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Low molecule heparin and salt thereof, pharmaceutical composition comprising same and producing method thereof

A low-molecular-weight heparin and its manufacturing method technology, applied in the field of low-molecular-weight heparin or its salt, can solve the problems of cost and difficult implementation of equipment, and achieve the effects of simple and efficient refining, economical production, and reduced impurity content

Inactive Publication Date: 2006-10-18
Q P CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, according to this method, in order to industrially produce low-molecular-weight heparin or its salt, large-scale industrial equipment is required, so it is not easy to implement in terms of cost and equipment.

Method used

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  • Low molecule heparin and salt thereof, pharmaceutical composition comprising same and producing method thereof
  • Low molecule heparin and salt thereof, pharmaceutical composition comprising same and producing method thereof
  • Low molecule heparin and salt thereof, pharmaceutical composition comprising same and producing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] (a) 15.0 g of heparin sodium specified in the Japanese Pharmacopoeia was dissolved in 250 mL of solvent (ionized water) to prepare a reaction solution, and then the pH of the reaction solution was adjusted to 2.5 with 4 mol / L hydrochloric acid aqueous solution.

[0117] (b) Next, 10 mL of 5% sodium nitrite was added to the reaction liquid, and a low molecular weight reaction (depolymerization reaction) was performed at room temperature for 1 hour. During the reaction, the pH of the reaction solution was maintained at pH 2.5 with 4 mol / L hydrochloric acid aqueous solution.

[0118] (c) Next, the pH of the reaction solution was adjusted to 7.0 with 4 mol / L sodium hydroxide aqueous solution to stop the reaction.

[0119] (d) Next, the reaction solution was heated to 40° C., 1.0 g of a reducing agent (sodium borohydride) was added, and a reduction reaction was performed for 2 hours.

[0120] (e) Next, adjust the pH of the reaction solution to 4.0 with 4 mol / L hydrochloric ...

Embodiment 2

[0131] Low-molecular-weight heparin sodium (dalteparin sodium) was obtained in the same manner as in Example 1, except that the pH of the solution in step (i) in Example 1 was adjusted to 3.8±0.3.

Embodiment 3

[0133] Except that the ethanol solvent in the steps (g), (k) and (m) in Example 1 is replaced with a mixture of methanol-acetone (1:1), use the same method as in Example 1 to obtain Low molecular weight heparin sodium (dalteparin sodium).

[0134] 4.5. Embodiment 4

[0135] Except that after the step (g) in Example 1, the chromatographic column purification of the step (l) is carried out, and then the treatment of the steps (h) to (k) is carried out, the method is the same as that of the example 1 to obtain low molecular weight heparin sodium (dalteparin sodium).

[0136] 4.6. Comparative example 1

[0137] Except that steps (h) to (k) in Example 1 are deleted (that is, step (l) is performed after step (g)), the same method as in Example 1 is used to obtain low-molecular-weight heparin sodium (dalteparin sodium ).

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PUM

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Abstract

To provide low-molecular-weight heparin or its salt that can be efficiently obtained by a simple method without requiring large-scale equipment and has extremely reduced impurity content, pharmaceutical compositions containing it, and production of low-molecular-weight heparin or its salt method. The low-molecular-weight heparin or its salt of the present invention can be treated with a reducing agent after reducing the molecular weight of the heparin and / or its salt, and after the reducing agent is removed and / or decomposed, the pH of the solution is adjusted to 4 Or get smaller.

Description

technical field [0001] The present invention relates to low-molecular-weight heparin or its salt, a pharmaceutical composition containing it, and a production method thereof. Background technique [0002] Heparin is a kind of mucopolysaccharide with a wide molecular weight distribution and an average relative molecular weight of 10,000 to 30,000. widely present in cells). Heparin has a strong anti-coagulation effect, so in addition to the treatment and prevention of various thromboembolic diseases such as myocardial infarction and cerebral embolism, it is also used in the insertion of vascular catheters or injection needles in hemodialysis, blood transfusion, blood tests, etc. To prevent blood clotting. [0003] In particular, when extracorporeal circulation devices such as hemodialysis equipment and artificial heart-lung equipment are used, the pores of the membranes may be clogged due to coagulation of the perfused blood on the dialysis membranes and filter membranes. I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10A61K31/727
Inventor 坂本和加子小田中亘
Owner Q P CORP
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