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目的采用一测多评法同时测定仙灵骨葆胶囊中5种成分。方法以淫羊藿苷为基准,建立仙灵骨葆胶囊中该成分与朝藿定C、川续断皂苷VI、补骨脂素及异补骨脂素的相对校正因子,利用相对校正因子分别计算其量,同时对一测多评法的计算值与外标法实测值进行比较,并用不同色谱柱考察相对保留时间及计算量,评价一测多评法在仙灵骨葆胶囊中应用的可行性和准确性。结果建立了仙灵骨葆胶囊中多成分一测多评的定量控制方法,外标法各成分的进样量淫羊藿苷在8.2~328.0 ng(r=0.999 5)、朝藿定C在0.055 6~2.224 0μg(r=0.999 6)、川续断皂苷VI在0.144 1~5.764 0μg(r=0.999 6)、补骨脂素在5.4~215.2 ng(r=0.998 0)、异补骨脂素在6.6~265.6 ng(r=0.998 5)线性关系良好,平均回收率分别为97.59%、98.58%、98.11%、97.86%、98.22%,RSD均小于2.0%;并采用夹角余弦法对一测多评计算值与外标实测值进行评价,结果无显著性差异。结论采用基于相对保留时间定位和相对校正因子计算的一测多评法既能利用一种对照品同时测定多成分的量,节约对照品,又能适合多指标质量评价模式的要求,提高工作效率。
Objective To determine the five components of Xianling Gubao Capsule simultaneously by a multi-evaluation method. Methods Based on icariin, the relative correction factors of Epimedium C, Dipsacus saponin VI, psoralen and isopsoralen in Xianling Gubao Capsule were established. Relative correction factors Calculate the amount, at the same time, compare the calculated value of one test with that of external standard method and compare the relative retention time and calculation amount with different chromatographic columns, and evaluate the application of multiple test in Xianlinggubao capsule Feasibility and accuracy. Results Quantitative control method of Xianlinggubao Capsule was established. The external standard method of icaritin was 8.2 ~ 328.0 ng (r = 0.999 5), epimedin C was (R = 0.999 6), 0.055 6 ~ 2.224 0μg (r = 0.999 6), Dipsacus saponin VI in the range of 0.144 1 ~ 5.764 0μg (r = 0.999 6), psoralen in 5.4 ~ 215.2 ng (R = 0.998 5). The average recoveries were 97.59%, 98.58%, 98.11%, 97.86% and 98.22%, respectively. The RSDs were all less than 2.0%. Multiple evaluation of measured values and external standard measured values were evaluated, the results showed no significant difference. Conclusion The method based on relative retention time and relative correction factor can not only use one reference substance to measure the amount of multiple components at the same time, save the reference substance, but also fit the requirements of multi-index quality evaluation mode and improve work efficiency .