HPLC法考察不同影响因素下雪诺同黄体酮阴道缓释凝胶的体外药物释放度  

HPLC Method Was Used to Investigate the Drug Release of Crinone Progesterone Vaginal Sustained Release Gel in Vitro with Different Influencing Factors

作　　者：宋歌 梅兴国[2] 陈振雄 SONG Ge;MEI Xing-guo;CHEN Zhen-xiong(School of Pharmacy,Xianning Medical College,Hubei University of Science and Technology,Xianning Hubei 437100,China)

机构地区：[1]湖北科技学院医学部药学院,湖北咸宁437100 [2]军事医学科学院毒物药物研究所 [3]咸宁市第一人民医院

出　　处：《湖北科技学院学报（医学版）》2023年第6期470-474,共5页Journal of Hubei University of Science and Technology(Medical Sciences)

摘　　要：目的考察Crinone黄体酮阴道缓释凝胶(8%)于不同因素下的药物累计释放度,筛选出最佳因素和水平。方法设计正交试验,采用药物释放度测定法-篮法,转速100r/min、水温(37±0.5)℃,于相同色谱条件下分析黄体酮阴道缓释凝胶于不同材质滤膜、不同孔径滤膜、不同释放介质3种因素下的药物累计释放率。结果滤膜材质对凝胶中药物的释放速率有明显影响,极差值(R)=74.88;滤膜孔径和释放介质对其影响较小,R分别为8.43和8.78;影响因素主次顺序为因子A(滤膜材质)>因子C(释放介质)>因子B(滤膜孔径);采用尼龙膜较聚碳酸酯膜更易发生反渗现象。结论采用孔径为0.05μm的聚碳酸酯膜作为滤膜以及0.5%十二烷基硫酸钠磷酸盐缓冲液(pH值4.0)作为释放介质时,药物释放效果最佳。Objective To investigate the cumulative dissolution rate of Crinone progesterone vaginal sustained release gel(8%)under different factors,and to screen out the best factors and levels.Methods Orthogonal test was designed.Basket method,a determination method of drug release,was used to analyze the drug dissolution rate of progesterone vaginal sustained release gel under the same chromatographic conditions with different filter materials,pore sizes and release media.The rotation speed was 100 r/min and the water temperature was(37±0.5)℃.Results The material of the filter membrane had a significant effect on the dissolution rate of the drug in the gel,and the range value(R)was 74.88.The pore size of the filter membrane and the dissolution medium had little influence on the dissolution rate,with R values of 8.43 and 8.78,respectively.The order of influencing factors was factor A(filter material)>Factor C(dissolution medium)>factor B(filter aperture).Nylon membrane was more likely to have reverse osmosis than polycarbonate fiber membrane.Conclusion The best drug dissolution results were obtained when the filter membrane was 0.05μm polycarbonate fiber membrane and the medium was 0.5%sodium dodecyl sulfate phosphate buffer(pH 4.0).

关 键 词：黄体酮 黄体酮阴道缓释凝胶 体外释放度 影响因素分析 

分 类 号：R969[医药卫生—药理学]