Study on method for establishing the relationship between chromatographic fingerprints / 中成药

ABSTRACT

Objective: To discuss the method for establishing the relationship between chromatographic fingerprints and its usage in process control. Methods: The relationship between chromatographic fingerprints of a fermentation product Ganoderma capense and its finished preparation had been developed according to guidance on fingerprint of Chinese traditional medicinal medica. As for peaks whose acceptance criteria of relative area should be set, their relative areas in chromatographic fingerprints of raw material and its finished product, the ratios of relative areas of peaks from raw material to those from finished product and their relative standard differences were calculated. Results: The relative standard differences of the rations of all peaks whose acceptance criteria areas should be set, were less than 8%. Conclusion: The results show that the rations and RSDs are enough to represent the quantitave relationship between chromatographic fingerprints, and the acceptance criteria of RSD should be less than 10% (n≥10). The quality of finished product can only be assured if the acceptance criteria of relative areas of peaks in chromatographic fingerprint of raw material are tighter than those set according to guidance, and the manufacture process keeps consistency.