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Linezolid injection

A technology for linezolid and injection, which is applied in the field of pharmaceutical preparations, can solve the problems of poor water solubility, poor stability, and unstable linezolid content of linezolid, and achieve stable linezolid content, simple production process, and low impurity content low effect

Inactive Publication Date: 2018-06-15
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because linezolid has the characteristics of poor water solubility, poor stability, and sensitivity to pH, the use of existing preparation methods may easily lead to endotoxins or pyrogens that do not meet drug standards, high drug impurity content, and unstable linezolid content. Affect product stability, safety and industrial application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The preparation steps are:

[0042] (1) Weighing: Weigh various raw and auxiliary materials according to the prescription amount;

[0043] (2) Pretreatment: Take 50% of the theoretical volume of water for injection, heat to boiling, add glucose and 0.012mg / mL activated carbon, boil for 5min, decarbonize to the liquid preparation tank;

[0044](3) Dosing: add 30% of the theoretical volume of water for injection, control the temperature at 55±5°C, add sodium citrate and citric acid, after the dissolution is complete, add linezolid, stir to dissolve completely, add Add water for injection (55±5°C) to the full amount, add 0.0075mg / ml activated carbon, stir and absorb for 15 minutes, decarbonize, adjust the pH value to 4.8 (4.7~4.9) with hydrochloric acid or sodium hydroxide;

[0045] (4) Filling, sterilization and packaging.

Embodiment 2

[0047] The preparation steps are:

[0048] (1) Weighing: Weigh various raw and auxiliary materials according to the prescription amount;

[0049] (2) Pretreatment: take 70% of the theoretical volume of water for injection, heat to boiling, add glucose and 0.012mg / mL activated carbon, boil for 30min, decarbonize to the liquid mixing tank;

[0050] (3) Dosing: add 10% of the theoretical volume of water for injection, control the temperature at 55±5°C, add sodium citrate and citric acid, and add linezolid after complete dissolution, stir to dissolve completely, then add Add water for injection (55±5°C) to the full amount, add 0.003mg / ml activated carbon, stir and absorb for 15 minutes, decarbonize, adjust the pH value to 4.8 (4.7~4.9) with hydrochloric acid or sodium hydroxide;

[0051] (4) Filling, sterilization and packaging.

Embodiment 3

[0053] The preparation steps are:

[0054] (1) Weighing: Weigh various raw and auxiliary materials according to the prescription amount;

[0055] (2) Pretreatment: take 55% of the theoretical volume of water for injection, heat to boiling, add glucose and 0.012mg / mL activated carbon, boil for 30min, decarbonize to the liquid mixing tank;

[0056] (3) Dosing: add 20% of the theoretical volume of water for injection, control the temperature at 55±5°C, add sodium citrate and citric acid, and add linezolid after complete dissolution, stir to dissolve completely, then add Add water for injection (55±5°C) to the full amount, add 0.0035mg / ml activated carbon, stir and absorb for 15 minutes, decarbonize, adjust the pH value to 4.8 (4.7~4.9) with hydrochloric acid or sodium hydroxide;

[0057] (4) Filling, sterilization and packaging.

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PUM

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Abstract

The invention relates to a linezolid injection, which comprises 2.0 mg / mL linezolid, 1.64 mg / mL sodium citrate dehydrate, 0.85 mg / mL anhydrous citric acid, 50.24 mg / mL glucose monohydrate, and a proper amount of hydrochloric acid / sodium hydroxide, wherein the PH value is adjusted to 4.8 (4.7-4.9), and a proper amount of water for injection is added to achieve the total volume of 1.0 mL. The preparation steps comprise: (1) weighing, (2) pretreatment, (3) liquid preparing, and (4) filling, wet sterilization and packaging, wherein 50-70% of the theoretical volume of water for injection and 0.012mg / mL active carbon are added in the preparation step (2), and 10-30% of the theoretical volume of water for injection and 0.003 mg / mL active carbon are added in the preparation step (3). According tothe present invention, the prepared linezolid injection has advantages of low impurity content, less impurity component and good stability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an injection containing linezolid. Background technique [0002] Linezolid (LINEZOLID, (S)-N-{[3-(3-fluoro4-(4-morpholinyl)benzene)2-oxo-5-oxazoline]methyl}-acetamide) also known as Linezolid Ketone, morpholinozolidone, is a new synthetic oxazolidinone antibiotic that acts on the 50S ribosomal subunit of bacteria and is closest to the site of action. Unlike other drugs, linezolid does not affect the activity of peptidyl transferase, but only acts on the initial stage of the translation system, inhibits the connection between mRNA and ribosomes, prevents the formation of the 70S initiation complex, and thus inhibits bacterial protein synthesis. [0003] Linezolid was researched and developed by Pharmacia & Upjohn Company of the United States, and was approved by the FDA in 2000 for the treatment of Gram-positive (G + ) cocci, including suspected or confirmed hospital-acquired pneu...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5377A61K47/04A61K47/02A61P31/04
CPCA61K9/08A61K9/0019A61K31/5377A61K47/02
Inventor 汪飞郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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