环形利尿剂非专利药片与品牌药片的比较与评估

Tamilveeran T, Karthikeyan B, Balamurugan K.
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引用次数: 0

摘要

品牌药是制药公司开发的原创产品,而仿制药则是专利到期的品牌药的复制品。研究工作的重点是比较和评价非专利药与品牌药福鲁塞米片。研究内容包括药典和非药典规定的片剂成品应检测的一些指标,如外观、厚度、直径、重量变化、硬度、易碎性、崩解时间、溶解度、硬度和厚度。仿制药和品牌药福鲁塞米片的质控结果均在 IP 规定的范围内。在 45 分钟内,非专利药福鲁塞米片的体外药物释放率为 96.7%,而品牌药福鲁塞米片在 45 分钟内的药物释放率为 98.3%。因此,可以得出结论,襻利尿剂氟塞米片的仿制药和品牌药氟塞米片的质量控制结果显示出与 IP 相同的偏差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Comparison and Evaluation of Loop Diuretic Frusemide Generic vs Brand Tablets
Branded medications are the original products developed by pharmaceutical companies and generic drugs are copies of branded drugs whose patent has expired. The research work focused on comparisons and evaluations of generic VS brand of frusemide tablets. The study includes some of the specifications that should tested in the finished products in tablets such as appearance, thickness, diameter, weight variation, hardness, friability, disintegration time,  dissolution, hardness and thickness as per pharmacopoeial & non pharmacopoeial tests were performed. The generic and brand frusemide tablets quality control results showed within the range as per IP. The in vitrodrug release of generic frusemide tablets was found to be 96.7 %in 45 min and branded tablets which showed drug release 98.3% in 45 min. Hence, it can be concluded that evaluation of loop diuretic frusemide tablets generic and brand frusemide tablets showed same deviations in the quality control results as per IP. 
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