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Preparation method of linezolid injection

A technology of linezolid and injection, applied in the field of pharmaceutical preparations, can solve the problems of unstable content of linezolid, unqualified pyrogen, etc., and achieve the effects of shortening adsorption time and reducing dosage

Active Publication Date: 2019-09-13
石药银湖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above method still has problems such as unstable content of linezolid and unqualified pyrogen.

Method used

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  • Preparation method of linezolid injection
  • Preparation method of linezolid injection
  • Preparation method of linezolid injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] The preparation method of a kind of linezolid injection of the present invention comprises:

[0104] 1) Concentrated

[0105] Under the condition of nitrogen protection, add 400mL of water for injection, sequentially add 2.3g of sodium acetate trihydrate and 1.2g of sodium chloride, place it at 0°C for 18-36 hours, and then add 1.62g of citron Natrate and 1.2g citric acid, stirred until completely dissolved, then added 50g of glucose, stirred until completely dissolved to obtain a medicinal solution, finally added activated carbon with a volume of 0.1% (g / mL) of the medicinal solution to the medicinal solution, and stirred at 60°C After 15 minutes of adsorption, decarburization was carried out, and a 4 μm titanium filter was used to obtain the first filtrate;

[0106] 2) rare match

[0107] Add 2g of linezolid, 0.01g of sodium bisulfite and 0.03g of aluminum chloride to the first filtrate obtained in 1), stir and mix at 80°C, then add 50mL of N-methylpyrrolidone, 10mL...

Embodiment 2

[0111] The preparation method of a kind of linezolid injection of the present invention comprises:

[0112] 1) Concentrated

[0113] Under the condition of nitrogen protection, add 400mL of water for injection, sequentially add 2.3g of sodium acetate trihydrate and 1.2g of sodium chloride, place it at 0°C for 18-36 hours, and then add 1.62g of citron Natrate and 0.85g citric acid, stir until completely dissolved, then add 50g glucose, stir until completely dissolved to obtain a medicinal solution, finally add activated carbon with a volume of 0.1% of the medicinal solution (g / mL) to the medicinal solution, and stir at 60°C After 15 minutes of adsorption, decarburization was carried out, and a 5 μm titanium filter was used to obtain the first filtrate;

[0114] 2) rare match

[0115] Add 2g of linezolid, 0.01g of sodium bisulfite and 0.03g of aluminum chloride to the first filtrate obtained in 1), stir and mix at 80°C, then add 50mL of N-methylpyrrolidone, 10mL of dimethyl su...

Embodiment 3

[0119] The preparation method of a kind of linezolid injection of the present invention comprises:

[0120] 1) Concentrated

[0121]Under the condition of nitrogen protection, add 400mL of water for injection, sequentially add 2.3g of sodium acetate trihydrate and 1.2g of sodium chloride, place it at 0°C for 18-36 hours, and then add 1.62g of citron Natrate and 1g of citric acid, stirred until completely dissolved, then added 50g of glucose, stirred until completely dissolved to obtain a medicinal solution, and finally added activated carbon with a volume of 0.1% of the medicinal solution (g / mL) to the medicinal solution, and stirred at 60°C for adsorption After 15 minutes, decarburization was performed, using a 6 μm titanium filter to obtain the first filtrate;

[0122] 2) rare match

[0123] Add 2g of linezolid, 0.01g of sodium bisulfite and 0.03g of aluminum chloride to the first filtrate obtained in 1), stir and mix at 80°C, then add 50mL of N-methylpyrrolidone, 10mL of ...

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Abstract

The invention relates to a preparation method of linezolid injection, and belongs to the field of pharmaceutic preparation. The preparation method of the linezolid injection includes the following steps: adding 400 mL of water for injection, adding 2.3 grams of acetic acid, sodium salt trihydrate and 1.2 grams of sodium chloride in turn, standing the mixture at 0-5 DEG C for 18-36 hours, then adding 1.62 grams of sodium citrate and 0.85- 1.2 grams of citric acid in turn, adding 50 grams of glucose, stirring the mixture until the mixture is completely dissolved to obtain medical solution, adding active carbon, stirring the mixture at 60-70 DEG C, followed by adsorption for 15-25 minutes, and carrying out decarbonizing to obtain first filtrate; adding 2 grams of linezolid, 0.01 gram of sodium bisulfite and 0.03 gram of aluminum chloride into the first filtrate, carrying out stirring and mixing at 80-90 DEG C, then adding 50 mL of N-methyl pyrrolidone, 10 mL of dimethyl sulfoxide and water for injection to 1000 mL, carrying out stirring to make the medical solution uniform, adjusting the pH value of the medical solution to 4.4-5.0, and carrying out filtering to obtain second filtrate;and carrying out filling on the second filtrate, thereby obtaining the linezolid injection. The linezolid injection obtained by the preparation method is stable in quality and qualified in pyrogen.

Description

technical field [0001] The invention relates to a preparation method of linezolid injection, which belongs to the field of pharmaceutical preparations. Background technique [0002] Linezolid, a synthetic oxazolidinone antibiotic, is used to treat infections caused by Gram-positive (G+) cocci, including suspected or confirmed nosocomial-acquired pneumonia (HAP) and community-acquired pneumonia (CAP) caused by MRSA ), complicated skin or skin and soft tissue infections (SSTI), and vancomycin-resistant enterococci (VRE) infections. Linezolid injection was first researched and developed by Pharmacia-Upjohn (which has been merged into Pfizer) in the United States. It was approved for marketing by the FDA in April 2000, and its import registration was approved in September 2006 in China. [0003] Activated carbon is mainly used in the decolorization of the solution in the pharmaceutical process and the adsorption of impurities and small molecule heavy metals in the solution. It ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5377A61L2/07A61P31/04
CPCA61K9/0019A61K9/08A61K31/5377A61L2/0023A61P31/04
Inventor 韩巧玲狄彩霞郭良姚春虎张俊燕董晓花高凯丽邵梦超于春杨
Owner 石药银湖制药有限公司
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