枸橼酸西地拉非阴道泡腾片的制备及体外质量评价

Preparation and in vitro Quality Evaluation of Sildenafil Citrate Vaginal Effervescent Tablets

目的:制备枸橼酸西地拉非(SC)阴道泡腾片,并对其体外质量进行评价。方法:采用酸、碱分开制粒法制备SC阴道泡腾片,并对其pH、发泡量、崩解时限、含量均匀度、稳定性、体外溶出度等质量指标进行考察。结果:本品水溶液呈酸性,与阴道正常pH吻合;发泡量、崩解时限、含量均匀度均符合中国药典的相关要求;影响因素试验结果表明本品在试验温度、光照及湿度条件下,稳定性良好;体外药物溶出较快,15 min内基本溶出完全。结论:SC阴道泡腾片制备简单,体外质量良好,值得进一步研发。

Objective:To prepare sildenafil citrate(SC)vaginal effervescent tablets and study the quality in vitro.Methods:SC vaginal effervescent tablets were prepared by an acid-base separated granulation method.The main quality indices including pH value,foaming volume,disintegration time,content uniformity,stability and dissolution in vitro were investigated.Results:The water solution of the tablets was acidic solution,which fit perfectly with the pH value of vagina.The foaming volume,disintegration time and content uniformity met the requirements described in Chinese Pharmacopoeia(2015 edition).The stability of the tablets under the conditions of stress testing was promising.SC could be released completely from the tablets in 15 min in vitro,suggesting the quick release of SC.Conclusion:SC vaginal effervescent tablets show simple preparation and good in vitro quality,which are valuable to be studied further.