Freeze dry powdered injection of moxfloxacin or its salts and preparation process thereof

A technology of freeze-dried powder injection and freeze-dried preparation, which is applied in the field of freeze-dried powder injection of moxifloxacin or its salt and its preparation, can solve the problems of poor drug stability, inconvenient carrying and transportation, and limited clinical application, etc., and achieve Stable quality, good for long-term storage, and low water content in finished products

Inactive Publication Date: 2006-02-08
吴祥根
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injection preparations have disadvantages such as poor drug stability, inconvenient to carry and transport, and tablets are not suitable for m

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Under sterile conditions, weigh 20.0 g of moxifloxacin hydrochloride (converted into moxifloxacin) and 20.0 g of mannitol, take the moxifloxacin hydrochloride of said weight, add 100 ml of water for injection to it, stir to make moxifloxacin hydrochloride Star is completely dissolved, add the weight of mannitol, stir to dissolve it completely, add 1mol / L sodium bicarbonate solution or sodium bicarbonate powder to adjust the pH value to 5.5, add water for injection until the total volume of the solution is 200mL, and use 0.45 μm microporous membrane for primary filtration, and the filtrate is finely filtered with 0.22 μm microporous membrane. The obtained filtrate is divided into 5mL controlled antibiotic vials, each bottle is filled with 2ml, and vacuum freeze-dried. The process flow and parameters are as follows:

[0035] Temp(℃) P(mba) Time(min)

[0036] Loading -10 - -

[0037] Freezing -40 - 40

[0038] -40 - 90

[0039] ...

Embodiment 2

[0052] Under aseptic conditions, take moxifloxacin hydrochloride (converted into moxifloxacin) to be 10g, glucose 20g, take moxifloxacin hydrochloride of said weight, add 100ml of water for injection wherein, stir to make moxifloxacin hydrochloride completely Dissolve, add the glucose of the stated weight, stir to dissolve it completely, add 1mol / L sodium bicarbonate solution or sodium bicarbonate powder to adjust the pH value to 5.0, add water for injection until the total volume of the solution is 200mL, and use a 0.45μm micropore The filter membrane is initially filtered, and the filtrate is finely filtered with a 0.22um microporous membrane filter. Gained filtrate is divided into 5mL control antibiotic vials, each bottle is filled with 2ml, vacuum freeze-dried, and the freeze-drying process is the same as in Example 1. Then it is out of the box, plugged and capped, and the finished product is packaged after passing the inspection.

[0053] The obtained moxifloxacin freeze...

Embodiment 3

[0055] Under sterile conditions, weigh 5 g of moxifloxacin hydrochloride (converted into moxifloxacin) and 10 g of lactose, take the moxifloxacin hydrochloride of said weight, add 100 ml of water for injection to it, stir to make moxifloxacin hydrochloride completely dissolve , add the lactose of the stated weight, stir to dissolve it completely, add 1mol / L sodium bicarbonate solution or sodium bicarbonate powder to adjust the pH value to 5.3, add water for injection until the total volume of the solution is 200mL, and filter through a 0.45μm microporous filter Membrane primary filtration, filtrate fine filtration with 0.22μm microporous membrane. Gained filtrate is divided into 5mL control antibiotic vials, each bottle is filled with 2ml, vacuum freeze-dried, and the freeze-drying process is the same as in Example 1. Then it is out of the box, plugged and capped, and the finished product is packaged after passing the inspection.

[0056] The obtained moxifloxacin freeze-drie...

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PUM

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Abstract

The invention provides a moxfloxacin for injection or freeze dried powder injection of its salts, and its preparation process, which is prepared from moxifloxacin or its salts, excipient, pH modifier and water for injection through freeze drying.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of moxifloxacin or its salt for injection with broad-spectrum antibacterial effect and a preparation method thereof. Background technique [0002] Moxifloxacin is a fourth-generation extended-spectrum quinolone antibacterial drug. This new quinolone drug not only maintains strong anti-gram-negative bacteria activity, but also has strong anti-gram-positive bacteria and other atypical pathogenic bacteria. Strong antibacterial activity. For Moraxella catarrhalis, Chlamydia, Bacteroides fragilis, Staphylococcus, Streptococcus, Enterobacter and anaerobic bacteria, it has stronger antibacterial activity than ciprofloxacin and ofloxacin. Its antibacterial spectrum covers all major respiratory pathogens, the most prominent one being Streptococcus pneumoniae. The mechanism of action of this product is similar to that of other quinolones, mainly inhibiting topoisomerase IV and DNA helicase, but the effec...

Claims

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Application Information

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IPC IPC(8): A61K31/4725A61K9/19A61P31/04
Inventor 吴祥根
Owner 吴祥根
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