| 摘要 |
1. Amorphous torasemide modification characterized by the following data: DSC: exothermic maximum at a temperature of about 147 degree C (onset at about 144 degree C); X-ray powder pattern (2theta): no diffraction maxima due to the amorphous nature; IR characteristic absorption bands at 2900 to 3366 cm<-1> and at 1400 to 1703 cm<-1>. 2. Amorphous torasemide modification according to claim 1, characterized in that it is chemically pure. 3. Process for the preparation of the amorphous torasemide modification according to claim 1, characterized in that torasemide modifications are dissolved in water with or without the addition of a base at a temperature from 5 C to 100 degree C within 5 minutes to 24 hours and then the solutions are cooled to a temperature from-20 C to-70 degree C and water is removed. 4. Process for the preparation of the amorphous torasemide modification according to claim 3, characterized in that as the torasemide modifications crystal torasemide modifications I, II or III or an amorphous torasemide modification or any mixture of the crystal torasemide modifications I, II and II and of an amorphous torasemide modification are used. 5. Process for the preparation of the amorphous torasemide modification according to claim 3, characterized in that lyophilization is used as the method for the removal of the water and the base. 6. The amorphous torasemide modification according to claim 1, characterized in that it is used as a raw material for the preparation of pharmaceutically acceptable torasemide salts. 7. The amorphous torasemide modification according to claim 1, characterized in that, as a form of torasemide, it is used as a diuretic, as an agent for preventing heart or heart tissue damages caused by metabolic or ionicabnormalities associated with ischemia, in the treatment of thrombosis, angina pectoris, asthma, hypertension, nephroedema, pulmonary edema, primary and secondary aldosteronism, Bartter's syndrome, tumour, glaucoma, for decreasing intraocular pressure, acute or chronic bronchitis, in the treatment of cerebral edema caused by trauma, ischemia, concussion of the brain, metastases or epileptic attacks and in the treatment of nasal infections caused by allergens. 8. A pharmaceutical form, characterized in that, as the active ingredient, it contains an effective amount of the amorphous torasemide modification according to claim 1 without or, for that purpose, combined with one or more pharmaceutically acceptable additives such as sugar, starch, starch derivatives, cellulose, cellulose derivatives, mould release agents, and antiadhesive agents and possibly agents for flowability regulation. 9. A pharmaceutical form according to claim 8, characterized in that it is a tablet, a capsule or an injection.
|
