Preparation method of fondaparinux sodium injection composition

Abstract

The invention discloses a preparation method of a fondaparinux sodium injection composition. The preparation method comprises the following steps of 1) according to a prescription of the fondaparinuxsodium injection composition, weighing all materials by prescription dosage; 2) taking fondaparinux sodium and sodium chloride, combining, then adding injection water with the weight being 75-85% of the total weight, after stirring and dissolving, adopting a pH regulator to regulate the pH to 5-8, then adding remaining injection water, stirring and mixing uniformly to obtain liquid medicine; 3) filling prepared liquid medicine, and carrying out high-temperature sterilization, cooling, lamp inspection, package and inspection to obtain the fondaparinux sodium injection composition. The fondaparinux sodium injection composition prepared by the invention has the advantages that by optimizing the pH and sterilization process of the fondaparinux sodium injection composition, the obtained solution is good in clarity and conforms to all detection requirements of the injection liquid item in Chinese pharmacopoeia, so that the quality stability of products is greatly improved, the crystallization and the turbidity of the solution are reduced, and the generation of impurities is reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of fondaparinux sodium injection composition. Background technique [0002] Fondaparinux Sodium Injection is used to prevent the occurrence of venous thromboembolism in patients undergoing major lower limb orthopedic surgery such as hip fracture, major knee surgery or hip replacement. For the treatment of patients with unstable angina or non-ST-segment elevation myocardial infarction (UA / NSTEMI) who are not indicated for urgent (<120 minutes) invasive treatment (PCI). For the treatment of patients with ST-segment elevation myocardial infarction treated with thrombolysis or not initially receiving other forms of reperfusion therapy. [0003] Fondaparinux Sodium Injection, the active ingredient is Fondaparinux Sodium, the chemical name is methyl O-(2-deoxy-6-O-sulfonic acid-2-sulfonamido-α-D-pyran Glucose)-(1→4)-O-(β-D-glucopyranose)-(1→4)-O-(2-deoxy-3,6-...

AI Technical Summary

Problems solved by technology

The composition described in patent CN 105596291 A contains 50-120ppm of silver ions. By adding metal ions, the injection composition that reduces the degradation of fondaparinux sodium can be reduced. However, although the fondaparinux sodium injection composition of this invention is stable Good, but prone to crystallization, poor clarity

The composition described in patent CN106727289 A solves the stability of precipitation and crystallization by adding a buffer solution, that is, a mixture of citric acid, sodium hydroxide and hydrochloric acid, but this invention does not affect the stability of fondaparinux sodium injection, including impurities. Changes are detailed

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