FIELD: pharmacology.
SUBSTANCE: invention relates to a crystalline anhydrous modification of benzyldimethyl[3-(myristoylamino)propyl]ammonium monohydrate chloride (miramistin is a trade name). Crystalline βmodification of benzyldimethyl[3-(myristoylamino)propyl]ammonium monohydrate chloride is characterized by the following set of interplanar distances (d, E) and the corresponding intensities (Irel., %): 26.725-48.53%; 23.333-39,88%; 11.491-13.65%; 9.918-9.14%; 9.196-24.68%; 9.139-24.75%; 7.942-15.44%; 7.265-14.22%; 7.230-14.29%; 7.035-13.48%; 6.615-13.06%; 6.288-16.18%; 6.065-18.06%; 5.951-15.27%; 5.475-13.73%; 5.182-18.55%; 4.985-19.53%; 4.762-33.90%; 4.572-100.0%; 4.445-91.35%; 4.235-84.24%; 3.914-94.68%; 3.647-28.26%; 3.500-20.76%; 3.316-20.91%; 3.235-27.03%; 3.131-17.40%; 3.047-16.67%; 3.001-16.84%; 2.918-17.48%; 2.799-16.42%; 2.790-14.95%; 2.663-18.80%; 2.524-13.31%; 2.480-10.54%; 2.365-12.01%; 2.352-11.52%; 2.231-12.92%; 2.162-14.71%; 2.100-12.57%; 2.032-10.37%; 1.991-9.31%; 1.955-9.80%; 1.908-8.58% and a set of endothermic effects on the DSC curve at temperatures: (59.6±0.5)°C; (89.9±0.5)°C; (221.3±0.5)°C. The method for production of the crystalline βmodification of benzyldimethyl[3-(myristoylamino)propyl]ammonium monohydrate chloride is implemented by freezing an aqueous solution of benzyldimethyl[3-(myristoylamino)propyl]ammonium monohydrate chloride with a concentration of 0.5-10 wt %, at 25-100°C, at a cooling rate of at least 60 deg/min and then subjected to freeze-drying. Freezedrying of the frozen solution is carried out at the following temperatures: on the condenser (-43…-75)°C; on the product (-196…+50)°C and the residual pressure in the chamber (9-3)×10-2 Torr for 22-26 hours. Crystalline βmodification of benzyldimethyl[3-(myristoylamino)propyl]ammonium monohydrate chloride is used to prepare a pharmaceutical composition as an antiseptic agent having bactericidal and antiviral effects.
EFFECT: composition is more active for suppression the microorganisms growth.
4 cl, 6 dwg, 4 tbl, 4 ex
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