光纤法与药典法测定氨茶碱片溶出度的比较研究

目的: 比较光纤法与药典法对氨茶碱片溶出度测定的相关结果,探索光纤法替代药典法的可能性。方法: 对25个批次氨茶碱片用光纤法进行溶出度测定,并与药典法所得结果进行比较。结果: 光纤法较药典法所得结果普遍偏高,光纤法能够监测药物的实时溶出过程,反映氨茶碱片的完整溶出行为。结论: 在氨茶碱片溶出度测定中,光纤法更为方便、快捷,并能客观反映药物溶出的全过程,但是该方法尚不能替代药典法。

Objective: To explore the possibility of replacing pharmacopoeia method with fiber-optic method by comparing their dissolution results of aminophylline tablets. Methods: Using fiber-optic method to assay the dissolution rate of 25 batches of aminophylline tablets and compared the results with those determined by pharmacopoeia method. Results: The results determined by fiber-optic method are generally higher than those determined by pharmacopoeia method.However,fiber-optic method can monitor dissolution process in real-time and reveal the dissolution behaviour completely. Conclusion: Fiber-optic method is more convenient and faster than pharmacopoeia method in determining the of dissolution rate of aminophylline tablets.Furthermore,it shows the whole process of medicine dissolution objectively.However,it cannot replace the pharmacopoeia method.