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目的建立新型胃癌治疗性疫苗的细菌内毒素检查方法。方法依据《中国药典》三部(2015版)通则1143细菌内毒素检查法,使用细菌内毒素分散剂消除供试品的干扰作用,检测新型胃癌治疗性疫苗的细菌内毒素含量。结果新型胃癌治疗性疫苗在使用细菌内毒素分散剂稀释2倍后,对细菌内毒素实验无干扰作用,其细菌内毒素限值符合规定。结论所建立的方法可用于该新型胃癌治疗性疫苗的细菌内毒素检查,该方法对同类产品的细菌内毒素检查具有借鉴意义。
Objective To establish a bacterial endotoxin test for a novel gastric cancer therapeutic vaccine. Methods According to the bacterial endotoxin test of 1143 General Principles of Chinese Pharmacopoeia (2015 Edition), the bacterial endotoxin dispersant was used to eliminate the interference effect of the test sample and the bacterial endotoxin content of the novel gastric cancer therapeutic vaccine was tested. Results The novel gastric cancer vaccine did not interfere with the bacterial endotoxin test after the bacterial vaccine was twice diluted with bacterial endotoxin dispersant. The bacterial endotoxin limit was within the limits. Conclusion The established method can be used for the bacterial endotoxin test of the novel gastric cancer therapeutic vaccine. This method is of reference value for the bacterial endotoxin test of similar products.