摘要
目的 探究Lowry法测定A群C群脑膜炎奈瑟菌(简称脑膜炎球菌)多糖原液蛋白质含量时,细菌内毒素对Lowry法的干扰情况。方法 根据《中华人民共和国药典》2015版(三部)规定的方法,测定含不同浓度的细菌内毒素的A群C群脑膜炎球菌多糖原液的蛋白质含量,对检测结果进行分析。以细菌内毒素为干扰物质,设计3种方法进行验证,对验证结果进行离散系数,即CV值分析,确定干扰限值。结果 当细菌内毒素含量较高时,A群C群脑膜炎球菌多糖原液的蛋白质含量明显增高,该结果可能为假阳性。验证试验结果显示,当溶液中细菌内毒素浓度达到0.313EU/mL时,会对检测结果产生干扰,浓度越高,干扰程度越高。结论 为获得准确的检测结果,当细菌内毒素浓度达到干扰限值时,应先消除干扰,再测定蛋白质含量。
Objective To investigate the interference from bacterial endotoxin on the Lowry method when this method was used in determination the protein content contained in group A/C meningococcal polysaccharides. Methods The protein content was determined in group A/C meningococcal polysaccharides solution with different concentrations of bacterial endotoxin according to the method published in the 《Chinese Pharmacopoeia》(2015 edition), and the detection results were analyzed. Three methods were designed in verification, by using bacterial endotoxin as an interfering substance, and the verified result was subjected to a coefficient of variation( CV), that is, in analysis of CV value to determine the interference limit. Results As the bacterial endotoxin content was high, the protein content in group A/C meningococcal polysaccharides was significantly increased, and the result may be a false positive. The verification test results showed that the bacterial endotoxin content in the solution reached to 0.313 EU/mL, the detection result will be disturbed. The high level of the bacterial endotoxin content resulted in the high interference degree. Conclusion In the case of the bacterial endotoxin content reaches to the interference limit, the interference should be eliminated first, and protein content determination performed afterward, in order to obtain accurate test results.
作者
马明霞
冯佳丽
魏振洲
张建飞
石超
杜送田
MA Ming-xia;FENG Jia-li;WEI Zhen-zhou;ZHANG Jian-fei;SHI Chao;DU Song-tian(The First Bacterial Vaccine Division, Lanzhou Institute of Biological Products Co., Ltd., Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province, China)
出处
《微生物学免疫学进展》
2019年第3期32-37,共6页
Progress In Microbiology and Immunology
