High-content oxytetracycline injection and preparation method thereof

Abstract

The invention discloses a high-content oxytetracycline injection and a preparation method thereof, belonging to the field of oxytetracycline injections for veterinary use. Every 100 mL of the oxytetracycline injection comprises 30 g to 35 g of oxytetracycline, 2.0 g to 3.0 g of magnesium oxide, 0.3 g to 1.0 g of sodium formaldehyde sulfoxylate, 20 g to 40 g of glycerolformal, 20 g to 40 g of N,N-dimethylacetamide, and 1.5 g to 2.0 g of monoethanolamine, with the balance being water for injection. The preparation method comprises the following steps: (1) adding a proper amount of water for injection to dissolve sodium formaldehyde sulfoxylate; (2) adding magnesium oxide and carrying out stirring to uniformly disperse the magnesium oxide; (3) continuing adding glycerolformal, N,N-dimethylacetamide and monoethanolamine; (4) introducing nitrogen, carrying out heating to 50-60 DEG C, adding oxytetracycline alkali, and carrying out stirring to dissolve the oxytetracycline alkali; (5) addingmonoethanolamine to adjust the pH value of the obtained solution to 8.4-8.7; and (6) supplementing water for injection until a volume is 100 mL. According to the invention, an optimal ratio is selected by screening the ratios of glycerolformal to dimethylacetamide; and it is verified that the oxytetracycline injection is good in stability, not prone to discoloring and content reduction after beingplaced for a long time, and free of sediments.

Description

technical field [0001] The invention belongs to the technical field of oxytetracycline injection for veterinary use, and in particular relates to a high-content oxytetracycline injection for veterinary use and a preparation method thereof. Background technique [0002] Oxytetracycline is a tetracycline antibiotic, which is a broad-spectrum antibiotic. It has a strong effect on Gram-positive bacteria such as Staphylococcus, hemolytic streptococcus, Bacillus anthracis, Clostridium tetani and Clostridium, and is also effective on Escherichia coli, Salmonella, Gram-negative bacteria such as Brucella and Pasteurella have good antibacterial activity. In addition, they also have inhibitory effects on Rickettsia, Chlamydia, Mycoplasma, Spirochetes, Actinomycetes and some protozoa. [0003] As the most widely used antibiotic in livestock and poultry and other animals, oxytetracycline is the basic medicine for livestock and poultry health care. It is mainly used for the treatment of r...

AI Technical Summary

Problems solved by technology

[0005] Chinese patents CN101966330A, CN101954084A, and CN101422479A all mentioned that glycerin formal and dimethylacetamide can be used as drug excipients in the three patents to improve drug stability, but the three did not treat glycerin formal and dimethylacetamide. In-depth research on the use ratio of amides, the optimal use ratio of the two excipients is not mentioned

The main reason is that it is easy to change color after long-term storage, or produce precipitation, and the stability is poor, resulting in the reduction of active ingredients and affecting its use effect

However, the 30% high content of oxytetracycline injection is even more difficult in terms of preparation process and product stability.

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