本文選題：家兔熱原檢查法 + 熱原結(jié)果判斷模式　； 參考：《中國(guó)藥學(xué)雜志》2015年14期

【摘要】：目的對(duì)熱原檢查法結(jié)果判斷新模式(NPRJA)進(jìn)行驗(yàn)證,以進(jìn)一步判斷該模式的實(shí)用性、準(zhǔn)確性和可靠性,為推進(jìn)該模式的耐用性提供理論依據(jù)。方法使用本實(shí)驗(yàn)室近3年的654批(1 962只)熱原實(shí)驗(yàn)初試數(shù)據(jù)進(jìn)行驗(yàn)證;對(duì)3 648只預(yù)檢溫合格家兔體溫波動(dòng)情況進(jìn)行統(tǒng)計(jì)分析,論證使用單只升溫作為判斷熱原合格與否的優(yōu)劣性;使用邏輯分析的方法對(duì)熱原檢查法結(jié)果判斷新模式進(jìn)行論證。結(jié)果與2010年版《中國(guó)藥典》三部熱原結(jié)果判斷模式的可疑率為28.0%相比,熱原檢查法結(jié)果判斷新模式可疑率僅為10.4%,可減少目前重復(fù)檢測(cè)次數(shù)的60%以上,同時(shí)對(duì)不合格供試品仍可全部檢測(cè)出。預(yù)檢溫合格的家兔中,前3 h內(nèi)有8%以上體溫波動(dòng)達(dá)到0.4℃。結(jié)論熱原檢查中因家兔自身體溫波動(dòng)較大,以單只家兔升溫≥0.6℃作為判定供試品復(fù)試的標(biāo)準(zhǔn)之一,會(huì)導(dǎo)致檢測(cè)結(jié)果復(fù)試率升高。熱原結(jié)果判斷新模式所采用的升溫總和閾值法不僅可保證現(xiàn)有熱原檢測(cè)結(jié)果的準(zhǔn)確性不變,而且還可顯著減少動(dòng)物使用量和實(shí)驗(yàn)重復(fù)次數(shù),從而降低實(shí)驗(yàn)成本和勞動(dòng)量。同時(shí),它簡(jiǎn)便實(shí)用、科學(xué)可靠,是一個(gè)值得采用與推廣的熱原結(jié)果判斷模式。
[Abstract]:Objective to verify the new model of judging the results of pyrogen test (NPRJAA) in order to further judge the practicability, accuracy and reliability of the model, and to provide a theoretical basis for promoting the durability of the model. Methods the data of 654 batches of 1 962 rabbits in our laboratory were used to verify the temperature fluctuation of 3 648 rabbits. The method of logic analysis is used to demonstrate the new model of judging the results of pyrogen test. Results compared with the Chinese Pharmacopoeia in 2010, the suspicious rate of the model was 28.0%. The suspicious rate of the new model was only 10.4%, which could reduce the number of repeated tests by more than 60%. At the same time, all the unqualified samples can be detected. More than 8% of the rabbits with qualified temperature in the first 3 hours had temperature fluctuation of 0.4 鈩，

本文編號(hào)：1888089