Preparation method of Fondaparinux sodium injection

A fondaparinux sodium and injection technology, which is applied in the field of medicine, can solve the problems of high impurity content, little practical application value, and difficult production, etc., to prolong the sterilization time, improve the clarity, and increase the sterilization temperature Effect

Inactive Publication Date: 2020-06-09
YANTAI DONGCHENG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] CN 108451899 A discloses a production method of Fondaparinux Sodium Injection, but this method adopts 125-126°C circulation steam sterilization for 5-10 minutes, which is difficult to realize in production. Compared with CN 107595769 A, the method has higher impurity content, Little practical value

Method used

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  • Preparation method of Fondaparinux sodium injection
  • Preparation method of Fondaparinux sodium injection
  • Preparation method of Fondaparinux sodium injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Composition Dosage effect Fondaparinux2.5g Active ingredient Sodium chloride4.2g Osmotic pressure regulator Sodium hydroxide Right amount pH regulator Water for Injection Add to 500ml Solvent

[0033] In this embodiment, the preparation method of fondaparinux sodium injection includes the following steps:

[0034] (1) According to the prescription of Fondaparinux Sodium Injection, weigh out Fondaparinux Sodium, Sodium Chloride, Sodium Hydroxide, and Water for Injection according to the prescription amount;

[0035] (2) Add 90% of the total water for injection into the liquid preparation container, heat to 100°C, let cool to room temperature, add Fondaparinux sodium and sodium chloride, and stir to dissolve;

[0036] (3) Adjust the pH to 7.0 with sodium hydroxide solution, add the remaining water for injection to make the volume;

[0037] (4) Filter the liquid medicine through a 0.22 micron microporous membrane or filter element;

[0038] (5) Fill the filtered liquid medici...

Embodiment 2

[0041] Composition Dosage effect Fondaparinux2.5g Active ingredient Sodium chloride4.2g Osmotic pressure regulator Sodium hydroxide Right amount pH regulator Water for Injection Add to 500ml Solvent

[0042] In this embodiment, the preparation method of fondaparinux sodium injection includes the following steps:

[0043] (1) According to the prescription of Fondaparinux Sodium Injection, weigh out Fondaparinux Sodium, Sodium Chloride, Sodium Hydroxide, and Water for Injection according to the prescription amount;

[0044] (2) Add 95% of the total amount of water for injection into the preparation container, heat to 100°C, keep for 10 minutes, let cool to room temperature, add Fondaparinux sodium and sodium chloride, and stir to dissolve;

[0045] (3) Adjust the pH to 6.5 with sodium hydroxide solution, add the remaining water for injection to make the volume;

[0046] (4) Filter the liquid medicine through a 0.22 micron microporous membrane or filter element;

[0047] (5) Fill th...

Embodiment 3

[0050] Composition Dosage effect Fondaparinux2.5g Active ingredient Sodium chloride4.2g Osmotic pressure regulator Sodium hydroxide Right amount pH regulator Water for Injection Add to 500ml Solvent

[0051] In this embodiment, the preparation method of fondaparinux sodium injection includes the following steps:

[0052] (1) According to the prescription of Fondaparinux Sodium Injection, weigh out Fondaparinux Sodium, Sodium Chloride, Sodium Hydroxide, and Water for Injection according to the prescription amount;

[0053] (2) Add 90% of the total amount of water for injection into the liquid preparation container, heat to 100°C, keep it for 5 minutes, let it cool to room temperature, add Fondaparinux sodium and sodium chloride, and stir to dissolve;

[0054] (3) Adjust the pH to 7.0 with sodium hydroxide solution, add the remaining water for injection to make the volume;

[0055] (4) Filter the liquid medicine through a 0.22 micron microporous membrane or filter element;

[0056]...

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Abstract

The invention discloses a preparation method of a Fondaparinux sodium injection. The method comprises the following steps: (1) weighing each raw material and subsidiary material according to a prescription amount according to a prescription of the Fondaparinux sodium injection; (2) adding part of water for injection into a liquid preparing container, performing heating to 100 DEG C, performing cooling to room temperature, then adding an active ingredient and an isotonic regulator, and performing stirring and dissolving; (3) adjusting a pH value of a solution obtained in the step (2) to 6.5-7.5with a pH regulator, and adding the remaining water for injection to make a constant volume; (4) filtering a drug solution through a 0.22 micron micro-porous filter membrane or filter element; (5) filling a filtered drug solution into a pre-filled syringe, and performing moist heat sterilization at 121-125 DEG C for 12-15 min; and (6) performing lamp inspection, packaging and inspection after sterilization to obtain the Fondaparinux sodium injection. The preparation method of the invention meets requirements of drug registration regulations, has few impurities, has good stability, has high sterility assurance level, and is suitable for industrial production.

Description

Technical field [0001] The invention belongs to the field of medical technology, and specifically relates to a production and preparation method of fondaparinux sodium injection. Background technique [0002] Fondaparinux is a chemically synthesized, structurally determined, single compound with a defined molecular weight. It is currently the most efficient selective inhibitor of factor Xa. Compared with heparins and low molecular weight heparins derived from animals, fondaparinux is a single compound with a clear structure, while heparin and low molecular weight heparins are complex compounds whose structures cannot be clearly characterized. Fondaparinux is an analogue of the pentose fragment that has the anticoagulant characteristic of the active site of low molecular weight heparin. It can reversibly bind to antithrombin, increasing the activity of antithrombin in inhibiting Xa by about 300 times, thereby effectively Inhibits the coagulation cascade. [0003] Fondapari...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/702A61K47/02A61P7/02A61L2/04
CPCA61K9/08A61K9/0019A61K31/702A61K47/02A61P7/02A61L2/0023A61L2202/21
Inventor 阎冬明李亚璟成琳
Owner YANTAI DONGCHENG PHARMA GRP
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