胃炎颗粒质量标准研究

目的建立胃炎颗粒中芍药苷的含量测定方法。方法采用反相高效液相色谱（RP—HPLC）法，色谱柱为C18柱（250mm×4．6mm，5μm），流动相为乙腈-水（19：81），检测波长229nm，流速1．0mL／min，柱温30℃，进样量10μL。结果芍药苷质量浓度在2．45～12．24μg／mL范围内与峰面积线性关系良好，平均回收率为99．80％，RSD=0．99％（n=9）。结论RP—HPLC法操作简单，检测结果准确可靠，可用于胃炎颗粒的质量控制。

Study on Quality Standard of Weiyan Granules

Objective To develop a method for determining the content of paeoniflorin in Weiyan Granules. Methods RP-HPLC was used. The chromatographic system consisted of C18 column （250 mm ×4.6 mm, 5 μm） and the mobile phase of MeCN-H20 （19：81） with the detection wavelength at 229 nm, the flow rate was 1.0 mL/min. The column temperature was 30 ℃ the sample size was 10 μL. Results The linear range for paeoniflorin was 2. 45 - 12. 24 μg/mL（ r=0. 9999）, and the average recovery rate was 99.80%, RSD = 0. 99% （ n = 9）. Conclusion Without complicated sampling procedure, the method is simple, rapid and accurate, which can be used to control the quality of this pharmaceutical formulation.