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目的:制备16-妊娠双烯醇酮(16-DHP)阴道栓并建立其质量控制方法。方法:以S-40和PEG 400为基质制备16-DHP阴道栓;以紫外分光光度法测定其溶出度和含量,并初步考察其稳定性。结果:所制栓剂为白色子弹型栓剂,软硬度合适;鉴别、检查等符合中国药典2010年版相应规定;溶出度为95%,含量测定线性范围为5.0~25.0μg·ml-1(r=0.999 6),低、中、高浓度平均回收率范围为99.1%~101.2%;初步稳定性试验结果显示各指标无明显变化。结论:该制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare 16-DHP vaginal suppository and establish its quality control method. Methods: 16-DHP vaginal suppository was prepared with S-40 and PEG 400 as matrix. The dissolution and content of 16-DHP were determined by UV spectrophotometry. Results: The prepared suppository was white bullet suppository with suitable hardness and hardness. The identification and inspection were in accordance with the corresponding requirements of the 2010 edition of Chinese Pharmacopoeia. The dissolution rate was 95% and the linear range was 5.0 ~ 25.0μg · ml-1 (r = 0.999 6). The average recoveries of low, medium and high concentrations ranged from 99.1% to 101.2%. The results of the preliminary stability test showed no significant change for each index. Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.