College of Pharmacy, Xinjiang Medical University, Urumqi, China.
The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
Pak J Pharm Sci. 2021 Jan;34(1):111-117.
The purpose of this investigation was to establish a mathematical model for determining the dissolution of diclofenac sodium and codeine phosphate simultaneously. Based on the dual-wavelength isosbestic point spectrophotometry, the dissolution of diclofenac sodium and codeine phosphate tablets was determined using Fiber-Optic Dissolution Test (FODT) instrument capable of real-time measurement. Dissolution curves showed that the dissolution process of diclofenac sodium was similar to that of codeine phosphate. The dissolution profile of diclofenac sodium and codeine phosphate at 45 min was concordant with that stated in Chinese pharmacopoeia. There was no significant difference between results obtained from FODT and HPLC (p>0.05). A fibre-optic dissolution test system assisted by the mathematical separation model of linear equations was able to detect the dissolution of diclofenac sodium and codeine phosphate simultaneously. The dissolution profiles and overall data, which can directly reflect the dissolution speed at each time point, can provide the basis for establishing standards for the quality evaluation of drugs.
本研究旨在建立一种同时测定双氯芬酸钠和磷酸可待因溶出度的数学模型。采用光纤溶出度测定仪（FODT）实时测定，基于双波长等吸收点分光光度法，对双氯芬酸钠和磷酸可待因片的溶出度进行了测定。溶出曲线表明，双氯芬酸钠的溶出过程与磷酸可待因相似。45 分钟时双氯芬酸钠和磷酸可待因的溶出曲线与中国药典规定的一致。FODT 与 HPLC 法的结果无显著性差异（p>0.05）。光纤溶出度试验系统与线性方程组的数学分离模型相结合，能够同时检测双氯芬酸钠和磷酸可待因的溶出度。可以直接反映各时间点溶出速度的溶出曲线和整体数据，为建立药物质量评价标准提供依据。
