromatogram column、mobile phase、wave length、temperature of the column etc, after researched we get fingerprints atlas of exclusive property、characteristic、stability and reproduction.
The research result of this thesis,it is provide feasible measure for controled quality of herb,also fill up vacancy that quality criterion about Rhodiola sachalinensis.
本实验采用成熟传统的HPLC法对该药材进行质量标准的建立和指纹图谱研究。在研究质量标准过程中,确定以红景天苷和甙元酪醇为定量指标,用定量方法进行了HPLC的方法学考察;在建立指纹图谱过程中,通过严格控制药材供试品的制备、参照峰的选择、色谱条件的优化等因素,最终建立了该药材的指纹图谱。
目前,已有几种高山红景天制剂应用于临床,如红景天口服液等,考虑到其药用效果、质量控制以及用药的安全性等多方面因素,本文制定了高山红景天的质量标准和指纹图谱,为全面、科学、有效地控制其质量奠定了理论基础。
Our country has joined WTO, For making the Chinese medicine industry integrate a big market of international medicine, the quality of its drugs controls very importance. The quality criterion of the drugs is the technique provision that the quality of drugs and the test method of a nation or territory,it is the legal basis that the drugs produce,supply, use and control section to follow together, it is the importance compositive part that the drugs modernization produces and quality control.
The our country Chinese herbal resources is very abundant, Add up to 12,807 kinds up to now, but different kinds of herbals have different quality criterions because they have different component, pharmacology and pharmic quality properties. Until now Rhodiola sachalinensis has been applied in clinic, For raising its medicine to use the result,the exaltation quality control,in this disquisition Establishing the Quality Criterion About Rhodiola sachalinensis,For overall, science, availably its quality to establish theories foundation.
In this thesis includes two parts that establishing the quality criterion and researching fingerprints atlas:
一、Establish the quality criterion:We make some physics and chemistry experimentize on Rhodiola sachalinensis from different habitat. For example moisture、ash component、heavy metal etc. Make sure with Salidroside and P-T-yrosol is index of quantitative analysis , obtain many data by other methods and technologies to determine both qualitative analysis and quantitative analysis. Thereby establish the Quality Criterion About Rhodiola sachalinensis.
二、Research Fingerprints Atlas : During the Research Fingerprints Atlas,via choose chromatogram column、mobile phase、wave length、temperature of the column etc, after researched we get fingerprints atlas of exclusive property、characteristic、stability and reproduction.
The research result of this thesis,it is provide feasible measure for controled quality of herb,also fill up vacancy that quality criterion about Rhodiola sachalinensis.
引文
[1]吉林省中医中药研究所等,长白山植物药志,吉林人民出版社,1982
[2] Li J X, Liu J T, Jin Y R, et al. Studies on chemical constituents from stem and leaf of Sachalin Rhodiola (rhodiola sachalinensis)[J].China Tradit Herb Drugs , 1998,29(10):659-661
[3] Fan W,Tezuka Y,Ni K M,et al.Prolyl endopeptidase inhibitors from the underground park of Rhodiola sachalinensis [J].Chem Pharm Bull,2001,49(4):396-401
[4] 周重楚等,李文亭,刘威,苗艳波,魏春荣.高山红景天化学成分与药理研究概况.特产研究.1993,1:25
[5] 陈亚东等.高山红景天对小鼠耐缺氧、抗疲劳及耐低温作用的影响.中国中医药科技.2002,9(3):157-158
[6] Hao L M,Jiang W H,Meng X T,et al.The effects of salidroside on the somatotropin of the old rats piruitary[J].Chin J Gerontol,2002,20(4):230-231. Li Y,Cui L,Pan L,et al.Experimental study of anti-aging effects of rhodosin on myocardium in rats[J].Chin J Gerontol,2001,21(1):55-57
[7] 苗艳波,师海波,孙英莲等.高山红景天的抗辐射作用.中药药理与临床.2004,20(3):21-22
[8] Zhuang J Q,Shi J R,Zeng A L,et al.Studies of errects of Rhodiola sachalinensis complex prescription on exercise capacity and red cell immune function in rats[J].Chin J Exp Tradit Med Form,1998,4(4):9-12.
[9] Shi J R,Zhuang J Q,Guo R X,et al.The regulation of Rhodiola ctenulata compound on immune function by heavy exercise[J].Chin J Immunol,1999,15(4):171-173.
[10]Хныкина,Л,А,и.др:Аптеч.Дел.1966,15(6):34
[11] 熊季霞,中药如何走向世界,中医药信息.2005,22(1):1-3
[12] 喻录容,刘新.建立中药指纹图谱方法的研究现状.华夏医学.2004,17(4):645-647
[13] 王夏炎. 现代分析技术在中药指纹图谱研究中的应用[J]. 中草药.2004,35(7):附 6-附 9
[14] 陈琴鸣.《美国药典》收载植物药情况简介[ J] .中国中药杂志.2002, 27( 9) : 714- 717
[15] 贺立中.《美国药典》对植物药品质的检测规定[J] .中国药事.2003, 17(11) : 703- 706
[16] 赵中振, 聂万达, 胡梅. 日本的中成药市场[J] .中国中医药信息杂志.1996, 3( 4) : 21- 22
[17] 侯锋, 林朝来, 吴忠, 等. 当前中成药质量控制性状分析[J] . 广东微量元素科学.2001, 8( 1) : 1- 10
[18] 祝国光, 董志林. 欧盟《传统药物产品法令》( 草案) 的剖析及中医药在欧洲发展战略的探讨[J] . 国外医学·中医中药分册.2002, 24(2) : 67- 72
[19] 吴伯平. 德国中药检测标准[ J] . 中国中医药信息杂志.1995, 2( 9) : 38
[20] 周玉新主编,中药指纹图谱研究技术,化学工业出版社
[21] 李晓波,屠鹏飞.中药材指纹体系.中草药.2003,34(5):385-387
[22] 李克,王曙东.中药指纹图谱研究的有关技术要点探讨.中草药.2003,34(11):附8-附10
[23] 李元宏,涂自良,陈吉炎.中药材标准指纹图谱制订与GAP实施.中国药房.2003,14(11):697-999
[24] 蒋晔,郝晓花,刘红菊.中药指纹图谱的构建与解析.中成药.2004,26(4):262-265
[25] 田进国,陈永林,任健,娄红祥,高彦慧.延胡索与全叶延胡索的红外光谱鉴别.中国中药杂志.1999,24(6):327-329
[26] 李彩君,林巧玲,谢培山,陈佃.高良姜中黄酮类成分薄层色谱指纹图谱鉴别.中药新药与临床药理.2001,12(3):183-188
[27] 钱浩泉,李彩君,谢培山.高良姜及其近缘植物挥发油成分的气相色谱指纹图谱研究.中药新药与临床药理.2001,12(3):179-183
[28] 王钢力,戴忠,鲁静,林瑞超.11种卷柏属药用植物HPCE指纹图谱的研究.中成药.2002,24(7):489-491
[29] 李宗孝,原春兰,聂菲.中药振荡指纹图谱.中国基础科学-研究论坛.2004.2:27-29
[30] 郭宝林,戴波.中药材DNA 分子标记研究的技术问题及RAPD 实验技术和方法学论述.中草药.2002,33(2):178-180
[31] 梁之桃,秦民坚,王峥涛,黄芸,王年鹤.柴胡属5 种植物RAPD 分析与分类鉴定.中草药.2002 ,33 (12 ):1117-1119
[32] 杨美华,张大明,刘健全,郑俊华,范国强.正品和伪品大黄的RAPD指纹图谱鉴定研究.中草药.2003,34(6):557-560
[33] 张南平,肖新月,张萍,符宏,林瑞超.建立中药“对照指纹图谱”的可行性探讨.中国药事.2003,17(6):347-350
[34]刘传斌,金郁,李宁,谢键,许建峰. 不同来源高山红景天材料中有效成分的HPLC分析.天然产物研究与开发.1999,11(2):18-22
[35]李向高,薛志革.高山红景天挥发油成分的分析.中成药.1992,14(8),34
[36]刘晔,杨建云,王文波. RP-HPLC法测定高山红景天中红景天苷含量的研究.中医药学刊.2002,20(6):863
[37]张早华,储戟农,林文翰,傅宏征. HPLC测定红景天注射液中酪醇的含量.中国中药杂志.2005,30(22):1775-1776
[38] 李建新,刘巨涛,金永日,张宏桂,吴广宣,奥山徹. 高山红景天茎叶的化学成分研究.中草药.1998,29(10):659-661
[39]中国药典2005年版一部
[40] 林玉琐,龚瑞忠,朱忠林. 农药与生态环境保护[M] . 北京:化学工业出版社,2001
[41] 许士奋,蒋新,冯建日方等. 环境科学学报,2000 ,20(4) :494
[42] 于彦彬,谭培功,王孝钢等. 分析试验室, 2004 , 23(7) : 47
[43] 朱雪梅,崔艳红,郭丽轻等. 环境科学,2002 ,23(5) :113
[44] 孔祥虹,何学文,成 俭等. 化学分析计量, 2004 , 13(1) : 21
[45] 邱月明,温可可,白桦. 分析化学, 1997 , 25 (12) :1391
[46] 王夔.中药研究现代方法学.化学工业出版社.2004
[47] 冯雪松, 董鸿晔. 中药指纹图谱中的数据挖掘技术.药学进展.2002,26(4):198-201
[48] 张丽芳,薛飞群. 中药指纹图谱的检测方法.广东药学.2004,14(6):11-12
[49] 王欣,刘新. 中药指纹图谱与质量控制.现代医药卫生.2005,21(15):1982-1983
[50] Xie Peishan. Traditional Chinese Drug Research & Clinical Pharmacology , 2001 , 12 (3) : 14
[2] Li J X, Liu J T, Jin Y R, et al. Studies on chemical constituents from stem and leaf of Sachalin Rhodiola (rhodiola sachalinensis)[J].China Tradit Herb Drugs , 1998,29(10):659-661
[3] Fan W,Tezuka Y,Ni K M,et al.Prolyl endopeptidase inhibitors from the underground park of Rhodiola sachalinensis [J].Chem Pharm Bull,2001,49(4):396-401
[4] 周重楚等,李文亭,刘威,苗艳波,魏春荣.高山红景天化学成分与药理研究概况.特产研究.1993,1:25
[5] 陈亚东等.高山红景天对小鼠耐缺氧、抗疲劳及耐低温作用的影响.中国中医药科技.2002,9(3):157-158
[6] Hao L M,Jiang W H,Meng X T,et al.The effects of salidroside on the somatotropin of the old rats piruitary[J].Chin J Gerontol,2002,20(4):230-231. Li Y,Cui L,Pan L,et al.Experimental study of anti-aging effects of rhodosin on myocardium in rats[J].Chin J Gerontol,2001,21(1):55-57
[7] 苗艳波,师海波,孙英莲等.高山红景天的抗辐射作用.中药药理与临床.2004,20(3):21-22
[8] Zhuang J Q,Shi J R,Zeng A L,et al.Studies of errects of Rhodiola sachalinensis complex prescription on exercise capacity and red cell immune function in rats[J].Chin J Exp Tradit Med Form,1998,4(4):9-12.
[9] Shi J R,Zhuang J Q,Guo R X,et al.The regulation of Rhodiola ctenulata compound on immune function by heavy exercise[J].Chin J Immunol,1999,15(4):171-173.
[10]Хныкина,Л,А,и.др:Аптеч.Дел.1966,15(6):34
[11] 熊季霞,中药如何走向世界,中医药信息.2005,22(1):1-3
[12] 喻录容,刘新.建立中药指纹图谱方法的研究现状.华夏医学.2004,17(4):645-647
[13] 王夏炎. 现代分析技术在中药指纹图谱研究中的应用[J]. 中草药.2004,35(7):附 6-附 9
[14] 陈琴鸣.《美国药典》收载植物药情况简介[ J] .中国中药杂志.2002, 27( 9) : 714- 717
[15] 贺立中.《美国药典》对植物药品质的检测规定[J] .中国药事.2003, 17(11) : 703- 706
[16] 赵中振, 聂万达, 胡梅. 日本的中成药市场[J] .中国中医药信息杂志.1996, 3( 4) : 21- 22
[17] 侯锋, 林朝来, 吴忠, 等. 当前中成药质量控制性状分析[J] . 广东微量元素科学.2001, 8( 1) : 1- 10
[18] 祝国光, 董志林. 欧盟《传统药物产品法令》( 草案) 的剖析及中医药在欧洲发展战略的探讨[J] . 国外医学·中医中药分册.2002, 24(2) : 67- 72
[19] 吴伯平. 德国中药检测标准[ J] . 中国中医药信息杂志.1995, 2( 9) : 38
[20] 周玉新主编,中药指纹图谱研究技术,化学工业出版社
[21] 李晓波,屠鹏飞.中药材指纹体系.中草药.2003,34(5):385-387
[22] 李克,王曙东.中药指纹图谱研究的有关技术要点探讨.中草药.2003,34(11):附8-附10
[23] 李元宏,涂自良,陈吉炎.中药材标准指纹图谱制订与GAP实施.中国药房.2003,14(11):697-999
[24] 蒋晔,郝晓花,刘红菊.中药指纹图谱的构建与解析.中成药.2004,26(4):262-265
[25] 田进国,陈永林,任健,娄红祥,高彦慧.延胡索与全叶延胡索的红外光谱鉴别.中国中药杂志.1999,24(6):327-329
[26] 李彩君,林巧玲,谢培山,陈佃.高良姜中黄酮类成分薄层色谱指纹图谱鉴别.中药新药与临床药理.2001,12(3):183-188
[27] 钱浩泉,李彩君,谢培山.高良姜及其近缘植物挥发油成分的气相色谱指纹图谱研究.中药新药与临床药理.2001,12(3):179-183
[28] 王钢力,戴忠,鲁静,林瑞超.11种卷柏属药用植物HPCE指纹图谱的研究.中成药.2002,24(7):489-491
[29] 李宗孝,原春兰,聂菲.中药振荡指纹图谱.中国基础科学-研究论坛.2004.2:27-29
[30] 郭宝林,戴波.中药材DNA 分子标记研究的技术问题及RAPD 实验技术和方法学论述.中草药.2002,33(2):178-180
[31] 梁之桃,秦民坚,王峥涛,黄芸,王年鹤.柴胡属5 种植物RAPD 分析与分类鉴定.中草药.2002 ,33 (12 ):1117-1119
[32] 杨美华,张大明,刘健全,郑俊华,范国强.正品和伪品大黄的RAPD指纹图谱鉴定研究.中草药.2003,34(6):557-560
[33] 张南平,肖新月,张萍,符宏,林瑞超.建立中药“对照指纹图谱”的可行性探讨.中国药事.2003,17(6):347-350
[34]刘传斌,金郁,李宁,谢键,许建峰. 不同来源高山红景天材料中有效成分的HPLC分析.天然产物研究与开发.1999,11(2):18-22
[35]李向高,薛志革.高山红景天挥发油成分的分析.中成药.1992,14(8),34
[36]刘晔,杨建云,王文波. RP-HPLC法测定高山红景天中红景天苷含量的研究.中医药学刊.2002,20(6):863
[37]张早华,储戟农,林文翰,傅宏征. HPLC测定红景天注射液中酪醇的含量.中国中药杂志.2005,30(22):1775-1776
[38] 李建新,刘巨涛,金永日,张宏桂,吴广宣,奥山徹. 高山红景天茎叶的化学成分研究.中草药.1998,29(10):659-661
[39]中国药典2005年版一部
[40] 林玉琐,龚瑞忠,朱忠林. 农药与生态环境保护[M] . 北京:化学工业出版社,2001
[41] 许士奋,蒋新,冯建日方等. 环境科学学报,2000 ,20(4) :494
[42] 于彦彬,谭培功,王孝钢等. 分析试验室, 2004 , 23(7) : 47
[43] 朱雪梅,崔艳红,郭丽轻等. 环境科学,2002 ,23(5) :113
[44] 孔祥虹,何学文,成 俭等. 化学分析计量, 2004 , 13(1) : 21
[45] 邱月明,温可可,白桦. 分析化学, 1997 , 25 (12) :1391
[46] 王夔.中药研究现代方法学.化学工业出版社.2004
[47] 冯雪松, 董鸿晔. 中药指纹图谱中的数据挖掘技术.药学进展.2002,26(4):198-201
[48] 张丽芳,薛飞群. 中药指纹图谱的检测方法.广东药学.2004,14(6):11-12
[49] 王欣,刘新. 中药指纹图谱与质量控制.现代医药卫生.2005,21(15):1982-1983
[50] Xie Peishan. Traditional Chinese Drug Research & Clinical Pharmacology , 2001 , 12 (3) : 14