Studies On The Bioactive Constituents Of Astragalus Membranaceus (Fisch) Bge. Var. Mongholicus (Bge.) Hsiao And The Quality Standard Of Shenqi Fuzheng Injection

Shenqi Fuzheng Injection, which is mainly used for the assistant curing of cancers, the treatment of the coronary heart disease and the angina pectoris, is made of the extractions of Codonopsis pilosula (Franch.) Nannf. and Astragalus membranaceus (Fisch) Bge. var. mongholicus (Bge.) Hsiao. In order to elucidate the principle of Shenqi Fuzheng Injection, for affording the scientific foundation of the quality control and the clinical application, and to improve the quality standard, this thesis systematically studied the ingredients of flavonoids and triterpenoids in the extraction of Astragalus membranaceus (Fisch) Bge. var. mongholicus (Bge.) Hsiao and the quality standard of Shenqi Fuzheng Injection.Air-dried roots of Astragalus membranaceus (Fisch) Bge. var. mongholicus (Bge.) Hsiao were extracted with water and precipitated with EtOH. By means of chromatography on macroporous resin and silica gel, 12 compounds were isolated. NMR and MS were employed for structure identification, and 11 of them were elucidated as: formononetin(1),calycosin(2),formononetin-7-O-β-D-glucopyranoside(3),calycosin-7-O-β-D -glucopyranoside(4),9,10-Dimethoxypeterocarpan-3-O-β-D-glucopyranoside(5),astragalosi de IV(6), isoastragaloside I (7),isoastragaloside II (8),acetylastragaloside I (9),β-sitosterol (10),daucosterol(11). Among them, compound 7, 8 and 9 were isolated from this plant for the first time.In addition, on the basis of chemical constituents research, the quality standard of Shenqi Fuzheng Injection was also studied. In order to establish the quality control method, we adopted astragaloside IV as reference and HPLC - ELSD method. The HPLC system consisted of an ODS column and acetonitrile-water(36:64) as mobile phase. The temperature of the detector drift tube was at 100℃and the nitrogen flow-rate was at 2.7ml·min^-1. Linear range of astragaloside IV: 1.3-13μg; correlation coefficient r=0.999, average recovery rate: 96.77%, RSD: 3.52% with perfect repeatability.Quantities of astragalosideⅣin 34 batches of Shenqi Fuzheng Injection were tested by the above mentioned method. It can be concluded from the results that this method was convenient and accurate. And this method was employed as an official standard that ratified by SFDA. It provided the assurance for progressive improving the quality of Shenqi Fuzheng Injection.