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

Abstract

The invention discloses a solvent system capable of effectively dissolving ornidazole or S-ornidazole and an application thereof, the active component is ornidazole or S-ornidazole, and the solvent system is an organic solvent mixed by short-chain polyethylene glycol and propylene glycol; and preferably, the short-chain polyethylene glycol is polyethylene glycol 300 or/and polyethylene glycol 400.The solvent system can be used for preparing an ornidazole injection or a S-ornidazole injection. The method has the technical advantages which cannot be achieved in the prior art; the prepared ornidazole injection or the S-ornidazole injection has the preparation advantages of being simpler in prescription, safer in production, more stable in preparation, less in solvent amount, lower in impurity (especially genotoxic impurities) content, not prone to crystallization at low temperature, low in phlebitis occurrence rate, free of low-pH infusion irritation, and more suitable for patients withdisulfiram reaction sensitivity and the like. The clinical medication safety is ensured, and the medication compliance of a patient is better.

Description

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AI Technical Summary

Benefits of technology

This patented technology improves upon existing methods such as injecting drugs into blood vessels (venous systems). These techniques improve absorption efficiency but they may have negative side effect on patient health due to their nonselective nature. To address this issue, these new formulations were designed specifically target certain areas where there could benefit from treatment. Additionally, it was found that adding surfactant(s), reducing lyophobicity, increasing solution viscosity, adjusting acid levels, controlling particle size distribution, optimizing preparative conditions, and minimizing contaminating substances during manufacturing processes. Overall, these improvements enhance the quality control and efficacy of medical treatments while preventing harmful reactions caused by administering them through other routes like intravitrosion injection.

Problems solved by technology

This patented describes various methods for improving the purity and performance of naloxynuprolin sodium salt solutions containing aluminum hydroxy chloride and other ingredients like EDTA152E, PEG-200503, HPLC3. These processes involve adding certain substances called buffer salts to enhance their properties while reducing unwanted components associated therewith. Additionally, they require careful handling procedures when injecting drugs because some metabolites could harm healthy cells if absorbed through intestinal walls.

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