含有十二烷基磺酸钠的生物制剂的内毒素检测不能采用鲎试验

Effect of the Sodium Dodecyl Sulfate on the LAL(Tachypleus tridentatus) Test for the Detection of Pyrogen in the Biological Products

重组人ＩＬ－２在大肠杆菌表达时形成包含体，需经过变性和复性才具有生物学活性，在分离提取过程中常加一定量的ＳＤＳ，最低浓度每毫升不小于０．２５ｍｇ；低于此浓度会发生沉淀。鲎试验（ＬＡＬ试验）是一种灵敏度很高的检查生物制剂中致热源的常规方法。我们发现，当样本中ＳＤＳ的浓度＞０．０２５ｍｇ／ｍｌ时，可抑制尝试制的酶反应，使阳性结果转变为阴性。据此，我们建议，凡生物制剂中含有ＳＤＳ或其他酶抑制剂的产品，以尝试验来检查内毒素含量是没有意义的。

The recombinant interleukin 2(rIL-2) was produced in E. coli as an inclusion body. The sodium dodecy1 sulfate(SDS)seems necessary during its denaturation and renaturation in some purification procedure. The final product(rIL-2)will become insoluble, when the concentration of SDS is lower than 0.25mg per ml. The LAL(Tachypleus tridentatus) test is a very sensitive method for the detection of pyrogen in the biological products. It was found that the preparation containing>0.025mg per ml of SDS, like LAL reaction and covert the positive result into negative. Based on the obtained result,it is suggested that the LAL test is not available for the detection of pyrogen in the biological products containing SDS.