氨水法制备的氢氧化铝佐剂吸附能力检测方法的建立及验证

发布时间：2018-10-12 13:28

【摘要】：目的建立氨水法制备的氢氧化铝佐剂吸附能力的检测方法,并进行验证。方法参照《欧洲药典》中氢氧化铝佐剂吸附能力检测方法的原理,将氨水法制备的氢氧化铝佐剂分别以0.25~1 mg/ml 6个最终铝浓度,吸附0.5~10 mg/ml 7个浓度的牛血清白蛋白(bovine serum albumin,BSA)溶液,根据吸附效果,筛选最佳吸附铝浓度和适合的BSA溶液浓度,建立氨水法制备的氢氧化铝佐剂吸附能力检测方法,并验证该方法的准确度、重复性和中间精密性。结果在最终铝浓度为0.3 mg/ml时,可完全吸附3个低浓度蛋白,3个高浓度蛋白呈较好的浓度梯度,符合《欧洲药典》要求。经验证,该方法检测氨水法配制的氢氧化铝佐剂的吸附能力准确度、重复性和中间精密性良好。结论建立了氨水法制备的氢氧化铝佐剂吸附能力的检测方法,为氢氧化铝佐剂相关质量标准的建立奠定了基础。
[Abstract]:Objective to establish and verify the determination method of adsorption ability of aluminum hydroxide adjuvant prepared by ammonia method. Methods according to the principle of measuring the adsorption ability of aluminum hydroxide adjuvant in European Pharmacopoeia, the adjuvant of aluminum hydroxide prepared by ammonia water method was used to adsorb bovine serum albumin (bovine serum albumin,BSA) solution with 6 final aluminum concentrations of 0.25 mg/ml and 7 concentrations of 0.5 ~ 10 mg/ml, respectively. According to the adsorption effect, the optimum concentration of aluminum adsorbed and the suitable concentration of BSA solution were selected, and the method of measuring the adsorption ability of aluminum hydroxide adjuvant prepared by ammonia solution method was established, and the accuracy, repeatability and intermediate precision of the method were verified. Results when the final aluminum concentration was 0. 3 mg/ml, three low concentration proteins could be completely adsorbed, and 3 high concentration proteins showed a good concentration gradient, which met the requirements of the European Pharmacopoeia. The method is proved to be accurate, reproducible and intermediate precision in the determination of the adsorption ability of aluminum hydroxide adjuvant prepared by ammonia water method. Conclusion A method for the determination of adsorption capacity of aluminum hydroxide adjuvant prepared by ammonia solution method was established, which laid a foundation for the establishment of quality standard of aluminum hydroxide adjuvant.
【作者单位】：成都生物制品研究所有限责任公司;
【分类号】：R392-33

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