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目的实验评价新型氨基壳聚糖(AC)腹膜透析液的理化性质,透析效果及生物安全性,为进一步临床研究奠定基础。方法参照艾考糊精透析液配方构建新型AC透析液,检测酸碱度,稳定性,胶体性及抑菌作用。将126只大鼠随机分为7组,各组SD大鼠腹腔分别注射不同浓度葡萄糖透析液、艾考糊精透析液、AC透析液5 ml,测量注射后1、2、3、4、8、12 h腹腔内液体含量。连续腹腔注射AC透析液2周,取肝、肾、肠系膜及腹膜组织,染色观察病理变化。结果新型AC透析液为无色透明状胶体,具有丁达尔效应,p H 7.0~8.0;经高温高压、反复冻融等处理后无不溶物析出。AC透析液对大肠杆菌和金黄色葡萄球菌的生长均有抑制作用。1.0%与1.5%AC透析液均可增加腹腔内液体体积,8 h达到最大容积分别为(7.15±0.107)ml与(9.43±0.232)ml,8 h与12 h腹腔液体含量变化无统计学意义(P>0.05)。大鼠长期腹腔注射AC透析液与葡萄糖透析液比较,肝、肾、肠系膜HE染色无区别,腹膜纤维化程度无加重。结论新型AC透析液生物安全性较高,透析效果明显,透析速度缓慢平和,且能抑制细菌生长,有较好的研究价值和临床应用前景。
Objective To evaluate the physicochemical properties, dialysis effect and biosecurity of the new type of amino chitosan (AC) peritoneal dialysate and lay the foundation for further clinical research. Methods A new type of AC dialysate was constructed according to the formulation of icocoate dialysate. The pH, stability, colloidality and antibacterial activity were tested. 126 rats were randomly divided into 7 groups. Each group of SD rats were injected intraperitoneally with different concentrations of glucose dialysate, icodextrin dialysate, and AC dialysate 5 ml, respectively. After 1, 2, 3, 4, 8 , 12 h intraperitoneal fluid content. Continuous intraperitoneal injection of AC dialysate for 2 weeks, take the liver, kidney, mesentery and peritoneal tissue, stained to observe the pathological changes. Results The new AC dialysate was a colorless and transparent colloid with the effect of Tyndall, p H 7.0 ~ 8.0. No insoluble substance was precipitated after high temperature and high pressure, repeated freezing and thawing treatments. AC dialysate has inhibitory effect on the growth of Escherichia coli and Staphylococcus aureus. 1.0% and 1.5% AC dialysate increased intraperitoneal fluid volume, and the maximum volume at 8 h was (7.15 ± 0.107) ml and (9.43 ± 0.232) ml, respectively. There was no significant difference in intraperitoneal fluid content between 8 h and 12 h (P> 0.05). Long-term intraperitoneal injection of AC dialysate and glucose dialysate in rats, liver, kidney, mesenteric HE staining no difference, no increase in the degree of peritoneal fibrosis. Conclusion The new AC dialysate has high biological safety, obvious dialysis effect, slow and steady dialysis speed, and can inhibit the growth of bacteria. It has good research value and clinical application prospect.