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 problem of high pain and irritation at the injection site of animals, high density and viscosity of injection liquid, and difficult administration operation Major problems, to achieve the effect of reducing the difficulty of the filtration system, easy injection, and simple and convenient clinical use
CN103494780BActive Publication Date: 2015-02-04QILU ANIMAL HEALTH PROD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
QILU ANIMAL HEALTH PROD
Publication Date
2015-02-04

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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.
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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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