Method for reducing content of sodium acetate impurities in Enoxaparin sodium
A technology of enoxaparin sodium and impurity content, applied in the field of biopharmaceuticals, can solve the problems of complex preparation process of enoxaparin, and achieve the effect of low cost and small environmental pollution
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Embodiment 1
[0020] 1) Salt formation: Add 180 mL of purified water to 30g crude heparin sodium at a ratio of 1:6 (w / v) to obtain a heparin sodium solution; at a ratio of 1:6 (w / v) to 80g benzethonium chloride Add 480mL of purified water to dissolve to obtain benzethonium chloride solution; add 360mL benzethonium chloride solution to 180mL heparin sodium solution in a ratio of 1:2 (v / v), stir while adding, and after stirring, let it stand still 2 hours; centrifuge and vacuum dry to obtain heparin benzethonium chloride salt.
[0021] 2) Esterification: Add 150 mL of dichloromethane to the heparin benzethonium chloride salt, stir to dissolve, and then add 150 mL of heparin benzethonium chloride benzyl chloride to it, maintain the temperature at 36°C, stir the reaction, and add heparin benzyl chloride to the end of the reaction 250 mL of 10% sodium acetate methanol solution of triethonium chloride, stirring for 10 minutes, standing for 4 hours, and filtering the precipitate to obtain wet crude h...
Embodiment 2
[0026] 1) Salt formation: Add 400ml of purified water to 60g crude heparin sodium to dissolve it to obtain heparin sodium solution; add 800ml of purified water to 120g benzethonium chloride to dissolve to obtain benzethonium chloride solution; add 700mL to 400mL heparin sodium solution The benzethonium chloride solution was stirred while adding, and after stirring, let it stand for 2 hours; centrifuge and vacuum dry to obtain heparin benzethonium chloride salt.
[0027] 2) Esterification: Add 350 mL of dichloromethane to heparin benzethonium chloride, stir to dissolve, then add 350 mL of heparin benzethonium chloride to it, maintain the temperature at 36°C, stir the reaction, and add heparin benzyl to the end of the reaction 400 mL of 10% sodium acetate methanol solution of triethonium chloride, stirred for 10 minutes, allowed to stand for 4 hours, and filtered the precipitate to obtain wet crude heparin benzyl ester.
[0028] 3) Decontamination of wet crude heparin benzyl ester: A...
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