3种氢氧化铝佐剂的理化性质分析

发布时间：2018-03-31 22:29

本文选题：氢氧化铝　切入点：佐剂　出处：《中国生物制品学杂志》2015年01期

【摘要】：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。
[Abstract]:Objective to analyze the physicochemical properties of three kinds of aluminum hydroxide adjuvants. Physical and chemical properties of aluminum hydroxide adjuvant (C) and two commercial aluminum hydroxide adjuvants (adjuvant A and adjuvant B) before and after sterilization. All of them are the crystal morphology of poorly-crystalline PCB. The particle size was mainly distributed at 1 ~ 10 渭 m, the adsorption capacity was more than 2 mg BSA/mg Al, and the sedimentation was in accordance with the requirement of European Pharmacopoeia (version 7. 0). The changes of pH value before and after sterilization were less than 0.5. Conclusion most of the parameters of aluminum hydroxide adjuvant prepared in our laboratory are close to those of commercial aluminum hydroxide adjuvant. But the adsorption capacity is higher than that of commercial adjuvant. This study provides a reference for the establishment of quality control standard of aluminum hydroxide adjuvant.
【作者单位】：武汉生物制品研究所有限责任公司细菌类疫苗室;
【基金】：国家科技支撑计划(2011BAI19B01) 重大新药创制(2013ZX09402-302)
【分类号】：R392-33

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