益龄精口服液中红景天苷的含量测定方法建立及其量值传递研究

Study on the Determination Method and Quality Value Transfer of Salidroside in Yilingjing Oral Liquid

目的 建立益龄精口服液中红景天苷的含量测定方法 ,研究其从饮片至制剂成品生产过程中的量值传递关系。方法 采用高效液相色谱-二极管阵列检测器法(HPLC-DAD)对指标成分红景天苷进行含量测定,以乙腈-水(7∶93)为流动相,等度洗脱;流速为1.0 m L·min^(-1);检测波长为220 nm;柱温为35℃;进样量为10μL。结果 所建立的红景天苷含量测定方法 的方法 学验证均良好,红景天苷在56.109~3 591 ng范围内与峰面积呈良好的线性关系(r^(2)=1.000 0),平均加样回收率为99.19%,RSD为0.27%(n=6),15批益龄精口服液中红景天苷从酒女贞子饮片到中间体和成品的平均转移率分别为(56.93±5.29)%、(47.60±4.32)%。结论 本研究建立了简便、准确、重现性好的指标成分定量方法 ,并进一步探讨了红景天苷在制剂生产过程中的量值传递规律,为完善益龄精口服液的质量标准和过程控制提供参考。

OBJECTIVE To establish a method for the determination of salidroside in Yilingjing oral liquid,and to investigate the quality value transmitting of salidroside in the production process from decoction pieces to finished products.METHODS The content of the indicator component Salidroside was determined by high performance liquid chromatography-diode array detector (HPLC-DAD) with the mobile phase of acetonitrile-H_2O(7∶93),using isocratic elution.The flow rate was 1.0 m L·min^(-1),and the detection wavelength was set at 220 nm.The column temperature was 35℃and the injection volume was 10μL.RESULTS The methodological validation of theestablished method for the content determination of salidroside was good,which showed a good linear relationship between the injection amount and peak area in the range of 56.109-3 591 ng (r^(2)=1.000 0),and the average recovery was99.19%with RSD 0.27%(n=6).The average quality value transfer rates of salidroside in 15 batches of Yilingjing oral liquid from decoction pieces of wine steaming of Ligustri lucidi Fructus to extract intermediates and finished product were (56.93±5.29)% and (47.60±4.32)%,respectively.CONCLUSION This study established a simple,accurate and reproducible quantitative method of indicator components and further discussed the quantitative value transfer rule of salidroside in the production process,which provided references for improving the quality standard and process control of Yilingjing oral liquid.