功能性氧化石墨烯/曲妥珠单抗包合物的制备及其质量评价

Preparation and Quality Evaluation of Functional Graphene Oxied/Trastuzumabcompound

合成新型的功能性氧化石墨烯/曲妥珠单抗(GO-DEX-β-CD/Trastuzumab)包合物,并对其进行质量评价。利用电子扫描显微镜(SEM)对其形貌进行表征;以高效液相色谱法(HPLC)测定曲妥珠单抗(Trastuzumab)含量,并对生成物的包封率、回收率以及精密度进行评价,以离心法测定GO-DEX-β-CD/Trastuzumab包合物的包封率。GO-DEX-β-CD/Trastuzumab包合物的平均粒径(n=8)为(138±3.83)nm,曲妥珠单抗检测浓度线性范围为10～100μg·m L-1(r=0.999 4),平均回收率(n=9)为(100.3±2.31)%,包封率(n=5)为(79.8±1.01)%。GO-DEX-β-CD/Trastuzumab包合物制备工艺可行,质量控制方法简便可靠。

To synthetize the new-type GO-DEX-β-CD/Trastuzumab inclusion compound,and evaluate their qualities,the microstructure of graphene oxid was characterized by scanning electron microscopy(SEM).The concentration of Trastuzumab was determined by high efficiency liquid chromatography.The recovery,precision and entrapment efficiency of GO-DEX-β-CD/Trastuzumab inclusion compoundwere studied,and the GO-DEX-β-CD/Trastuzumabinclusion compoundentrapment efficiency was determined by centrifugation.The mean diameter(n=8)of GO-DEX-β-CD/Trastuzumab inclusion compoundwas(138±3.83)nm,the linear detection concentration range of Trastuzumab was 10~100μg·mL-1(r=0.999 4)with the average recovery(n=9)of(100.3±2.31)%and the entrapment efficiency(n=5)of(79.8±1.01)%.The preparation technique of GO-DEX-β-CD/Trastuzumab inclusion compoundis feasible,and the quality control method is convenient and reliable.