摘要
目的:建立重组人表皮生长因子(rhEGF)滴眼液中rhEGF含量的检测方法,并进行方法学验证。方法:应用商品化试剂盒Quantikine ELISA,采用酶联免疫定量测定技术(ELISA)测定样品中的rhEGF含量。结果:标准曲线的线性范围为20~200 pg/mL;中间精密度所得相对标准偏差RSD为14.98%(n=9)。低、中、高3个质量浓度的平均回收率分别为94.08%、100.46%、104.89%,相对标准偏差分别为11.03%、9.85%、8.75%(n=3),重复检测10次的相对标准偏差为5.58%。结论:该研究建立的ELISA方法专属性强,精密度、准确度、稳定性均良好,适用于重组人表皮生长因子滴眼液中rhEGF含量的检测。
Objective:To establish a method for the determination of rhEGF content in rhEGF(recombinant human epidermal growth factor)eye drops and perform method validation.Methods:The content of rhEGF in eye drops was determined using a commercial kit Quantikine by enzyme-linked immuno sorbent assay(ELISA).Results:The linear range of the standard curve was 20-200 pg/mL.The relative standard deviation(RSD)of intermediate precision was 14.98%(n=9).The average recoveries of low,medium,and high concentrations of samples were 94.08%,100.46%and 104.89%with RSD 11.03%,9.85%,8.75%(n=3),respectively.The RSD for 10 replicates was 5.58%.Conclusion:The ELISA method established in this study has a good specificity,precision,accuracy and stability,and is suitable for the determination of the content of rhEGF in rhEGF eye drops.
作者
张军
李玉柱
樊婷婷
ZHANG Jun;LI Yuzhu;FAN Tingting(Shanghai Haohai Biotechnology Co.,Ltd.,Shanghai 201613,China;Shanghai Li Kang Rui Biological Engineering Co.,Ltd.,Shanghai 201707,China)
出处
《上海医药》
CAS
2024年第5期77-80,共4页
Shanghai Medical & Pharmaceutical Journal
