一测多评法在舒肝健脾丸质量控制中的应用

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。

Application of QAMS in the Quality Control of Shuganjianpi Pill

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.