亚硝酸降解法制备低分子肝素(LMWH)的工艺参数优化与确定___

Abstract Objective: Study on the optional preparation conditions of the low molecular weight heparin, LMWH). Method: Degradation of heparin by nitrous acid, studied on different temperature，time，pH and nitrous acid concentrations, researched single factors experiment and  dual quadratic rotary combinational design，measured the molecular and distribution of relative molecular mass. Results: Research showed that the degradation time was 4h,temperature was about 25℃, pH2.6, nitrous acid concentration was 0.6%,under those conditions，both the preparation of relative molecular mass and the distribution of relative molecular mass were corresponding with general rule of Chinese Pharmacopoeia. The distribution of relative molecular mass less than 8000 was 89.95%.Conclusion: The method of degradation of heparin by nitrous acid for the preparation of LMWH is feasible.