CRYSTALLINE ORGANIC ACID SALT OF AMLODIPINE

摘要

PURPOSE: A crystalline organic acid salt of amlodipine is provided, which has improved physicochemical properties such as water-resistance, stability, solubility and processing easiness, especially improved photostability. Therefore, it can be easily moved within the body of a patient and be stored for a long time. CONSTITUTION: A photostable crystalline form adipic acid salt of amlodipine has diffraction X-ray peaks at diffraction angle of 10.85 degree, 13.02 degree, 15.10 degree, 16.31 degree, 18.21 degree, 21.69 degree, 23.70 degree, 26.18 degree and 28.74 degree measured by X-ray powder diffraction method, and has X-ray powder diffraction pattern shown in figure 1 and melting point of 164 to 168 deg. C. A method for preparing the crystalline form adipic acid salt of amlodipine comprises reacting amlodipine with adipic acid in an inert solvent such as methanol. A pharmaceutical composition for treating ischemic heart disease or hypertension contains the crystalline form adipic acid salt of amlodipine, and pharmaceutically acceptable diluents or carriers.