关键词: font-size:medium, ">阿托伐他汀钙；溶出曲线；相似因子；一致性评价

Abstract: Objective： To establish a new method for the dissolution curve determination of Atorvastatin Calcium Tablet， and evaluate the dissolution profiles of domestic generic tablets and the original tablet in 4 kinds of mediums. Methods： The paddle method of dissolution determination method was adopted， the rotation speed was 50 r·min-1， with dissolution medium volume of 900 mL； HPLC was adopted to determine the content of Atorvastatin Calcium in water， pH 1.0 hydrochloride acid， pH 4.5 phosphoric acid and pH 6.8 phosphate buffer solution； calculate the cumulative dissolution and draw dissolution profiles， then similarity factor (f2) was used to evaluate the similarity of dissolution profiles. Results： In four different pH solvents， Atorvastatin calcium tablets of domestic manufactures dissolve behavior was similar to original drug， except for 10mg sample from one manufacturer. Conclusion： The method is suitable for in vitro quality consistency evaluation of Atorvastatin Calcium Tablet.
   

Key words: font-size:medium, ">Atorvastatin Calcium； Dissolution curve； Similarity factor； Consistency evaluation