鲎试验法检测A群流脑多糖菌苗中内毒素的研究

Study of LAL Test for Quantitation of Endotoxin in Meningococcal Polysaccharide Vaccine Group A

本文应用鲎试验凝胶法定量测定了２１２批Ａ群流脑多糖菌苗中内毒素含量，并与家兔热原试验结果进行了比较，通过试验求得内毒素标准品对家兔体温升温变化关系的线性方程和内毒素对家兔最小致热剂量。结果表明，占检定总批数９４．３％的制品中内毒素含量＜１００ＩＵ／μｇ多糖，家兔热原试验合格率为１００％，５．７％的制品中内毒素含量≥１００ＩＵ／μｇ多糖，家兔热原试验合格率为５８．３％。根据实验结果，可制订用凝胶法替代家兔法进行Ａ群流脑多糖菌苗的热原质试验的判定标准。作者建议：内毒素含量＜１００ＩＵ／μｇ多糖者，热原质试验判为合格，≥１００ＩＵ／μｇ多糖者，用家兔法予以仲裁。

The endotoxin concentration of 212 lots of meningococcal polysaccharide vaccine group A was determined quantitatively by LAL test. The results were compared with rabbit test.The Linear regression relation beween endotoxin concentration and temparature rise of rabbit was established ,the minimus rabbit pyrogen dose was got. The results showd that when endotoxin concentation of praduct is ＜100IU/μg polysacchoride,rabbit test was pass 100%,there were 94. 3% lots of product in this range; when endotoxin concentration of product was≥ 100IU/μg polysacchoride,rabbit test was pass 58.3%,there were 5. 7% lots of product in this range. Depending on the results,the judgement of LAL assay to replace rabbit method for pyrogen test of meningococcal polysaccharide vaccine group A was built up ,and writer suggest:if the endotoxin concentration was ＜100IU/μg,the product should be considered to pass pyrogen test；if the endotoxin concentration was≥ l00IU/μg,the rabbit method should be used to arbitrate finally.