抑制／增强系数鲎试验法检查注射液细菌内毒素

Inhibition/Enhance Coefficient of Limulus Lysate Test:A New Method for Detecting Bacterial Endotoxin in Injection

抑制／增强系数鲎试验法是用于检查注射液中细菌内毒素的新方法。结果是不同的注射液抑制／增强系数不同，但每一种注射液的抑制／增强系数又是恒定的。本文测定了６种注射液及其１→２和１→４稀释液的抑制／增强系数和其细菌内毒素限量校正值。其抑制／增强系数：复方氯化钠注射液（及其稀释液）１；２０％甘露醇注射液（及其稀释液）１．２；葡萄糖氟化钠注射液（及其稀释液）１．４；５０％葡萄糖注射液１３０，（其１→２和１→４稀释液均为５）；２５％葡萄糖注射液４５，（其１→２和１→４稀释液均为５）；甲硝唑注射液８，（其１→２和１→４稀释液分别为２．５）。本法与经典的家兔法试验结果一致，两方法间无显著差异（ｐ＞０．０５）。我们认为本法可以用于注射液细菌内毒素的检查。

Inhibition/enhance coefficient of limulus lysate test was used to determine the bacterial endotoxin in injections.The results were as follows:different injections showed different inhibition/enhance coefficients and in given injection.the coefficient was always constant.The inhibition/enhance coefficients and their rectified values of limiting quantity of endotoxin were evaluated in 6 kinds of injections and their dilute solutions.The coefficient was 1 in compound sodium chloride injection and its dilute solution:1.2 in 20% mannitole injection and its dilute solution:1.4 in glucose and sodium chloride injection and its dilute solution:130 in 50% glucose injection and 5 in its twice and 4-times-dilute solutions:45 in 25% glucose injection and 5 in its twice and 4-times-dilute solutions:8 in metronidazole injection and 2.5 in its twice and 4-times-dilute solutions.The results coincided with those of rabbit pyrogenic test(p>0.05).We suggest that this method can be used to detect the endotoxin in the injection with inhibition/enhance effect.