Gamithromycin injection and preparation method thereof

A technology of gamimycin and injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve cumbersome operations, increase of gamimycin degradation impurities, and production cycle Long and other problems, to achieve the effect of easy crystallization
CN113133968APending Publication Date: 2021-07-20BAODING JIZHONG PHARMA +2
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
BAODING JIZHONG PHARMA
Publication Date
2021-07-20

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Abstract

The invention discloses gamithromycin injection and a preparation method thereof, and belongs to the technical field of veterinary pharmaceutical preparations. The gamithromycin injection comprises the following components: gamithromycin, an inclusion agent, an antioxidant, ethanol and water for injection, wherein the inclusion agent is hydroxypropyl-beta-cyclodextrin or sulfobutyl ether-beta-cyclodextrin. According to the injection prepared by carrying out an inclusion reaction on the gamithromycin and the inclusion agent to form an inclusion compound, the defect that the gamithromycin is insoluble in water is overcome, the defects that the gamithromycin injection is easy to crystallize, poor in stability, high in viscosity and serious in animal stress reaction are overcome, and product storage and clinical application are facilitated.
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Description

technical field

[0001] The invention belongs to the field of veterinary pharmaceutical preparations, and relates to an injection and a preparation method thereof, in particular to a gamimycin injection and a preparation method thereof. Background technique

[0002] Gamithromycin (Gamithromycin) is a new generation of semi-synthetic, 15-membered azamacrolide antibacterial drug, which was developed into veterinary injection (trade name Zactran) by Merial of France. In 2010 and 2011, it was approved by the European Medicines Agency (EMA), the Canadian Health Products and Food Administration (HPFB) and the U.S. Food and Drug Administration (FDA) for the prevention and treatment of Mannella hemolyticus, Pasteurella multocida and Respiratory disease in cattle caused by Histophilia somniferus. In 2016, EMA extended the scope of application of gamimycin injection to pigs and sheep for the prevention and treatment of porcine respiratory diseases caused by Actinobacillus pleuropneumo...

Claims

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