首页|超滤离心-HPLC法测定鲁索替尼固体脂质纳米粒的包封率

超滤离心-HPLC法测定鲁索替尼固体脂质纳米粒的包封率

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目的 建立鲁索替尼固体脂质纳米粒(Ru-SLN)包封率的测定方法.方法 以熔融乳化-超声法制备Ru-SLN,以超滤离心法分离游离药物和Ru-SLN,采用HPLC法测定Ru的含量,并计算其包封率.结果 Ru在4.08~408.00μg/mL浓度范围内线性关系良好(r=0.9997),平均回收率为101.60%,RSD为1.09%(n=9);超滤离心法选择截留分子量为10 kDa的超滤离心管,10961×g离心10 min,无显著膜吸附作用,测得Ru-SLN的包封率为(97.01±1.23)%.结论 超滤离心法结合HPLC法测定Ru-SLN包封率快速便捷、准确性高,可为Ru制剂含量及包封率的测定提供有效的试验指导.
Determination of encapsulation rate of ruxolitinib solid lipid nanoparticles by ultrafiltration centrifugation-HPLC method
Objective To establish a method for determining the encapsulation rate of ruxolitinib solid lipid nanoparticles (Ru-SLN). Methods Ru-SLN was prepared using the melt emulsification-ultrasonic method,and the free drug and Ru-SLN were separated using ultrafiltration centrifugation. The Ru content was determined using HPLC,and the encapsulation rate was calculated accordingly. Results Ru had a good linear relationship within the concentration range of 4.08-408.00 μg/mL (r=0.9997),and its average recovery rate was 101.60%,with the RSD of 1.09% (n=9). The ultrafiltration centrifugation selected ultrafiltration centrifuge tubes with a cut-off molecular weight of 10 kDa,centrifuged at 10961 × g for 10 minutes,and showed no significant membrane adsorption. The encapsulation rate of Ru-SLN was determined to be (97.01±1.23)%. Conclusion The combination of ultrafiltration centrifugation and HPLC method for determining the encapsulation efficiency of Ru-SLN is fast,convenient,and highly accurate,providing effective experimental guidance for the determination of Ru formulation content and encapsulation effciency.

RuxolutinibSolid lipid nanoparticlesMelt-emulsification ultrasonic methodHigh performance liquid chromatographyUltrafiltration centrifugationEncapsulation rateMethodology

冯世权、于佳岐、董德峤、甘昌冉、彭浩洋、段成成、秦贞苗、高亚男

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海南医科大学药学院,海口 571199

海南医科大学国际教育学院,海口 571199

鲁索替尼 固体脂质纳米粒 熔融乳化超声法 高效液相色谱法 超滤离心法 包封率 方法学

2024

中国药师
国家药品监督管理局高级研修学院,武汉医药(集团)股份有限公司

中国药师

CSTPCD
影响因子:0.944
ISSN:1008-049X
年,卷(期):2024.28(12)