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目的用高效液相色谱-蒸发光散射检测器(HPLC-ELSD)法测定医用涂敷系统体内降解主要产物聚乙二醇(PEG)15000的含量,评价其体内降解规律。方法将医用涂敷系统植入大鼠背部,分别在术后0,1,2,3,4,5,6,7,8,9,10,12周(n=6)大鼠脱颈处死,并用磷酸盐缓冲液冲洗,收集剩余凝胶及冲洗液,用HPLC-ELSD法测定剩余凝胶和冲洗液中聚乙二醇15000的含量。结果凝胶在大鼠体内至第3周末前完好,至第6周呈无色透明碎块,后向液态转化,至第9周呈现为水样,至第12周肉眼未见。剩余凝胶中聚乙二醇15000的含量随实验周数的延长而递减。结论聚乙二醇15000在大鼠体内降解速率呈现为慢—快—慢的规律,符合硬脑膜缺损修复生理过程的要求。
OBJECTIVE To determine the degradation of polyethylene glycol (PEG) 15000 in medical coating system by HPLC-ELSD and evaluate its degradation in vivo. Methods The medical application system was implanted into the back of rats. The rats were sacrificed at 0,1,2,3,4,5,6,7,8,9,10,12 weeks after operation (n = 6) , And rinsed with phosphate buffer to collect the remaining gel and rinse, and the content of polyethylene glycol 15000 in the remaining gel and rinse was measured by HPLC-ELSD. Results The gel was intact by the end of the third week in rats, colorless and transparent fragments were formed in the 6th week, and then turned into liquid state. The water appeared as the 9th week and disappeared by the 12th week. The content of polyethylene glycol 15000 in the remaining gel decreased with the experimental weeks. Conclusion The degradation rate of polyethylene glycol 15000 in rats is slow-fast-slow, which is consistent with the physiological process of dura-defect repair.