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Gamithromycin composition lyophilized powder for injection and preparation method

A technology of garamimycin and its composition, which is applied in the field of lyophilized powder and preparation of garamimycin composition for injection, which can solve the problems of high pain and irritation at the injection site of animals, high density and viscosity of injection liquid, and difficulty in administration operation Major problems, to achieve the effect of reducing the difficulty of the filtration system, easy injection, and simple and convenient clinical use

Active Publication Date: 2014-01-08
QILU ANIMAL HEALTH PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still problems in production, preparation and use of Gamithromycin Injection
Gamimycin Injection The solvent used in the injection is a non-aqueous solvent, which leads to high density and viscosity of the injection, and high requirements on the filtration system when the preparation is produced by filter sterilization; in clinical use, the operation of syringe suction and injection site administration is difficult, and the animal injection site is painful. Irritating

Method used

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  • Gamithromycin composition lyophilized powder for injection and preparation method
  • Gamithromycin composition lyophilized powder for injection and preparation method
  • Gamithromycin composition lyophilized powder for injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Gamimycin freeze-dried powder formula:

[0030]

[0031] Preparation:

[0032] Take the prescribed amount of gamimycin and citric acid, add them to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 5.65 with sodium hydroxide, filter aseptically with a 0.22μm filter membrane, and use 10ml per bottle aseptically Subpackage.

[0033] Freeze-drying: first lower the temperature to -31~-32°C, and maintain the low temperature for 2 hours to fully freeze the sample, then turn on the vacuum system to make the vacuum of the front box reach 132Pa, and raise the temperature of the freeze-drying shelf to -1°C, Dry by sublimation until free of solvent. A sterile lyophilized powder was obtained.

[0034] The resulting sterile freeze-dried powder is dissolved in normal saline for 24 hours and 48 hours in test tube photos as shown figure 1 , figure 2 shown.

Embodiment 2

[0036] Gamimycin freeze-dried powder formula:

[0037]

[0038] Preparation method: Take the prescribed amount of gamimycin and L-malic acid, add them to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 5.75 with sodium hydroxide, filter aseptically with a 0.22 μm filter membrane, press 10ml sterile aliquots per bottle. The freeze-drying steps are the same as in Example 1.

Embodiment 3

[0040] Gamimycin freeze-dried powder formula:

[0041]

[0042] Preparation:

[0043] Take the prescribed amount of gamimycin and DL-tartaric acid, add them to the prescribed amount of water for injection, stir to dissolve, then adjust the pH value to 5.66 with sodium hydroxide, filter aseptically with a 0.22 μm filter membrane, and use 10ml per bottle Bacteria packing. Then, first lower the temperature to -30°C and maintain the low temperature for 3 hours to fully freeze the sample, then turn on the vacuum system to make the vacuum of the front box below 133Pa, raise the temperature of the freeze-dried laminate to -1.5°C, and carry out sublimation drying to nothing. solvent to obtain a sterile lyophilized powder.

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Abstract

The invention discloses a gamithromycin composition lyophilized powder for injection. The gamithromycin composition lyophilized powder contains gamithromycin serving as an active ingredient and pharmaceutical excipients, the pharmaceutical excipients are at least one of citric acid, L-malic acid, tartaric acid and succinic acid, the weight ratio of the active ingredient and the pharmaceutical excipients is 1:0.27-0.65, and the pH value of a solution is adjusted to be 5.5-6.0 by using sodium hydroxide before lyophilizing. The invention further provides a preparation method of the gamithromycin composition lyophilized powder for injection. By the method, sterile gamithromycin composition lyophilized powder can be prepared; during clinic use, the gamithromycin composition lyophilized powder is dissolved in sterile normal saline, the solution is small in viscosity, easy for suction and easy for injection, and the gamithromycin composition lyophilized powder is simple and convenient in clinic use and small in irritancy to animals. Consequently, stability, safety and convenience in use of gamithromycin for injection are improved.

Description

technical field [0001] The invention relates to a freeze-dried powder of gamithycin composition for injection and a preparation method thereof, belonging to the field of animal injection preparations. Background technique [0002] Gamithromycin is a second-generation macrolide aza7α antibiotic. It is an azamacrolide with a single propyl group substitution at the 7α position. This special structure can be used under physiological pH conditions. , is conducive to rapid absorption, and is conducive to long-term effects in the target tissue lung. The existing preparation is Gamimycin Injection, which was first developed and successfully developed by Merial Co., Ltd. of France. The trade name is Zikwei The specification is that every 1ml of solution contains 150mg of gamithromycin. In July 2008, it was approved by the European Union to be marketed in Europe. It is used for the treatment and prevention of bovine respiratory diseases caused by Mannella hemolytica, Pasteurella mu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7052A61K47/12A61P31/04
Inventor 王海挺梁秀婷孔梅吴连勇王甜
Owner QILU ANIMAL HEALTH PROD
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