高效液相色谱法测定板蓝根颗粒中（R,S）-告依春的含量

摘要

目的：建立高效液相色谱(HPLC)法测定板蓝根颗粒中(R,S)-告依春的含量并讨论含量限度。方法色谱柱为 SHIMADZU VP-ODS 柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.02%磷酸溶液(7：93),流速1.0 mL·min-1,检测波长为245 nm,自动进样器进样,进样量10μL。分别依照转移率、测定结果统计数据讨论含量限度。结果(R, S)-告依春在0.0587~150.3495μg·mL-1质量浓度范围内线性关系良好(r=0.9997,n=7),低、中、高加入量平均回收率分别为98.72%,98.40%,98.60%,RSD 分别为1.84%,0.50%,1.82%。依照转移率、测定结果统计数据确定含量限度存在问题。结论该法操作方便、结果准确,精密度好,专属性强,可用于板蓝根颗粒的质量控制；(R,S)-告依春的含量限度应依据药动学和药效学数据确定。%Objective To establish HPLC method for determination of (R,S)-epigoitrin in Banlangen granules and discuss the content limitation. Methods The samples were separated on SHIMADZU VP-ODS (150 mm×4. 6 mm, 5 μm) and the mobile phase consisted of methol-0. 02% phosphoric acid solution (7:93) at a flow rate of 1. 0 mL. min-1 . The detection wavelength was set at 245 nm and the injection volume (in automatic sampler) was 10 μL. The content limitation was assessed according to the transfer rate and statistical data of the results. Results (R,S)-epigoitrin showed a good linear relationship at concentration of 0. 058 7 – 150. 349 5 μg·mL-1(r = 0. 999 7, n = 7). The average recovery rate was 98. 72% , 98. 40% and 98. 60% , respectively; RSD was 1. 84% , 0. 50% and 1. 82% , respectively. The content limitation of (R,S)-epigoitrin was unreasonable according to the transfer rate and the statistical data of the results. Conclusion The method is easy and simple to operate, accurate and stable in results, and highly specific, thus it is applicable for the quality control of Banlangen granules. The content limitation should be determined on the basis of pharmacokinetic and pharmacodynamic data.