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

A technology for freeze-dried powder injection and injection, applied in the field of freeze-dried powder injection of moxifloxacin or its salt for injection and its preparation, can solve the problems of poor solubility and inconvenience of moxifloxacin hydrochloride, and achieve long-term storage , Overcome the effects of drug decomposition 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

Application No. 00811427.7 patent discloses moxifloxacin / sodium chloride preparation, using sodium chloride as an isotonic regulator, although subvisible particles are reduced, subvisible particles are still prone to appear in varying degrees, especially in storage Temperature is higher, under the condition that there is certain iron content in the solution (drug is easily brought into a certain amount of iron because of contact with container, production line etc. in the production process), as in embodiment 1, under the solution iron content 540ppb, store at 40 ℃ After 4 weeks, the number of particles with a particle size greater than 25 μm was 0.13 / ml, and after storage for 8 weeks, the number of particles with a particle size greater than 25 μm was 0.17 / ml; in Example 2, the solution was stored at 25°C for 95 weeks Afterwards, the number of particles with a particle size greater than 25 μm was 0.16 grains / ml, which must strictly control the storage conditions of moxifloxacin sodium chloride preparations such as low temperature, and also limit the validity period to some extent
In addition, in the presence of sodium chloride, the solubility of moxifloxacin hydrochloride is too poor, and it is necessary to use a narrow concentration of active compounds and isotonic regulators to obtain a certain concentration of moxifloxacin solution, which brings great challenges to industrial preparation and production. inconvenient

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Then it is out of the box, plugged and capped, and the finished product is packaged after passing the inspection.

[0025] The obtained moxifloxacin freeze-dried preparation is a white lump with a loose texture, and each bottle contains 200 mg of the active drug moxifloxacin hydrochloride converted into moxifloxacin.

Embodiment 2

[0027] 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.

[0028] The obtained moxifloxacin freeze...

Embodiment 3

[0030] 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.

[0031] The obtained moxifloxacin freeze-drie...

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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, which solves the problem of instability and easy occurrence of moxifloxacin solution due to the need to add an isotonic regulator. Subvisible particles, and easy to form amorphous particles during storage and other technical problems. Background technique [0002] Moxifloxacin (moxifloxacin) is a fourth-generation novel extended-spectrum quinolone antibacterial drug, and its structure is as follows: [0003] [0004] 1-cyclopropyl-7-([S,S]-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-1,4-dihydro-8-methanol Oxy-4-oxo-3-quinolonecarboxylic acid [0005] In addition to maintaining strong anti-gram-negative bacteria activity, this new type of quinolone drug also has strong antibacterial activity against gram-positive bacteria and other atypical pathogenic bacteria. For Moraxella c...

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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