目的 考察自制磷酸铝佐剂在不同条件下的性状表征。方法 使用3批产业化规模的磷酸铝佐剂，分别考察不同灭菌次数和室温保存时间下的等电点、磷铝比、pH值、最大吸附能力、表面电荷、沉降率和粒径大小及分布。结果 3批自制磷酸铝佐剂灭菌3次，其等电点均为4.6±0.2，磷铝比均为0.9±0.1，pH值均为7.3±0.1，Zeta电位均为（-13±2） mV，最大能吸附4倍量的HPV16型L1抗原，沉降率均为21%±1%，90%粒径分布（Dv90）均为（15.5±0.5） μm，Dv50均为（6.0±1.0） μm，Dv10均为（1.5±0.5） μm；室温保存2年，其等电点均为4.6±0.2，磷铝比均为0.9±0.1，pH值均为7.4±0.1，Zeta电位均为（-13±3） mV，最大能吸附4倍量的HPV16型L1型抗原，沉降率基本均为21%±1%，Dv(90)均为（18.0±4.0） μm，Dv50均为（6.0±1.0） μm， Dv10均为（1.0±1.0） μm，各项均符合质量标准。结论 3批自制磷酸铝佐剂灭菌3次和室温保存2年仍可保证其质量；初步建立了磷酸铝佐剂稳定性评价平台，以确保自制磷酸铝佐剂的使用安全。

Objective To study the characterizations of self-made aluminum phosphate adjuvant under different conditions. Methods Three batches of industrialized aluminum phosphate adjuvants were used to detect the isoelectric point, phosphorus-aluminum ratio, pH value, maximum adsorption capacity, surface charge, sedimentation rate, particle size and distribution under different sterilization times and room temperature storage time. Results After sterilized for three times, the isoelectric points of three aluminum phosphate adjuvants were 4.6±0.2, phosphorus aluminum ratios were 0.9±0.1, pH values were 7.3±0.1, Zeta potentials were (-13±2) mV, the maximum adsorption capacity of HPV16 L1 antigen was 4 times, the sedimentation rates were 21%±1%, 90% particle size distribution (Dv90) values were (15.5±0.5) μm, Dv50 values were (6.0±1.0) μm, and Dv10 values were (1.5±0.5) μm. After storing at room temperature for 2 years, the isoelectric points of three aluminum phosphate adjuvants were 4.6±0.2, phosphorus aluminum ratios were 0.9±0.1, pH values were 7.4±0.1, Zeta potential were (-13±3) mV, the maximum adsorption capacity of HPV16 L1 antigen was 4 times, the sedimentation rates were 21%±1%, Dv90 values were (18.0±4.0) μm. Dv50 values were (6.0±1.0) μm, and Dv10 values were (1.0±1.0) μm. All items met the requirement. Conclusions The quality of aluminum phosphate adjuvant can be stable after sterilized for 3 times and stored at room temperature for 2 years. Through this study, the evaluation platform of aluminum phosphate adjuvant has been established to ensure the continuous and safe use of self-made aluminum phosphate adjuvant.