吡罗昔康贴剂溶出度的测定及不同测定方法结果的评估  

Determination of dissolution of piroxicam patch and evaluation of the results of different measurement methods

作　　者：马迅[1] 江霞 毛睿[1] 文强 尹利辉[1] 陈华[1] MA Xun;JIANG Xia;MAO Rui;WEN Qiang;YIN Lihui;CHEN Hua(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drug,Beijing 102629,China;School of pharmacy Yantai University,Yantai 264005,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629 [2]烟台大学药学院,山东烟台264005

出　　处：《中国药品标准》2024年第2期134-140,共7页Drug Standards of China

基　　金：中国食品药品检定研究院关键技术研究基础项目(GJJS-2022-4-3)。

摘　　要：目的:采用桨碟法、转筒法、扩散池法测定吡罗昔康贴剂的溶出度,并对溶出结果进行评价,以期选择能更加准确反映吡罗昔康贴剂释药过程的测定方法,为科学准确评价药品质量提供参考。方法:建立检测吡罗昔康的液相色谱测定方法,分别使用桨碟法、转筒法、扩散池法考察吡罗昔康贴剂的24 h溶出曲线,分别使用f 1差异因子法、f 2相似因子法、Weibull模型拟合对溶出曲线进行比较,评估不同测定方法的结果。结果:吡罗昔康在1~150μg·mL^(-1)范围内线性关系良好(r=1.000),准确度100.9%(n=9),精密度1.7%(n=9),样品溶液在72 h内稳定。溶出曲线比较结果表明,吡罗昔康贴剂的溶出曲线更符合Weibull模型。在相同溶出介质和温度的条件下,桨碟法和转筒法差异不大,存在相互替代的可能性,扩散池法与其他2种方法均存在显著性差异。结论:扩散池法的装置更加符合吡罗昔康贴剂在实际使用中的溶出过程,为该药物的质量评价提供更多的参考。Objective:Different methods were used to determine the dissolution of piroxicam patch,and the dissolution results were evaluated,in order to select a determination method that could more accurately reflect the drug release process of piroxicam patch,so as to provide a reference for the scientific and accurate evaluation of drug quality.Methods:The liquid chromatography method for the detection of piroxicam was established,and the 24 hour dissolution curves of piroxicam patch were investigated by paddle over disk method,rotating cylinder method and vertical diffusion cell method,and the dissolution curves were compared by f 1 difference factor method,f 2 similarity factor method and Weibull model fitting,and the in vitro dissolution behavior of different methods was evaluated.Results:Piroxicam had a good linear relationship in the range of 1-150μg·mL^(-1)(r=1.000),the accuracy was 100.9%(n=9),the precision was 1.7%(n=9),and the sample solution was stable within 72 hours.The results of the comparison of dissolution curves showed that the dissolution of piroxicam patch was more in line with the Weibull model.Under the same conditions of dissolution medium and temperature,there was little difference between the paddle over disk method and rotating cylinder method,and there was a possibility of substitution for each other,and there were significant differences between the vertical diffusion cell method and the other two methods.Conclusion:The vertical diffusion cell method is more in line with the dissolution process of drugs in actual use,and provides more references for quality evaluation.

关 键 词：吡罗昔康贴剂 溶出度 桨碟法 转筒法 扩散池法 

分 类 号：R921.2[医药卫生—药学]