目的评价自制磷酸铝佐剂在不同储存条件下的稳定性，为该佐剂的储存和有效期设置提供数据支持。
方法选取连续3批产业化规模的自制磷酸铝佐剂，分别置于（5±3）℃和（25±2）℃储存。定期取样考察磷酸铝佐剂的主要评价指标（外观、pH值、铝含量、吸附率、氯化钠含量、沉降上清分析、无菌性、细菌内毒素、砷盐、铁盐、硫酸盐、铵盐、重金属、磷铝摩尔比、零电荷点、粒径大小与分布）。
结果3批磷酸铝佐剂在2种温度下储存15个月后，外观、无菌性均合格，pH值在5.4~6.2之间，吸附率在93%~100%之间，铝含量在2.77~3.36 mg/mL之间，氯化钠含量在7.90~8.60 g/L之间，沉降上清分析在12~15 mL之间，细菌内毒素在0.5~3.0 内毒素单位/mg铝之间，磷铝摩尔比在0.82~1.13之间，累积分布达到10%、50%、90%时对应的粒径大小分别为1.75~2.53、2.87~3.98和4.94~6.90 μm，零电荷点在5.11~5.47之间，残留杂质砷盐≤0.001‰、铁盐≤0.015‰、硫酸盐≤0.5%、铵盐≤0.005%、重金属≤0.002%，佐剂各项主要评价指标均稳定且符合质量标准。
结论3批自制磷酸铝佐剂在（5±3）℃和（25±2）℃条件下保存15个月后稳定性良好，为磷酸铝佐剂储存条件及效期的制定提供了依据。
ObjectiveTo evaluate the stability of the self-made aluminum phosphate adjuvant under different storage conditions so as to provide supportive data for the storage and expiration date of the adjuvant.
MethodsThree consecutive batches of industrial-scale self-made aluminum phosphate adjuvant were selected and stored at (5±3) ℃ and (25±2) ℃, respectively. The main evaluation indices of aluminum phosphate adjuvant (appearance, pH value, aluminum content, adsorption rate, sodium chloride content, analysis of sedimentation supernatant, sterility, bacterial endotoxin, arsenic salt, iron salt, sulfate salt, ammonium salt, heavy metals, phosphorus to aluminum molar ratio, zero charge point, particle size and distribution) were investigated by sampling at regular intervals.
ResultsThe appearance and sterility of 3 batches of aluminum phosphate adjuvant were qualified after stored at two temperatures for 15 months. The pH value was 5.4-6.2, the adsorption rate was 93%-100%, the aluminum content was 2.77-3.36 mg/mL, the sodium chloride content was 7.90-8.60 g/L, and the sedimentation supernatant analysis ranged from 12 to 15 mL .The bacterial endotoxin ranged from 0.5 to 3.0 endotoxin unit/mg aluminum, and the molar ratio of phosphorus to aluminum ranged from 0.82 to 1.13. The particle size corresponding to the cumulative distribution reaching 10%, 50% and 90% were 1.75-2.53, 2.87-3.98 and 4.94-6.90 μm, respectively. The zero charge point was 5.11-5.47, with the residual impurity of arsenic salt ≤0.001‰, iron salt ≤0.015‰, sulfate salt ≤0.5%, ammonium salt ≤0.005% and heavy metal ≤0.002%. All main evaluation indices of the adjuvant were stable and in line with the quality standard.
ConclusionThree batches of self-made aluminum phosphate adjuvant show good stability after being stored at (5±3) ℃ and (25±2) ℃ for 15 months, which provides a basis for the formulation of storage conditions and efficacy of aluminum phosphate adjuvant.
杜娇,洪文浩,许哲,等. 自制磷酸铝佐剂稳定性研究[J]. 国际生物制品学杂志,2025,48(01)：10-15.
DOI:10.3760/cma.j.cn311962-20240717-00050版权归中华医学会所有。
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杜娇：实验设计、研究实施、论文撰写、数据分析；洪文浩、许哲：研究实施、数据分析；姚钰：数据分析；刘倩、冯潇、杨英英：数据采集；周海飞：实验设计、研究指导、论文修改
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