Gamithromycin injection and preparation method thereof

Abstract

The invention discloses a gamithromycin injection and a preparation method thereof. The gamithromycin injection is composed of gamithromycin, vitamin C and water for injection. Every 100 ml of the gamithromycin injection comprises 5-35 g of gamithromycin, 1-10 g of vitamin C and the balance water for injection. In the gamithromycin injection, the vitamin C is used to increase a dissolving speed and a solubility of the gamithromycin raw medicine, has a very good solubilizing effect, also has an antioxidant effect, and can improve stability of the product. The gamithromycin injection is a weaklyacidic water-phase injection, can be matched with most of medicines for use, greatly increases long-term storage stability of gamithromycin, has small irritation to an injection part, quick absorption, a remarkable effect, high safety and simple prescription, is convenient for controlling quality of raw materials and auxiliary materials, saves cost, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of veterinary antibiotics, in particular to gamimycin injection and a preparation method thereof. Background technique [0002] Gamimycin is a representative drug of the second-generation macrolide antibiotics developed by Merial, France. It inhibits bacterial RNA-dependent protein synthesis to inhibit and kill bacteria. It has a wide antibacterial spectrum and antibacterial activity. Strong, widely distributed in the body, fast absorption, low residue and high safety, etc. It is mainly used for the prevention and treatment of respiratory diseases in non-lactating cows caused by pathogenic bacteria such as Mannella hemolyticus, Pasteurella and histophilia. Veterinary clinical field has broad application prospects. [0003] Gamimycin is a new type of semi-synthetic macrolide antibiotics. Due to its large molecular chain, its solubility in water is very poor, and it needs to be dissolved by adding a cosolvent...

AI Technical Summary

Problems solved by technology

[0003] Gamimycin is a new type of semi-synthetic macrolide antibiotics. Due to its large molecular chain, its solubility in water is very poor, and it needs to be dissolved by adding a cosolvent. On the other hand, its stability is not good. In order to prevent its Oxidation generally requires the addition of antioxidants, but the addition of cosolvents and antioxidants is likely to cause irritation to the injection site. For example, patents EP0508699A1 and CN102516331A disclose a preparation method of gamithycin. Manufacturers use glycerol formal as a solvent, succinic acid as a co-solvent, and thioglycerol as a preservative. The injection is more irritating and costly;

[0004] Patent CN103462884A discloses a preparation method of gamimycin injection, water for injection is used as a solvent, phosphoric acid is used as a co-solvent, and sodium bisulfite is used as an antioxidant, which reduces the production cost, but there is a problem of unstable pH value of the product. During long-term storage, the antioxidant sodium bisulfite is easily oxidized to sodium bisulfate, resulting in a decrease in pH, which affects product stability and increases the irritation of injection

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