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目的考察2种不同蛋白质含量测定方法对乌司他丁比活的影响。方法分别采用凯氏定氮法和福林酚法对乌司他丁原料药中的蛋白质含量进行测定,再结合效价计算比活。结果由凯氏定氮法得到的比活分别为4 035、3 933和4 010mg·mg-1;由《日本药局方》福林酚法得到的比活分别为3 472、3 360和3 423 mg·mg-1;由《中国药典》2010年版福林酚法得到的比活分别为3 621、3 503和3 570 mg·mg-1。结论由《日本药局方》和《中国药典》福林酚法测得的蛋白质含量结果差异较小,但与凯氏定氮法测得的蛋白质含量差异较大。
Objective To investigate the influence of two different protein content determination methods on the specific activity of ulinastatin. Methods The content of protein in ulinastatin was determined by Kjeldahl method and Folin phenol method, respectively. Results The specific activities obtained by Kjeldahl method were 4 035, 3 933 and 4 010 mg · mg-1, respectively. The specific activities obtained from Folin Phenolic Method of Japanese Pharmacopoeia were 3 472, 3 360 and 3 respectively 423 mg · mg-1. The specific activities obtained from the Chinese Pharmacopoeia 2010 edition of Forlin’s phenol method were 3 621, 3 503 and 3 570 mg · mg-1, respectively. Conclusion The results of protein content determined by the method of “Japanese Pharmacopoeia” and “Chinese Pharmacopoeia” Folin phenol have little difference, but the protein content determined by Kjeldahl method is quite different.