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Preparation method of high-stability linezolid injection liquid

A technology for linezolid and derivatized linezolid, which is applied in the field of highly stable linezolid injection and its preparation, can solve problems such as hidden dangers of medication safety, great influence on quality, short shelf life and the like

Inactive Publication Date: 2015-06-03
北京众和民健医药科技有限公司 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Citric acid and sodium citrate are commonly used to adjust the pH of commercially available linezolid injections, but the stability of citric acid is not good, which has a great impact on the quality, and its impurities are relatively large immediately after production, and gradually become larger during storage , the shelf life is short, and the existence of impurities poses hidden dangers to the safety of medication

Method used

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  • Preparation method of high-stability linezolid injection liquid

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Effect test

Embodiment 1

[0029] Add 200L of purified water to a 500L preparation container, add 15kg of glucose monohydrate, add 0.5 sodium dihydrogen phosphate, then adjust the pH to 4.0 with phosphoric acid, add 0.6kg of linezolid, stir for 30min, continue to add water to the total volume after clarification 300L, add 9kg of activated carbon, raise the temperature to 60°C, keep warm for 30min, press filter, bottle the filtrate, and sterilize at 121°C for 30min to obtain linezolid injection. The impurity content determined by liquid chromatography is less than 0.34%.

Embodiment 2

[0031] Add 200L of purified water to a 500L preparation container, add 15kg of glucose monohydrate, add 0.8kg of sodium dihydrogen phosphate, then adjust the pH to 4.5 with phosphoric acid, add 0.6kg of linezolid, stir for 30min, continue to add water to the total With a volume of 300 L, add 9 kg of activated carbon, heat up to 60°C, keep warm for 30 minutes, press filter, bottle the filtrate, and sterilize at 121°C for 30 minutes to obtain linezolid injection. The impurity content determined by liquid chromatography is less than 0.35%.

Embodiment 3

[0033] Add 200L of purified water to a 500L preparation container, add 15kg of glucose monohydrate, 1.5kg of calcium sodium edetate and 1.5kg of proline, add 1.5kg of sodium dihydrogen phosphate, and then adjust the pH with phosphoric acid and disodium hydrogen phosphate =5.0, add 0.6kg of linezolid, stir for 30min, continue to add water to a total volume of 300L after clarification, add 9kg of activated carbon, heat up to 60°C, keep warm for 30min, press filter, bottle the filtrate, and sterilize at 121°C for 30min to obtain Linezolid Injection. The impurity content determined by liquid chromatography is less than 0.40%.

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Abstract

The invention discloses a preparation method of high-stability injection linezolid, wherein the preparation method comprises the steps: with linezolid as a raw material, adding water, glucose and sodium dihydrogen phosphate, dissolving, and then adjusting the pH with phosphoric acid or sodium dihydrogen phosphate to make the pH in a certain range. The content of impurities in a linezolid injection liquid is reduced, the product quality is improved, and the shelf life is extended.

Description

technical field [0001] The invention relates to a highly stable linezolid injection and a preparation method thereof. Background technique [0002] Linezolid, a synthetic oxazolidinone antibiotic, is used to treat infections caused by aerobic Gram-positive bacteria. The in vitro antibacterial spectrum of linezolid also includes some Gram-negative and anaerobic bacteria. It was approved by the US FDA in 2000. [0003] The structural formula of linezolid is as follows: [0004] [0005] It is found that the content of the current linezolid injection is relatively higher than that of the raw material drug, and it gradually increases with time. The main impurity is the structural formula of PNU-140155: [0006] [0007] Citric acid and sodium citrate are commonly used to adjust the pH of commercially available linezolid injections, but the stability of citric acid is not good, which has a great impact on the quality, and its impurities are relatively large immediatel...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5377A61K47/02A61K47/12A61K47/18A61K47/22A61P31/04
Inventor 邵文利宫庆创龚海燕郭小星李国丽翟兆彬司志现
Owner 北京众和民健医药科技有限公司
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