海藻酸盐基胃黏膜保护胶作为黏膜下注射剂的可行性研究及其安全性

      Safety of Alginate-based Gastric Mucosal Protective Adhesive and Feasibility Study of Its Use as Submucosal Injection

      • 摘要: 目的 对海藻酸盐基胃黏膜保护胶的安全性及作为黏膜下注射液的可行性进行研究。方法 通过猪离体胃黏膜隆起试验及大鼠体内胃黏膜隆起试验对海藻酸盐基胃黏膜保护胶作为黏膜下注射剂的可行性进行评价。参照医疗器械生物学评价GB/T 16886系列标准通过细胞毒性试验、急性毒性试验及口腔黏膜刺激试验对海藻酸盐基胃黏膜保护胶的安全性进行评价;结果 不同浓度海藻酸盐基黏膜保护胶溶液注射后隆起高度显著高于生理盐水(P<0.05)。胃黏膜保护胶无细胞毒性、口腔黏膜刺激性和急性毒性。结论 胃黏膜保护胶作为黏膜下注射隆起剂有可行性且具有良好的生物相容性,是非常有前景的新型医疗器械产品。

         

        Abstract: Objective To study the safety of alginate based gastric mucosal protective adhesive and its feasibility as a submucosal injection. Methods The feasibility of using alginate-based gastric mucosal protective gel as submucosal injection was evaluated by in vitro gastric mucosal uplift test in pigs and in vivo gastric mucosal uplift test in rats. The safety of alginate based gastric mucosa protective adhesive was evaluated by cytotoxicity test, acute toxicity test and oral mucosa stimulation test according to GB/T 16886 series standard of biological evaluation of medical devices. Results After injection of different concentrations of alginate base mucosal protective adhesive solution, the uplift height was significantly higher than that of normal saline (P<0.05). Gastric mucosal protection glue has no cytotoxic oral mucosal irritation or acute toxicity. Conclusion Gastric mucosa protector is a promising new medical device product with feasibility and good biocompatibility as submucosal uplift injection agent.

         

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