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Preparation method of dalteparin sodium and application of method in preparation of low-molecular-weight heparin sodium

A technology of dalteparin sodium and molecular weight, which is applied in the field of dalteparin sodium preparation, can solve problems such as quality loss, and achieve the effects of reducing residue, convenient operation, and simple method

Pending Publication Date: 2021-06-22
山东万邦赛诺康生化制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

High-quality heparin sodium will also bring inevitable quality loss in the molecular weight fractionation process

Method used

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  • Preparation method of dalteparin sodium and application of method in preparation of low-molecular-weight heparin sodium
  • Preparation method of dalteparin sodium and application of method in preparation of low-molecular-weight heparin sodium
  • Preparation method of dalteparin sodium and application of method in preparation of low-molecular-weight heparin sodium

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Embodiment 1

[0046] In this embodiment, a method for preparing dalteparin sodium using crude heparin sodium as a raw material is provided, and the preparation method includes the following steps:

[0047] (1) Crude product dissolution: Take crude heparin sodium, dissolve it at a concentration of 15% (w / v), add 3% (w / v) enteric salt, heat up to 52°C, and stir until dissolved.

[0048] (2) Primary enzymatic hydrolysis of the crude product: adjust the pH of the solution in (1) to 8.5 with 40% sodium hydroxide solution. Then add 0.5% trypsin by weight of crude heparin to start enzymatic hydrolysis. During the enzymolysis process, the pH was controlled within the range of 8.5-9.0, the temperature was controlled at 49°C, and the mixture was stirred every 20 minutes for 10 minutes each time at a speed of 60-70 rpm. The enzymolysis was performed for 5 hours, and the temperature and pH were recorded every 30 minutes.

[0049] (3) Heating up to remove impurity proteins: After enzymatic hydrolysis, ...

Embodiment 2

[0077] In the present embodiment, another preparation method of dalteparin sodium is provided, and the preparation method comprises the following steps:

[0078] (1) Dissolving the crude product: take the crude heparin sodium, dissolve it at a concentration of 14% (w / v), add 2% (w / v) enteric salt, heat up to 52°C, and stir until dissolved.

[0079] (2) Primary enzymatic hydrolysis of the crude product: adjust the pH of the solution in (1) to 9.0 with 40% sodium hydroxide solution. Then add 0.4% trypsin by weight of crude heparin to start enzymatic hydrolysis. During the enzymolysis process, control the pH within the range of 8.5-9.0, control the temperature at -52°C, stir once every 22 minutes, stir for 11 minutes each time, and rotate at 60-70rpm, enzymolysis for 4 hours, and record the temperature and pH every 30 minutes.

[0080] (3) Heating up to remove impurity proteins: After the enzymatic hydrolysis, adjust the pH to 6.0 with 4mol / L hydrochloric acid, quickly raise the...

Embodiment 3

[0108] (1) Crude product dissolution: take crude heparin sodium, dissolve it at a concentration of 16% (w / v), add 5% (w / v) enteric salt, heat up to 49°C, and stir until dissolved.

[0109] (2) Primary enzymatic hydrolysis of the crude product: adjust the pH of the solution in (1) to 9.0 with 40% sodium hydroxide solution. Then add 0.5% trypsin by weight of crude heparin to start enzymatic hydrolysis. During the enzymatic hydrolysis process, the pH was controlled within the range of 8.5-9.0, the temperature was controlled at 52°C, the mixture was stirred every 18 minutes, each stirring was 9 minutes, the speed was 60-70 rpm, the enzymatic hydrolysis was 6 hours, and the temperature and pH were recorded every 30 minutes.

[0110] (3) Heating up to remove impurity protein: After the enzymatic hydrolysis is completed, use 4mol / L hydrochloric acid to adjust the pH to 6.5±0.5, pass steam through the interlayer to quickly raise the temperature to 90°C, keep warm for 20min, then pass ...

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Abstract

The invention particularly relates to a preparation method of dalteparin sodium and application of the method in preparation of low-molecular-weight heparin sodium. As low molecular weight heparin sodium, dalteparin sodium has high bioavailability and is a new generation of antithrombotic active drug. According to an existing dalteparin sodium preparation method, high-quality heparin sodium is used as a raw material for degradation, and the high-quality heparin sodium needs to be obtained by purifying crude heparin sodium, so that an existing dalteparin sodium preparation process is relatively complex, and the damage degree of the heparin sodium in preparation engineering is relatively large. According to the method for preparing dalteparin sodium by using crude heparin sodium as the raw material, the enzymolysis mode of the crude heparin sodium and the treatment mode of dermatan sulfate are optimized in the preparation method, the process steps from the crude heparin sodium to the dalteparin sodium are effectively shortened, and the reaction yield is increased.

Description

technical field [0001] The invention belongs to the technical field of dalteparin sodium preparation, and in particular relates to a preparation method of dalteparin sodium and the application of the preparation method in the preparation of low-molecular-weight heparin sodium. Background technique [0002] The information disclosed in this background section is only intended to increase the understanding of the general background of the present invention, and is not necessarily taken as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. [0003] Low-molecular-weight heparin is a subdivided or cleaved fragment of unfractionated heparin (SH), with low molecular weight and simple structure. It is a new generation of heparin anticoagulant drugs developed in the past ten years. Due to the small molecular weight of low-molecular-weight heparin products, it is not easy to be neutralized by factor IV,...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0078C08B37/0003
Inventor 文良柱高岩郑会武李玲
Owner 山东万邦赛诺康生化制药股份有限公司
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