Preparation method of gamithromycin composite solution

Abstract

The invention provides a preparation method of a gamithromycin composite solution, and relates to the technical field of veterinary drug antibiotics. The preparation method of the gamithromycin-based composite solution comprises a premix, gamithromycin freeze-dried powder, a cosolvent, a solubilizer, a substrate solvent, a pH value neutralizer and a pH value buffer, and comprises the following steps: precisely weighing 20 parts of the premix, and pouring into a water bath mixing tank for later use; and taking 5-10 parts of the gamithromycin freeze-dried powder, adding the gamithromycin freeze-dried powder into the mixing tank in which the premix is added, then adding 0.8-1.2 parts of the cosolvent, heating in a water bath at the temperature of 60-80 DEG C for 20-30 minutes, and stirring and mixing by using stirring equipment. According to invention, the gamithromycin can be dissolved in the organic solvent in advance by using the premix, and then is mixed with the substrate solvent through the solubilizer, so that the irritation of the composite solution is successfully reduced under the condition of ensuring the solubility of the gamithromycin, and the practicability of the composite solution is improved.

Description

technical field [0001] The invention relates to the technical field of veterinary antibiotics, in particular to a method for preparing a compound solution of gamithromycin. Background technique [0002] Gamimycin is an antibacterial drug prepared from the raw material erythromycin A oxime. It is a new type of semi-synthetic azalide with a 15-membered ring for animals. It mainly binds to the 50S subunit of the bacterial ribosome to block the polypeptide chain. Prolong, inhibit bacterial protein synthesis, inhibit hemolytic Brucella, Pasteurella multocida, Actinomyces pleuropneumoniae, Haemophilus parasuis, Streptococcus, Staphylococcus aureus, Enterococcus and Mycoplasma effect. It can inhibit the synthesis of bacterial RNA-dependent proteins, and has antibacterial and bactericidal effects on bacteria. Gamithromycin has strong antibacterial activity against Mannella haemolytica, Pasteurella multocida and Mycoplasma bovis of bovine respiratory disease (BRD). The 7a position...

AI Technical Summary

Problems solved by technology

[0003] Existing gamithromycin has poor solubility in water due to its large molecular chain, 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, it is generally necessary to add an antioxidant, but After the addition of anti-oxidants, it is easy to cause irritation to the injection site. For example, patents EP0508699A1 and CN102516331A disclose a preparation method of gamithromycin respectively. Since the raw material drug is insoluble in water, the original manufacturer uses glycerol formal as a solvent, and succinic acid As a co-solvent, thioglycerol is used as a preservative, and its injection is more irritating and costly. However, a gamimycin injection and its preparation method disclosed in patent CN202011499790.4 use a large amount of vitamin C as a co-solvent , although the above problems have been solved, the extensive use of vitamin C will also cause certain harm to livestock