摘要
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.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第1期27-31,共5页
Chinese Journal of Hospital Pharmacy
基金
沈阳市科技局项目(编号:F11-148-9-00)
辽宁省教育厅创新团队项目(编号:LT2012018)
关键词
16-妊娠双烯醇酮
阴道栓
制备
质量控制
紫外分光光度法
16-dehydropregnenolone
vaginal suppository
preparation
quality control
UV spectrophotometry