色谱指纹图谱分析是中草药质量控制的可行策略

A Feasible Strategy for Applying Chromatography Fingerprint to Assess Quality of Chinese Herbal Medicine

作为中药材常规鉴别的延伸 ,色谱指纹图谱质量控制的模式 ,现在逐步受到重视 ,同时也引起热烈的争论。色谱指纹图谱的最基本的属性是完整性和模糊性。作为一种综合的、可量化的鉴别模式 ,中药产品的真实性和质量的一致性以及稳定性均可有效地加以检测和控制。显然 ,不论采用何种色谱方法 ,对指纹图谱的要求最主要的是专属性、重现性和可应用性。只有认真实施药材种植的GAP、产品生产过程的GMP以及实验室研究的GLP ,色谱指纹图谱才能有效地评价中药的内在质量的真实性和一致性。从方法学而言 ,色谱指纹图谱的建立、辨认、分析、判断应进行方法学的验证。研究指纹图谱的难度不容低估。指纹图谱与药效学和临床结合才是更有意义地评价药品质量的手段。

Chromatographic fingerprint, as extended progress of conventional identification of Chinese herbal medication, is nowadays gradually applied to quality assessment of TCM preparations and at the same time it is under heat debate. It should be significant to define the integrity and fuzziness is the fundamental attributions of chromatographic fingerprint. As a comprehensive quantifiable identification method, the authenticity, quality consistency and stability of herbal medication can be monitored and evaluated effectively. Obviously defining an herbal specification of chromatographic fingerprints. whichever method is chosen, demands the highly concern on its specificity, reproducibi1ity and applicability. It is understood, only with precision and attention to detail on the implementation of GAP on herbal material cultivation, GMP on manufacture procedure and GLP on experimental laboratories may chromatographic fingerprints be developed successfully as criteria for analysis. As for methodology, criteria on chromatographic experimental, fingerprint recognition, comparison, evaluation, and verification must be carried out . The difficulty of implementing chromatographic fingerprint should be underestimated. Combining pharmacological and clinical study, chromatographic fingerprint would be a most significant approach for assessing the quality of herbal medicinal products.