{"title":"兔血浆中重组葡萄激酶间接竞争性酶联免疫吸附测定法的建立与验证:在药代动力学研究中的应用","authors":"Anmol Kumar, K. Pulicherla, K. S. Rao","doi":"10.1080/15321819.2015.1126600","DOIUrl":null,"url":null,"abstract":"The relatively short circulatory half-life (2–3 min) of staphylokinase is a major drawback in the development of SAK- (staphylokinase) based thrombolytic drug. A rapid and sensitive method, based on indirect competitive ELISA, was developed and validated for quantitative determination of SAK in rabbit plasma. The dynamic range of the assay varied between 0.41 ± 0.16 μg/L and 9.03 ± 0.38 μg/L (R2 = 0.98) for SAK in rabbit plasma. There were no dilution linearity issues apparent with this assay. The precision (% CV) ranged from 4.6–9.7% for the intraassay and from 17.1–19.3% for interassay. This validated method was successfully employed for evaluation of various pharmacokinetic parameters of SAK in rabbit.","PeriodicalId":15987,"journal":{"name":"Journal of Immunoassay and Immunochemistry","volume":"10 1","pages":"228 - 242"},"PeriodicalIF":0.0000,"publicationDate":"2016-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Development and validation of an indirect competitive ELISA for quantification of recombinant staphylokinase in rabbit plasma: Application to pharmacokinetic study\",\"authors\":\"Anmol Kumar, K. Pulicherla, K. S. Rao\",\"doi\":\"10.1080/15321819.2015.1126600\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The relatively short circulatory half-life (2–3 min) of staphylokinase is a major drawback in the development of SAK- (staphylokinase) based thrombolytic drug. A rapid and sensitive method, based on indirect competitive ELISA, was developed and validated for quantitative determination of SAK in rabbit plasma. The dynamic range of the assay varied between 0.41 ± 0.16 μg/L and 9.03 ± 0.38 μg/L (R2 = 0.98) for SAK in rabbit plasma. There were no dilution linearity issues apparent with this assay. The precision (% CV) ranged from 4.6–9.7% for the intraassay and from 17.1–19.3% for interassay. This validated method was successfully employed for evaluation of various pharmacokinetic parameters of SAK in rabbit.\",\"PeriodicalId\":15987,\"journal\":{\"name\":\"Journal of Immunoassay and Immunochemistry\",\"volume\":\"10 1\",\"pages\":\"228 - 242\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-03-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Immunoassay and Immunochemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/15321819.2015.1126600\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Immunoassay and Immunochemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/15321819.2015.1126600","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Development and validation of an indirect competitive ELISA for quantification of recombinant staphylokinase in rabbit plasma: Application to pharmacokinetic study
The relatively short circulatory half-life (2–3 min) of staphylokinase is a major drawback in the development of SAK- (staphylokinase) based thrombolytic drug. A rapid and sensitive method, based on indirect competitive ELISA, was developed and validated for quantitative determination of SAK in rabbit plasma. The dynamic range of the assay varied between 0.41 ± 0.16 μg/L and 9.03 ± 0.38 μg/L (R2 = 0.98) for SAK in rabbit plasma. There were no dilution linearity issues apparent with this assay. The precision (% CV) ranged from 4.6–9.7% for the intraassay and from 17.1–19.3% for interassay. This validated method was successfully employed for evaluation of various pharmacokinetic parameters of SAK in rabbit.
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