壳聚糖聚乳酸膜的制备和毒性试验研究

Preparation and toxicity test of chitosan-polylactic acid film

目的研制结肠瘘的一期修复生物膜,并进行相关急性毒性和细胞毒性试验。方法制备聚乳酸膜和壳聚糖聚乳酸膜,按照药典要求进行壳聚糖聚乳酸膜的小鼠急性全身毒性试验和细胞毒性试验(台盼蓝计数细胞活性和MTT法检测细胞活性)。结果建立了壳聚糖聚乳酸膜的制备方法,聚乳酸膜与壳聚糖聚乳酸膜的物理性能比较无统计学差异;小鼠急性全身毒性试验无动物死亡和异常反应;细胞毒性试验显示,两膜比较无统计学差异。结论壳聚糖聚乳酸膜的物理指标达到药典要求,无急性全身毒性反应和细胞毒性反应,初步评价生物相容性好。

Objective To manufacture a biomembrane for the primary repair of colonic fistula, and to evaluate its acute general toxicity and cytotoxicity. Methods After the preparation of polylactic acid film （PAF） and chitosan - polylactic acid film （CPAF）, acute general toxicity and cytotoxicity examinations were performed with trypanblau cytoactive count and MTT reduction assay according to pharmacopeia for CPAF. Results A method for the preparation of CPAF was successfully established. There were no significant differences in physical performances between PAF and CPAF. No death and paradoxical reaction in mice were found by acute general toxicity test. Trypanblau cytoactive count and MrIT reduction assay showed no significant differences between the two biofilms. Conclusion CPAF meets physic requirement of pharmacopeia with no acute general toxicity and cytotoxicity. Its biocompatibility is good according to preliminary assessment.