结合雌激素阴道软胶囊质量研究

The Study of the Quality of Conjugated Estrogens Vaginal Soft Capsule

目的建立结合雌激素阴道软胶囊(Conjugated Estrogens vaginal soft capsule)质量标准。方法采用高效液相色谱法测定结合雌激素阴道软胶囊含量;检查其崩解、融变时限,并与参比制剂进行对比研究。结果马烯雌酮硫酸钠和雌酮硫酸钠分别在2.02～10.09μg、4.03～20.16μg内呈良好的线性关系(r=0.9999),马烯雌酮硫酸钠3个浓度回收率分别为100.0%,101.3%和99.4%,雌酮硫酸钠3个浓度回收率分别为99.0%,99.4%和101.8%。结合雌激素阴道软胶囊崩解、融变时限与参比制剂间无差异(P>0.05)。结论本法专属性强,重复性、精密度好,结果准确可靠,可作为结合雌激素阴道软胶囊的质量控制方法。

OBJECTIVE The purpose of the research is to establish the quality standard of conjugated estrogens （CE） vaginal soft capsule. METHODS The HPLC method was conducted for the determination of the content of CE vaginal soft capsule. The disintegration of CE vaginal soft capsule was detected and the indicators were compared between CE vaginal soft capsule and the reference preparation. RESULTS There was good linearity of sodium estrone sulfate and sodium equilin sulfate in the range of 2.02-10.09 μg and 4.03-20.16 μg （r=0.999 9）, the recovery of three kinds content were 100.0%, 101.3%, 99.4% and 99.0%, 99.4%, 101.8%. CE vaginal soft capsules were examined, there was no difference between these indicators and those of the reference preparation. CONCLUSION The method is specific, reliable and accurate. It can be used for the quality control of CE vaginal soft capsule effectively.