Research On Quality Standard Of Safflor Yellow As Material For Injection

Safflor Yellow, extracted from Safflor, with proved pharmacological effect that can expand coronary artery, lower blood pressure, resist thrombus, endure anoxemia and restrain immunity, will have a good developing and applying future. Since 1970's, more than 200 kinds of components such as flavone, lignocelluloses and alkine, have been extracted from Safflor. On the base of retrieving papers in the world, the main work of this article is shown following:1. Preparation of the Hydroxy Safflor Yellow AHydroxy Safflor Yellow A is separated from Safflor Yellow, which is an effective component of Carthamus tinctorius L.. It can be obtained by HPLC and then purified by Polyamide Chromatograph column. The standard sample of Hydroxy Safflor Yellow A with concentration above 98% can be gotten by this way.2. Identification of Hydroxy Safflor Yellow A's StructureThe following methods are used for identifying the structure of Hydroxy Safflor Yellow A, they are Mass Spectrum, Infrared Spectrometry, Ultraviolet Spectrometry, and NMR(1H-NMR, 13C-NMR, 2D NMR, HSQC and HMBC).3. Setting up the quality standards of Safflor YellowBy the requirement of modernistic medicine, a systematic research about Safflor Yellow is carried out, which can identify and analysis both Safflor Yellow and Hydroxy Safflor Yellow A. The chemical control of Safflor Yellow is founded, such as Characters, Qualitative Identification, Analysis (including water, burning residue, heavy metal, arsenide, resin residue, fingerprint spectrum, etc.), Content Assays (By the research on systematic adaptability test, chromatographic condition, preparation of control solution, preparation of sampler solution and analysis method, the best way to assay the content of Safflor Yellow is by Ultraviolet Spectrometry, and Hydroxy Safflor Yellow A is by HPLC), Storage, etc. On the basis work above, the quality standard of Safflor Yellow as material for injection has been finished in which the limit of resin residue and fingerprint spectrum are applied to this compound for the first time.