自制阿托伐他汀钙片与立普妥的体外溶出行为相似性评价

Evaluation of Similarity of Dissolution Profiles between Self-made Atorvastatin Calcium Tablets and Lipitor

测定了自制阿托伐他汀钙片与立普妥在水、pH 1.2盐酸、pH 4.5乙酸盐缓冲液、pH 6.8磷酸盐缓冲液4种溶出介质中的溶出曲线,并进行相似性评价。结果表明,自制片与立普妥在水、pH 4.5乙酸盐缓冲液、pH 6.8磷酸盐缓冲液中,15min时溶出度均达85%以上,在pH 1.2盐酸中相似因子f_2为75.1。提示自制阿托伐他汀钙片与立普妥体外溶出行为相似。

The dissolution behaviors of the self-made atorvastatin calcium tablets and Lipitor in four dissolution mediums including water, hydrochloric acid （pH 1.2）, acetate buffer （pH 4.5） and phosphate buffer （pH 6.8） were determined. The similarity of the in vitro dissolution profiles between the self-made tablets and Lipitor was evaluated. The results showed that the dissolution at 15 min of the two products were all over 85 % in water, acetate buffer （pH 4.5） and phosphate buffer （pH 6.8）, and the similarity factor （f2） was 75.1 in hydrochloric acid （pH 1.2）. It revealed that the dissolution behavior of the self-made product was similar to that of Lipitor.