沉降篮对盐酸罗匹尼罗缓释片释放度的影响

Effect of Sinker on Dissolution Release of Ropinirole Hydrochloride Extended-release Tablet

目的研究沉降篮对盐酸罗匹尼罗缓释片释放度的影响。方法在FDA推荐的释放度检测方法基础上,比较增加沉降篮前后,盐酸罗匹尼罗缓释片在各取样时间点释放度的变化情况。结果增加沉降篮后,盐酸罗匹尼罗缓释片释放度结果没有明显变化,但相同时间点不同片之间RSD明显变小。结论沉降篮可以有效控制盐酸罗匹尼罗缓释片位置,得到稳定的结果,更有利于产品质量控制。

OBJECTIVE To research the effect of sinker on dissolution of Ropinirole Hydrochloride Extended-release tablet. METHODS According to the dissolution method from FDA, the release of Ropinirole Hydrochloride Extended-release tablet at each time point was compared between without and with sinker. RESULTS Adding sinkers could efficiently improve the RSD, but less affect the product whole dissolution rate. CONCLUSION Sinkers can control the position of tablet sinking in the vessel. Data are more stable. It is suitable for the product.