FIELD: chemistry.
SUBSTANCE: invention relates to a crystalline form of N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide, characterized by positions of peaks in an X-ray powder pattern, θ, degrees: 16.9±0.2, 20.0±0.2, 21.2±0.2, 26.7±0.2, 28.8±0.2. Crystalline form of N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide according to the invention is characterized by a monoclinic system, crystal cell edges, Å (angstrom): 8.51±0.50 Å, 4.59±0.50 Å and 18.00±0.50 Å; and angle value (degrees): 99.32°±5.00°. Invention relates to a method of producing a crystalline form of N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide, involving reaction of histamine with dimethylmalonate and treatment of the obtained product with a mineral acid, followed by alkalization or addition of a base until the precipitation of the crystalline form is completed N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide. Invention also relates to a pharmaceutical composition and a solid drug for treating and/or preventing inflammation of the mucous membrane of the upper respiratory tract, containing a crystalline form N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide according to the invention in a therapeutically effective amount and at least one pharmaceutically acceptable excipient.
EFFECT: crystalline form of N,N'-bis-[2-(1H-imidazol-4-yl)ethyl]propanediamide, having high storage stability, reduced hygroscopicity with preservation of sufficient solubility of form, improved bioavailability, effective antipyretic and analgesic action in therapy of inflammations of mucous membrane of upper respiratory tract.
15 cl, 9 dwg, 15 tbl, 12 ex
