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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 To establish the quality standard of Conjugated Estrogens vaginal soft capsule. Methods The contents of estrogen-containing vaginal soft capsules were determined by high performance liquid chromatography (HPLC). The disintegration and thawing time were examined and compared with reference preparations. Results There was a good linear relationship between sodium estrone sulphate and estrone sodium sulphate in the range of 2.02 ~ 10.09μg and 4.03 ~ 20.16μg respectively (r = 0.9999). The recoveries of three concentrations of equestrone sodium sulfate were 100.0% , 101.3% and 99.4% respectively. The recoveries of three estrone sulphate concentrations were 99.0%, 99.4% and 101.8% respectively. Combination of estrogen vaginal soft capsule disintegration, fusion time limit and reference preparations no difference (P> 0.05). Conclusion This method is of high specificity, repeatability, good precision and accurate and reliable results. It can be used as a quality control method for combining estrogen vaginal soft capsules.