Production process of nadroparin calcium with low ethanol residue
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A technology of nadroparin calcium and production process, applied to the production field of nadroparin calcium, to achieve the effects of convenient maintenance, low production cost and stable process
Active Publication Date: 2013-07-17
SHENZHEN SCIPROGEN BIO PHARMA
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[0008] For the ethanol residue problem in the production process of nadroparin calcium, the object of the present invention is to provide a kind of low ethanol residue nadroparin calcium production process, so that ethanol content≤0.5% in the nadroparin calcium, so that the quality of the nadroparin calcium meets European Pharmacopoeia EP7.0 requirements
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Embodiment 1
[0033] Embodiment 1 discloses a production process of nadroparin calcium with low ethanol residue, and the specific process is as follows:
[0034] Weigh 1 kg of heparin sodium and split it with nitrous acid, reduce it, concentrate it by ultrafiltration, which contains about 0.7 kg of nadroparin calcium;
[0035] The mass of the above concentrate is about 3kg, add purified water until the mass of the solution reaches 4.2kg (4.2 times the amount of heparin sodium), at this time the concentration of the nadroparin calcium solution is about 16.6%, and the volume is about 4L;
[0036] Add 14L absolute ethanol (3.5 times the volume of the above-mentioned nadrixarin calcium solution) to the alcohol sink tank, add the above-mentioned feed solution dropwise under stirring, stir for 3 hours after the addition, and let stand for 10 hours;
[0037] Aspirate 9.5L of the supernatant, the volume of the remaining feed liquid is about 8.5L, add 6.8L of absolute ethanol with 0.8 times the volu...
Embodiment 2
[0042] Embodiment 2 discloses a production process of nadroparin calcium with low ethanol residue, and the specific process is as follows:
[0043] Weigh 1 kg of heparin sodium and split it with nitrous acid, reduce it, concentrate it by ultrafiltration, which contains about 0.7 kg of nadroparin calcium;
[0044]The mass of the above concentrate is about 3kg, add purified water until the mass of the solution reaches 6.6kg (6.6 times the amount of heparin sodium), at this time the concentration of the nadroparin calcium solution is about 10.6%, and the volume is about 6.2L;
[0045] Add 24.8L of absolute ethanol (4 times the volume of the above-mentioned nadrixarparin calcium solution) to the alcohol sink tank, add the above-mentioned feed solution dropwise under stirring, stir for 2 hours after the addition, and let stand for 15 hours;
[0046] Aspirate 12.7L of the supernatant, the volume of the remaining feed liquid is about 18.3L, add 7.3L of absolute ethanol 0.4 times the ...
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Abstract
The invention discloses a production process of nadroparin calcium with low ethanol residue. The process comprises the following steps of: performing cracking, reduction, ultrafiltration and concentration on heparin sodium which is taken as a raw material to obtain a solution of the nadroparin calcium, and then regulating the concentration of the solution of the nadroparin calcium, the using quantity of anhydrous ethanol during an alcohol precipitation process, the using quantity of the anhydrous ethanol during a pulping process and the temperature during vacuum drying so as to finally obtain a finished product of the nadroparin calcium. According to the production process of the nadroparin calcium with the low ethanol residue, disclosed by the invention, the problem of the ethanol residue during the production process of the nadroparin calcium is solved, the ethanol residue in the nadroparin calcium is not more than 0.5% and in line with the requirements of European Pharmacopoeia EP7.0, the use of freeze-drying equipment is avoided, and the production process has the advantages of low price of the equipment, low operation energy consumption, convenience in maintenance, small floor area, easiness in production amplification, low production cost, stable process and the like.
Description
technical field [0001] The invention belongs to the production field of nadroparin calcium, and in particular relates to a production process of nadrixarin calcium with low alcohol residue. Background technique [0002] Heparin is a sulfated glycosaminoglycan compound extracted from mammalian tissues (eg, small intestinal mucosa, lung, liver). In 1916, Mclean first discovered this substance in the liver of dogs while studying blood clotting problems, and named it "heparin". Heparin is a mixture of mucopolysaccharide sulfates, with molecular weights ranging from 3kd to 30kd. The molecular structure is extremely complex, and it cannot be synthesized artificially for a long time. Currently, only heparin derived from porcine small intestinal mucosa can be used in clinical treatment. [0003] Heparin series drugs are mainly used for the prevention and treatment of acute coronary syndrome, the prevention and treatment of ischemic cerebral thrombosis, and also for the prevention ...
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