人用狂犬病疫苗浓缩前后内毒素含量变化的研究

本文采用显色鲎试验法测定人用狂犬病疫苗浓缩前后半成品中内毒素含量。经鲎试验抑制增强实验确定人用狂犬病疫苗半成品对鲎试验法测定内毒素无干扰作用。样品经系列稀释，测定光吸收值（５４５ｎｍ），然后将其对数回归直线与标准品的反应直线比较，结果表明，两者间有平行关系，经对四个生物制品研究所的样品进行测定，结果显示，人用狂犬病疫苗经超滤浓缩后内毒素含量有所增加，但在被检３１批样品中，除一所二批浓苗外，其余２９批均低于以往测得的最低家兔致热剂量（３．３２ＥＵ／ｍｌ／Ｋｇ）。

Study of Endotoxin Content in Concentrated and Unconcentrated Rabies Vaccine for Human Use

The endotoxin content in final bulk of concentrated and unconcentrated rabies vaccine for human use were mersured by colorimeric LAL test.Inhibition or enhancement test of LAL showed LAL and final bulk of rabies vaccine for human use was not interact each other.Samples were diluted seriesly and the OD values were detected at 545nm.The results that the logical linear regrression of samples compared with the reference showed there is parallel relationship between them.The samples from four institute of biological products were measured.The endotoxin contend of rabies vaccine for human use rised by super filter and concentration.In 31 lots of samples the endotoxin content of 29 lots of samples were under the lowest fever dosage for rabbit which detected early(3.32EU/ml/kg).