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目的:利用光纤溶出度过程分析方法,监测苯妥英钠片的溶出度,通过瞬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》规定的检测苯妥英钠片溶出度的条件,利用光纤传感溶出度实时过程分析方法对6个不同厂家的苯妥英钠片进行了实时监测。结果:6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在位在线,反映了体外溶出特性,并真实地反映了由于不同厂家生产的药片质量的不同而造成的不同厂家药片的溶出行为不同,对考察体内外相关性、评价药品内在品质及其生物等效性提供了有效方法。
OBJECTIVE: To monitor the dissolution of phenytoin sodium tablets by using the optical fiber dissolution process analysis method, and to reflect the differences of the tablet quality produced by different manufacturers by monitoring the instant dissolution of the tablets. Methods: The conditions of dissolution of phenytoin sodium tablets were determined according to the Chinese Pharmacopoeia, and real-time monitoring of phenytoin sodium tablets from 6 different manufacturers was carried out by real-time optical fiber sensing dissolution process. Results: The dissolution curves of the six manufacturers were significantly different and could truly reflect the dissolution process of each tablet. Conclusion: The optical fiber dissolution process is online, which reflects the in vitro dissolution characteristics and truly reflects the dissolution behavior of different manufacturers due to the different quality of tablets produced by different manufacturers. The inherent quality of medicines and their bioequivalence provide an effective method.