| Objective In this study to optimize the flocculation technology of water-extraction solution from Danshen Yin with chitosan by Response Surface Method, and compared the fingerprint before and after purification. Process of optimization and validation, and quality standards of systematic research to ensure that the drug preparation of safe and effective, stable and controllable. Based products to medicinal extracts and preparations provide a basis for quality control.Methods Under the basis of single factor analysis with the effects of influence factors such as solid-liquid ratio, chitosan amount, flocculation temperature and flocculation time, with the light transmission, the salvianolic acid B retention rate as the synthesis indicators. To optimize the formulations by Box-Behnken design, and use Design Expert 8.0.6b program for statistical analysis of experimental results. This flocculation clarification technology was feasible and stable with high rate of impurity removal and high retention rate of active ingredient. With the study we attempted to establish its high-performance liquid chromatographic fingerprint analysis method. The sample preparation methods were screened and chromatographic conditions (including the mobile phase, detection wavelength, gradient elution procedure, etc) were optimized by the separation, analysis time and chromatographic peak number. In this paper, then we used the software named "chromatographic fingerprints of TCMs similarity evaluation system 2004 A Edition" to analyze and evaluate.Result Optimum flocculation conditions were:solid-liquid was 10.7mL/g, chitosan amount was 1.2mL/g, flocculation temperature was 51℃ and flocculation time was 1h. Through the study on the characteristic chromatogram of Danshen Yin, there are 11 common peaks, and identify the 8 peak was salvianolic acid B.Conclusion This flocculation clarification technology was feasible and stable with high rate of impurity removal and high retention rate of active ingredient. The result was no significant difference of fingerprint before and after purify. |