Preliminary exploration of quality control on adsoption capacity of aluminum hydroxide adjuvant for human vaccine

Abstract

Objective To establish the quality control method for adsorption capacity of aluminum hydroxide adjuvant in vaccine.Methods The grain size,specific surface area and zero charge point of domestic and Denmark aluminum hydroxide adjuvants were measured,and the adsorption capacity of both aluminum hydroxide adjuvants to different concentration of BSA and FHA were compared.Results The grain sizes of DV50 for 3 lots of domestic aluminum hydroxide adjuvant were 4.49,5.83 and 6.28 μm,respectively,and 4.58 μm for Denmark Alhydrogel(R).The specific suface areas were 1 602,1 093 and 1 014 m2/kg for 3 lots of domestic aluminum hydroxide adjuvant,respectively,and 2 230m2/kg for Denmark Alhydrogel(R).Zero charge points were 10.2,10.3 and 10.2 for 3 lots of domestic aluminum hydroxide adjuvant,respectively,and 8.5 for Denmark Alhydrogel(R).The adsorption capacities of 3 lots of domestic aluminum hydroxide adjuvant (5 g/L) to 2 g/L BSA were 98.69％,99.41％ and 99.72％,respectively,and 98.04％ for Denmark Alhydrogel(R) (5 g/L),both met the requirement of standard in European Pharmacopoeia.The adsorption capacities of both domestic aluminum hydroxide adjuvant and Denmark Alhydrogel(R) (1.3 mg/L) to 50-1 000 mg/L FHA were above 97％.Conclusion Series of parameters for quality control are established to evaluate the adsorption capacity of domestic aluminum hydroxide adjuvant according to the study on relative quality indexes of domestic aluminum hydroxide adj uvant. Key words: Aluminum hydroxide; Adjuvant,immunologic; Quality control