CAJ | 학술논문

目的：对孟鲁司特钠片进行全程的实时、原位在线溶出度测定，并与该品种现有标准溶出度测定结果进行比较。方法采用 FODT -601光纤药物溶出仪，选择284/500 nm 双波长法，消除辅料的干扰，按该品种现有标准溶出度检查项溶出条件，测试该药物溶出曲线，并将二者测得的溶出曲线进行比较。结果在1.0~12μg· mL -1范围内，浓度对应的溶出量（Q）%与吸光度（A ）呈良好的线性关系，相关系数为0.9993；3个浓度的平均回收率为99.3%、98.9%、98.5%；对应的 RSD 分别为0.86%、1.02%、0.91%（n =18）。结论与现有标准方法相比，光纤药物溶出仪能连续提供药品溶出过程的信息，可更好的为药品生产工艺和内在质量提供有效的评价依据。
목적：대맹로사특납편진행전정적실시、원위재선용출도측정，병여해품충현유표준용출도측정결과진행비교。방법채용 FODT -601광섬약물용출의，선택284/500 nm 쌍파장법，소제보료적간우，안해품충현유표준용출도검사항용출조건，측시해약물용출곡선，병장이자측득적용출곡선진행비교。결과재1.0~12μg· mL -1범위내，농도대응적용출량（Q）%여흡광도（A ）정량호적선성관계，상관계수위0.9993；3개농도적평균회수솔위99.3%、98.9%、98.5%；대응적 RSD 분별위0.86%、1.02%、0.91%（n =18）。결론여현유표준방법상비，광섬약물용출의능련속제공약품용출과정적신식，가경호적위약품생산공예화내재질량제공유효적평개의거。
Objective To monitor the instantaneous dissolution of montelukast sodium tablets by fiber - optic dissolu-tion test system and comparison with state standard test method. Methods The dissolutions of six tablets were determined simultaneously with FODT - 601 fiber - optic medicine dissolution system. The interference of excipients was cancelled by two wavelengths 284 / 500 nm. The stripping curves were completed according to dissolution conditions of existent standard for dissolution detection,and compared the stripping curves. Results The calibration curve was linear in the range of 1. 0~ 12 μg·mL - 1(r = 0. 999 3). The average recoveries of three concentration were 99. 3% ,98. 9% ,98. 5% ,with corre-sponding RSD of 0. 86% ,1. 02% ,0. 91%(n = 18),respectively. Conclusion Compared with the state standard,the fiber- optic dissolution test system is capable of monitoring the real dissolution process of drug,and it was better to provide the efficient way for the drug productive technology and inherent quality.