Scheer R
Carl Gustav Carus-Institut, Niefern-Oschelbronn.
Arzneimittelforschung. 1993 Jul;43(7):795-800.
Former reports about too high and from batch to batch changing endotoxin contents in mistletoe preparations and phytopharmaceuticals for parenteral administration correlated with clinically observed side effects led to investigations of the endotoxin content of ABNOBA-viscum. For that purpose the endotoxin levels of the raw materials, the equipment and the production steps were observed by using the limulus amebocyte lysate (LAL) test. The mean value found in the preparation containing the highest available concentration (dilution level 2 containing 15 mg of plant extract from 20 mg of fresh mistletoe in 1 ml) came to 66.7 endotoxin units (EU) per ml, corresponding to about one fifth of the commonly accepted limit value of 350 EU/ml, the human pyrogenic dose. Depending on their dilution level, lower concentrated preparations led also to lower LAL test results. It could be proved that lectins contained in mistletoe preparations cause false positive LAL tests. Such results implicate false too high contents of endotoxin. Different lysates, i.e. Limusate, Pyrogel, Pyrogent, and Pyroquant showed approximately the same results. Microbiological and LAL test results indicate that only 10% of the total amount of the LAL test result was caused by endotoxins. So it is necessary to form a new estimation of the former results of determination of the endotoxin content of mistletoe preparations.
先前有关槲寄生制剂和用于肠胃外给药的植物药中内毒素含量过高且批次间存在变化的报道,这些报道与临床观察到的副作用相关,这促使人们对ABNOBA - viscum的内毒素含量展开调查。为此,通过使用鲎试剂(LAL)试验观察了原材料、设备及生产步骤的内毒素水平。在含有最高可用浓度的制剂(稀释度2,1毫升中含有15毫克源自20毫克新鲜槲寄生的植物提取物)中发现的平均值为每毫升66.7内毒素单位(EU),约为公认的人体致热剂量350 EU/ml限值的五分之一。根据其稀释度,较低浓度的制剂LAL试验结果也较低。已证实槲寄生制剂中含有的凝集素会导致LAL试验出现假阳性。这样的结果意味着内毒素含量存在过高的假象。不同的鲎试剂,即Limusate、Pyrogel、Pyrogent和Pyroquant,显示出大致相同的结果。微生物学和LAL试验结果表明,LAL试验结果总量中仅有10%是由内毒素引起的。因此,有必要对先前槲寄生制剂内毒素含量测定结果进行重新评估。