Research On Pharmacokinetics Analytical Methods Of Sulfated Polysaccharide 916

916 is one kind of polyanion sulfated amino polysaccharide which is derived from marine chitin and by ways of multiple molecular modification including deacetylation , carboxymethlation and sulfatation . After systematical research of pharmacology , pharmacodynamics and toxicology, 916 shows good antiatherosclerotic activity and was authorized to go into clinicle study further by National Drug and Foods Administration at the name of 1 level new drug.The purpose of this paper is to affording prophase study of 916 in demic pharmacokinetics. The stability of 916 under some conditions were investigated and a analytical method in biological sample梤abbit serum is established by HPLC. Two methods including high performance gel permeation chromatography and gelatin nephelometry were used to test the stability of 916 by lysozyme and trypsin. The different indices of stability include the change of molecular weight and molecular skeleton together with deciduous effective group. Molecular weight and molecular weight distribution and dissociative sulfate content were determined by these methods respectively. The result shows that 916 is stable by lysozyme and trypsin under this experimental condition , which make preparations for next research including pretreatment of biological sample and stability of 916 in vitro.In this paper, post - column fluorescent derivation HPLC is firstly used to analyze 916 in rabitte serum using guanidine hydrochloride and a analytical method is established. Ion exclusion column Aminex HPX-87H were selected to be analytical column of 916 after contrasted with Asahipak NH2P-50 4E, Sephardex TSK-Gel G2000PW. In the pretreatment of rabbit serum contrasting with trichloroacetic acid, perchlric acid, zinc salt, acetonitrile, methanol, alcohol and saturated ammonium sulfate, acetonitlyl was selected to precipitate protein. Standard curve and liner range were builded , the limit of detection and limit of quantitation were determined , that is 2.5ug/ml and 10ug/mL, respectively. The precision ,. reproducibility and recovery of 916 were tested. All these research provide basic method for 916 preclinicle and clinicle pharmacokinetice studies.