同时检测伐地那非及其类似物的免疫学方法

Development of the an Immumoassay for Simultaneous Analysis of Vardenafil and Its Analogues

摘要:

伐地那非是用于治疗阳痿的磷酸二酯酶(phosphodiesterase type-5,PDE-5)抑制剂药物。违法添加到保健品和中成药的伐地那非及其结构类似物对公众健康构成了威胁。单克隆抗体4B9被鉴别为能够同时检测伐地那非及其类似物。以这株抗体建立的间接竞争ELISA方法,对伐地那非的检测限为5.0 ng/mL,线性范围为5.0~40 ng/mL(R2=0.952),IC50值为18.2 ng/mL。对20个中成药进行检测没有发现假阳性,伐地那非最低检出浓度为0.08 mg/g;添加回收率76%~116%,批内差异为9.7%~16.2%。

Abstract:

Vardenafil is a phosphodiesterase type-5(PDE-5) inhibitor for the treatment of erectile dysfunction.Undeclared vardenafil and the related analogues adulterated in herbal commodities are a threat to human health.The anti-vardenafil McAb of 4B9 was the specific to vardenafil and its analogues,based on this result,an indirect competitive enzyme-linked immunosorbent assay(ic-ELISA) was developed.The limit of detection of vardenafil was 5.0 ng/mL-1,the calibration curve was linear from 5.0 to 40 ng/mL-1(R2=0.952) with an IC50 value of 18.2 ng/mL-1.In the extracts of 20 Chinese traditional drugs,the detection capability(CCβ) of vardenafil was 0.08 mg/g-1,the recoveries were 76-116% and the coefficients of variation(C.V.) were 9.7%-16.2%.