颈复康颗粒中芍药苷的含量测定方法研究

Study on the Method for the Determination of Paeoniflorin in Jingfukang Granule

目的：研究颈复康药业集团有限公司独家生产几十年的中药大复方制剂-颈复康颗粒中芍药苷的含量测定方法。方法用 HPLC法测定颈复康颗粒中芍药的含量，采用 C18（5μm，4.6 mm＆#215;250 mm）色谱柱，流动相：乙腈-0.1%磷酸（14∶86）；检测波长：230 nm；流速：1 mL/min；柱温：25℃。结果所建立的芍药苷含量方法，线性范围为0-0.4896mg/mL，r=0.9999，平均加样回收率为99.7%，RSD=1.27%（n ＝9）。最低检测限为4.938 ng。结论所建立的方法简便准确，重现性好，按现行工艺制备的阴性样品无干扰，专属性强；通过方法的优化，通过不同年份、不同批号的多批数据检测，认为可作为颈复康颗粒中芍药苷的含量测定方法。

Objective To study the method for the determination of Paeoniflorin in Jingfukang granule-the Exclusive varieties of Jingfukang Pharmaceutical Group Co.,Ltd. Methods HPLC was used to determine Paeoniflorin. C18 column （5 μm, 4.6 mm＆#215;250 mm） was used under the mobile phase of acetonitrile-0.1%phosphoric acid （14∶86）.The flow rate was 1.0 mL/min,and the detected wavelength was 230 nm.The column temperature was maintained at 25 ℃. Results The linearity of Paeoniflorin was good in the range of 0-0.4896mg/mL, r=0.9999,The average recovery was 99.7% with RSD=1.27%（n=9）.The detection limits of Paeoniflorin was 4.938ng. Conclusion The results show that the method were simple and reproducible. No interference were found in the negative control. It is accurate and reproducible for the determination of Paeoniflorin in Jingfukang granule, with the detection results of different years and batch numbers.