| 摘要 |
The present invention relates to the field of pharmaceutics and concerns the application of highly pure safinamide (a) or ralfinamide (b) or a pharmaceutically acceptable acid salt thereof, wherein the content of respective impurity of (S)-2-[3-(3-fluorobenzyl)-4-(3-fluorobenzyloxy)benzylamino]propanamide (IIa) or (S)-2-[3-(2-fluorobenzyl)-4-(2-fluorobenzyloxy)benzylamino]propanamide (IIb) or a pharmaceutically acceptable acid salt thereof is lower than 0.03% by mass for production of a medicinal preparation for the treatment of, respectively: (a) epilepsy, Parkinson's disease, Alzheimer's disease, depression, jimmy-legs syndrome and migraine, or (b) diseased states including chronic pain and neuropathic pain, migraine, bipolar disorders, depressions, cardiovascular, inflammatory, genitourinary, metabolic and gastroenteric disorders in conditions that do not suppress activity of CYP450 system cytochromes and do not manifest blocking properties in respect of HERG channel. The invention also relates to a pharmaceutical formulation comprising said compounds and designed for the treatment of said states, and to a method for the treatment of said states using said highly pure safinamide or ralfinamide, or a pharmaceutically acceptable acid salt thereof. The claimed invention makes it possible to provide higher safety of the treatment of the above-listed states using safinamide- and ralfinamide-based medicines, and to extend the possibility of such treatment to groups of patients for which it was inaccessible earlier. |
