人参茎叶总皂苷注射液质量标准及其指纹图谱研究
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摘要
人参茎叶总皂苷注射液由人参茎叶总皂苷提取物制备而成，用于滋补强壮、安神益智、增强机体免疫功能，调节内分泌和植物神经功能紊乱，增强心肌收缩力，提高心脏功能和保肝作用。为了控制人参茎叶总皂苷注射液的质量，确保临床用药的安全性与有效性，本课题采用先进的分析测试手段，对人参茎叶总皂苷注射液及其原料药材(人参叶药材)、中间体(人参茎叶总皂苷中间体)的质量标准和指纹图谱进行了研究。
本课题用薄层色谱法对药材、中间体与注射液进行了定性鉴别，并分别鉴出人参皂苷Rg_1和人参皂苷Re的特征斑点。以高氯酸-香草醛比色法测定人参总皂苷的含量，分析结果准确、灵敏、简便。用高效液相色谱法对其所含人参皂苷Rg_1、人参皂苷Re进行含量测定，方法灵敏、准确、重现性好、结果可靠。此外，本文照《中国药典》的方法对中间体与注射液成品进行了相关检查，结果表明所建立的检查方法可有效地用于成品的质量控制。
本文参照国家药监局颁布的《中药注射剂指纹图谱研究的技术要求(暂行)》，采用薄层色谱法对人参叶总皂苷注射液及其原料药材(人参叶药材)、中间体(人参茎叶总皂苷提取物)进行了指纹图谱的研究，并建立了一套完整的指纹图谱检测方法和相似度评价方法。结果表明：该方法成本低、直观、快速、准确、易于推广。
本课题的研究结果对建立人参茎叶总皂苷注射液及其原料的质量评价方法，推广薄层色谱指纹图谱技术，指导实际生产，保证成品质量的稳定性及药品的安全性具有重要意义。
The General Ginsenosides Injection (GGSI) of Ginseng Folium and Stem is made from the general Ginsenoside extracts of Ginseng Folium and Stem (Panax ginseng C.A.Mey ). It has the efficacy of tonification and invigoration, tranquilizing the mind and benefitting wisdom. Therefore it is not only used to reinforce immunity function, accommodate disturbance of endocrine and vegetative nerve function, but also used to enhance cardiac muscle contraction, improve the heart action and nourish the liver. In order to control the quality and insure the security and efficiency of the Injection, we studied the quality standard and fingerprints of the GGSI and raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts) with modern analytical and testing technics.
Qualitative identification of them was made with TLC and the spots of Ginsenoside Rgi and Re were detected distinctly. The general contents of Ginsenoside were determined accurately, sensitively and conveniently with Perchloricacid-Vanilin Chromometry. The contents of Ginsenoside Rg1 and Re were determined by HPLC and the technique was sensitive, accurate ,repeatable and credible. The intermediates and GGSI were tested by different methods mainly from Chinese Pharmacopoeia, the established testing standards were testified as the effective quality control methods of GGSI.
According to the decree of 《Technic Requirements of Injection Fingerprints of Chinese Materia Medica》 enacted by State Drug Adminisrtation, fingerprints of GGSI, raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts of Folium and Stem of Ginseng) were studied with TLC (including scanning method and images analysis).Then a complete detecting technic of fingerprints and the method of it's similarity evaluating were established. All technics and methods were low-cost, straight, speedy, accurate and generalizable.
Our study results will contribute great importance to the establishment of the evaluating methods of GGSI and its raw materials, prompt the use of TLC on fingerprint study of Chinese Herbs, serve as guidance of manufacture and quality control of raw materials, it also can be the guarantee of the stability and security of the finished product.
本课题用薄层色谱法对药材、中间体与注射液进行了定性鉴别，并分别鉴出人参皂苷Rg_1和人参皂苷Re的特征斑点。以高氯酸-香草醛比色法测定人参总皂苷的含量，分析结果准确、灵敏、简便。用高效液相色谱法对其所含人参皂苷Rg_1、人参皂苷Re进行含量测定，方法灵敏、准确、重现性好、结果可靠。此外，本文照《中国药典》的方法对中间体与注射液成品进行了相关检查，结果表明所建立的检查方法可有效地用于成品的质量控制。
本文参照国家药监局颁布的《中药注射剂指纹图谱研究的技术要求(暂行)》，采用薄层色谱法对人参叶总皂苷注射液及其原料药材(人参叶药材)、中间体(人参茎叶总皂苷提取物)进行了指纹图谱的研究，并建立了一套完整的指纹图谱检测方法和相似度评价方法。结果表明：该方法成本低、直观、快速、准确、易于推广。
本课题的研究结果对建立人参茎叶总皂苷注射液及其原料的质量评价方法，推广薄层色谱指纹图谱技术，指导实际生产，保证成品质量的稳定性及药品的安全性具有重要意义。
The General Ginsenosides Injection (GGSI) of Ginseng Folium and Stem is made from the general Ginsenoside extracts of Ginseng Folium and Stem (Panax ginseng C.A.Mey ). It has the efficacy of tonification and invigoration, tranquilizing the mind and benefitting wisdom. Therefore it is not only used to reinforce immunity function, accommodate disturbance of endocrine and vegetative nerve function, but also used to enhance cardiac muscle contraction, improve the heart action and nourish the liver. In order to control the quality and insure the security and efficiency of the Injection, we studied the quality standard and fingerprints of the GGSI and raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts) with modern analytical and testing technics.
Qualitative identification of them was made with TLC and the spots of Ginsenoside Rgi and Re were detected distinctly. The general contents of Ginsenoside were determined accurately, sensitively and conveniently with Perchloricacid-Vanilin Chromometry. The contents of Ginsenoside Rg1 and Re were determined by HPLC and the technique was sensitive, accurate ,repeatable and credible. The intermediates and GGSI were tested by different methods mainly from Chinese Pharmacopoeia, the established testing standards were testified as the effective quality control methods of GGSI.
According to the decree of 《Technic Requirements of Injection Fingerprints of Chinese Materia Medica》 enacted by State Drug Adminisrtation, fingerprints of GGSI, raw materials (Folium and Stem of Ginseng) and intermediates (the general Ginsenoside extracts of Folium and Stem of Ginseng) were studied with TLC (including scanning method and images analysis).Then a complete detecting technic of fingerprints and the method of it's similarity evaluating were established. All technics and methods were low-cost, straight, speedy, accurate and generalizable.
Our study results will contribute great importance to the establishment of the evaluating methods of GGSI and its raw materials, prompt the use of TLC on fingerprint study of Chinese Herbs, serve as guidance of manufacture and quality control of raw materials, it also can be the guarantee of the stability and security of the finished product.
引文
1 中华人民共和国卫生部药典委员会中国药典[S]一部2000年版，化学工业出版社，2000：6～7．
2 沈映君主编 中药药理学[M]人民卫生出版社，2000：861～874．
3 Zhang S C. Pharmacological effect of ginsenoside from different parts of Panax ginseng[J]. Chin Tradit Pat Med, 1980(5):45.
4 徐任生主编，天然产物化学[M]．科学出版社，1997：568～573．
5 LING Chang-quan. Effects of ginsenosides on glucocorticoid receptor in hemorrhagic shock rats[J].Chin Tradit and Herbal Drugs, 2003(5):433
6 何正有，分光光度法测定藏药翼首草中总皂苷的含量[J]．华西药学杂志，2002，17(1)：43～45．
7 陈发奎主编，常用中草药有效成分含量测定[M]，人民卫生出版社，1997：1～6．
8 谢培山 中药质量控制模式的发展趋势[J]中药新药与临床药理 2001，12(3)：188～191．
9 Larry Kelly药检分析实验室面临草药的挑战[J]，中药新药与临床药理 2001，12(5)：152～159．
10 吴昊，田燕华等．多元统计在参麦注射液指纹图谱中的应用[J]．中成药．2002．6(3)：123．
11 翟为民 袁永生等，人参、西洋参及三七参指纹图谱鉴别[J]，中国中药杂志，2001，26(7)：481～482．
12 中华人民共和国卫生部药典委员会编著．中华人民共和国药典中药薄层色谱
彩色图集[M]．广州：广东科技出版社．1993．
13 王惠清主编，中药材产销[M]，四川科学技术出版社，2004．
14 何正有，分光光度法测定藏药翼首草中总皂苷的含量[J]．华西药学杂志，2002，17(1)：43～45．
15 中华人民共和国卫生部药典委员会中国药典[S]一部2000年版，化学工业出版社，2000：6～7．
16 陈发奎主编，常用中草药有效成分含量测定[M]，人民卫生出版社，1997：1～4．
17 贾晓斌，施亚芳等，复方人参注射液的HPLC指纹图谱研究[J]．中成药．2002．23(4)243．
18 俞瑜 吴谦，免疫印迹技术在参属药材鉴别中的应用[J]，中药新药与临床药理，2000，11(3)，164～166.
19 王培训 黄丰，商品西洋参DNA指纹图谱鉴别[J]，中药新药与临床药理，1999，10(6)，367～369．
20 梁逸曾，谢培山 指纹图谱的化学模式识别分析—若干实质性问题的探讨(三)[J]，世界科学技术，2002，4(5)：47～51．
21 余杰 吴永江等，一种基于分析数据可视化技术的中药材质量分析与评价新方法[J]，中国中药杂志，2002，27(2)：97～100．
22 王龙星，肖红斌等，一种评价中药色谱指纹谱相似性的新方法：向量夹角法[J]，药学学报，2002，37(9)：713～717．
23 国家药典委员会中药注射剂色谱指纹图谱实验研究技术指南(试行)[S] 2002年4月27日
2 沈映君主编 中药药理学[M]人民卫生出版社，2000：861～874．
3 Zhang S C. Pharmacological effect of ginsenoside from different parts of Panax ginseng[J]. Chin Tradit Pat Med, 1980(5):45.
4 徐任生主编，天然产物化学[M]．科学出版社，1997：568～573．
5 LING Chang-quan. Effects of ginsenosides on glucocorticoid receptor in hemorrhagic shock rats[J].Chin Tradit and Herbal Drugs, 2003(5):433
6 何正有，分光光度法测定藏药翼首草中总皂苷的含量[J]．华西药学杂志，2002，17(1)：43～45．
7 陈发奎主编，常用中草药有效成分含量测定[M]，人民卫生出版社，1997：1～6．
8 谢培山 中药质量控制模式的发展趋势[J]中药新药与临床药理 2001，12(3)：188～191．
9 Larry Kelly药检分析实验室面临草药的挑战[J]，中药新药与临床药理 2001，12(5)：152～159．
10 吴昊，田燕华等．多元统计在参麦注射液指纹图谱中的应用[J]．中成药．2002．6(3)：123．
11 翟为民 袁永生等，人参、西洋参及三七参指纹图谱鉴别[J]，中国中药杂志，2001，26(7)：481～482．
12 中华人民共和国卫生部药典委员会编著．中华人民共和国药典中药薄层色谱
彩色图集[M]．广州：广东科技出版社．1993．
13 王惠清主编，中药材产销[M]，四川科学技术出版社，2004．
14 何正有，分光光度法测定藏药翼首草中总皂苷的含量[J]．华西药学杂志，2002，17(1)：43～45．
15 中华人民共和国卫生部药典委员会中国药典[S]一部2000年版，化学工业出版社，2000：6～7．
16 陈发奎主编，常用中草药有效成分含量测定[M]，人民卫生出版社，1997：1～4．
17 贾晓斌，施亚芳等，复方人参注射液的HPLC指纹图谱研究[J]．中成药．2002．23(4)243．
18 俞瑜 吴谦，免疫印迹技术在参属药材鉴别中的应用[J]，中药新药与临床药理，2000，11(3)，164～166.
19 王培训 黄丰，商品西洋参DNA指纹图谱鉴别[J]，中药新药与临床药理，1999，10(6)，367～369．
20 梁逸曾，谢培山 指纹图谱的化学模式识别分析—若干实质性问题的探讨(三)[J]，世界科学技术，2002，4(5)：47～51．
21 余杰 吴永江等，一种基于分析数据可视化技术的中药材质量分析与评价新方法[J]，中国中药杂志，2002，27(2)：97～100．
22 王龙星，肖红斌等，一种评价中药色谱指纹谱相似性的新方法：向量夹角法[J]，药学学报，2002，37(9)：713～717．
23 国家药典委员会中药注射剂色谱指纹图谱实验研究技术指南(试行)[S] 2002年4月27日
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