摘要
该研究采用往复筒溶出度测定装置,对释放介质体积、筛网孔径、浸入时间、沥水时间、表面活性剂、消泡剂、往复频率等参数进行考察,建立了硝苯地平(1)缓释片(Ⅰ)的体外释放度测定法,即采用大杯法,释放介质900 mL,不添加表面活性剂,上、下筛网孔径分别为590、38μm,浸入时间5 s,沥水时间60 s,往复频率5 dip/min,多排管模式测定。以该法测定3批体内释放速度有差异的仿制制剂样品的释放曲线,并与参比制剂进行比较。结果表明,该研究建立的测定条件对不同释放速度的样品具有区分力,但体内外相关性不佳。
A method for determining the in vitro release of nifedipine(1)sustained-release tablets(Ⅰ)was established by using the reciprocating cylinder dissolution testing device,and parameters such as the volume of release medium,screen mesh size,immersion time,drip time,surfactant,defoamer,and reciprocating rate were investigated.The release curves of three batches of generic preparation samples with different release rates in vivo were determined under the optimized conditions of 900 mL medium without adding surfactants;the mesh size of upper screen and lower screen were 590μm and 38μm;5 seconds immersion time;60 seconds drip time;reciprocating rate 5 dip/min using multirow mode of large dissolving cup method,and were compared with the release curves of reference preparations.The results showed that the determination method established in this study could distinguish generic preparation samples with different release rates,but the in vitro-in vivo correlation of the method was unsatisfactory.
作者
区淑蕴
高永坚
梁思韵
赵淑晶
肖艳
OU Shuyun;GAO Yongjian;LIANG Siyun;ZHAO Shujing;XIAO Yan(Sinopharm Group Guangdong Medi-world Pharmaceutical Co.,Ltd.,Foshan 528305)
出处
《中国医药工业杂志》
EI
CAS
CSCD
北大核心
2023年第12期1761-1767,共7页
Chinese Journal of Pharmaceuticals
关键词
硝苯地平缓释片
往复筒法
释放曲线
体内外相关性
nifedipine sustained-release tablet
reciprocating cylinder method
release curve
in vitro-in vivo correlation
