Study On The Fingerprinting Analysis And Preparation Process Of SHENMAI Injection

Evaluation of TCM's quality is the important subjects to TCM's modernization. The normative fingerprinting technology will promote the process of TCM's modernization powerfully. In this paper, SHENMAI injection was selected as an object for exploring the methodology of TCM's fingerprinting, and ginsenosides were selected for investigating the influence of the preparation method of SHENMAI injection.The RP-HPLC methods were developed and proved for analyzing SHENMAI injection and two original herbs. Then the chromatographic fingerprints of SHENMAI injection and its original herbs were established. From these chromatographic fingerprints, 17 mutual peaks were selected as fingerprint peaks. All the peaks were well reproducible, special to SHENMAI injection and they could reflect SHENMAI injection's quality. Additionally, the relationship among SHENMAI injection, SHENMAI injection's semi-manufactured products and their two original herbs were investigated. Origins of 17 chromatographic peaks in SHENMAI injection were identified through comparing retention time and UV spectra. The researches laid a good foundation for investigating the quality relationship between SHENMAI injection and its herbs. After that, a practical quality control method would be established possibly.The effect of preparation method on the quality of SHENMAI injection was investigated. Changes of SHENMAI inject process were examined by HPLC fingerprinting. Process of extracting red ginseng was optimized by uniform design. Additionally, the adsorption effect of active carbon on ginsenosides in ginseng extract was evaluated. The different amount of active carbon was added into the red ginseng extract solutions at different temperature. Then ginsenosides in the solutions were analyzed by HPLC. The HPLC fingerprints were obtained and chromatographic peak area variations of 14 ginsenosides were calculated. The results indicated that the adsorption effect of active carbon on ginsenosides was obvious. With the amount of active carbon and the adsorption temperature increasing, the loss of ginsenosides was exacerbated. Finally, the SHENMAI injection samples were prepared using three preparation methods. Red ginseng, red ginseng semi-manufactured products andSHENMAI injection were analysed by HPLC. The fingerprints were obtained after the analysis. This HPLC method was also applied to determine the contents of ginsenoside Rgl- Re and Rbl. And the gross of ginsenoside of SHENMAI injection were determined by colorimetry. There was remarkable difference in fingerprints and contents between red ginseng semi-manufactured products and SHENMAI injections while using different preparation methods. So the conclusions were that the quality of SHENMAI injection was deeply influenced by the preparation method and the HPLC fingerprints could be applied for determination of the quality of SHENMAI injection.