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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 compare the results of optical fiber and pharmacopoeia in the determination of dissolution of aminophylline tablets and to explore the possibility of using optical fiber method instead of pharmacopoeia. Methods: The dissolution of 25 batches of aminophylline tablets by optical fiber method was measured and compared with the results obtained by the pharmacopoeia. Results: The optical fiber method was generally higher than that obtained by the pharmacopoeia method. The optical fiber method could monitor the real-time dissolution process of the drug and reflect the complete dissolution behavior of aminophylline tablets. Conclusion: In the determination of dissolution of aminophylline tablets, the optical fiber method is more convenient, faster and can objectively reflect the whole process of drug dissolution, but this method can not replace the pharmacopoeia.