Ursocycline injection composition

Abstract

A terramycin injection composition has long pharmacodynamic action time, wherein each unit of the terramycin injection composition contains 30% terramycin free alkali, 2%-3% magnesium compound, 30%-50% 2-ketopyrrolidine, 5%-20% propylene glycol, 5%-20% glycerol formal, 1%-5% moderator and the rest is water for injection. The invention prolongs pharmacodynamic action time of terramycin, decreases possibilities of pain, swelling, tissue stimulation and tissue necrosis at the injection sites of animals and improves stability of terramycin at high temperature.

Description

technical field [0001] The invention relates to a veterinary injection preparation, especially an injection composition containing 30% oxytetracycline. technical background [0002] The oxytetracycline injection composition in the prior art has higher viscosity at low temperature, thus makes injection more difficult, shows poor stability and destroys active ingredient at high temperature, and because Limited by the solubility of the aqueous solution, there are some problems in the preparation of the pharmaceutical composition containing oxytetracycline, including affecting the stability of the composition, affecting the convenience of gastrointestinal administration, and irritating the animal body. In order to overcome these shortcomings, extensive research has been carried out to select appropriate complexing agents and better co-solvents, and a review in the field has described the addition of calcium and magnesium as complexing agents in formulations to adjust and Some i...

AI Technical Summary

Problems solved by technology

There is another preparation based on glycerin formal, CN1156963A utilizes glycerin formal, polyethylene glycol, magnesium compound, etc. to obtain a composition of 30% oxytetracycline, which includes 300mg / kg of oxytetracycline, Shows good low temperature stability, but poor stability at high temperatures

In Journal of the American Pharmaceutical Association, 1957, Vol XLVI, the solubility of oxytetracycline in non-aqueous solvents is studied in the 587-591 page, this scheme still has the deficiency of poor stability, and described in US-A-4386083 Glycerol formal was combined with calcium acetate and magnesium oxide, but US-A-4772460 tried to use N-methylpyrrolidone and a soluble magnesium compound

US-A-5075295 describes a composition for obtaining up to 30% oxytetracycline, which includes polyethylene glycol-400 and magnesium oxide, but the examples given only show up to 25% oxytetracycline The possibility of element and as far as the applicant is aware is currently not commercially available with a product greater than 20%, and this product is also less stable at high temperatures

And because the content of oxytetracycline in oxytetracycline injection is low at present, thereby its drug effect time is also relatively short, once the animal is infected with the disease, it needs to be injected many times, so it is easy to cause pain at the injection site of the animal. , swelling, severe and even lead to muscle necrosis at the injection site, which may cause animal death, and cause irreversible losses for farmers