目的  通过强制降解试验观察冻干b型流感嗜血杆菌（Haemophilus influenzae type b，Hib）结合疫苗在高温、高湿、强光照射下的稳定性，为疫苗生产工艺、包装材料和贮存条件的确定提供科学依据。 方法  分别采用40 ℃温度、（75±5）%相对湿度、（4 500 ±500）lx光照处理冻干Hib结合疫苗，取样进行疫苗的全部项目检测。 结果  疫苗经40 ℃处理10 d，水分由2.0%上升至2.9%，多糖分子大小（分配系数小于0.2的洗脱液回收率）由94%下降至85%，但仍分别符合≤3.0%和＞60%的质量标准；而高分子结合物含量由87%降至75%，不符合≥80%的质量标准。（75±5）%相对湿度和（4 500±500）lx光照处理10 d对疫苗的影响不明显，疫苗质量指标仍符合规定。结论  高温是影响冻干Hib结合疫苗稳定性的主要因素。

Objective  To observe stability of freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine under high temperature, high relative humidity and strong light with compulsory degradation tests, and provide scientific basis for determination of vaccine production process, packaging materials and storage conditions. Methods  The freeze-dried Hib conjugate vaccine was treated with temperature of 40 ℃, relative humidity of (75±5)% and light of (4 500±500) lx, respectively. Then the vaccine was sampled and tested for all items. Results  After 10 d of 40 ℃ treatment, the water content of the vaccine increased from 2.0% to 2.9%, the molecular size of polysaccharide (the recovery rate of elute with distribution coefficient <0.2) decreased from 94% to 85%, but still met quality standards of ≤3.0% and >60%, respectively. The content of high molecular weight conjugates decreased from 87% to 75%, failing to meet the quality standard of ≥80%. The effect of (75±5)% relative humidity and (4 500±500) lx light irradiation for 10 d on the vaccine was not obvious, and the quality of the vaccine was still in line with requirements.  Conclusion  High temperature is the main factor affecting the stability of freeze-dried Hib conjugate vaccine.