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

Development and verification of detection method for adsorption capacity of aluminum hydroxide adjuvant prepared by ammoniacal liquor method

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。

Objective To develop and verify a method for determination of adsorption capacity of aluminum hydroxide adjuvant prepared by ammoniacal liquor method. Methods The aluminum hydroxide adjuvant prepared by ammoniacal liquor method was diluted to five final aluminum concentrations of 0. 25 - 1 mg / ml,and used for adsorption of bovine serum albumin（BSA）at seven concentrations of 0. 5 - 10 mg / ml according to the principle in European Pharmacopoeia（EP）, based on which the aluminum and BSA concentrations were optimized,and a method for determination of adsorption capacity of the prepared aluminum hydroxide adjuvant was developed,and verified for accuracy,reproducibility and intermediate precision. Results The BSA at three low concentrations were completely adsorbed by aluminum hydroxide adjuvant at a final aluminum concentration of 0. 3 mg / ml,while good concentration gradient was observed in BSA at three high concen- tration,which met the requirements in EP. The developed method for determination of adsorption capacity of alumiacal liquor adjuvant prepared by ammoniacal liquor method showed high accuracy,reproducibility and intermediate precision. Conclusion A method for determination of adsorption capacity of aluminum hydroxide adjuvant prepared by ammoniacal liquor method was developed,which laid a foundation of establishment of quality standard for alumiacal liquor adjuvant.