壳聚糖微球的制备和动物皮内刺激评价

Preparation of Chitosan Microsphere and Evaluation of Creatural Skin Test

[目的]研究壳聚糖微球的制备以及其对动物皮内的刺激影响,为壳聚糖微球进一步临床应用提供依据。[方法]以壳聚糖(CS)为原料,通过乳化交联法制备CS微球,显微镜观察壳聚糖微球微观形态,研究微球理化特性受壳聚糖脱乙酰度、壳聚糖醋酸溶液浓度、交联剂用量等工艺条件影响,并将壳聚糖微球进行兔子皮内刺激试验。[结果]优化得出壳聚糖微球制备工艺为壳聚糖醋酸质量浓度0.3 g/L,Span80为油相体积的8%,油水相体积比3∶1,交联时间1 h。该壳聚糖微球不会对兔子产生损害。[结论]壳聚糖微球符合医疗器械生物学评价要求,为壳聚糖微球进一步临床应用奠定了基础。

[Objective] The aim was to establish the foundation for farther clinical application based on the study of preparation of Chitosan microsphere and their stimulation influence on animals.[Method] Using Chitosan as material,Chitosan microsphere was prepared by crosslinking emulsification process,and its microstructure morphology was observed through microscopy.And the physical and chemic property of Chitosan microsphere was fluctuated by such factors as acetic acid concentration,the degree of deacetylation of Chitosan,Chitoan concentration,crosslink reagent dosage and so on.And Chitosan microsphere was injected to rabbit skin.[Result] The preparation process had been optimized as mass concentration of chitosan acetate for 0.3 g/L,Span80 occupying oil phase volume for 8%,proportion of oil/water phase volume for 3/1,crosslink time for 1 hour.Such chitosan microsphere had no damage to the rabbit.[Conclusion] Chitosan microsphere measured up the biological evaluation the medical appliance,thus this research is established the foundation for farther clinical application.