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目的探讨Lowry法测定b型流感嗜血杆菌结合疫苗蛋白含量干扰现象的排除方法。方法分别应用《中国药典》三部(2005版)中Lowry法与第5版《欧洲药典》2.5.16法测定b型流感嗜血杆菌结合疫苗原液的蛋白含量,并以碳二亚胺(EDAC)为干扰性物质,验证两方法排除干扰的能力。结果同一批结合疫苗原液用两种方法测定的结果不一致,应用《中国药典》方法测定的结果明显高于第5版《欧洲药典》的方法。在多糖的活化衍生及多糖蛋白结合过程中加入EDAC、己二酰二肼(ADH)等,可干扰测定结果,使结果偏高。结论应用Lowry法测定多糖蛋白结合疫苗中蛋白含量时,应排除干扰性物质的影响。
OBJECTIVE To investigate the method of eliminating the interference of protein content of Haemophilus influenzae type b conjugate vaccine by Lowry method. Methods The protein content of Haemophilus influenzae type b conjugate vaccine was determined by the Lowry method in the third edition of Chinese Pharmacopoeia (2005 version) and the European Pharmacopoeia 2.5.16 method in the fifth edition. The EDAC ) As an interfering substance, verify the ability of both methods to eliminate interference. The results of the same batch of vaccine combinations with the two methods of determination of the results are inconsistent, the application of “Chinese Pharmacopoeia” method was significantly higher than the results of the fifth edition of the “European Pharmacopoeia” method. In the activation of polysaccharide derivatization and polysaccharide protein binding process by adding EDAC, adipic dihydrazide (ADH), may interfere with the determination of the results, the result is high. Conclusion The Lowry method for determining the protein content of polysaccharide conjugate vaccine should be ruled out the impact of interfering substances.