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鲎法即细菌内毒素检查法(LT),用以检查四种大输液(注射用水、氯化钠注射液、5％和10％葡萄糖注射液)的热原,自卫生部标准(试行)WS2—288(Y—47)—88文规定试行,到正式收载中国药典(Ch.P.)95版使用至今已十年。但是该法结果的准确性及试验的灵敏度受多种因素的影响。本文就我们十多年实验过程中出现的问题及资料文献的积累进行一些探讨。 1.阳性对照管不凝 Ch.P.规定,LT必须做阳性对照。其目的就是证实实验条件下鲎试剂的活性。然而在我们试验过程中多次出现阳性对照管不凝,是一个实验过程中带普遍性的问题,在实验中曾出现阳性凝胶未形成或凝胶形成不好的现象。究其原因不外乎以下三种情况:一是鲎试剂灵敏
Bacteria endotoxin test (LT) is used to check the pyrogen of four large infusion solutions (water for injection, sodium chloride injection, 5% and 10% glucose injection) -288 (Y-47) -88 text prescribing trial to the official collection of Chinese Pharmacopoeia (Ch.P.) 95 version has been used for ten years. However, the accuracy of the results and the sensitivity of the test are affected by many factors. This article discusses some of the problems that have occurred in our more than 10 years of experiments and the accumulation of information and literature. 1. Positive control tube is not condensing Ch.P. provisions, LT must do positive control. Its purpose is to confirm the activity of the limulus reagent under experimental conditions. However, in our experiment, the positive control tube appeared several times without coagulation, which was a common problem during the experiment. In the experiment, positive gel did not form or gel formation was not good. The reason is nothing more than the following three conditions: First, 鲎 reagent sensitive