HPLC法测定断血流分散片的溶出度

HPLC determination of dissolution of Duanxueliu dispersible tablets

目的:建立断血流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100r·min^(-1),用高效液相色谱法测定醉鱼草皂苷Ⅳ b,色谱柱为汉邦C_(18)柱(5μm,4.6mm×250mm);流动相为甲醇-水(80∶20);流速是1.0mL·min^(-1);检测波长为250nm;柱温为30℃。绘制断血流分散片的累积溶出度曲线,并运用电子表格Excel软件处理药物溶出度数据,提取参数(T_d,m),并对参数进行相关性检验。结果:本法线性范围为2.06～22.62μg·mL^(-1),r=0.9999;平均回收率为99.86%,RSD为0.46%(n=9)。对不同批次的断血流分散片进行了溶出度测定,溶出参数差异无显著性意义(P<0.01)。结论:本方法具有灵敏、准确、快速的优点,适用于断血流分散片的质量控制。

Objective：To establish an HPLC method for the dissolution of Duanxueliu dispersible tablets, and provide methods for the evaluation and controlling of medicine quality. Method：6 tablets were placed separately into small solution vessels filled with dissolution medium of pure water, paddle method was used at rotary speed of 100 r · min^-1. The dectation on the chromatography glass column of Hanbon C18 （5 μm,4. 6 mm × 250 mm） with methanol - water （ 80： 20） as mobile phase at the flow - rate of 1.0 mL· min ^- 1. The detective wave - length was 250 nm. The column temperature was 30 ℃. Drawing the dissolution curve, the data of drug dissolution was processed by Excel for calculating parameter, with the test of correlation. Results：The calibration curve was linear in the range of 2. 06 -22. 62 μg·mL^-1,r =0. 9999,the average recovery of buddlejasaponins Ⅳ b was 99. 86% ,RSD =0.46% （ n = 9 ）. The dissolution of tablets produced in different batches had no significantly difference after detection. Conclusion：The method is sensitive, accurately and quickly for the quality control of Duanxueliu dispersible tablets.