Ratification of highly purified tranexamic acid injection and quality standard thereof

Abstract

The invention in the end effectively reduces the impurities in tranexamic acid injection preparation through controlling the conductivity of the injection water to control the quality of the tranexamic acid injection preparation, and limits and controls the sort and the quantity of the impurities according to quality standard, thus obviously improving the stability of the preparation and the quality of the tranexamic acid injection preparation.

Description

[0001] Technical Field The present invention effectively controls the quality of tranexamic acid injection preparations by controlling the conductivity of water for injection, and effectively controls the types and amounts of impurities in the quality standards, which significantly improves the stability of the preparations and improves It guarantees the quality of tranexamic acid injection preparations and belongs to the field of chemical pharmacy. Background technique [0002] Metal ions are often catalysts for drug autoxidation reactions, among which Cu 2+ , Fe 3+ , Pb 2+ , Mn 2+ 、Pt 2+ 、Au 2+ is the most common. Such as ion-sensitive drugs, thiazide drugs (such as promethazine hydrochloride), adrenaline drugs with catecholamine structure, ascorbic acid, procaine hydrochloride, sodium salicylate, dopamine hydrochloride, etc., in the presence of trace metal ions In the presence of it, it can accelerate discoloration or decomposition, resulting in the increase of inject...

AI Technical Summary

Problems solved by technology

[0003] Tranexamic acid also belongs to this type of ion-sensitive drugs. The presence of metal ions in the production of its injection preparations often increases the cis-p-aminomethylcyclohexanecarboxylic acid and other impurities of tranexamic acid, resulting in the Impurities will increase to about 2.5% within three years, which will affect the quality of the final product and bring certain safety concerns to clinical applications