关键词: font-size:medium, ">盐酸伊立替康脂质体；葡聚糖凝胶；柱回收率；体外释放率

Abstract: Objective： To study the method of the pretreatment of the separation condition of the release in vitro of irinotecan hydrochloride liposome injection by using Sephadex Gel Column Chromatography. Methods： The separation effect of different particle sizes (G25， G50)， the swelling time of Sephadex gel，the pretreatment method of Sephadex gel column，the type and volume of the eluent influenced the separating of free drug from liposomes was investigated. With the column recovery and the release in vitro results as index，the optimal condition for the seperation of the release free drug and the liposome was selected. Results： Sephadex G50 had better separation effect on samples. The preferred determination conditions were that the swelling time of Sephadex gel was at least 2 hours， the inner diameter of Sephadex gel column was 2.8-3.2 cm. The pretreatment method of Sephadex gel column was to centrifuge with 5% glucose solution for 2 minutes that a centrifugal speed up to 2 600 r·min-1. The internal phase (A phase)eluent was 5% glucose solution，and the external phase (B phase) eluent was 3% triethylamine (pH 3.5)-acetonitrile (77∶23) solution. Conclusion： The established method for the pretreatment of the separation condition of the release in vitro of irinotecan hydrochloride liposome has good reproducibility and column recovery.

Key words: font-size:medium, ">Rinotecan hydrochloride liposome； Sephadex gel； The column recovery；The release in vitro