3种氢氧化铝佐剂的理化性质分析

Analysis of physicochemical properties of three aluminum hydroxide adjuvant

目的分析3种氢氧化铝佐剂的理化性质。方法通过X-射线衍射（X-ray diffraction,XRD）、透射电镜观察、颗粒大小和吸附能力检测、沉降分析及灭菌前后p H变化检测分析本室配制的氢氧化铝佐剂（佐剂C）与两种商品化的氢氧化铝佐剂（佐剂A和佐剂B）的理化性质。结果 3种氢氧化铝佐剂均为弱晶型勃姆石（poorly-crystalline boehmite,PCB）的晶体形态,颗粒大小主要分布在1～10μm,吸附能力均大于2 mg BSA/mg Al,沉降情况符合《欧洲药典》（7.0版）的要求,灭菌前后p H值变化均小于0.5。结论本室配制的氢氧化铝佐剂与商品化氢氧化铝佐剂多数检测参数值较接近,但吸附能力高于商品化佐剂。本研究为氢氧化铝佐剂质控标准的建立提供了参考。

Objective To analyze the physicochemical properties of three aluminum hydroxide adjuvant. Methods The physicochemical properties of aluminum hydroxide adjuvant C prepared by the authors were analyzed by X-ray diffraction, transmission electron microscopy, determination of particle size and protein adsorptive capacity, sedimentation and the alteration of pH value after autoclaving, and compared with those of two commercial adjuvant A and B. Results All the three aluminum hydroxide adjuvant were poorly crystalline boehmite, of which the primary particles formed loose aggre- gates at sizes of 1 ～ 10 μm and the protein adsorptive capacity was more than 2 mg BSA/mg Al, while the sedimentation met the requirements in the European Pharmacopoeia 7. 0, and the alteration of pH value after autoclaving was less than 0. 5. Conclusion Most of parameters of aluminum hydroxide adjuvant prepared by the authors were similar to, while the protein adsorptive capacity was significantly higher, than those of commercial adjuvant. The study provided a reference for the establishment of quality control standard of aluminum hydroxide adjuvant.