A kind of preparation method of nocafloxacin freeze-dried powder injection

A technology for freeze-dried powder injection and nokafloxacin, which is applied in the field of medicine, can solve the problems of complex prescription process, poor stability of nokafloxacin, etc., and achieves the effects of simple prescription process, good reconstitution and good stability.

Active Publication Date: 2016-08-17
NANJING BIOTICA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In view of the fact that the nocafloxacin formulations disclosed in the existing literature are all preparations with complicated prescription process, and the research shows that the stability of nocafloxacin is poor

Method used

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  • A kind of preparation method of nocafloxacin freeze-dried powder injection
  • A kind of preparation method of nocafloxacin freeze-dried powder injection
  • A kind of preparation method of nocafloxacin freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] (1) Weigh 5.0g nocafloxacin Ⅰ and 100g polyethylene glycol 400, stir to dissolve;

[0048] (2) Weigh 5.0g of citric acid and 50g of dextran 40, add 800mL of water for injection, stir and dissolve in a water bath at 80°C, and cool to room temperature.

[0049] (3) Mix the above two solutions, and adjust the pH to 5.0 with 0.5N citric acid or sodium hydroxide solution;

[0050] (4) Add water for injection to 1000mL;

[0051] (5) Pass the above solution through a 0.22μm microporous membrane, and dispense into 10mL brown vials, 2mL per bottle. Freeze-dried, denocafloxacin Ⅰ freeze-dried powder injection.

Embodiment 2

[0053] (1) Weigh 0.250g of nocafloxacin I and 25g of polyethylene glycol 400, stir to dissolve;

[0054] (2) Weigh 5.0g acetic acid, 150g mannitol, add 800mL water for injection, stir to dissolve;

[0055] (3) Mix the above two solutions, and adjust the pH to 8.0 with 0.5N sodium hydroxide solution;

[0056] (4) Add water for injection to 1000mL;

[0057] (5) Pass the above solution through a 0.22μm microporous membrane, and dispense into 10mL brown vials, 2mL per bottle. Freeze-dried, denocafloxacin Ⅰ freeze-dried powder injection.

Embodiment 3

[0059] (1) Weigh 0.50g nocafloxacin I and 40g polyethylene glycol 400, stir to dissolve;

[0060] (2) Weigh 6.0g tartaric acid, 200g glucose, add 800mL water for injection, stir to dissolve;

[0061] (3) Mix the above two solutions, and adjust the pH to 7.0 with 0.5N sodium hydroxide solution;

[0062] (4) Add water for injection to 1000mL;

[0063] (5) Pass the above solution through a 0.22μm microporous membrane, and dispense into 10mL brown vials, 2mL per bottle. Freeze-dried, denocafloxacin Ⅰ freeze-dried powder injection.

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Abstract

The invention provides a preparation method of nocafloxacin freeze-dried powder injection, comprising the following steps: (1) preparing nocafloxacin, a hydrophilic carrier, a pH regulator, an excipient and water for injection into a medicinal solution , sterilizing, filtering, and filling; (2) Freeze-drying the nocafloxacin medicinal solution. The freeze-dried powder injection prepared by the method of the present invention, under the premise of improving the solubility of nocafloxacin, reduces the consumption of hydrophilic carriers such as solubilizers and latent solvents as much as possible, and has a simple prescription process, is suitable for industrial production, and has stable products. Good solubility and resolubility.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a preparation method of nocafloxacin freeze-dried powder injection. Background technique [0002] Nocafloxacin is a new type of anti-drug-resistant bacteria isolated from soil with a novel structure and significant antibacterial activity. It is a member of the most clinical application prospects among thiopeptide antibiotics (see: J . Antibiot. 2003, 26: 232-242). As a newly discovered thiopeptide antibiotic, nocafloxacin is effective against most Gram-positive bacteria, especially methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant pneumonia at a level lower than μg / ml. Streptococcus (PRSP), vancomycin-resistant enterococci (VRE) and drug-resistant Mycobacterium tuberculosis have strong bactericidal activity (see: J. Antibiot. 2003, 56: 226-231), and it has been reported that Nocafloxacin also has a significant curative effect on the mouse model of S...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/12A61K47/34A61K47/40A61K47/26A61P31/04
CPCA61K9/0019A61K9/19A61K38/12A61K47/10A61K47/26A61K47/36A61K47/40A61P31/04
Inventor 陈依军
Owner NANJING BIOTICA PHARMA
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