Production process of nadroparin calcium with low ethanol residue
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A technology of nadroparin calcium and production process, which is applied to the production field of nadroparin calcium, and achieves the effects of low production cost, low equipment price and low operating energy consumption
Active Publication Date: 2015-04-01
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 process for producing nadroparin calcium with low ethanol residue, and the specific process is as follows:
[0034] After weighing 1kg of heparin sodium and splitting it with nitrous acid, it is reduced and concentrated by ultrafiltration, which contains about 0.7kg of nadroparin calcium;
[0035] The above-mentioned concentrated solution quality is about 3kg, and purified water is added until the solution quality reaches 4.2kg (4.2 times of the heparin sodium feeding amount), and the concentration of nadroparin calcium solution is about 16.6% at this moment, and the volume is about 4L;
[0036] Add 14L of absolute ethanol (3.5 times the volume of the above-mentioned nadroparin calcium solution) to the alcohol precipitation tank, add the above-mentioned feed liquid dropwise under stirring, stir for 3 hours after adding, and let stand for 10 hours;
[0037] Aspirate 9.5L of the supernatant, the remaining feed liquid volume is about 8.5L, add 6.8L...
Embodiment 2
[0042] Embodiment 2 discloses a process for producing nadroparin calcium with low ethanol residue, and the specific process is as follows:
[0043] After weighing 1kg of heparin sodium and splitting it with nitrous acid, it is reduced and concentrated by ultrafiltration, which contains about 0.7kg 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 ethano...
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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, in particular to a production process of nadroparin calcium with low ethanol residue. Background technique [0002] Heparin is a sulfated glycosaminoglycan extracted from mammalian tissues (eg, 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 weight ranging from 3kd to 30kd. The molecular structure is extremely complex and cannot be synthesized artificially for a long time. Currently, only heparin derived from porcine intestinal mucosa can be used for 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, the prevention and treatment of postoperative anticoagulation and...
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