工艺研发

喷雾式添加氨水对氢氧化铝佐剂质量一致性的影响

  • 杨希飞 刘少祥 胡高翔 周阳 黄攀 张华 张莉 杨坤 张飞伟
展开
  • 1成都生物制品研究所有限责任公司细菌性疫苗一室,成都 6100232成都生物制品研究所有限责任公司,成都 610023

网络出版日期: 2025-08-16

Effects of spray adding ammoniawateron quality consistency of aluminum hydroxide adjuvant 

Expand
  • Yang Xifei1Liu Shaoxiang2Hu Gaoxiang1Zhou Yang1Huang Pan1Zhang Hua1Zhang Li1Yang Kun1Zhang Feiwei1


Online published: 2025-08-16

摘要

目的  通过喷雾式添加氨水制备氢氧化铝佐剂,分析其对佐剂质量批间一致性的影响。 方法  分别以喷雾和流加方式添加氨水至三氯化铝溶液各制备3批氢氧化铝佐剂,比较两种氨水添加工艺制备的佐剂粒径、pH、外观等质量指标。 结果  喷雾方式添加氨水制备的3批佐剂平均粒径为(96.7±8.6) nm,pH为4.93±0.02,透析后沉淀量为(20.9±0.4) g/L;流加方式添加氨水制备的3批佐剂平均粒径为(161.0±24.7) nm,pH为4.85±0.06,透析后沉淀量为(105.6±13.8) g/L。相较于流加,以喷雾式添加氨水制备3批佐剂为均一的乳白色悬液,粒径更小,透析后透析袋底部大颗粒沉淀明显减少,批间一致性更好。 结论  采用喷雾方式将氨水加入三氯化铝溶液中,可使氨水与三氯化铝溶液接触更加充分,产物更加均匀,有助于提高氢氧化铝佐剂外观、粒径、pH等质量指标的批间一致性。

本文引用格式

杨希飞 刘少祥 胡高翔 周阳 黄攀 张华 张莉 杨坤 张飞伟 . 喷雾式添加氨水对氢氧化铝佐剂质量一致性的影响[J]. 国际生物制品学杂志, 2022 , 45(4) : 196 -199 . DOI: 10.3760/cma.j.cn311962-20211215-00085

Abstract

Objective  To prepare aluminum hydroxide adjuvant by spray adding ammonia water,and to analyze its influence on inter-batch consistency of quality index.  Methods  Three batches of aluminum hydroxide adjuvants were produced by spray and flow addition of ammonia water into aluminum trichloride solutionrespectively. The quality indexes including particle sizepH and appearance of the adjuvant produced by two ammonia water adding ways were compared.  Results  The average particle size,pH,post-dialysis precipitation of three batches of adjuvants using the spray adding way of ammonia water were (96.7±8.6) nm,4.93±0.02, (20.9±0.4) g/L,respectively. Howeverthe average particle size,pH,post-dialysis precipitation were (161.0±24.7) nm,4.85±0.06,(105.6±13.8) g/L,respectively,when the three batches of adjuvants were made by adding ammonia water in flow. Comparing with the way of flow adding,the three batches of adjuvants made by spray adding had the characteristics of uniform milky suspension appearance,smaller particle size,less post-dialysis precipitation,and better inter-batch consistency.  Conclusion  The reaction between ammonia water and aluminum trichloride is more uniform and sufficient when the ammonia water is added into the aluminum chloride solution by spray,and the inter-batch consistency of quality indexes including appearanceparticle sizeand pH is improved.
文章导航

/