摘要
目的分析静脉注射给药的固体脂质纳米粒的工业化制备可能和临床应用前景。方法与结果查阅了20篇国内外有代表性的文献并进行比较、归纳和分析。综述了几种现有SLN制备方法中各步骤的工业化潜力及存在问题,并展望了静脉注射的临床应用前景,其中包括混悬液制备、灭菌、冻干和喷雾干燥、物理化学稳定性、辅料安全性等。结论现有手段中高压均质法制备静脉注射用SLN具有良好的工业化潜力。提高SLN载药量、建立准确的SLN表征手段优化制剂处方与工艺、研究开发新型可注射用辅料和迅速有效的辅料安全性评价方法利于将SLN静脉注射剂推向临床应用。
Objective To analyze the potential of scale-up production and clinical application of solid lipid nanoparticles (SLN) for intravenous administration. Methods Twenty-onerepresentative literatures were analyzed, compared and summarized. Results The scale-up potential and existing problems of each step in SLN production were reviewed. The perspective of intravenous SLN for clinical application was evaluated. Conclusions High pressure homogenization has better scale-up feasibility to produce intravenous SLN. Increasing drug-loading, establishing accurate methods to optimize the formulation and process parameters , developing novel intravenous excipients and rapid safety evaluation methods for those excipients will favor the clinical application of intravenous SLN.
出处
《中国药剂学杂志（网络版）》
2009年第2期52-58,共7页
Chinese Journal of Pharmaceutics：Online Edition
关键词
药剂学
固体脂质纳米粒
静脉注射
工业化生产
灭菌
安全性
pharmaceutics
solid lipid nanoparticle
intravenous injection
scale-up production
sterilization
safety
