Studies On The Methodology For Quality Analysis Of Danhong Injection And Shengmai Injection

Traditional chinese medicine (TCM) injections is a new formulation of TCM, which is widely used to treat many severe diseases in China. However, their clinical adverse reactions are higher than other TCM formulations. To ensure the satety and efficacy of TCM injections, it's today's mandatory to strengthen their quality. In this study, taking Danhong Injection and Shengmai Injection as examples, we developed several fingerprinting and quantitative analysis approaches to main bioactive components of injections, which will provide technical support for quality control of these TCM injections. The main results are described as follows:1. To overcome the published methods, which are difficult to characterize chemical information of safflower in Danhong injection, we established HPLC-UV-MS fingerprinting method. Compared to existing chromatographic fingerprinting method, the proposed method. More importantly, the proposed fingerprinting can be also used to simultaneously determine nine components of Danhong injection,'including 5-hydroxymethyl furfural, salvianic acid a sodium, protocatechuic aldehyde,coumaric acid, salvianolic acid D, rosmarinic acid,salvianolic acid B, salvianolic acid A and kaempferol-3-O-rutinoside. It provides a new effective method for quality control of Danhong injection.2. A UPLC fingerprinting method was develpoed for quality control of Shengmai injection. Twenty compounds in thirty common peaks were identified in the fingerprint, among them, seventeen compounds come from red ginseng, two come from schisandra chinensis and one comes from sugar degradation products. The method choose HSS T3 UPLC chromatographic column which can retain polar compounds strongly, which can reflects more information of organic acids in schisandra chinensis. It has the advantages of short analysis time, rich information.3. A simple and quick method was established for quantitative analysis of Shengmai injection. It can simultaneously determine nine active components i.e. ginsenoside Rgi, ginsenoside Re, ginsenoside Rf, ginsenoside Rb1, ginsenoside Rg2, ginsenoside Rc, ginsenoside Rb2, schisandrin and ginsenoside Rd in twenty five minutes.