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Fondaparinux sodium composition injection and preparation method thereof

A fondaparinux sodium and composition technology, which is applied in the field of fondaparinux sodium composition injection, can solve problems such as poor clarity and easy crystallization, and achieve clarity assurance, stability improvement, and stable product quality Effect

Inactive Publication Date: 2017-05-31
ABA CHEM SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although the fondaparinux sodium injection composition of this invention has good stability, it is prone to crystallization and has poor clarity.

Method used

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  • Fondaparinux sodium composition injection and preparation method thereof
  • Fondaparinux sodium composition injection and preparation method thereof
  • Fondaparinux sodium composition injection and preparation method thereof

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preparation example Construction

[0026] The preparation method of the above-mentioned fondaparinux sodium composition injection, the specific steps of the preparation method are as follows:

[0027] (1) Weighing raw materials: Weigh fondaparinux sodium, sodium chloride, buffer and water for injection according to the respective proportions;

[0028] (2) Take the buffer solution, add a certain amount of water for injection and stir to dissolve, add sodium chloride after dissolution, stir to dissolve, then add water for injection, and add fondaparinux sodium while stirring;

[0029] (3) After fondaparinux sodium is completely dissolved, add water for injection to the full amount, add activated carbon and stir, filter, reflux, fill, nitrogen fill, melt seal, high temperature sterilization, light inspection after cooling, packaging and inspection , to obtain fondaparinux sodium composition injection.

[0030] As an example, a more specific implementation is that the stirring in step (2) is stirred at a temperatu...

Embodiment 1

[0032] Recipe: 1000ml divided into 500 pieces of 2ml

[0033] Fondaparinux Sodium 5g

[0034] Sodium chloride 12g

[0035] Buffer 3g

[0036] Add water for injection to 1000ml

[0037] Among them, citric acid 1.36g, sodium hydroxide 0.57g and hydrochloric acid 1.07g in the buffer solution.

Embodiment 2

[0039] Recipe: 1000ml divided into 500 pieces of 2ml

[0040] Fondaparinux Sodium 5g

[0041] Sodium chloride 12g

[0042] Buffer 3g

[0043] Add water for injection to 1000ml

[0044] Wherein, citric acid 1.59g, sodium hydroxide 0.61g and hydrochloric acid 0.8g in the buffer solution.

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Abstract

The invention relates to a Fondaparinux sodium composition injection and a preparation method thereof. The injection is prepared from raw materials as follows: 5-10 parts by mass of Fondaparinux sodium, 6-12 parts by mass of sodium chloride, 2.6-3 parts by mass of a buffer solution and 3-6 parts by volume of water for injection, wherein the buffer solution is a mixture of citric acid, sodium hydroxide and hydrochloric acid, and a mass ratio of citric acid, sodium hydroxide and hydrochloric acid is (2.4-2.6):1:(1.3-1.9); the raw materials are subjected to orderly feeding, stirring, filtering, reflowing, filling, nitrogen charge, fused sealing, high-temperature sterilization, light inspection after cooling, packaging and checking, and the Fondaparinux sodium composition injection is obtained. The Fondaparinux sodium composition injection prepared with the method cannot produce crystals, is good in clarity, greatly improves the stability and is better applied to clinical treatment.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a fondaparinux sodium composition injection [0002] liquid and its preparation method. Background technique [0003] Fondaparinux Sodium Injection, common name: Fondaparinux Sodium Injection, English name: Fondaparinux Sodium Injection, chemical name: methyl O-(2-deoxy-6-O-sulfonic acid group-2-sulfonamide group -α-D-glucopyranose)-(1→4)-O-(β-D-glucopyranose)-(1→4)-O-(2-deoxy-3,6-O-di Sulfonate-2-sulfonamido-α-D-glucopyranose)-(1→4)-O-(2-O-sulfo-α-L-iduronic acid)-( 1→4)-2-Deoxy-6-O-sulfonic acid-2-sulfonamido-α-D-glucopyranoside decasodium salt, chemical structural formula: [0004] [0005] Molecular formula: C31H43N3Na10O49S8, molecular weight: 1728. [0006] Fondaparinux sodium, also known as pentosan sodium, is a specific inhibitor of activated coagulation factor X (Xa), and its antithrombotic activity is the result of selective inhibition of Xa mediated by antithro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/702A61K47/12A61K47/04A61K47/02A61P7/02A61P9/10
CPCA61K9/08A61K9/0019A61K31/702A61K47/02A61K47/12
Inventor 徐军蒋信义石炜徐萌张敏康
Owner ABA CHEM SHANGHAI
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