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中药质量控制的发展趋势 被引量:29

An Overview of trends of quality control of Chinese Medicines
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摘要 以化学药品的质量控制模式为“模板”应用于中药的质量检测虽然已延续了半个多世纪,但由于建立在现代科学基础上的具有确定性(Certainty)特征的化学药品(西药)和基于悠久历史传统的具有不确定性特征(Uncertainty)的中药的完全不同,用于西药的这种建立在线性思维基础上的质量控制模式解决中药质量控制问题日益显露出它的不足,在现行的质量标准中甚至执行起来有许多矛盾之处。面对这一实际情况,总要寻找一条出路,才能跨上一个新的台阶。也就是说中药质量的评价需要用综合的、宏观的、非线性的分析观念来适应,现阶段指纹图谱就是适应这一特点的另一种质量控制模式。自上世纪70年代以来,许多从事指纹图谱分析的学者都在有意无意地探索这条路子。本文就中药采取指纹图谱模式控制质量的意义、作用和发展趋势作一论述。 For more than half a century , the quality control of Chinese medicines has basically been modeled after the mode of quality control of Western chemical drugs. The drawback, however, is gradually surfaced when the mode of quality control of Western medicines, that is based on linear thinking, is used to deal with the problems existing in the quality control of Chinese midicines, and even paradoxes emerge in the implementation of the present standards for the quality control of Chinese medicines due to the fact that chemical medicines (Western medicines) featured by their certainty and based on modern science are completely different from Chinese herbal medicines featured by their uncertainty and based on a long historical tradition. Facing such a practical situation, a way-out should be found out so as to step onto a new stage, i.e., for the assessment of the quality control of Chinese medicines, a comprehensive, macroscopical and non-linear concept is needed and at present, chromatographic fingerprint can serve as a new mode for this purpose. Since the 1970s a lot of scholars engaged in fingerprinting analysis have consciously or unconsciously made explorations in this field. This article expounds the significance, the functions and the trends of the development of fingerprinting mode used for the quality control of Chinese medicines.
作者 谢培山
出处 《世界科学技术-中医药现代化》 2003年第3期56-59,共4页 Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
关键词 中药产业 质量控制 发展趋势 质量检测 指纹图谱 模糊数学 Trends of quality control mode of Chinese medicines,Chinese medicine,Chromatographic fingerprint
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  • 1Philipsom JD. British HerbalPharmacopoeia [M]. British Herbal Medicine Association Publucations. 1996 Forward.
  • 2Indian Drug Manufacturere' s Association. Indian Herbal Pharmacopoeia [M]. VedamsBooks International. 1998 Volume 1.
  • 3Natalie Lazarowych. Use of Fingerprinting and Marker Compounds for Identificationand Standardization of Botanical Drugs: Strategies for Applying Pharmceutical HPLCAnalysis to Herbal Products [J]. Drug Information Journal, 1998, 32: 497-512.
  • 4Peter John Houghton. Establishing Identification Criteria for Botanicals [J]. DrugInformation Journal, 1998, 32: 461 - 469.
  • 5FDA Guidance for Industry- Botanical Drug Products (Draft Guidance), Ⅷ, B, 2e;3e; August 2000.
  • 6WHO. Guidelines for the Assessment of Herbal Medicines 1996.
  • 7毕开顺,李玉娟.中药材指纹图谱质量控制方法研究.国际色谱指纹图谱评价中药质量研讨会论文集.i10-13.2001.广州.
  • 8中国药典委员会.中国药典中药薄层色谱彩色图集[M].广州:广东科技出版社,1993.[M].广州:广东科技出版社,1993.
  • 9Xie Peishan, Yan Yuzhen. Differentiation & Evaluation of Commercial Ginseng& Their Products by Mesaans of HPTLC Fingerprint Aralysis [J]. Journal of PlanarChromatography- Modem TLC, 1988, 1 (1): 29 - 32.
  • 10Xie Peishan, Yan Yuzhen. Appication of HPTLC Fingerprint Analysis to StabilityEvaluation of Ginsen Preparations [J]. Journal of Planar Chromatography- Modem TLC, 1988,1 (3): 258.

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