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目的:对3个厂家的阿莫西林胶囊进行了溶出度的实时监测,绘制体外溶出曲线,比较产品的内在质量差异。方法:分别对3个厂家的12颗阿莫西林胶囊进行7个时间点的溶出度分析,并用f2因子对溶出结果进行分析,解析其溶出过程。结果:3个厂家的产品在相同的溶出条件下,单点溶出度都符合现行的法定标准,但是从实时溶出曲线和f2因子计算结果比较来看,其内在质量存在较大的差异。结论:实时溶出度分析与单点溶出度相比,能比较全面正确地反映产品的溶出性能与内在质量,反映出产品之间的质量差异。
OBJECTIVE: To monitor in real time the dissolution of amoxicillin capsules from three manufacturers and draw out the in vitro dissolution curve to compare the intrinsic quality differences of the products. Methods: Dissolution of 12 amoxicillin capsules from 3 manufacturers were analyzed respectively at seven time points. The dissolution results were analyzed by f2 factor, and the dissolution process was analyzed. Results: Under the same dissolution conditions, the single-point dissolution rates of the three manufacturers all met the current statutory standards. However, there are big differences in the intrinsic quality of the three manufacturers when compared with the results of real-time dissolution curve and f2 factor. Conclusion: Compared with single-point dissolution, real-time dissolution analysis can reflect the dissolution performance and intrinsic quality of products comprehensively and correctly, which reflects the quality difference between products.