Stable and safe edaravone injecta

Abstract

The invention belongs to the field of pharmaceutical preparations, in particular to an edaravone injecta and a preparation process thereof. The edaravone injecta contains edaravone and pharmaceutically acceptable auxiliary materials and is characterized in that the injecta contains an antioxidant and a pH regulator, wherein the antioxidant contains phosphate, L-cysteine hydrochloride and sodium bisulfite. A whole-process nitrogen-filing and oxide-emitting method and a post-sterilization rapid cooling method are adopted in the preparing and filling process of the edaravone injecta to improve the stability of the edaravone injecta, remarkably reduce the content of a related substance, i.e., dimmer and provide the stable and safe edaravone injecta for clinical administration.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a stable edaravone injection and a preparation process thereof. Background technique [0002] Stroke is a common and frequently-occurring disease among middle-aged and elderly people. It is one of the three diseases with the highest human mortality rate, and it is also the disease with the fastest development, the slowest recovery, and the most deaths among the three major diseases. Stroke can be divided into ischemic stroke and hemorrhagic stroke according to the pathogenesis, and ischemic stroke includes cerebral thrombosis and cerebral embolism, and the latter two are collectively referred to as cerebral infarction clinically. Acute cerebral infarction not only causes great suffering to patients, but also brings heavy mental and economic burdens to patients' families and society. According to the data released by WHO, among the 57 countries, 40 countries rank the deat...

AI Technical Summary

Problems solved by technology

Through the test, we found that because Edaravone has the defects of low solubility and poor stability in the alkaline aqueous solution, it is difficult to reach the concentration and quality standard for clinical use of the Edaravone preparation in the above-mentioned prior art by simply utilizing alkaline substances for preparation. Moreover, there are potential safety hazards to human health when the organic solvent / water system is applied to intravenous injections, so it will become a potential adverse factor in clinical application.

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