两种常用中药材的质量标准研究
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摘要
本课题作为涉及根据要求的基本工作和根据委员会要求的深入研究工作。基本工作既是对川芎、何首乌进行了生药学研究，包括性状鉴别、显微鉴别；对川芎指标性成分藁本内酯、何首乌指标性成分二苯乙烯和大黄素建立含量测定方法；对川芎、何首乌分别建立指纹图谱鉴定方法。
根据委员会的要求，对川芎的深入研究包括：1)对建立川芎、何首乌较高质量标准和指纹图谱峰鉴定所需的对照品进行分离；2)证明四甲基吡嗪(TMP)在川芎样品中的含量低于所用分析仪器的检测限；根据研究结果以及有关TMP发现过程的报道文献，认为TMP不宜命名为川芎嗪，也不宜作为川芎以及含有川芎制剂质量标准的指标性成分；3)通过定量分析比较，提出了以Senkyunolide A作为指标性成分，进行川芎与当归的质量评价和化学区别；4)用LC-MS、HPLC-DAD技术对川芎的主要成分进行了定性和定量分析，对川芎指纹图谱的20个共有色谱峰进行了鉴定，并对其中6个进行了同时定量；研究表明多酚类、苯酞类是川芎的主要化学成分，应作为川芎质量控制的指标性成分；5)由于商品藁本内酯价格较贵，为了满足日益增长的使用需求，提出了一种新的分离纯化藁本内酯的方法。这种方法节省时间和溶剂，利用当归中极性杂质溶解于水，以及藁本内酯二聚体在热水中转化成藁本内酯的性质，提高了粗提物中藁本内酯的含量，减少了进一步用半制备HPLC纯化的上样量。结果显示，该方法分离纯化藁本内酯效率较高；6)为了比较四种相关伞形科药材(川芎、日本川芎、当归、日本当归)在化学成分种类和含量上的异同，对5份川芎、5份日本川芎、5份当归、5份日本当归样品进行了定性鉴定、定量分析。结果显示，这四种同种中药材的化学成分种类一致，但是含量差异较大。Senkyunolide
The present dissertation involved in the The basic research and the advanced research have
been performed acting on the principle of and the comments of
committee of HKCMMS, respectively. The basic research included the pharmacognostical studies on the rhizome of Ligusticum Chuanxiong Hort and the root tuber of Polygonum multiflorum Thunb; the quantitative analysis of Z-Ligustilide in Rhizoma Chuanxiong, stilbene and emodin in Radix Polygoni Multiflori by HPLC; as well as the HPLC fingerprint of Rhizoma Chuanxiong and Radix Polygoni Multiflori, respectively.
The advanced studies on Rhizoma Chuanxiong were as follows: 1) The chemical standards were isolated for the quantitative analysis and the identification of HPLC peaks; 2) The content of TMP was found to be less than the limit of detection (LOD) by the present analytical instruments. Based on the findings of the present paper and all the literatures on the discovery of TMP, it is also first concluded that chuanxiongize or ligustrazine is not a suitable nomenclature for TMP. In other words, the limited in quantity of TMP implying that it is not a suitable marker compound for quality assessment of Chuanxiong herb and Chuanxiong-containing preparations; 3) Via comparison of quantitative analysis, it was feasible to choose senkyunolide A as a characteristic compound for the quality evaluation and chemical distinguish between Rhizoma Chuanxiong and Radix Angelicae Sinensis; 4) An HPLC-DAD-MS method was developed for the qualitative and quantitative analysis of the major constituents in Rhizoma Chuanxiong. Twenty compounds including
根据委员会的要求，对川芎的深入研究包括：1)对建立川芎、何首乌较高质量标准和指纹图谱峰鉴定所需的对照品进行分离；2)证明四甲基吡嗪(TMP)在川芎样品中的含量低于所用分析仪器的检测限；根据研究结果以及有关TMP发现过程的报道文献，认为TMP不宜命名为川芎嗪，也不宜作为川芎以及含有川芎制剂质量标准的指标性成分；3)通过定量分析比较，提出了以Senkyunolide A作为指标性成分，进行川芎与当归的质量评价和化学区别；4)用LC-MS、HPLC-DAD技术对川芎的主要成分进行了定性和定量分析，对川芎指纹图谱的20个共有色谱峰进行了鉴定，并对其中6个进行了同时定量；研究表明多酚类、苯酞类是川芎的主要化学成分，应作为川芎质量控制的指标性成分；5)由于商品藁本内酯价格较贵，为了满足日益增长的使用需求，提出了一种新的分离纯化藁本内酯的方法。这种方法节省时间和溶剂，利用当归中极性杂质溶解于水，以及藁本内酯二聚体在热水中转化成藁本内酯的性质，提高了粗提物中藁本内酯的含量，减少了进一步用半制备HPLC纯化的上样量。结果显示，该方法分离纯化藁本内酯效率较高；6)为了比较四种相关伞形科药材(川芎、日本川芎、当归、日本当归)在化学成分种类和含量上的异同，对5份川芎、5份日本川芎、5份当归、5份日本当归样品进行了定性鉴定、定量分析。结果显示，这四种同种中药材的化学成分种类一致，但是含量差异较大。Senkyunolide
The present dissertation involved in the The basic research and the advanced research have
been performed acting on the principle of and the comments of
committee of HKCMMS, respectively. The basic research included the pharmacognostical studies on the rhizome of Ligusticum Chuanxiong Hort and the root tuber of Polygonum multiflorum Thunb; the quantitative analysis of Z-Ligustilide in Rhizoma Chuanxiong, stilbene and emodin in Radix Polygoni Multiflori by HPLC; as well as the HPLC fingerprint of Rhizoma Chuanxiong and Radix Polygoni Multiflori, respectively.
The advanced studies on Rhizoma Chuanxiong were as follows: 1) The chemical standards were isolated for the quantitative analysis and the identification of HPLC peaks; 2) The content of TMP was found to be less than the limit of detection (LOD) by the present analytical instruments. Based on the findings of the present paper and all the literatures on the discovery of TMP, it is also first concluded that chuanxiongize or ligustrazine is not a suitable nomenclature for TMP. In other words, the limited in quantity of TMP implying that it is not a suitable marker compound for quality assessment of Chuanxiong herb and Chuanxiong-containing preparations; 3) Via comparison of quantitative analysis, it was feasible to choose senkyunolide A as a characteristic compound for the quality evaluation and chemical distinguish between Rhizoma Chuanxiong and Radix Angelicae Sinensis; 4) An HPLC-DAD-MS method was developed for the qualitative and quantitative analysis of the major constituents in Rhizoma Chuanxiong. Twenty compounds including
引文
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[1] YJ Li, KS Bi. HPLC determination of ferulic acid in rat plasma after oral administration of rhizoma chuanxiong and its compound preparation. Biomed Chromatogr, 2003; 17(8): 543-546.
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[1] The State Pharmacopoeia Commission of People's Republic of China, "The Pharmacopoeia of the People's Republic of China," Part I., Chemical Industry Press, Beijing, 2005, p. 28
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[4] YZ Hou, GR Zhao, J Yang, YJ Yuan, GG Zhu, R Hiltunen. Protective effect of Ligusticum chuanxiong and Angelica sinensis on endothelial cell damage induced by hydrogen peroxide. Life Sci, 2004; 75(14), 1775-1786.
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[1] The State Pharmacopoeia Commission of People's Republic of China, "The Pharmacopoeia of the People's Republic of China, Part I." Chemical Industry Publishing Press: Beijing, 2005; p. 28, p. 89
[2] Society of Japanese Pharmacopoeia. "Japanese Pharmacopoeia XIV," Tokyo: Junkudo Book Shop.2001; p. 899, p. 956
[3] KJ Chen, K Chen. Ischemic stroke treated with Ligusticum chuanxiong. Chin Med J, 1992; 105(10): 870-873.
[4] T Naito, K Kubota, Y Shimoda, T Sato, Y Ikeya, M Okada, M Maruno. Effects of constituents of a Chinese crude drug, Ligustici Chuanxiong Rhizoma, on vasoconstriction and blood viscosity. Nat Med, 1995; 49(3): 288-292.
[5] YZ Hou, GR Zhao, J Yang, YJ Yuan, GG Zhu, R Hiltunen. Protective effect of Ligusticum chuanxiong and Angelica sinensis on endothelial cell damage induced by hydrogen peroxide. Life Sci, 2004; 75(14): 1775-1786.
[6] X Zhang, H Xiao, Q Xu, X Li, J Wang, X Liang. Characterization of phthalides in Ligusticum chuanxiong by liquid chromatographic—atmospheric pressure chemical ionization-mass spectrometry. J Chromatogr Sci, 2003; 41(8): 428-433.
[7] LZ Lin, XG He, LZ Lian, W King, J Elliott. Liquid chromatographic-electrospray mass spectrometric study of the phthalides of Angelica sinensis and chemical changes of Z-ligustilide. J Chromatogr A, 1998; 810: 71-79.
[8] GH Lu, K Chan, YZ Leung, K Leung, CL Chan, ZH Jiang, ZZ Zhao. Development of high-performance liquid chromatographic fingerprints for distinguishing Chinese Angelica from related umberlliferae herbs. J Chromatogr A, 2005; 1073(1-2): 383-392.
[9] HX Li, MY Ding, JY Yu. Separation and identification of the phthalic anhydride derivatives of Ligusticum chuanxiong Hort by GC-MS, TLC, HPLC-DAD, and HPLC-MS. J Chromatogr Sci, 2002; 40(3): 156-161.
[1] The State Pharmacopoeia Commission of People's Republic of China, "The Pharmacopoeia of the People's Republic of China, Part Ⅰ." Chemical Industry Publishing Press: Beijing, 2005; p. 28, p. 89
[2] Society of Japancsc Pharmacopoeia. "Japanesc Pharmacopoeia ⅩⅣ," Tokyo: Junkudo Book Shop. 2001; p. 899, p. 956
[3] KJ Chen, K Chen. Ischemic stroke treated with Ligusticum chuanxiong. Chin MedJ, 1992; 105(10): 870-873.
[4] T Naito, K Kubota, Y Shimoda, T Sato, Y Ikeya, M Okada, M Maruno. Effects of constituents of a Chinese crude drug, Ligustici Chuanxiong Rhizoma, on vasoconstriction and blood viscosity. Nat Med, 1995; 49(3): 288-292.
[5] YZ Hou, GR Zhao, J Yang, YJ Yuan, GG Zhu, R Hiltunen. Protective effect of Ligusticum chuanxiong and Angelica sinensis on endothelial cell damage induced by hydrogen peroxide. Life Sci, 2004; 75(14): 1775-1786.
[6] YJ Li, KS Bi. HPLC determination of ferulic acid in rat plasma after oral administration of rhizoma chuanxiong and its compound preparation. Biomed Chromatogr, 2003; 17(8): 543-546.
[7] SG Ji, YF Chai, YT Wu, XP Yin, DS Liang, ZM Xu, X Li. Determination of ferulic acid in Angelica sinensis and Chuanxiong by capillary zone electrophoresis. Biomed Chromatogr, 1999; 13(5): 333-334.
[8] http://www.chromadex.com
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[8] GH Lu, K Chan, YZ Leung, K Leung, CL Chan, ZH Jiang, ZZ Zhao. Development of high-performance liquid chromatographic fingerprints for distinguishing Chinese Angelica from related umberlliferae herbs. J Chromatogr A, 2005; 1073(1-2): 383-392.
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[7] SG Ji, YF Chai, YT Wu, XP Yin, DS Liang, ZM Xu, X Li. Determination of ferulic acid in Angelica sinensis and Chuanxiong by capillary zone electrophoresis. Biomed Chromatogr, 1999; 13(5): 333-334.
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