Study On Extraction Of Sodium Danshensu And Development Of Sodium Danshensu For Injection

Danshensu[D-(+)-β-(3,4-dihydoxy-phenylalanine)], Danshensu is an effectivecompound extracted from the water phase of the dried roots of Salvia miltiorrhizaof Labiatae Salvia. Because Danshensu is unstable dissociated fatty acid, it is usedas sodium salt.Danshensu is effective anti-myocardial ischemia substance, hascertain effect in curing cornonary heart disease. Danshensu can inhibit bloodplatelet synthesizing, gather and release TXA2d, improve flow rate of cornonarycirculation, protect .cardiac muscle and improve its oxygen-deficiency proofcapability. Meanwhile Danshensu is the quality standard of some Chinese patentdrug. So Danshensu has a broad prospect.As danshen has lots of components and the content of Danshensu is low,besides Danshensu is easily oxidized for its phenolic parts, so the purificationprocess of Danshensu is quite difficult. And the synthetic route is not practical. Thispaper discusses the method to extract and purify Sodium Danshensu. According tothe uniform design, the extraction technology of Danshensu from Salviamiltiorrhiza was studied in this paper. We improved the content of Danshensuthrough degration. This research studies the extraction and purification ofDanshensu by macrophoros adsorptive resin, and obtains a more simple andreasonable route of technics. Finally, We get 95% purified Sodium Danshensu by macrophoros adsorptive resin together with other methods. It will provide abeneficial reference for the development of Danshensu.The structure of Sodium Danshensu was validation by four spectrumtechniques (UV,IR,MS,¹H-NMR,¹³C-NMR) together with option rotation,melting point and DSC.A new method to determine the content of Danshensu by HPLC wasestablished,This article presented a foundation research on Sodium Danshensu instability and enhancing stability. The effect of pH, light, oxygen, ionic strength andmetal ion on Sodium Danshensu were examined. Prescription was optimized andSodium Danshensu for injection was produced in base of the former foundationstudy.From the article,we can conclude that Sodium Danshensu was more stable inacidity than in neutral or alky. Sodium Danshensu could be hydrolyzed in higer pH.The light may accelerate Sodium Danshensu's autoxidation. O₂ could convertortho- phenolic hydroxyl groups into quinone. Metal ion may catalyze SodiumDanshensu's oxidation.The basic prescription and preparation technology of Sodium Danshensufor injection was initially defined by the study about formulation screeningand technology optimizing, based on the elementary pharmaceutical rule asindex.