【摘要】 目的建立丙硫氧嘧啶胃内滞溜片的含量测定方法,并制定释放度标准。方法采用高效液相色谱法测定含量,色谱柱为日本岛津公司ODS柱(4.6 mm×250 mm,5μm),流动相为醋酸-水-乙腈(1∶84∶15),流速为1.0 m l.m in-1,柱温为40℃,检测波长为275 nm,进样量为20μl;采用转篮法和紫外分光光度法测定释放度。结果丙硫氧嘧啶浓度在0.48~1.92 mg.L-1范围内,峰面积与进样量呈良好线性关系,r=0.9999,平均回收率为100.2%。1、4和8 h的平均释放度分别为19.2%、64.6%和91.2%。结论本文建立的含量测定方法简便,重现性好,可用于丙硫氧嘧啶胃内滞溜片的质量控制。更多还原

【Abstract】 AimTo develop determination methods for content of propylthiouracil stomach-retained tablet and to determine standard of its release degree.MethodA RP-HPLC method with Shimadzu-ODS column(4.6 mm×250 mm,5μm) was used for assay of content of propylthiouracil stomach-retained tablet,and the mobile phase was the mixture of acetic acid-water-acetonnitrile(1∶84∶15)at the flow rate of 1.0 ml·min~-~1.The column temperature was 40℃.The UV detection wave length was 275 nm.Propylthiouracil release degree was determined with UV spectrophotometer and revolving basket method.Result The calibration curve was linear(r=0.9999) in the range of 0.48~1.92 mg·L~-~1 for Propylthiouracil.The mean recovery was 100.2 %.The mean release degree of propylthiouracil was 19.2 %,64.6 % and 91.2 % respectively at 1,4 and 8 h.Conclusion Those determination methods for content of propylthiouracil stomach-retained tablet were simple and reproducible,and suitable for the quality control of propylthiouracil stomach-retained tablet.更多还原