枸橼酸西地那非与辅料相容性研究

Study on the Compatibility of Sildenafil Citrate and Related Excipients

目的研究不同辅料与枸橼酸西地那非的相容性,为枸橼酸西地那非固体制剂筛选辅料。方法分别将枸橼酸西地那非和各种辅料按一定比例混合,并做平行对照实验,按稳定性影响因素试验方法,检查含量和有关物质前后的变化。结果在强光、高温、高湿的实验条件下,枸橼酸西地那非和辅料经对比实验,显示各辅料与主药相容性良好。结论微晶纤维素、羟丙纤维素、羟丙甲纤维素可作为枸橼酸西地那非固体制剂的处方辅料。

Objective To study the compatibility of different excipients screening excipients of sildenafil citrate solid preparation. Method According influence factors of stability,the sildenafil citrate and different excipients were portion. The changes of sildenafil citrate and periment. Results the compatibility of cellulose, hyprolose Under the experimental c sildenafil citrate and the and hypromellose are pre and sildenafil citrate, for to the test method for the blended by a certain prorelated excipients were measured by parallel controlled exonditions of high light, high temperature and high humidity, related excipients were good. Conclusion Microcrystalline scription excipients of sildenafil citrate solid preparation.