本文選題：過敏反應(yīng) + 補(bǔ)體��； 參考：《藥學(xué)學(xué)報(bào)》2017年05期

【摘要】：補(bǔ)體激活相關(guān)的假性過敏反應(yīng)(complement activation-related pseudo-allergic reactions,CARPA)占全部免疫介導(dǎo)的直接過敏反應(yīng)的77%。由于CARPA臨床普遍性,以及該反應(yīng)與藥物理化性質(zhì)的相關(guān)性,補(bǔ)體活性檢測(cè)被建議作為藥物免疫毒性和藥物一致性的評(píng)價(jià)指標(biāo)之一。但是,由于補(bǔ)體活性的體內(nèi)檢測(cè)較為復(fù)雜、不同個(gè)體之間以及人與動(dòng)物之間存在免疫差異,使得有必要建立一個(gè)標(biāo)準(zhǔn)、快捷的模型,用于評(píng)價(jià)藥物對(duì)補(bǔ)體活性的影響。本研究使用人混合血清作為標(biāo)準(zhǔn)反應(yīng)血清,通過加入熱聚集Ig G和酵母多糖激活血清得到標(biāo)準(zhǔn)陽性對(duì)照,將SC5b-9、C5a、C4d和Bb作為檢測(cè)指標(biāo)并確定評(píng)價(jià)標(biāo)準(zhǔn),建立了藥物對(duì)補(bǔ)體活性影響的體外評(píng)價(jià)模型。應(yīng)用該評(píng)價(jià)模型,以抗真菌類藥物兩性霉素B的不同處方和注射用伏立康唑?yàn)檠芯繉?duì)象,對(duì)這些藥物的免疫毒性以及仿制與市售制劑的一致性進(jìn)行了初步評(píng)價(jià)。
[Abstract]:Complements activation-related pseudo-allergic reacts (CARPA) accounted for 77% of all immune-mediated direct allergic reactions. Because of the clinical universality of CARPA and the correlation between the reaction and the physicochemical properties of the drug, the detection of complement activity is suggested as one of the evaluation indexes of drug immunotoxicity and drug consistency. However, due to the complexity of in vivo detection of complement activity and the difference of immunity between individuals and animals, it is necessary to establish a standard and fast model to evaluate the effect of drugs on complement activity. In this study, the human mixed serum was used as the standard reactive serum, and the standard positive control was obtained by adding heat agglomeration IgG and yeast polysaccharide activated serum. The SC5b-9 C5aAX C4d and BB were used as the detection indexes and the evaluation criteria were determined. An in vitro evaluation model of the effect of drugs on complement activity was established. Using this evaluation model, the different prescriptions of amphotericin B and voleconazole for injection were used to evaluate the immunotoxicity of these drugs and the consistency between imitative and commercial preparations.
【作者單位】： 石家莊市第五醫(yī)院;石藥集團(tuán)中奇制藥技術(shù)(石家莊)有限公司;河北中醫(yī)學(xué)院;
【基金】：國(guó)家“十二五”重大新藥創(chuàng)制資助項(xiàng)目(2014ZX09507001) 石家莊市科技支撐計(jì)劃(151461193)
【分類號(hào)】：R96

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