Ratification of highly purified tranexamic acid injection and quality standard thereof

A technology of tranexamic acid and quality standards, applied in the field of chemical pharmaceuticals, can solve problems such as safety concerns, affecting product quality, and increased impurities, and achieve the effects of improving quality standards, avoiding opalescence, and reducing potential adverse reactions

Inactive Publication Date: 2008-06-18
BEIJING JIACHENG MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 oth

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1 Tranexamic acid sodium chloride injection (100ml: 0.5g)

[0031] Tranexamic acid 5.0g

[0032] Sodium chloride 8.5g

[0033] Water for injection (at 20°C: conductivity 0.4μS.cm -1 ) to 1000ml

Embodiment 2

[0034] Example 2 Tranexamic acid sodium chloride injection (100ml: 0.5g)

[0035] The composition of the prescription is the same as in Example 1, except that the conductivity of the water for injection used when the injection is prepared is 0.5 μS.cm -1 (20°C)

Embodiment 3

[0036] Example 3 Tranexamic acid injection (5ml: 0.5g)

[0037] Tranexamic acid 100g

[0038] Edetate Disodium 0.01g

[0039] Water for injection (at 20°C: conductivity 0.8μS.cm -1 ) to 1000ml

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/195G01N30/02
Inventor 杨立新祁静金珠
Owner BEIJING JIACHENG MEDICINE
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