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纸质出版日期:2014
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董宇, 陈新. 一测多评法在舒肝健脾丸质量控制中的应用[J]. 中国实验方剂学杂志, 2014,20(4):70-73.
DONG Yu, CHEN Xin. Application of QAMS in the Quality Control of Shuganjianpi Pill[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(4): 70-73.
董宇, 陈新. 一测多评法在舒肝健脾丸质量控制中的应用[J]. 中国实验方剂学杂志, 2014,20(4):70-73. DOI: 10.11653/syfj2014040070.
DONG Yu, CHEN Xin. Application of QAMS in the Quality Control of Shuganjianpi Pill[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(4): 70-73. DOI: 10.11653/syfj2014040070.
目的:建立舒肝健脾丸一测多评的测定方法,验证此方法在舒肝健脾丸质量评价中应用的准确性、适应性和可行性。方法:将舒肝健脾丸为研究对象,以橙皮苷为内参物,建立橙皮苷与柚皮苷、柑属苷B的相对校正因子,并将校正因子应用于橙皮苷、柚皮苷和柑属苷B的含量测定,实现一测多评;同时采用外标法测定上述3种黄酮类成分的含量,比较计算值与实测值的差异。结果:线性考察Y橙皮苷=56 644X-2 272.9(r=0.999 8);Y柚皮苷=41 070X+779.59(r=0.999 9);Y柑属苷B=33 619X+2 289.8(r=0.999 9),线性关系良好;校正因子,柚皮苷RSD 0.286%,柑属苷B RSD 0.259%;阴性无干扰,专属性良好;精密度,橙皮苷RSD 0.48%,柚皮苷 RSD 1.02%,柑属苷B RSD 0.97%;重复性,橙皮苷 RSD 0.94%,柚皮苷 RSD 0.89%,柑属苷B RSD 1.27%;回收率,橙皮苷平均回收率99.26%,RSD 0.90%,柚皮苷平均回收率99.30%,RSD 0.92%,柑属苷B平均回收率 98.34%RSD 0.78%,该方法准确、可靠;一测多评法柚皮苷含量为6.11,6.09,6.13 mg·g-1,柑属苷B为 4.96,4.93,4.99 mg·g-1,外标法柚皮苷含量为6.12,6.08,6.17 mg·g-1,柑属苷B为 4.98,4.95,5.01 mg·g-1,两种方法含量测定结果差异不显著。结论:一测多评法可同时对疏肝健脾丸中的橙皮苷、柚皮苷和柑属苷B进行含量测定,该方法简便、准确、可靠,可有效提高疏肝健脾丸的质量水平。
Objective: To establish the measurement method of the multi-component with a single-marker(QAMS) of Shuganjianpi pill
and verify the accuracy
adaptability
geasibility of QAMS in the quality control. Method: Shuganjianpi pill was used as the research object and the hesperidin was used as the internal reference. The relative correlation factor (RCF) of naringin and citrus genus glycosides B were established
and the RCF in the determination of naringin and citrus genus glycosides B was adopted. The external standard method(ESM) was used to determin the naringin and citrus genus glycosides B
and the results of the two determination methods were compared. Result: Linear experiment
hesperidin:Y=56 644X-2 272.9 (r=0.999 8)
naringin:Y=41 070X+779.59(r=0.999 9)
citrus genus glycosides B:Y=33 619X+2 289.8(r=0.999 9)
linear relationship was good;RCF
naringin:RSD 0.286%
citrus genus glycosides B:RSD 0.259%;there was no negative interference
specificity was good;precision enperiment
hesperidin:RSD 0.48%
naringin:RSD 1.02%
citrus genus glycosides B:RSD 0.97%;repeatability enperiment
hesperidin:RSD 0.94%
naringin:RSD 0.89%
citrus genus glycosides B:RSD 1.27%;recovery experiment
hesperidin:average recovery was 99.26%
RSD 0.90%
naringin:average recovery was 99.30%
RSD 0.92%
citrus genus glycosides B:average recovery was 98.34%
RSD 0.78%. The method was accurate and reliable;determination result of QAMS:naringin 6.11
6.09
6.13 mg·g-1
citrus genus glycosides B 4.96
4.93
4.99 mg·g-1;ESM:naringin 6.12
6.08
6.17 mg·g-1
citrus genus glycosides B 4.98
4.95
5.01 mg·g-1
there was no significant difference in the results of determination between the two methods. Conclusion: Using QAMS can determine the hesperidin
naringin and citrus genus glycosides B in the Shuganjianpi pills simultaneously with convenience preciseness and raliablity
which effectively improve the level of Shuganjianpi pill quality control.
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