CAJ | 학술논문

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。
목적：재b형류감기혈간균결합역묘생산과정중채용응효법화동태탁도법검측중간품、원액화성품중세균내독소함량，이차공제열원，제고제품질량，병대량충방법진행비교。방법채용《중화인민공화국약전》（2010년판）삼부부록ⅫE세균내독소검사법중적응효법화동태탁도법。결과 Hib중간품、원액급성품경응효법화동태탁도법측정，내독소함량균＜25EU/μg、5EU/μg、25EU/제，부합규정。결론각항검정결과표명：응용동태탁도법화응효법검측b형류감기혈간균결합역묘중간품、원액화성품세균내독소함량결과상부，동태탁도법정량검측대우내독소함량내공지표유흔호적지도의의。
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.