冻干技术在注射用盐酸吉西他滨脂质体中的应用

Application of Freeze-Drying Technology in Gemcitabine Hydrochloride Liposome for Injection

为研究影响冻干过程的主要影响因素,考察冻干技术在注射用盐酸吉西他滨脂质体中的应用,以外观性状、水分、复溶、粒径、含量、有关物质为指标,对冻干工艺中参数进行优化。优化后的冻干工艺为:2.5%甘露醇为冻干保护剂;快速预冻,温度为-50℃,时间为4h;真空度为15Pa;升华干燥的温度为-38℃,时间为25h;解析干燥的温度为30℃,时间为6h。通过优化冻干工艺参数,所得的盐酸吉西他滨脂质体冻干制品外观平整、质地疏松,加水后分散均匀,含量及有关物质均符合规定,多次重复实验结果基本稳定。

To study the main influence factors in the freeze-drying, and the application of freeze-drying technology in Gemeitabine Hydrochloride liposome for injection was investigated, With the index of the appearance, moisture content,redissolving, particle size, content and related substances were optimizd in the proces of freeze-drying. The optimized process of the freeze-drying： using 2.5% mannitol as the cryoprotectant; quick-freeze, pre-freezing at --50℃ for 4 hours; Vacuum degree 15Pa, Primary drying at --38℃ for 25 hours; Secondary drying at 30℃ for 6 hours. By the optimized factors of the process, the freeze-dried products of gemeitabine hydrochloride lipo- some looks smooth, loose texture, dispersed evenly after adding water, the content and related substances are in accordance with regulations and the experiment had better repeatability.