乐脉分散片的溶出度测定方法的研究

Dissolution determination of Lemai dispersible tablets

目的建立乐脉分散片的溶出度测定方法，为评价和控制药品质量提供方法。方法采用小杯法以纯化水作为溶出介质，转桨转速为75r·min^-1，用高效液相色谱法测定芍药苷，Hypersil C18柱（5μm，4．6mm×250mm）；流动相为甲醇-0．05mol·L^-1磷酸二氢钾溶液（40：60）；检测波长为230nm；柱温为30℃。绘制乐脉分散片的累积溶出度曲线。结果本法线性范围为0．196～0．98μg，r为0．9999，平均回收率为99．61％，RSD为1．2％（n=3）。结论本方法具有灵敏、准确、快速的优点，适用于乐脉分散片的质量控制。

Objective To establish an HPLC method for the dissolution of Lemai dispersible tablets, and to provide methods for the evaluation and control of quality of medicine. Methods Six tablets were placed separately in small solution vessels filled with dissolution medium of pure water, and paddle method was used at the rotary speed of 75 r · min^-1. HPLC was used to determine peoniflorin. Column was Hypersil C18 column （5 μm, 4.6 mm×250 mm） and the mobile was methanol-0.05 mol · L〈 potassium dihydrogen phosphate solution. The detective wavelength was 230 nm. The column temperature was 30 ℃. The dissolution curve was drawn. Results The calibration curve was linear at 0. 196-0.98μg, r=0. 999 9. The average recovery of peoniflorin was 99.61^, RSD： 1.16^ （n=3）. Conclusion The method is sensitive, accurate and quick for the quality control of Lemai dispersible tablets.