首页|ELISA方法测定重组人表皮生长因子滴眼液中rhEGF含量

ELISA方法测定重组人表皮生长因子滴眼液中rhEGF含量

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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.
Determination of recombinant human epidermal growth factor(rhEGF)content in rhEGF eye drops by ELISA
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.

rhEGFELISAeye drop

张军、李玉柱、樊婷婷

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上海昊海生物科技股份有限公司 上海 201613

上海利康瑞生物工程有限公司 上海 201707

重组人表皮生长因子 ELISA 滴眼液

2024

上海医药
上海医药行业协会

上海医药

影响因子：0.781
ISSN：1006-1533
年,卷(期)：2024.45(5)
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