| 摘要 |
The invention provides a process for preparing substantially pure amorphous lercanidipine hydrochloride. The amorphous lercanidipine hydrochloride prepared as disclosed herein is substantially pure and has a greater aqueous solubility and faster onset of the antihypertensive effect when administered to a patient, compared to crystalline lercanidipine hydrochloride. In a particular embodiment, the invention provides a method of preparing amorphous lercanidipine hydrochloride comprising (a) dissolving lercanidipine in an organic solvent to form a first solution, (b) contacting such a first solution with water or with a second water and/or organic HCl solution, (c) optionally adding water and, (d) recovering the precipitated amorphous lercanidipine hydrochloride. |
