格列美脲片剂与滴丸体外溶出度比较

目的:比较格列美脲片剂和滴丸体外溶出度。方法:按2005年版《中国药典》中相关方法进行体外溶出度试验,以紫外分光光度法测定格列美脲的含量,分别计算累积溶出百分率;以Weibull方程拟合溶出参数T50、Td、m、r,再对溶出百分率数据进行分析。结果:溶出时间5min时片剂与滴丸溶出百分率分别约为18.70%、40.25%,45min时,片剂与滴丸的累积溶出百分率分别约为90.32%、99.96%,片剂与滴丸T50、Td、m、r结果分别为14.55、6.14,20.35、8.45,1.091、1.146,0.9968、0.9884,片剂与滴丸体外溶出度比较具有显著性差异(P<0.05)。结论:格列美脲滴丸比片剂溶出速度快。

Glimeiride Tablets vs. Glimeiride Dropping Pills in Dissolution in Vitro

OBJECTIVE： To compare the vitro dissolution between glimepiride tablets and glimepiride dropping pills. METHODS： In vitro dissolution test was conducted in accordance with the related methods specified in Chinese Pharmacopeia （2005 Edition） with the content of glimepiride determined by UV spectrophotometry. The accumulative dissolution percentages of the two formulations were computed respectively. The dissolution parameters （T50, Td, m, r） were fitted using Weibull equation and the data about the accumulative dissolution percentage were analyzed. RESULTS： There were significant differences between glimepiride tablets and glimepiride dropping pills in dissolution rate （18.70% vs. 40.25% at 5 min and 90.32% vs. 99.96% at 45 min, P〈0.05） . T50, Td, m, r were 14.55 vs. 6.14, 20.35 vs. 8.45, 1.091 vs. 1.146, 0.996 8 vs. 0.988 4 respectively. CONCLUSION： Glimepiride dropping pills had faster dissolution and higher accumulative dissolution rate as compared with Glimepiride tablets.