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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。
In this paper, 鲎 test gel method was used to quantitatively determine the endotoxin content of 212 batches of Group A meningitis polysaccharide vaccine and compared with the results of pyrogen test in rabbits. The changes of body temperature in rabbits were determined by endotoxin standard Linear equation of relationship and endotoxin to rabbits minimum pyrogenic dose. The results showed that the endotoxin content was less than 100 IU / μg polysaccharide in 94.3% of the total batches of the test, the pass rate of the pyrogen test in the rabbit was 100%, the endotoxin content in the 5.7% of the product was ≥100 IU / μg polysaccharide , Rabbit pyrogen test pass rate of 58.3%. According to the experimental results, we can formulate the gel method instead of the rabbit method to determine the standard of pyrogen test of A group meningitis polysaccharide vaccine. The authors suggest: endotoxin content <100IU / μ g polysaccharides, pyrogen test was judged qualified, ≥ 100IU / μ g polysaccharides, rabbits were arbitrated.