国内外药典右旋糖酐40原料药含氮量测定方法的比较

Comparison of the Chinese Pharmacopoeia method and abroad pharmacopoeia methods in determining total nitrogen content of dextran 40

目的比较国内外药典中右旋糖酐40原料药含氮量测定的方法。方法分别采用《中国药典》(2010年版)、《美国药典》(USP-32)、《日本药局方》(JPⅩⅤ)、《英国药典》(BP 2010)和《欧洲药典》(EP 6.0)中右旋糖酐40原料药项下含氮物质的测定方法,对11批右旋糖酐40原料的含氮量进行分析。结果实验结果表明,《中国药典》所采用的纳氏比色法与国外药典所采用的的凯氏定氮法测定结果基本一致。结论纳氏比色法操作方法简单,作为限度检查时具有一定的实用价值;凯氏定氮法操作虽比较复杂,但定量测定结果更准确。

Objective To compare the methods for determining the total nitrogen content of dextran 40 raw materials in Chinese Pharmacopoeia and abroad pharmacopoeia.Method The nitrogen content in 11 batch dextran 40 raw materials were analyzed by using the methods of Chinese Pharmacopoeia（2010 version）,the United States Pharmacopoeia（USP-32）,the Japanese Pharmacopoeia（JP Ⅹ Ⅴ）,British Pharmacopoeia（BP 2010） and European Pharmacopoeia（EP 6.0）,respectively.Results The results showed that the Nessler＇s colorimetric method of Chinese Pharmacopoeia and the Kjeldahl method of foreign pharmacopoeia were consistent.Conclusion The Nessler＇s colorimetric method is easy and simple as a limit test,and has some practical value.The Kjeldahl method is more complicated,but the quantitative results are accurate.