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Moxifloxacin hydrochloride injection aqua

A technology of moxifloxacin hydrochloride and water preparation, which is applied in the field of pharmaceutical preparations, can solve the problem that the concentration should not be higher than 3.0%, and achieve the effect of improving storage stability

Inactive Publication Date: 2013-10-23
HUNAN WARRANT PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application uses sodium hydroxide to adjust the pH value to 5.6-7.0, which is said to be stable under low temperature storage, but the concentration of the preparation should not be higher than 3.0%
[0008] The existing technology still needs new technology to solve the contradiction between the drug concentration and storage stability of moxifloxacin water

Method used

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  • Moxifloxacin hydrochloride injection aqua

Examples

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Effect test

preparation example Construction

[0024] The specific operation steps of the above-mentioned preparation method are to adjust the solution of the drug and the pH value at an operating temperature of 30-50°C. During the adjustment, the pH value at the end point of the adjustment is determined according to the pH value drop curve and the target pH value and the drop range. After the end point, the heating was stopped, and the mixture was stirred weakly or allowed to stand for 2-3 hours at room temperature. Then continue the follow-up operation. It is easy to understand that the standing time can also be other times, such as less than 2 hours or more than 3 hours, which can be regarded as equivalent replacements.

[0025] As a further preference, the preparation obtained by the above operations is encapsulated in a carbon dioxide atmosphere. The preparation obtained by the method is still stable after being stored for two years at a temperature of 15° C., no precipitation occurs, and the effective content is abo...

Embodiment 1

[0028] Take 4.0g of moxifloxacin hydrochloride raw material, add 80ml of water for injection, stir and dissolve below 40°C, slowly add Na 2 CO 3 Solution until the drug is completely dissolved, then maintain the temperature, continue to drop Na 2 CO 3 solution to pH 7.3, stop heating, add Na 2 CO 3 The solution was about 15ml, and the pH value dropped to 7.1 under weak stirring at room temperature for 3 hours. Filtered at 0.45 μm and 0.22 μm, sampled for measurement, supplemented with water for injection to the full amount, and finally packaged. The preparation has no crystal precipitation when stored at 1-5°C for 12 months, and the effective content is not less than 90% when stored at 15-25°C for 12 months.

Embodiment 2

[0030] Take 6.0g of moxifloxacin hydrochloride raw material, add 50ml of water for injection, stir and dissolve below 40°C, slowly add Na 2 CO 3 Solution until the drug is completely dissolved, then maintain the temperature, continue to drop Na 2 CO 3 solution to pH 7.8, stop heating, add Na 2 CO 3 The solution was about 45ml, and the pH value dropped to 7.4 under weak stirring at room temperature for 3 hours. Filtered at 0.45 μm and 0.22 μm, sampled for measurement, supplemented with water for injection to the full amount, and finally packaged. The preparation has no crystal precipitation when stored at 1-5°C for 12 months, and the effective content is not less than 90% when stored at 15-25°C for 12 months.

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Abstract

The invention relates to a moxifloxacin hydrochloride injection aqua. The moxifloxacin hydrochloride injection aqua is characterized in that the moxifloxacin hydrochloride injection aqua is formed by using a sodium carbonate solution as a pH adjusting agent, and the pH value of the above preparation is 7.1-8.0. The preparation method of the preparation is characterized in that water accounting for 50-80% of the total water consumption is preferably used for dissolving moxifloxacin hydrochloride, and water accounting for 15-35% the total water consumption is introduced in a sodium carbonate solution manner, and standing or weak stirring for a period of time is carried out at room temperature after the adjustment of the pH value to make the pH value constant. The preparation obtained in the invention has a high effective concentration and a good storage stability.

Description

technical field [0001] The invention relates to moxifloxacin aqueous solution type injection and belongs to the field of pharmaceutical preparations. Background technique [0002] Moxifloxacin (Moxifloxacin, MOX) (see the structure below) is an 8-methoxyfluoroquinolone antibacterial drug with broad-spectrum activity and bactericidal effect commonly used clinically, mainly for Gram-positive bacteria and Gram-negative bacteria , anaerobic bacteria, acid-fast bacteria and atypical microorganisms (such as mycoplasma, chlamydia and legionella) infection. Due to the widespread clinical application of quinolone antibiotics in recent years, the problem of bacterial resistance to quinolones has become increasingly serious. The 8-methoxy part of moxifloxacin has high activity and low selectivity for Gram-positive bacteria and drug-resistant mutations, and the bulky 7-position diazo heterocyclic substituent can prevent the activity efflux, which is the fluoroquinolone resistance. dru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4709A61K47/04A61P31/04
Inventor 周志刚庞永清姚玲肖利辉
Owner HUNAN WARRANT PHARMA
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