目的 评价组分无细胞百日咳-白喉-破伤风（百白破）（diphtheria, tetanus, component acellular pertussis，DTacP）-Sabin株灭活脊髓灰质炎病毒（Sabin strain inactivated poliovirus vaccine，sIPV）联合疫苗在模拟运输振动条件下的稳定性。方法  选取3批DTacP-sIPV，设计振动条件模拟疫苗运输过程进行稳定性评价。分别于振动前和振动后取样，按照中国药典2020年版三部和内部制造检定规程要求进行成品检测（包括外观、装量、pH、渗透压摩尔浓度、铝含量、游离甲醛含量、戊二醛含量、鉴别、sIPV D抗原含量、百白破效价、无菌、内毒素含量、特异性毒性、异常毒性和毒性逆转检测）、sIPV效力试验、Zeta电位测定、上清液中抗原测定及电子显微镜观察。 结果  振动前后，3批DTacP-sIPV的检测结果均符合质量标准要求，百白破效价与D抗原水平以及sIPV效力试验结果差异无统计学意义（t值分别在0.21~0.73、0.05~1.34和0.16~1.90，P值均>0.05）；Zeta电位以及上清液中抗原（百日咳毒素、丝状血凝素、黏附素）含量与振动前结果差异无统计学意义（t值分别为0.49和0.20~0.80，P值均>0.05）；电子显微镜观察结果与振动前比较无明显变化。结论  DTacP-sIPV联合疫苗在模拟运输振动条件下稳定性良好。

Objective  To evaluate the stability of diphtheria, tetanus, component acellular pertussis (DTacP) and Sabin strain inactivated poliovirus (sIPV) combined vaccine in simulated transportation vibration test.  Methods  Three batches of DTacP-sIPV were randomly selected for simulated transportation vibration test, and samples were taken before and after vibration for tests required in Chinese pharmacopoeia 2020 edition volume Ⅲ and manufacture instructions, including final product detection (appearance, deliverable volume, pH, osmolality, aluminum content, residual free formaldehyde content, residual glutaraldehyde content, identification, D-antigen content of sIPV, potency of pertussis, diphtheria and tetanus, sterility, endotoxin content, specific toxicity, undue toxicity, and reversion to toxicity tests), potency test of sIPV, Zeta potential determination, antigens determination in supernatant and electron microscope observation to evaluate the stability. Results  All test results of 3 batches of DTacP-sIPV after vibration were in line with quality control criteria. No statistically significant difference was observed among results for potency of diphtheria, tetanus and pertussis, D antigen content of sIPV, and potency of sIPV before and after vibration (t values were 0.21-0.73, 0.05-1.34 and 0.16-1.90, all P>0.05). The results of Zeta potential and the contents of pertussis toxin, filamentous haemagglutinin and pertactin antigens in supernatant were similar to those before vibration (t values were 0.49 and 0.20-0.80, all P>0.05). No obvious changes were observed under electron microscope. Conclusion  DTacP-sIPV shows high stability under the simulated vibration conditions.