目的 研究氨水法制备氢氧化铝佐剂时工艺中使用超滤替代透析工艺去除NH₄⁺的可行性。 方法 取氨水法制备的氢氧化铝胶体溶液稀释并超滤至氨质量浓度低于0.04%，浓缩定量至起始体积；另取等体积氢氧化铝胶体溶液透析至氨含量质量浓度低于0.04%。超滤或透析后，收集氢氧化铝胶体溶液进行高压蒸汽灭菌。依据中国药典2020年版三部及《预防用含铝佐剂疫苗技术指导原则》对2种工艺制备的佐剂进行外观、pH、铝含量、吸附率、沉降率、等电点、粒径大小及分布、X-射线衍射等质量指标检测。结果 超滤工艺制备的3批佐剂pH为4.63±0.04、铝含量为（4.963±0.027）mg/ml、平均粒径为（123.2±7.3） nm、粒径分布为（40~500） nm、等电点为10.9±0.1、回收率为 91.4%±0.5%；透析工艺制备的3批佐剂pH为4.86±0.25、铝含量为（4.959±0.340） mg/ml、平均粒径为（120.6±6.2） nm、粒径分布为（40~500） nm、等电点为10.9±0.4、回收率为91.5%±2.5%。2种工艺制备的氢氧化铝佐剂质量指标差异无统计学意义(t值为﹣1.58~0.46，P值为0.251~0.918)。 结论 相较于透析工艺，采用超滤工艺制备的氢氧化铝佐剂所有质量指标未改变，且质量一致性更好。

Objective To study the feasibility of using ultrafiltration instead of dialysis to remove NH₄⁺ in aluminum hydroxide adjuvant preparation by ammonia water method. Methods Aluminum hydroxide colloid solution was prepared by ammonia water method . The solution was diluted and ultrafiltrated until the ammonia mass concentration was ＜0.04%, and then the ultrafiltrate was concentrated to the original volume. Solution with the same volume was dialysed until the ammonia mass concentration was ＜0.04%. The solution after ultrafiltration or dialysis was collected for autoclaving. The appearance, pH, aluminum content, adsorption rate, sedimentation rate, isoelectric point, average particle size and size distribution, and X-ray diffraction expansion quality indexes of the adjuvants prepared by two processes were detected according to China pharmacopoeia 2020 edition and “Technical Guidelines for Aluminium-containing Adjuvant Vaccines for Prevention”. Results The pH, aluminum content, average particle size, size distribution, isoelectric point, recovery rate of the 3 batches of adjuvants prepared by ultrafiltration were 4.63±0.04, (4.963±0.027) mg/ml, (123.2±7.3) nm, (40-500) nm, 10.9±0.1, and 91.4%±0.5%, respectively, and were 4.86±0.25, (4.959±0.340) mg/ml, (120.6±6.2) nm, 40-500 nm, 10.9±0.4, 91.5%±2.5% respectively by dialysis. The differences of these quality indexes were not statistically significant for adjuvants prepared by the two crafts (t values were﹣1.58-0.46，P values were 0.251-0.918). Conclusion Aluminum hydroxide adjuvants prepared by ultrafiltration shows similar quality with those prepared by dialysis, with better quality consistency.