| 摘要 |
A crystalline or amorphous atorvastatin strontium salt or a hydrate thereof is provided to improve purity, thermal stability, filterability, dryability and solubility, and to be useful for preventing and treating diseases associated with HMG-CoA(3-hydroxy-3-methyl-glutaryl-coenzyme A) reductase including hyperlipidemia and hypercholesterolemia. A crystalline atorvastatin strontium salt represented by a formula(1) or hydrate thereof is prepared by (i) reacting atorvastatin represented by a formula(2) or atorvastatin lactone represented by a formula(3) with strontium hydroxide, (ii) reacting atorvastatin sodium salt or potassium salt with reactive strontium selected from strontium chloride, strontium bromide, strontium sulfide, strontium nitride, strontium perchlorate, strontium acetate, strontium carbonate, strontium oxalate or a mixture thereof, or (iii) converting the pre-prepared atorvastatin strontium salt or hydrate thereof into another crystalline form. A pharmaceutical composition for prevention and treatment of hyperlipidemia and hypercholesterolemia comprises 0.1-95 wt.% of the crystalline atorvastatin strontium salt represented by the formula(1) or hydrate thereof, and is administered orally.
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