【摘要】 目的制备复方螺内酯凝胶,并建立质量控制方法。方法以卡波姆-940为凝胶基质,以螺内酯和红霉素为主要药物制备凝胶剂;采用高效液相色谱法测定螺内酯和红霉素的含量。结果所制凝胶质地细腻,无色透明,粘度适中,p H值为7.0⁷.5;螺内酯和红霉素的线性范围分别为0.251 6⁵.032μg·m L^-1,0.577 2¹1.54μg·m L^-1;范围内与其峰面积呈良好的线性关系（r=0.999 9、0.999 9）;平均回收率分别为97.80%（RSD=0.74%,n=9）、96.7%（RSD=2.60%,n=9）。结论本制剂制备工艺简便可行,性质稳定,质量可控。更多还原

【Abstract】 Objective To prepare compound spironolactone gel and to establish a method for its quality control. Methods The gel was prepared using carbomer-940 as the matrix,and spironolactone and erythromycin as the main ingredients,and the contents of spironolactone and erythromycin was detected by high performance liquid chromatography. Results The gel was exquisite,colorless and transparent,the viscosity was moderate,and the pH value was 7. 0 7. 5. The linear range was 0. 251 6 5. 032 μg·m L^-1 for spironolactone（ r = 0. 999 9） and 0. 577 2 11. 54μg·m L^-1 for erythromycin（ r = 0. 999 9）. The average recoveries were 97. 80%（ RSD =0. 74%,n = 9） and 96. 7%（ RSD = 2. 60%,n = 9）,respectively. Conclusion The method is simple,and the quality is stable and controllable.更多还原