Preparation method of nocathiacin 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: 2013-04-17
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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  • Preparation method of nocathiacin freeze-dried powder injection
  • Preparation method of nocathiacin freeze-dried powder injection
  • Preparation method of nocathiacin 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 nocathiacin freeze-dried powder injection. The method comprises the following steps of: (1) preparing liquor from nocathiacin, hydrophilic carriers, a pH regulator, an excipient and injection water, removing bacteria, and filtering and filling the liquor; and (2) performing freeze drying on the nocathiacin liquor. According to the freeze-dried powder injection prepared by the method, on the premise of enhancing the dissolvability of the nocathiacin, the consumption of the hydrophilic carriers such as a solubilizer and a cosolvent is reduced as much as possible; and the formulation and preparation are simple, the method is suitable for industrialized production, and the nocathiacin freeze-dried powder injection is high in stability and re-dissolution.

Description

Technical field [0001] The invention is a medical field in the field of pharmaceuticals, which involves a preparation method for a Nokashaxing frozen powder injection. Background technique [0002] Nokashaxing is a new type of antibiotic drugs that is separated from the soil and has a novel structure and significant antibacterial activity..Stibiot.2003, 26: 232 ~ 242).As the latest discovered sulfur peptide antibiotics, Noka Sarradisharine is at a level below μg / ml.Chain bacteria (PRSP), Evergreen (VRE), and drug -resistant tuberculosis (see: J.ANTIBIOT.2003, 56: 226-231), and some reports point outDue to its unique di metamyramtosaccharides, Nokasar has also presents a significant healing effect on mouse models in the infection of Golden Bacizone (see: Antimicrob Agents Chemother, 2004, 48 (10):3697 ~ 3701). [0003] As the common feature of sulfur peptide antibiotics, Nokashaxing has a special strong hydrophobic multi -ring structure like other similar antibiotics, leading to i...

Claims

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Application Information

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Patent Type & Authority Applications(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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