CAJ | 학술논문

探讨了纳米激光粒度仪测定生物药品团聚物质量浓度的方法。以SALD-7500nano颗粒测试仪为例，介绍其在测量纳米级颗粒物粒度范围方面的应用。通过进一步分析颗粒浓度与光强度成正比的关系获得以质量浓度形式给出的粒度分布数据。通过牛血清蛋白(BSA)团聚物测量的实例，验证了颗粒物质量浓度的测试方法。该方法可用于生物制药领域对团聚物的监控测量以及评价药品药效、安全性能等。
탐토료납미격광립도의측정생물약품단취물질량농도적방법。이SALD-7500nano과립측시의위례，개소기재측량납미급과립물립도범위방면적응용。통과진일보분석과립농도여광강도성정비적관계획득이질량농도형식급출적립도분포수거。통과우혈청단백(BSA)단취물측량적실례，험증료과립물질량농도적측시방법。해방법가용우생물제약영역대단취물적감공측량이급평개약품약효、안전성능등。
A method for detecting the mass concentration of bio-pharmaceuticals aggregate by nano laser particle sizer was discussed. SALD-7500nano particle analyzer was taken as an example, the application of it on measurement of aggregates size was introduced. Furthermore,by analyzing the relationship of light amount data with aggregate concentrations,particle distribution data was obtained in the form of aggregate concentration. The method was verified by measurement of bovine serum albumin (BSA) aggregates. The method can be used for monitoring and measurement of aggregates in the field of biological pharmacy and evaluation of drug efficacy and safety performance.