目的 评价阿达木单抗注射液的运输稳定性。方法 以武汉市至哈尔滨市作为公路运输起止点，进行1次往返运输，模拟药品运输过程的最差条件，以考察非温度因素条件下的药品稳定性。以极端温度及温度循环等破坏性试验来模拟药品脱冷链后的情况，通过检测阿达木单抗注射液常规质量检定项目考察药品温度偏移稳定性。结果 运输后3批次药品内包材均完整，破瓶率为0%，所有检测项目均符合企业标准，药品运输前后差异无统计学意义(t=﹣3.23~4.00,P=0.057~0.840)。3批次药品分别在(40±2) ℃、(﹣20±5) ℃条件下放置7 d后所有检测项目均符合企业标准。其中药品在(40±2) ℃条件下放置7 d后，分子排阻色谱法测定的单体含量和离子色谱法测定的纯度与2~8 ℃及(﹣20±5) ℃下的差异均有统计学意义(t=﹣142.00~97.00，P=0.000~0.020)。(﹣20±5) ℃条件下放置7 d后，药品所有检定项目与2~8 ℃条件下差异均无统计学意义(t=0.70~3.46，P=0.074~0.556)。3批次药品经过3次冻融后所有检测项目均符合企业标准，与未经冻融试验样品差异无统计学意义(t=﹣4.06~1.73，P=0.056~0.478)。结论 在本实验条件下长途运输非温度因素对药品的质量没有影响，药品在短期内温度偏移对药品的质量影响较小。

Objective To evaluate the transportation stability of adalimumab injection.Methods The worst-case transport conditions were simulated by conducting a round-trip road transport from Wuhan to Harbin, to assess drug stability under non-temperature factors. Destructive tests, including extreme temperature exposure and temperature cycling, were employed to simulate post-cold-chain-break scenarios. Stability under temperature excursions was evaluated by testing routine quality attributes of adalimumab injection.Results The primary packaging of all 3 batches remained intact post-transportation, with 0% breakage rate. All tested attributes complied with the company’s registered specifications, showing no statistically significant differences compared to pre-transport samples (t=﹣3.23-4.00,P=0.057-0.840). After storage at (40±2) °C or (﹣20±5) °C for 7 d, all attributes for 3 batches met the company’s registered specifications. However, monomer content (determined by size exclusion chromatography) and purity (determined by ion chromatography) exhibited statistically significant differences (t=﹣142.00-97.00，P=0.000-0.020) between samples stored at (40 ± 2) °C and those stored at 2-8 °C or (﹣20±5) °C. No statistically significant differences (t=0.70-3.46，P=0.074-0.556) were observed in any attributes between samples stored at (﹣20±5) °C for 7 days and those stored at 2-8 °C. All attributes met the company’s registered specifications after 3 freeze-thaw cycles, with no statistically significant differences compared to samples not subjected to freeze-thaw testing (t=﹣4.06-1.73，P=0.056-0.478).Conclusion Under the experimental conditions, non-temperature factors during long-distance transportation have no impact on drug quality, and short-term temperature excursions have minimal effect on the quality of adalimumab injection.