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目的:对制备的重组水蛭素-2(rHV2)壳聚糖鼻腔黏附纳米粒进行体外评价。方法:测定纳米粒的形态、粒径大小分布及表面电位;以超速离心测定纳米粒在不同介质中的释放度;采用在体蟾蜍上腭纤毛运动试验法考察纳米粒的纤毛毒性。结果:制备的rHV2壳聚糖纳米粒呈较为均匀分散的颗粒状,平均粒径为213.2 nm,纳米粒带正电荷,Zeta电位值为+30.61 mV,体系相对稳定性较高;rHV2纳米粒在乙酸缓冲液中的累积释放百分数明显高于在磷酸缓冲液中的累积释放百分数;rHV2纳米粒溶液的纤毛毒性较小(与生理盐水组相比,P>0.05)。结论:壳聚糖鼻腔黏附纳米粒有望成为rHV2鼻腔给药的递释系统。
OBJECTIVE: To evaluate the in vitro evaluation of recombinant hirudin-2 (rHV2) chitosan nasal adherent nanoparticles. Methods: The morphology, size distribution and surface potential of nanoparticles were measured. The release of nanoparticles in different media was determined by ultracentrifugation. The ciliary toxicity of nanoparticles was examined by paired ciliary motion test in vivo toad. Results: The prepared rHV2 chitosan nanoparticles were uniformly dispersed with a mean particle size of 213.2 nm. The nanoparticles were positively charged with a Zeta potential of +30.61 mV and the relative stability of the system was high. The rHV2 nanoparticles The cumulative release percentage in acetate buffer was significantly higher than the cumulative release percentage in phosphate buffer solution; the cilium toxicity of rHV2 nanoparticle solution was smaller (P> 0.05 compared to saline group). CONCLUSIONS: Chitosan nasal adherence nanoparticles are expected to be nasal delivery systems for rHV2 delivery.