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目的:利用光纤溶出度过程分析方法监测盐酸二甲双胍片的溶出度,通过实时在线监测药片溶出情况而反映不同厂家生产的药片质量的差异。方法:采用《中国药典》中规定的检测盐酸二甲双胍片溶出度的条件,利用光纤传感溶出度实时过程分析方法对14个不同厂家的盐酸二甲双胍片进行了实时监测。结果:14个厂家的溶出曲线明显不同,可真实地反映每粒药片的溶出过程。结论:光纤溶出度过程分析真实地反映了不同厂家药片的溶出行为,对改进制剂工艺、监控制剂工艺稳定性及控制产品质量以及评价药品内在品质提供了有效方法。
OBJECTIVE: To monitor the dissolution of metformin hydrochloride tablets by optical fiber dissolution process analysis, and to reflect the difference of the quality of tablets produced by different manufacturers by online real-time monitoring of the dissolution of tablets. Methods: Metformin hydrochloride tablets were tested in real time by the method of real-time fiber-optic-based dissolution-sensing analysis of the metformin hydrochloride tablets prescribed in the Chinese Pharmacopoeia. Results: The dissolution curves of 14 manufacturers were significantly different, which could truly reflect the dissolution process of each tablet. Conclusion: The analysis of optical fiber dissolution process truly reflects the dissolution behavior of tablets from different manufacturers. It provides an effective method to improve the preparation technology, monitor the stability of the preparation process, control the product quality and evaluate the intrinsic quality of the drug.