热原检查法结果判断新模式的验证

发布时间：2018-05-14 13:47

  本文选题：家兔热原检查法 + 热原结果判断模式　； 参考：《中国药学杂志》2015年14期

【摘要】：目的对热原检查法结果判断新模式(NPRJA)进行验证,以进一步判断该模式的实用性、准确性和可靠性,为推进该模式的耐用性提供理论依据。方法使用本实验室近3年的654批(1 962只)热原实验初试数据进行验证;对3 648只预检温合格家兔体温波动情况进行统计分析,论证使用单只升温作为判断热原合格与否的优劣性;使用逻辑分析的方法对热原检查法结果判断新模式进行论证。结果与2010年版《中国药典》三部热原结果判断模式的可疑率为28.0%相比,热原检查法结果判断新模式可疑率仅为10.4%,可减少目前重复检测次数的60%以上,同时对不合格供试品仍可全部检测出。预检温合格的家兔中,前3 h内有8%以上体温波动达到0.4℃。结论热原检查中因家兔自身体温波动较大,以单只家兔升温≥0.6℃作为判定供试品复试的标准之一,会导致检测结果复试率升高。热原结果判断新模式所采用的升温总和阈值法不仅可保证现有热原检测结果的准确性不变,而且还可显著减少动物使用量和实验重复次数,从而降低实验成本和劳动量。同时,它简便实用、科学可靠,是一个值得采用与推广的热原结果判断模式。
[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，

本文编号：1888089