中药质量控制的发展趋势

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。

An Overview of trends of quality control of Chinese Medicines

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.