Studies on a Foreign Matter and the Improvement of Formula in Eptazocine Hydrobromide Injection

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  • 臭化水素酸エプタゾシン注射剤の不溶性異物および着色に対する安定化

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<p>Just before the first release of eptazocine·hydrobromide injection, foreign matter in the parenteral solution filled in ampules was found among products in a factory. It was traced to its origin, and analysis revealed that the foreign matter was barium sulfate (BaSO4). Barium dissolved from the glass ampule might react with sulfate. It is supposed that the bisulfite of an antioxidant added in the parenteral solution was oxidized to sulfate by the bromine remaining or formed in the process of eptazocine hydrobromide production. As a result of investigations, it is suggested for improvement that low alkali ampules should be used and sodium bisulfite should not be added as the antioxidant. Amino acid, for example glycine, could be selected in the new formula for eptazocine hydrobromide injection, and a combination with hydrochloric acid was effective for the prevention of foreign matter and coloration, and to promote pH stability.</p>

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