中药新药研究中多糖含量测定方法探讨

Discussion on polysaccharide determination methods in new Chinese drug research

该文结合新药申报中多糖测定方法中存在的问题,对多糖测定方法的适应范围、对照品的选择、各成分之间的干扰情况、方法研究进展等方面进行了介绍。作者建议:应根据所含多糖的结构及性质选择合适的检测方法,并进行方法学验证,考查所用显色试剂的稳定性、用量、显色时间、最大检测波长等因素,以增加方法的准确性。在多糖的含量测定中应排除单糖及其他水溶性成分的影响;注意对照品的选择;测定波长的选择;关注中性糖和酸性糖测定时的相互干扰,必要时可加人糖抑制剂排除干扰。对于由不同糖残基构成的杂多糖的测定,由于不同单糖的标准曲线的斜率不同,在选择对照品时建议通过研究搞清组成多糖的单糖种类及比例,按此比例配制成混合对照品制作标准曲线,进行测定。

According to existing problems in polysaccharide determination methods in new Chinese drug applications, the method suitability, chemical reference selection, components interference and method research were introduced. The author suggests that suitable determination method should be selected according to the structure and property of the polysaccharide, and validated. Some influent factors should be examined to assure the accuracy of the method, such as the stability and using amount of the visualizing reagent, visualizing time, maximum detection wavelength etc. Monosaccharide and other water soluble components should be removed from polysaccharide sample, and suitable reference substance and detection wavelength should be selected. It should pay attention to mutual interference of neutral and acidic saccharide, and use inhibitor to eliminate the interference. Because the slopes of the standard curves are different for different monosaccharide, it is proposed that the types and ratios of the monosacchafide in heteroglycan should be understood, and mixed reference substance solution in the ratio is prepared for determination.