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[A chromatographic fingerprinting-based approach to evaluating the stability of production process of traditional Chinese medicine].

OBJECTIVE
To study a new method for the evaluation of the stability of production process of Traditional Chinese Medicines (TCM) based on chromatographic fingerprinting.


METHOD
Taking the extraction process of Red Ginseng for example, the fingerprints of extracts produced with fluctuating processing factors, i.e. ratio of solvent to liquid, solvent concentration, extraction durations and extraction times, were acquired. Meanwhile, the similarity of fingerprinting based on Euclidean distance was calculated and each fingerprint was fitwith cubic spline.


RESULT
Similarities of fingerprints of the extracts responded to the fluctuation of processing factors, and it showed that taking similarity as index, quantitative relation between chromatographic fingerprints and processing factors could be established.


CONCLUSION
The method proposed in the paper was able to describe the quality of products resulting from fluctuating conditions in extracting process, and therefore, can be developed as a practicable strategy to evaluate the stability Traditional Chinese Medicines in production process.