防风色原酮类对照提取物在玉屏风颗粒含量测定中的应用

目的 通过以防风色原酮类对照提取物及升麻素苷、升麻素、5-O-甲基维斯阿米醇苷和亥茅酚苷4种单体对照品为对照的对比研究,建立以防风色原酮类对照提取物为对照的对于含防风药味的复方制剂玉屏风颗粒的质量控制方法,考察对照提取物在制剂质量研究中应用的可行性。方法 采用CAPCELL PAK C₁₈色谱柱(4.6 mm × 150 mm,5 μm),以甲醇(A)-体积分数0.3%磷酸水溶液(B)为流动相梯度洗脱,对玉屏风颗粒进行含量测定。结果 4种指标性成分在各自的检测质量浓度范围内具有良好的线性关系(r≥ 0.999 5),精密度、重复性、准确度相对标准偏差(RSD)值均小于3%且稳定性良好。结论 综上,防风色原酮类对照提取物可以替代单体对照品用于玉屏风颗粒含量测定,且操作简便、稳定可靠,为中药质量控制模式的转变提供新的思路与方法。

Application of the Reference Extract Chromone from Saposhnikovia divaricata in Content Determination of Yupingfeng Granules

OBJECTIVE To investigate the feasibility of conducting quality control of Yupingfeng granules by using the reference extract chromone from Saposhnikovia divaricata. METHODS By using CAPCELL PAK C₁₈ column(4.6 mm×150 mm, 5 μm) and methanol(A)-0.3% phosphoric acid aqueous solution(B) as mobile phase, gradient elution was conducted. The contents of Yupingfeng granules were determined by HPLC with the reference extract chromone from Saposhnikovia divaricata and the reference substances prim-O-glucosylcimifugin, cimifugin, 4′-O-β-D-glucosyl-5-O-methylvisamminol, and sec-O-glucosylhamaudol. RESULTS The linear relationship of the four index components was good in their respective detection concentration ranges. The RSD values of precision, repeatability and accuracy for determination of Yupingfeng granules were all less than 3%, and their stability was good. CONCLUSION This study preliminarily verifies that the reference extract of chromone from Saposhnikovia divaricata can replace the monomer reference substance for the content determination of Saposhnikovia divaricata in Yupingfeng granules, and it provides new ideas and methods for the transformation of the quality control mode of traditional Chinese medicine.