中文摘要：

目的研究新型聚乙二醇接枝聚乳酸（PPLA）自组装纳米微球浓度、微球粒径对溶血率的影响。方法研究按照国家医疗器械生物学评价IS010993．1—1997和GB／T16886．1—2001标准和要求进行，采用透析法，用动态激光光散射仪（DLS）进行粒径及Zeta电位检测，制备不同浓度、不同行粒径的PPLA自组装纳米微球。就制备的纳米微球采用水浴法及测量540nm处光密度值并计算出纳米微球的溶血率。结果随着微球浓度的增加，溶血率增加，粒径为960．8nm的微球，在浓度为2．0mg／mL时出现了轻度溶血；相同浓度（1．0mg／mL或1．5mg／mL）的微球，随着粒径（200—300nm）的减小，溶血率增加，但都小于5％，可作注射用；在0．9％NaCl溶液中，PPLA纳米微球的临界溶血浓度为1．5—2．0mg／mL，在此范围符合国家药物溶血标准。结论纳米药物的纳米效应对其临床应用存在负面影响，粒径在纳米微球的溶血及其他性能评价存在显著影响，相同浓度下，微球的粒径越大，溶血率越小。

英文摘要：

Objective To determine the effect of concentration and size of self-assembly nanometer microsphere particles made by polyethylene glycol （peg） grafted poly （lactic acid） （PPLA） on hemolysis rate. Methods According to the national medical equipment biological evaluation ISO10993. 1-1997 and GB/T16886.1-2001 standard and requirement, dialysis was carried out with a dynamic laser light scattering instrument （DLS） to measure particle size and Zeta potential. Different concentrations and particle sizes of PPLA self-assembly nanometer microspheres were prepared. Hemolysis rate of the nanometer microspheres was determined by water bath method and absorption value at 540 nm. Results With the increase of the concen- tration, hemolysis rate of microspheres was increased. For the microspheres in the size of 960.8 nm, they appeared light hemolysis when the concentration was 2.0 mg/mL. For the microspheres at the concentration of 1.0 or 1.5 mg/mL, their hemolysis rate was increased with the decrease of particle size （300 to 200 nm） , though less than 5%, indicating that they can be injected. In 0. 9% NaC1 solution, the critical hemolysis concentration of PPLA nanometer microspheres was 1.5 to 2.0 mg/mL, which was in this range accord of national drug standards hemolysis. Conclusion Our research shows the negative effects of the nano drug＇ nano effect in the clinical application. Particle size exerts remarkable effect on hemolysis and other performance in the nanome- ter microspheres. When the concentration is same, the larger microspheres are, the lower hemolysis rate is.