Application of micro-kinetic chromogenic method in bacterial endotoxin test of influenza vaccine(split virion, inactivated)
10.13200/j.cnki.cjb.004576
- VernacularTitle:微量动态显色法在流感病毒裂解疫苗细菌内毒素含量检测中的应用
- Author:
YANG Haiyan
- Publication Type:Journal Article
- Keywords:
Influenza vaccine(split virion,inactivated);
Bacterial endotoxin;
Micro-kinetic chromogenic method;
Limulus Amebocyte Lysate(LAL)
- From:
Chinese Journal of Biologicals
2025;38(10):1235-1240
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the feasibility of micro-kinetic chromogenic method for quantitative detection of bacterial endotoxin in influenza vaccine(split virion, inactivated), so as to establish a detection method that saves the dosage of Limulus Amebocyte Lysate(LAL).Methods The working standard of bacterial endotoxin was detected by micro-kinetic chromogenic method, and the standard curve of bacterial endotoxin was established to verify the reliability. The minimum dilution of the test sample with no interference on test results was determined by the interference test. The bacterial endotoxin content of seven batches of influenza vaccines(split virion, inactivated) was detected by micro-kinetic chromogenic method, and the results were compared with those of the conventional kinetic chromogenic method.Results The standard curve of the micro-kinetic chromogenic method showed good linearity in the range of 0. 05-5. 0 EU/mL, with a correlation coefficient(r)of -0. 999 7. When the influenza virus was diluted 16 times or below, there was no interference in the detection, and the recovery rates was between 50% and 200%. The bacterial endotoxin content of seven batches of influenza vaccines(split virion, inactivated) detected by microkinetic chromogenic method all met the company's specification(< 10 EU/mL) and were consistent with the test results of conventional kinetic chromogenic method.Conclusion The micro-kinetic chromogenic method can be adopted for the quantitative detection of bacterial endotoxin in influenza vaccine(split virion, inactivated).The method is accurate and reliable, and can greatly reduce the dosage of LAL under the premise of ensuring quality control,which is of great significance to protect endangered limulus resources.
