| 摘要 |
FIELD: medicine. ^ SUBSTANCE: invention describes pharmaceutical atorvastatin composition granulated by humid method with at least ca. 5% (mass) addition of alkali-earth metal salt containing: (a) atorvastatin, where atorvastatin is at least partly disordered form or mix of crystal and disordered atorvastatin forms, or its pharmaceutically acceptable salt; and (b) fluffer or combination of fluffers selected out of a group including sodium starch glycolate, starch, corn starch, preliminarily gelatinised starch, sodium alginate, cellulose powder, hydroxypropyl cellulose, magnesium aluminosilicate and potassium polacrylin, where the claimed atorvastatin composition granulated by humid method contains not more than ca. 3% of atorvastatin lactone, on the basis of ratio of lactone peak to the combined peak areas of total formulation, defined by high-efficiency liquid chromatography. Also the invention describes method of obtaining the claimed composition and assays of the composition content. ^ EFFECT: high purity grade; stable formulation of atorvastatin and good decomposition and bioavailability rate. ^ 23 cl, 4 tbl, 16 ex |
