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Linezolid injection and preparation method thereof

A technology for linezolid and injection, applied in the field of linezolid injection and its preparation, capable of solving the problems of linezolid injection product quality and medication safety, and not proposing to reduce linezolid injection

Active Publication Date: 2020-09-22
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 3-Fluoro-4-(4-morpholino)aniline is a genotoxic impurity that will affect the product quality and drug safety of Linezolid Injection
At present, no method has been proposed to reduce the content of 3-fluoro-4-(4-morpholino)aniline in linezolid injection to improve the product quality and drug safety of linezolid injection

Method used

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  • Linezolid injection and preparation method thereof
  • Linezolid injection and preparation method thereof
  • Linezolid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A linezolid injection, the prescription is as follows:

[0044]

[0045]

[0046] The preparation method of the linezolid injection, the steps are as follows:

[0047] (1) Washing rubber plugs: Use a fully automatic rubber plug cleaning machine to clean the rubber plugs;

[0048] (2) Weighing: Weigh the prescribed amount of linezolid, anhydrous citric acid, sodium hydroxide and sodium chloride respectively;

[0049] (3) Preparation: Add water for injection to 90% of the full amount in the concentrated preparation tank, control the temperature at 60-65°C, and fill nitrogen under the liquid surface (that is, the nitrogen input port is located under the liquid surface to fill the liquid with nitrogen) , the nitrogen pressure is 0.3MPa, and when the dissolved oxygen in the water for injection is less than 2ppm, put the weighed anhydrous citric acid and sodium hydroxide into the concentrated tank, stir to dissolve completely, and add the weighed line Stir to dissolve...

Embodiment 2

[0057] A kind of linezolid injection, prescription is the same as embodiment 1, the preparation method of this linezolid injection, the steps are as follows:

[0058] (1) Washing rubber plugs: Use a fully automatic rubber plug cleaning machine to clean the rubber plugs;

[0059] (2) Weighing: Weigh the prescribed amount of linezolid, anhydrous citric acid, sodium hydroxide and sodium chloride respectively;

[0060] (3) Preparation: Add water for injection to 90% of the total amount in the concentrated preparation tank, control the temperature at 60-65°C, fill the liquid with nitrogen, the nitrogen pressure is 0.3MPa, and detect when the dissolved oxygen in the water for injection is <2ppm Put the weighed anhydrous citric acid and sodium hydroxide into the concentrated mixing tank, stir to dissolve completely, add the weighed linezolid, stir to dissolve completely, then add the weighed sodium chloride , stir to make it completely dissolve, keep the temperature of the liquid me...

Embodiment 3

[0068] A kind of linezolid injection, prescription is the same as embodiment 1, the preparation method of this linezolid injection, the steps are as follows:

[0069] (1) Washing rubber plugs: Use a fully automatic rubber plug cleaning machine to clean the rubber plugs;

[0070] (2) Weighing: Weigh the prescribed amount of linezolid, anhydrous citric acid, sodium hydroxide and sodium chloride respectively;

[0071] (3) Preparation: Add water for injection to 90% of the total amount in the concentrated preparation tank, control the temperature at 60-65°C, put weighed anhydrous citric acid and sodium hydroxide into the concentrated preparation tank, stir to make them completely Dissolve, add the weighed linezolid, stir to dissolve completely, then add the weighed sodium chloride, stir to dissolve completely, keep the liquid temperature at 60-65°C during the preparation process, transfer the liquid To dilute the tank, make up the water for injection to the full amount, stir unti...

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Abstract

The invention provides a linezolid injection and a preparation method thereof. The preparation method of the linezolid injection comprises the steps of weighing, preparation, filtration, encapsulationand sterilization, and nitrogen filling protection is carried out on liquid medicine in the steps of preparation and / or encapsulation. The content of 3-fluoro-4-(4-morpholinyl) aniline in the linezolid injection product can be obviously reduced by performing nitrogen charging protection on the liquid medicine in the steps of preparation and / or encapsulation, so that the product quality and the medication safety of the linezolid injection are favorably improved, and the medication risk of the variety is also obviously reduced by reducing the content of genotoxic impurities.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a linezolid injection and a preparation method thereof. Background technique [0002] Linezolid, molecular formula C 16 h 20 FN 3 o 4 , the chemical name is (S)-N[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide, The chemical structural formula is as follows: [0003] [0004] Linezolid is a synthetic oxazolidinone antibiotic approved by the US FDA in 2000 for the treatment of infections caused by Gram-positive (G+) cocci, including suspected or confirmed hospital-acquired pneumonia (HAP) caused by MRSA , community-acquired pneumonia (CAP), complicated skin or skin and soft tissue infection (SSTI), and vancomycin-resistant enterococci (VRE) infection. There are mainly two ways of administering linezolid: oral administration and injection. At present, related products include linezolid tablets and linezolid injection. Linezolid injection is a colorless...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5377A61K47/04A61P31/04B65B3/00B65B31/04
CPCA61K9/08A61K9/0019A61K31/5377A61K47/02A61P31/04B65B3/003B65B31/04
Inventor 王丹梅高怡蓉李瑜顾静燕邓银来陈东华
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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