Solvent system capable of effectively dissolving ornidazole or left-ornidazole and application thereof

Abstract

The invention discloses a solvent system capable of effectively dissolving ornidazole or left-ornidazole and its application. The active ingredient is ornidazole or left-ornidazole, and the solvent system is an organic solvent mixed with short-chain polyethylene glycol and propylene glycol; The short-chain polyethylene glycol is preferably polyethylene glycol 300 or / and polyethylene glycol 400. The solvent system can be used in the preparation of ornidazole injection or left-ornidazole injection. The present invention has technical advantages that cannot be achieved by the prior art. The preparation of ornidazole injection or left-ornidazole injection has the advantages of simpler prescription, safer production, more stable preparation, less solvent content, and impurities (especially genes) Toxic impurities) content is lower, low temperature is not easy to crystallize, low incidence of phlebitis, no irritation of low pH infusion, more suitable for patients with sensitive disulfiram reactions, etc., to ensure safer clinical medication and drug compliance of patients better.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a solvent system capable of effectively dissolving ornidazole or left-ornidazole and its application, and provides a safer ornidazole injection or left-ornidazole injection and a preparation method thereof . Background technique [0002] Ornidazole and left-ornidazole are the third-generation nitroimidazole broad-spectrum anti-anaerobe and antiprotozoal drugs after metronidazole and tinidazole. They have good curative effect, good tolerance, good tissue permeability, Wide distribution in the body, long biological half-life and other advantages, therefore, ornidazole and left-ornidazole are the first choice drugs for the prevention and treatment of anaerobic infection. [0003] At present, the existing marketed ornidazole injections include small-volume injections and large-volume injections, and left-ornidazole injections only have large-volume injections. Y...

AI Technical Summary

Problems solved by technology

[0015] For the above-mentioned deficiency of prior art, the purpose of the present invention is to provide a kind of solvent system and application that can dissolve ornidazole or left-ornidazole effectively, solve the impurity growth control that prior art exists, pH value is too low, propylene glycol Excessive use, easy crystallization at low temperature, drug-induced disulfiram reaction, production safety and many other technical problems, in order to meet the clinical safety drug needs to the greatest extent and increase patient drug compliance

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