TERTIARY AMINE PHARMACEUTICAL COMPOSITION AND INDUSTRIAL BATCH PREPARATION METHOD THEREFOR

Provided is a tertiary amine pharmaceutical composition, comprising a drug having a tertiary amine structure, a biocompatible polymer material, and a quaternary ammonium salt impurity. The pharmaceutical composition is obtained by dissolving or dispersing the drug in a halogenated hydrocarbon or a m...

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Bibliographische Detailangaben
Hauptverfasser:	LIAN, Yuanfa, LIU, Feng, CAO, Fuchun, LAI, Shuting, ZHENG, Yang
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung:	Provided is a tertiary amine pharmaceutical composition, comprising a drug having a tertiary amine structure, a biocompatible polymer material, and a quaternary ammonium salt impurity. The pharmaceutical composition is obtained by dissolving or dispersing the drug in a halogenated hydrocarbon or a mixed solvent mainly containing halogenated hydrocarbon or a solution containing halogenated hydrocarbon, and the quaternary ammonium salt impurity is generated from reacting the drug having the tertiary amine structure with the halogenated hydrocarbon, wherein the pharmaceutical composition comprises 40wt% to 80wt% of the biocompatible polymer material, and 20wt % to 60wt% of the drug with the tertiary amine structure; the content of the quaternary ammonium salt impurity is less than 0.05wt%; and the content of the halogenated hydrocarbon in the composition is less than 1.5wt%, and the quaternary ammonium salt impurity does not increase or increase slowly during storage, complying with requirements of pharmaceutical regulations.