OBJECTIVETo develop the system for the exclusive control substance of plant drug (CSPD) in traditional Chinese herbal medicines (TCHM), this paper investigated the (CSPD) of Radix Stephaniae Tetrandrae as well as its proton nuclear magnetic resonance (1H-NMR) and high performance liquid chromatography (HPLC) analytical methods for the purpose of original identification and quality control of the crude drug.

METHODThe CSPDs and their 1H-NMR and HPLC profiles of Radix Stephaniae Tetrandrae were obtained by standardized procedure. Chemical components were isolated from the CSPD by silica gel column chromatography. The assignments of the characteristic signals in 1H-NMR and HPLC profiles were achieved on the basis of elucidation of the isolates structures.

RESULTFor nine samples from the different sources in this paper, the 1H-NMR and HPLC profiles from eight sources had wonderful reproducibility and characteristics, and the other gave differences compared with the eight samples in the signal strength of the main components. Furthermore, seven compounds were isolated from CSPD and their chemical structures were authenticated by spectral analysis as tetrandrine, fangchinoline, tetrandrine-2'-N-beta-oxide, tetrandrine-2'-N-alpha-oxide, dicentrine, dicentrinone, and adenine, respectively. The 1H-NMR and HPLC profiles of the CSPD of Radix Stephaniae Tetrandrae showed mainly the characteristic signals of the bisbenzylisoquinoline alkaloids isolated in this work.

CONCLUSIONThe 1H-NMR and HPLC profiles of the CSPD of Radix Stephaniae Tetrandrae exhibit the structures and total composition of the main active constituents in it, and can be used for its original identification and quality evaluation.