高效液相色谱法测定茵栀黄软胶囊的稳定性

目的 建立茵栀黄软胶囊中黄芩苷的高效液相色谱含量测定方法。并用此方法对茵栀黄软胶囊进行稳定性考察。方法 含量测定采用反相高效液相色谱法，Diamonsil—C18色谱柱，流动相为甲醇-0．4％磷酸（51：49），检测波长为277nm，流速为1．0ml／min，柱温为40℃。稳定性研究采用加速实验法。结果黄芩苷进样浓度在0.05149～0．574mg／ml范围内与峰面积呈良好线性关系（r=0．9999），该制剂中黄芩苷的平均加样回收率为98．4％，RSD=0．69％（n=5）。自制茵栀黄软胶囊经过3个月加速实验，黄芩苷相对含量无明显变化。结论 HPLC法能很好地分离、检测茵栀黄软胶囊中的黄芩苷，可用于该制剂中黄芩苷的含量测定；自制茵栀黄软胶囊的稳定性较好。

Determination of stability of yinzhihuang soft capsules by HPLC

Objective To establish HPLC method for determination of baicalin in Yinzhihuang Soft Capsules,and determinate the stability of the sample. Methods The HPLC method was carried on Diamonsil C18 column using methanol-0.4% phosphoric acid（ 51 ： 49 ）as the mobile phase, and the detection wavelength was 277 nm, the flow rate was 1.0 ml/min and the temperature of column was 40℃. The stability of Yinzhihuang Soft Capsule was studied by accelerated test method. Results In the HPLC method the calibration curve for baicalin was linear in the range of 0. 051 49-0. 574 mg/ml. The average recovery was 98.4% ,RSD was 0.69% （ n =5）. The relative content of baicalin in the soft capsule by accelerated test method is around 100%. Conclusion The HPLC method is convenient, precise and reliable for determine of baicalin in the yinzhihuang soft capsules, and the stability of the soft capsule is good.