基于一测多评法对丁蔻理中丸中6种成分的质量控制研究

目的:建立一测多评法同时测定丁蔻理中丸中白术内酯Ⅲ、白术内酯Ⅰ、丁香酚、6-姜辣素、8-姜酚、10-姜酚6种成分的含量。方法:以白术内酯Ⅰ为内标物,建立白术内酯Ⅰ与白术内酯Ⅲ、丁香酚、6-姜辣素、8-姜酚、10-姜酚之间的校正因子,计算待测成分含量,并将外标法测定值与一测多评法计算值进行对比,验证所建立一测多评法的准确性。结果:白术内酯Ⅲ、白术内酯Ⅰ、丁香酚、6-姜辣素、8-姜酚和10-姜酚分别在1.09~21.80μg·mL-1、0.71~14.20μg·mL-1、13.67~273.40μg·mL-1、6.04~120.80μg·mL-1、1.46~29.20μg·mL-1、1.78~35.60μg·mL-1范围内线性关系良好;各成分一测多评法计算值与外标法实测值无显著性差异。结论:利用校正因子对丁蔻理中丸中6种成分的含量测定是可行的,一测多评法可以用于丁蔻理中丸的质量评价研究。

Quality control study on six components in Dingkou Lizhong pills based on quantitative analysis of multi-components with a single-marker

Objective:To establish a method of quantitative analysis of multi-components with a single marker(QAMS)to determine the content of atracylenolideⅢ,atracylenolideⅠ,eugenol,6-gingerol,8-gingerol and 10-gingerol in Dingkou Lizhong Pills.Methods:The correlation factors between atracylenolideⅢ,atracylenolideⅠ,eugenol,6-gingerol,8-gingerol,10-gingerol and atracylenolideⅠwere established by using atracylenolideⅠas the internal standard.The content of components to be measured was obtained by calculation and compared with that of external standard method in order to prove the accuracy of QAMS method.Results:AtracylenolideⅢ,atracylenolideⅠ,eugenol,6-gingerol,8-gingerol and 10-gingerol showed good linear relationships within the ranges of 1.09–21.80μg·mL-1,0.71–14.20μg·mL-1,13.67–273.40μg·mL-1,6.04–120.80μg·mL-1,1.46–29.20μg·mL-1 and 1.78–35.60μg·mL-1 respectively.No significant differences were found in the contents of six components obtained by external standard method and QAMS method.Conclusion:It was feasible to determine the content of six components in Dingkou Lizhong pills by using correction factors.The QAMS method could be used for the quality assessment of Dingkou Lizhong pills.