A Feasible Strategy for Applying Chromatography Fingerprint to Assess Quality of Chinese Herbal Medicine / 中药新药与临床药理

ABSTRACT

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.