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作 者:韩倩倩[1] 李彦红[1] 杨昭鹏[1] 王春仁[1] 冯小明[1] 鲁葵[1]
出 处:《中国药事》2013年第8期833-837,841,共6页Chinese Pharmaceutical Affairs
摘 要:目的可降解PGA材料作为一种组织工程支架材料,在组织工程产品中的应用越来越广泛。通过实验观察PGA材料的细胞相容性和是否引发动物的全身毒性反应。方法观察PGA材料的细胞相容性是将细胞在PGA材料上进行共培养,通过扫描电子显微镜观察细胞的贴壁状态,按照GB/T 16886.11-2001规定方法,对PGA材料的生理盐水浸提液进行小鼠急性毒性试验和大鼠亚慢性毒性试验。结果与结论L929细胞可以在可降解PGA纤维材料上正常贴壁;PGA材料的生理盐水浸提液对小鼠尾静脉注射50mL.kg-1后,未见急性毒性反应;可降解PGA纤维材料生理盐水浸提液对SD雄性大鼠尾静脉注射(10mL.kg-1),连续给药14天,结果样品各剂量组与对照组体重增长均正常,未发现临床征象等一般毒理学指标方面的异常,组织病理学检查未显示有相关的毒性靶器官或组织。Objective The application of degradable PGA in tissue engineering is used more and more widely as a tissue engineering scaffold material. In this study, we investigated the cell compatibility of the PGA material and whether it would induce systemic toxic reactions in animals. Methods The L929 cells were co-cultured on the PGA scaffold to examine the cell compatibility of the PGA scaffold. And the cell adhesive situation was observed through the scanning electron microscope. The acute systemic toxicity test in mice and the subchronic toxicity test in rats were also performed with the normal saline leach liquid of the PGA material according to the specified method in GB/T 16886. 11-2001 to evaluate the safety property. Results and Conclusion The results showed that the L929 cells were adherent normally on the degradable PGA scaffold. No acute toxic reactions were observed after the administration of 50 mL · kg-1 normal saline leach liquid of the PGA material to mice through tail vein injection. The male SD rats received 10 mL · kg-1 normal saline leach liquid of the degradable PGA material through tail vein injection for 14 days and the results showed the weight gain was normal in each sample dose group and control group, no abnormalities were found in the general toxicological indicators such as clinic signs, and the histopathologic examination did not show related target organs or tissues of toxicity.
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