Quality control method for edaravone and edaravone-containing preparation

Abstract

The invention discloses a quality control method for edaravone and an edaravone-containing preparation. In the method, an impurity, namely, 2,2',4,4'-tetrahydrophthalic anhydride-5,5'-dimethyl-2,2'-diphenyl-[4,4'-di-3H-parazole]-3,3'-dione in the edaravone and an edaravone preparation is determined quantitatively by photoelectric technology. By the technical scheme of the invention, the qualities of the edaravone and an edaravone-containing medicament preparation can be evaluated and controlled more reliably and accurately.

Description

Technical field: [0001] The invention relates to a quality control method of a medicine and its preparation, in particular to a quality control method of a cranial nerve protective agent edaravone and a preparation containing edaravone. Background technique: [0002] Edaravone is one of pyrazolone derivatives, its chemical name is 3-methyl-1-phenyl-2-pyrazolin-5-one, molecular formula C 10 h 10 N 2 O, the chemical structural formula is as follows: [0003] [0004] Edaravone was first developed by Japan's Mitsubishi Tokyo Pharmaceutical Company, and was approved for clinical use by the Ministry of Medical Labor and Welfare in Japan on April 4, 2001, with a trade name of Radicut. The dosage form of the drug listed in Japan is water injection, the specification is 30mg / 20ml, and the excipients are sodium bisulfite and cysteine ​​hydrochloride. The usual dosage is 30mg each time, twice a day, dissolved in normal saline or other diluents Intravenous infusion, generally us...

AI Technical Summary

Problems solved by technology

[0005] Because Edaravone is easy to produce impurities in the process of synthesis and preparation preparation, which affects the efficacy and activity of the drug and may increase the adverse reactions of the drug, which brings difficulties to production and clinical use.

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