英脱利匹特注射剂的稳定性研究

Studies on the Stability of Intralipid

在8℃、15℃、30℃、40℃下不同贮藏时间(最长达26个月),对英脱利匹特进行“静置分层”观察,测定其pH、游离脂肪酸及乳粒大小等项目,观察及测定结果表明:本品贮藏期内会产生分层现象,但乳化体系稳定,不影响使用。贮藏期间,药液pH下降,游离脂肪酸含量增加。贮藏温度升高会加速产品水解。

The Parameters of stability of Intralipid, including sights of phase seperation, pH, ree fatty acids and particle size, were investigated after different periods of storage (up to 26 months) at temperatures of 8℃, 15℃, 30℃ and 40℃. The results indicate that during storage, phase seperation can occur but the emulsion system remains stable with no negative influence on its clinical use. It was found that the pH value decreased while the levels of free fatty acids increased after storage. Ppreserving at higher temperature can accelerate its hydrolysis.