Refining and purification method of enoxaparin
A technology of enoxaparin and purification method, which is applied in the refining and purification of drugs, and in the field of refining and purification of enoxaparin, which can solve the problems of unstable product quality, complex production process, high cost, etc., achieve high recrystallization yield and improve product quality. Quality, easy-to-handle results
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Embodiment 1
[0027] Take 5g of crude enoxaparin, dissolve it with 20g of deionized water, and prepare a homogeneous solution; the solution is irradiated with microwaves under stirring, with a microwave frequency of 400MHz, a power of 170W, and an irradiation time of 6s; g: The temperature of the material is slowly lowered to 5°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 98.4%. All indicators of the tested products meet the standards of the European Pharmacopoeia.
[0028] Average molecular weight: 4800 Daltons;
[0029] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Dalton is 11.8.0%, and the content of polysaccharide molecules with molecular weight between 2000-8000 Dalton is 80.3%.
[0030] Anti-Xa / anti-II: 4.6;
[0031] Anti-Xa: 118.4IU / mg;
[0032] 231nm absorption value: 14.56.
Embodiment 2
[0034] Take 5g of crude enoxaparin, dissolve it with 15g of deionized water, and prepare a homogeneous solution; the solution is intermittently irradiated with microwaves under stirring, with a microwave frequency of 400MHz, a power of 170W, and an irradiation time of 6s; g: The temperature of the material is slowly lowered to 5°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 97.3%. All indicators of the tested products meet the standards of the European Pharmacopoeia.
[0035] Average molecular weight: 4800 Daltons;
[0036] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Dalton is 10.8.0%, and the content of polysaccharide molecules with molecular weight between 2000-8000 Dalton is 79.0%.
[0037] Anti-Xa / anti-II: 4.6;
[0038] Anti-Xa: 118.4IU / mg;
[0039] 231nm absorption value: 14.56....
Embodiment 3
[0041] Take 5g of crude enoxaparin, dissolve it with 20g of deionized water, and prepare a homogeneous solution; the solution is irradiated with microwaves under stirring, the microwave frequency is 380Mhz, the power is 170W, and the irradiation time is 6s; add 0.001g of pure enoxaparin to the solution The temperature of the material is slowly cooled to 0°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 98.0%. All indicators of the tested products meet the standards of the European Pharmacopoeia.
[0042] Average molecular weight: 4800 Daltons;
[0043] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Daltons is 11.3.0%, and the content of polysaccharide molecules with molecular weights between 2000-8000 Daltons is 79.5%.
[0044] Anti-Xa / anti-II: 4.6;
[0045] Anti-Xa: 118.4IU / mg;
[0046] ...
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