目的 模拟制剂工艺中自制磷酸铝佐剂的无菌处理过程，对其在储存的不同时间点进行第2次高压灭菌，检测高压灭菌前后佐剂质量特性的变化情况，为磷酸铝佐剂的储存、使用和有效期设置提供基础数据。方法 将3批自制产业化规模磷酸铝佐剂储存于（25 ±2） ℃，分别在0、1、3、6、9、12、18和24个月定期取样进行第2次高压灭菌（121 ℃、30 min）。检测高压灭菌前后佐剂的质量特性，包括外观、pH、吸附率、粒径大小与分布、零电荷点、Zeta电位、上清液磷含量、磷/铝摩尔比等。结果 在（25 ±2） ℃储存24个月，3批磷酸铝佐剂各项质量特性稳定；在储存期间的不同时间点进行第2次高压灭菌，3批磷酸铝佐剂外观合格，pH维持在6.33~6.44，吸附率维持在55.8%~65.9%，10%、50%、90%分布粒径大小分别维持在2.166~2.574 μm、3.866~4.539 μm、6.250~8.049 μm，零电荷点维持在4.33~4.75，Zeta电位绝对值维持在32.4~36.0 mV，上清液磷含量维持在0.15~0.16 mg/mL，磷/铝摩尔比维持在0.93~1.07。结论 自制磷酸铝佐剂在（25 ±2） ℃储存24个月性质稳定，在储存期间的不同时间点进行第2次高压灭菌不会影响其性质。

Objective To simulate the aseptic processing of self-prepared aluminum phosphate adjuvant in the formulation manufacturing process, perform secondary autoclaving on the adjuvant at different storage time points, and observe changes in the quality characteristics of the adjuvant before and after secondary autoclaving, so as to provide basic data for the storage, application, and shelf life setting of aluminum phosphate adjuvant.Methods Three batches of industrial-scale self-prepared aluminum phosphate adjuvants were stored at (25 ±2) ℃. Samples were taken regularly at 0, 1, 3, 6, 9, 12, 18, and 24 months for secondary autoclaving (121 ℃, 30 minutes). The quality characteristics of the adjuvant were tested before and after autoclaving, including appearance, pH, adsorption rate, particle size and distribution, point of zero charge (PZC), Zeta potential, phosphorus content in the supernatant, and P/Al molar ratio.Results When stored at (25±2) ℃ for 24 months, all quality characteristics of 3 batches of aluminum phosphate adjuvants remained stable. After secondary autoclaving at different storage time points, the appearance of 3 batches of the adjuvants met specifications, and the pHs were maintained at 6.33-6.44. The adsorption rates were maintained at 55.8%-65.9%. Particle sizes at the cumulative distribution of 10%, 50%, and 90% were kept within 2.166-2.574 μm, 3.866-4.539 μm, and 6.250-8.049 μm, respectively. PZCs were maintained at 4.33-4.75, and the absolute values of Zeta potential were maintained at 32.4-36.0 mV; the phosphorus contents in the supernatant were maintained at 0.15-0.16 mg/mL, and the P/Al molar ratios were maintained at 0.93-1.07.Conclusion The self-prepared aluminum phosphate adjuvant maintains stable properties during 24 months of storage at (25±2) ℃, and secondary autoclaving performed at different time points throughout the storage period does not affect its properties.