Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum

doi:10.3389/fphar.2020.00700

科研成果详情

题名	Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum
作者	Hui, Qi1,2; Yang, Rongshuai 1,2; Lu, Chao 1,2; Bi, Jianing1,2; Li, Lijia 1,2; Gong, Jianxiang 1,2; Zhang, Li 1; Jin, Zi1,2; Li, Xiaokun1,2,3; Wang, Xiaojie 1,2,3
发表日期	2020-05-19
发表期刊	FRONTIERS IN PHARMACOLOGY 影响因子和分区
语种	英语
原始文献类型	Article
关键词	enzyme-linked immunosorbent assay (ELISA) method validation rh-aFGF hydrogel pharmacokinetics relative bioavailability
其他关键词	IMMUNOSORBENT-ASSAY ELISA ; FIBROBLAST-GROWTH-FACTOR ; PLASMA
摘要	In this study, we validated a double-sandwich enzyme-linked immunosorbent assay (ELISA) to investigate the pharmacokinetics of a recombinant human acidic fibroblast growth factor (rh-aFGF) hydrogel in rat skin and serum. A total of 130 Sprague-Dawley rats were divided into a control group, rh-aFGF hydrogel group, and a positive-control group (commercial rh-aFGF-Ai). We first determined the dilution ratio of skin homogenate and then validated the quantitative range, specificity, precision, and accuracy of our double-sandwich ELISA method, as well as the stability of our rh-aFGF hydrogel. For our pharmacokinetic study, skin and serum samples were collected at 0.5, 1, 2, 4, 6, and 10 h after rh-aFGF administration, and the concentration of rh-aFGF was measured by ELISA. The results showed that a 10-fold dilution of the skin tissue homogenate circumvented non-specific interference with endogenous proteins. The quantitative scope of the rh-aFGF calibration curve ranged from 62.5 to 4,000 pg/mL. The precision and accuracy of rh-aFGF quality-control samples were below 20%. Furthermore, bFGF, FGF21, KGF-2, and insulin did not interfere with the detection of aFGF, confirming that our method was specific. Rh-aFGF was stable under normal storage conditions. The maximum concentration (C-max) and time to peak (T-max) of the rh-aFGF hydrogel were 909.2 pg/cm(2) and 0.5 h, respectively. The relative bioavailability (F) of the rh-aFGF hydrogel was 120% compared with that of rh-aFGF-Ai. The serum concentration of rh-aFGF was too low to be detected. Taken together, the pharmacokinetics of this rh-aFGF hydrogel provide further support for clinical research on rh-aFGF, and our double-sandwich ELISA method may be useful for pharmacokinetic studies of other protein-based drugs.
资助项目	National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81601695]; Science and Technology Project of Wenzhou [Y20180150]
出版者	FRONTIERS MEDIA SA
出版地	LAUSANNE
ISSN	1663-9812
卷号	11 页码:700
DOI	10.3389/fphar.2020.00700
页数	9
WOS类目	Pharmacology & Pharmacy
WOS研究方向	Pharmacology & Pharmacy
WOS记录号	WOS:000538880000001
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	32508643
PMC记录号	PMC7248203
SCOPUSEID	2-s2.0-85085892611
通讯作者地址	[Li, Xiaokun]The Department of Dermatology of the First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China
Scopus学科分类	Pharmacology;Pharmacology (medical)
引用统计	被引频次：1[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/15633
专题	附属第一医院_皮肤科药学院（分析测试中心）第一临床医学院（信息与工程学院）、附属第一医院
通讯作者	Li, Xiaokun
作者单位	1.The Department of Dermatology of the First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 2.School of Pharmacy,Wenzhou Medical University,Wenzhou,China; 3.Engineering Laboratory of Zhejiang Province for Pharmaceutical Development of Growth Factors,Biomedical Collaborative Innovation Center of Wenzhou,Wenzhou,China
第一作者单位	附属第一医院; 第一临床医学院（信息与工程学院）、附属第一医院; 药学院（分析测试中心）
通讯作者单位	附属第一医院; 第一临床医学院（信息与工程学院）、附属第一医院
第一作者的第一单位	附属第一医院
推荐引用方式 GB/T 7714	Hui, Qi,Yang, Rongshuai,Lu, Chao,et al. Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum[J]. FRONTIERS IN PHARMACOLOGY,2020,11:700.
APA	Hui, Qi., Yang, Rongshuai., Lu, Chao., Bi, Jianing., Li, Lijia., ... & Wang, Xiaojie. (2020). Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum. FRONTIERS IN PHARMACOLOGY, 11, 700.
MLA	Hui, Qi,et al."Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum".FRONTIERS IN PHARMACOLOGY 11(2020):700.