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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。
Objective To establish a HPLC method for determination of baicalin in Yinzhihuang soft capsules. This method was used to investigate the stability of Yinzhihuang soft capsules. The content of the method was determined by reversed-phase high performance liquid chromatography with Diamonsil-C18 column. The mobile phase was methanol-0.4% phosphoric acid (51∶49), the detection wavelength was 277 nm, the flow rate was 1.0 ml/min, and the column temperature was 40°C. Stability studies use accelerated experiments. Results The concentration of baicalin in the range of 0.05149-0.574 mg/ml showed a good linear relationship with the peak area (r=0.9999). The average recovery of baicalin in the preparation was 98.4%, and the RSD was 0.69% (n= 5). After three months of accelerating the experiment, the Yinzhihuang soft capsule made no significant change in the relative content of baicalin. Conclusion The HPLC method can be used to separate and detect baicalin in Yinzhihuang soft capsules. It can be used for the determination of baicalin in this preparation. The stability of self-made Yinzhihuang soft capsules is good.