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目的:研究LY294002白蛋白结合型纳米注射剂的制备工艺,对其理化性质及体外释放进行表征。方法:以NabTM法成功制备LY294002白蛋白纳米乳剂及其冻干制剂,利用纳米粒度仪、透射电子显微镜、X射线粉末衍射仪对其形态、结构表征;透析法研究其体外释放。结果:纳米乳剂颗粒为球形或椭球形,冻干粉复溶后粒径约40 nm,Zeta电位约-45 mV,药物包封率约99%,体外24 h释放81.2%。LY294002以无定形被白蛋白包裹。结论:纳米乳剂性质稳定,制备方法简便,有望成为其新型给药系统。
Objective: To study the preparation process of LY294002 albumin-binding nano-injection and to characterize the physicochemical properties and in vitro release. Methods: LY294002 albumin nanoemulsion and its lyophilized preparation were successfully prepared by NabTM method. The morphology and structure of LY294002 albumin nanoemulsion were characterized by means of nano-particle size analyzer, transmission electron microscope and X-ray powder diffractometer. Results: The nanoemulsion particles were spherical or ellipsoidal. The diameter of reconstituted lyophilized powder was about 40 nm and the zeta potential was about -45 mV. The entrapment efficiency of the nanoemulsion was about 99% and the release rate was 81.2% in vitro. LY294002 is albumin-bound in amorphous form. Conclusion: The nanoemulsion is stable in nature and easy to prepare. It is expected to become a new drug delivery system.