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Production method for nadroparin calcium

A production method and technology of heparin calcium, applied in the field of biomedicine, can solve the problems of relying on freeze dryers, cumbersome operations, and short process steps

Active Publication Date: 2015-04-22
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with the disclosed method for preparing nadroparin calcium from heparin sodium, this method has shorter process steps, simpler operation, more thorough calcium transfer, and higher yield, and overcomes the long technical route for the current production of nadroparin calcium. Complicated, relying on the problem of freeze dryer

Method used

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  • Production method for nadroparin calcium
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Examples

Experimental program
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Effect test

Embodiment 1

[0021] Add 45L of purified water and 5kg of heparin sodium into the degradation tank, stir to dissolve completely, adjust the pH of the solution in the tank to 2.7 with 4mol / L hydrochloric acid, weigh 0.135kg of sodium nitrite into the beaker, and add 1350mL of purified water into the beaker , after stirring and dissolving, add it into the degradation tank, maintain the pH of the solution in the tank at 2.7±0.1, and stir and react at 25±2°C for 3.6h. Use 5mol / L sodium hydroxide solution to adjust the pH of the system to 9.6, add 0.054kg of sodium borohydride to the degradation tank, stir and react for 18 hours, then adjust the pH of the solution to 3.5 with 4mol / L hydrochloric acid, stir for 20min, and then use 5mol / L Adjust the pH of the system to 7.3 with sodium hydroxide solution, irradiate the degradation solution with a 254nm ultraviolet lamp for 20 minutes, the solution volume is 48L, so pour 48L of ethanol into the degradation tank, stir at 15-20°C for 5-10min, stop stir...

Embodiment 2

[0026] Add 42.5L of purified water and 5kg of heparin sodium into the degradation tank, stir to dissolve completely, adjust the pH of the solution in the tank to 2.6 with 4mol / L hydrochloric acid, weigh 0.10kg of sodium nitrite into the beaker, and add 1000mL of purified Water, after stirring and dissolving, was added into the degradation tank, and the pH of the solution in the tank was maintained at 2.7±0.1, and the reaction was stirred at 25±2°C for 3.4 hours. Use 5mol / L sodium hydroxide solution to adjust the pH of the system to 9.5, add 0.03kg sodium borohydride to the degradation tank, stir and react for 17h, then adjust the pH of the solution to 3.4 with 4mol / L hydrochloric acid, stir for 20min, and then use 5mol / L hydrogen Sodium oxide solution adjusts the pH of the system to 7.4, irradiates the degradation solution with a 254nm ultraviolet lamp for 20 minutes, and the solution volume is 44.8L, so pour 44.8L of ethanol into the degradation tank, stir at 15-20°C for 5-10m...

Embodiment 3

[0031] Add 50L of purified water and 5kg of heparin sodium into the degradation tank, stir to dissolve it completely, adjust the pH of the solution in the tank to 2.8 with 4mol / L hydrochloric acid, weigh 0.15kg of sodium nitrite into the beaker, and add 1500mL of purified water into the beaker , after stirring and dissolving, add it into the degradation tank, maintain the pH of the solution in the tank at 2.7±0.1, and stir and react at 25±2°C for 3-4h. Use 5mol / L sodium hydroxide solution to adjust the pH of the system to 10.5, add 0.075kg sodium borohydride to the degradation tank, stir and react for 16 hours, then adjust the pH of the solution to 3.6 with 4mol / L hydrochloric acid, stir for 20min, and then use 5mol / L Sodium hydroxide solution adjusts the pH of the system to 7.5, irradiates the degradation solution with a 254nm ultraviolet lamp for 20 minutes, and the solution volume is 53.6L, so pour 53.6L of ethanol into the degradation tank, stir at 15-20°C for 5-10min, stop...

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Abstract

The invention discloses a production method for nadroparin calcium. Accoding to the production method, heparin sodium is adopted as raw material and subjected to degradation, deoxidation, ethanol precipitation, ion exchange resin calcium conversion, oxidation, filtration, precipitation and dehydration to obtain nadroparin calcium; the one-pot boiling technology is realized through oxidation, sterile filtration, precipitation and dehydration and the simplified operation is realized; compared with the disclosed methods, steps adopted in the heparin sodium preparation technology are fewer, the operation is simpler and more convenient, the calcium conversion is more complete and the yield is higher.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for producing nadroparin calcium. Background technique [0002] Heparin Sodium is a mucopolysaccharide sulfate anticoagulant. Heparin sodium is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle, and belongs to mucopolysaccharides. It has anticoagulant effect both in vivo and in vitro, and is currently the mainstream anticoagulant drug. However, the bioavailability of unfractionated heparin is low and the side effects are large. Later, it was discovered that the sodium salt of aminodextran sulfate fragment obtained by cleavage of heparin sodium has an average molecular weight of 4000-6000 Daltons, which is called low molecular weight heparin sodium. Low molecular weight heparin sodium injection, like heparin sodium injection, is an antithrombin Ⅲ (AT Ⅲ) dependent thrombin inhibitor. However, compared with heparin sodium injection,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 唐咏群黄锡伟段艳冰娄媛媛刘玉辉
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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