16-妊娠双烯醇酮阴道栓的制备与质量控制

Preparation and quality control of 16-dehydropregnenolone vaginal suppository

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-dehydropregnenolone （DHP） vaginal suppository and establish corresponding quality control standards. METHODS 16-DHP suppository was prepared with PEG 400 and S-40 as base materials and 16-DHP as the ingredient. The dissolution rate and content of 16-DHP in the suppository were determined by UV spectrophotometry, and its stability was preliminarily observed. RESULTS The suppository was white and bullet-shaped, with proper hardness. The identification and tests were in line with the standards stated in Chinese Pharmacopeia （2010 edition）. The accumulative dissolution rate was 95 %, linear range of 16-DHP content was 5 - 25 μg · ml^-1 （r = 0. 9996）, with average recovery rate between 99. 1 % and 101.2% at low, moderate and high concentrations. The preliminary stability test showed no significant changes of different parameters. CONCLUSION The preparation process of suppository is simple and feasible, with stable and controlla- ble quality.