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目的分析吸附无细胞百白破联合疫苗(adsorbed diphtheria-tetanus-acellular pertussis combined vaccine,DTa P)细菌内毒素检查方法的可行性。方法确定供试品最大有效稀释倍数(maximum valid dilution,MVD),并将两个厂家的鲎试剂(λ=0.25 EU/ml)进行灵敏度复核试验后,按照《中国药典》三部(2010版)附录ⅫE细菌内毒素检查法要求,采用稀释法进行供试品干扰试验,确定无干扰稀释倍数;采用凝胶限量试验对13批DTa P进行细菌内毒素检测,并采用动态显色法定量检测其中6批DTa P细菌内毒素含量。结果供试品MVD为800倍;两个厂家鲎试剂灵敏度均在0.125~0.5(0.5~2λ)范围内,符合《中国药典》三部(2010版)规定的标准。将DTa P稀释400倍可排除干扰。13批DTa P凝胶限量试验结果均<12 EU/剂,其中6批DTa P动态显色法结果均<2.5 EU/剂,相同6批疫苗两种检测方法的结果趋势一致。结论凝胶限量试验与动态显色法均可用于DTa P细菌内毒素检查,但凝胶限量试验更经济,操作更简便,适用范围更广。
Objective To analyze the feasibility of bacterial endotoxin test for adsorbed diphtheria-tetanus-acellular pertussis combined vaccine (DTa P). Method to determine the maximum valid dilution (MVD) of the test sample, and the sensitivity test of the two manufacturers’ reagent (λ = 0.25 EU / ml), according to the Chinese Pharmacopoeia (2010 Edition) Appendix ⅫE bacterial endotoxin test requires the use of dilution method for the interference test of the test to determine the non-interference dilution factor; gel limit test of 13 batches of DTa P bacterial endotoxin testing and dynamic colorimetric assay Six batches of DTa P bacterial endotoxin content. The results showed that the MVD of the test sample was 800-fold. The sensitivity of the two manufacturers was within the range of 0.125-0.5 (0.5-2λ), which was in line with the standards of the third part of the Chinese Pharmacopoeia (2010 edition). Dilute DTa P by 400 times to eliminate interference. Thirteen batches of DTa P gel limit test results were <12 EU / dose, of which 6 batches of DTa P dynamic colorimetric results were <2.5 EU / dose, the same six batches of vaccine results of the two detection trends consistent. Conclusion Both gel limit test and dynamic colorimetric assay can be used for DTa P bacterial endotoxin test. However, the gel limit test is more economical, easier to operate and has a wider scope of application.