Study On The Chromatographic Fingerprint Of Salvia Miltiorrhize Extract

Salvia miltiorrhiz is a primary herb which is widely used in Traditional Chinese Medicine (TCM), but the difference of its quality is very great. 43 samples of Salvia were collected from main producing areas in this work. The content of effective components was determined by HPLC. The results showed that the content difference was very great among these samples, which revealed the truth; the GAP was not popularization at all. The contents of effective components in Salvia in the west of Henan province are higher than the others. It can be seen that the content had correlation with regionalism. Salvia extract is a new dosage form also could be used as raw medicine in GMP standardization production, and the quality of Salvia extract is the primary factor in the whole production quality control. So research on standardize extraction technology of Salvia extract is very important. Because Salvia is heat-sensitive, room temperature extraction technology is the first choice. Using fat-soluble constituents concluding dihydrotanshinone, tanshinoneI, cryptotanshinone and tanshinone IIA, and water-soluble constituents (Salvianolic acid B) as index, the percolation method, ultrasonic method, flash extaction and MCCE were compared. Through a comparison of the four, it is found that percolation method provides higher content, higher yield and the consistency of spectra of raw medicine.The currently quality assurance and quality control (QA/QC) methods for Salvia,based on the single major component assaying, can not meet the requirement of principle of TCM theory and the modern pharmaceutical quality assurance. The chromatographic fingerprint assaying is the feasible measures, which match the feature of TCM, so it is significant to set up the standard TLC and HPLC fingerprints. In order to obtain Salvia chromatographic fingerprint, sampling, detection of marked analytes and pattern recognition were studied. The proposed method was successfully applied to show the global feature of using dihydrotanshinone, tanshinoneI, cryptotanshinone, tanshinoneIIA and Salvianolic acid B as index, which also could be considered as quality characterization of Salvia . The Salvia fingerprints have satisfactory resolution, reproducibility, stability, reliability and practicability, and which could be used as the quality assessment method for Salvia extract. Thus, this work provided the information for making full use of salvia extract, and reached the goals that were clear constituent, clear content, proportion of stability, controllable quality.