流通池法测定尼古丁缓释贴剂的释放度

Determination of Release Rate of Nicotine Sustained-release Patches by Flow-through Cell Method

目的:建立测定尼古丁缓释贴剂中尼古丁释放度的方法。方法:采用流通池法,并与原研厂采用的碟上桨法进行结果比较。流通池法测定条件:释放介质为0.0015mol·L-1磷酸水溶液,流速为4mL·min-1,层流流动方式;采用高效液相色谱法测定尼古丁的释放度;用模型法零级、一级、Higuchi方程等和相似因子法分别对不同释放介质的释放曲线进行拟合,提取释放参数并进行统计学分析。结果:建立的流通池法与碟上桨法测定结果无显著性差异(P>0.05)。结论:所建立的方法简便、可行,为缓释贴剂释放度测定方法提供了一种新的选择,并可用于相关制剂的质量控制。

OBJECTIVE：To develop a method for the determination of the release rate of Nicotine sustained-release patches.METHODS：Flow-through cell method was compared with paddle plate method of the originator.0.001 5 mol·L-1 phosphoric acid solution was used as the medium at the flow rate of 4 mL·min-1 in laminar flow mode.HPLC method was used to determine the release rate of nicotine.Model method such as zero-order,one-order,Higuchi equations and similarity factor method were used to fit the release curves of nicotine in different medium.The main parameters were calculated and analyzed statistically.RESULTS：The results of flow-through cell method was consistent with that of paddle plate method（P0.05）.CONCLUSION：The established method is simple and convenient,and it can be used as a new choice to determine the release rate of sustained-release patch and quality control of those dosage forms.