凝胶法和动态浊度法在b型流感嗜血杆菌结合疫苗细菌内毒素控制中的应用比较

摘要

Objective To detect the content of bacterial endotoxin in the intermediate, final bulk and finishied products of haemophilus type B conjugate vaccine with Kinetic turbidinetric method and gel clot test for the control of pyrogen and improving the quality of the products .Meanwhile compare with two methods. Method According to the Methods of Detection of Bacterial Endotoxin in the AppendixⅫE of The Pharmacopoeia of the People’s Republic of China of the year 2010 edition.Results The detection limit for acterial endotoxin of the intermediate,final bulk and finishied products of Hib defined 25EU/µg、5 EU/µg、25 EU/dose,in accordance with the provisions. Conclusion The results of the tests indicate that application of kinetic turbidinetric method and gel clot test for detection of Haemophilus influenza type B conjugates vaccine intermediates,final bulk and finished products in accordance with the results of the content of bacterial endotoxin,quantitative Kinetic turbidinetric method is a good guidance for endotoxin content of internal control index.%目的：在b型流感嗜血杆菌结合疫苗生产过程中采用凝胶法和动态浊度法检测中间品、原液和成品中细菌内毒素含量，以此控制热原，提高制品质量，并对两种方法进行比较。方法采用《中华人民共和国药典》（2010年版）三部附录ⅫE细菌内毒素检查法中的凝胶法和动态浊度法。结果 Hib中间品、原液及成品经凝胶法和动态浊度法测定，内毒素含量均＜25EU/µg、5EU/µg、25EU/剂，符合规定。结论各项检定结果表明：应用动态浊度法和凝胶法检测b型流感嗜血杆菌结合疫苗中间品、原液和成品细菌内毒素含量结果相符，动态浊度法定量检测对于内毒素含量内控指标有很好的指导意义。