格列本脲多源片5mg以参比品为参照的体外治疗等效性研究

Á. Alvarado-Yarasca, Ana Muñoz-Jauregui, L. Quiñones-Sepúlveda, F. Lizaraso-Soto, A. Salazar-Granara, Luis Sullón-Dextre, Juan J. Palomino-Jhong, Jorge Antonio García-Ceccarelli
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摘要

药物的治疗等效性是通过体外和体内研究进行的,称为生物等效性研究。目的:以对照药为参照,确定5 mg格列本脲多源片的体外治疗等效性。材料与方法:多源药物格列本脲5mg和参比药物glidiabetes 5mg均为秘鲁产,购自秘鲁伊卡市一家药店。使用试剂和分析级标准。三种溶出介质均采用300 nm紫外吸收法。结果:在pH为1.2和pH为4.5的条件下,多源药物T和对照药物R在15分钟和30分钟内均未溶解85%。然而,在pH为6.8时发生溶解。这些结果符合美国食品和药物管理局和美国药典的标准。三个试验ph值的相似因子值均在可接受范围(50-100)内。溶出率分别为68.66% (pH 1.2)、56.59% (pH 4.5)和95.98% (pH 6.8)。平均体外溶出时间分别为28.56 min (pH 1.2)、39.97 min (pH 4.5)和4.54 min (pH 6.8)。结论:根据相似因子(f2)和溶出效率,得出本研究多源药物5mg格列本脲与参比药物5mg glidiabetes体外治疗等效的结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study of in vitro Therapeutic Equivalence of the 5 mg Glibenclamide Multi-source Tablets Respecting the Reference Medicine Product
Introduction: Therapeutic equivalence of medications is carried out through in vitro and in vivo studies called bioequivalence studies. Objective: To determine the in vitro therapeutic equivalence of the 5 mg glibenclamide multi-source tablets respecting the reference medicine. Materials and methods: Both, the multi-source drug 5 mg glibenclamide and the reference 5 mg Glidiabet are made in Peru, and were acquired in a drugstore of Ica city (Peru). Reagents and an analytical grade standard were used. The Ultraviolet absorption method at 300 nm was used on each of the three dissolution media. Results: Neither the multi-source drug T nor the reference R dissolved by 85% at pH 1.2 and at pH 4.5, during 15 or 30 minutes. However, at pH 6.8 dissolution occurs. These results correspond to Food and Drug Administration and United States Pharmacopoeia criteria. The similarity factor value was within the acceptance range (50-100) for the three tested pHs. Dissolution efficiency was 68.66% (pH 1.2), 56.59% (pH 4.5) and 95.98% (pH 6.8). The mean of in vitro dissolution time was 28.56 min (pH 1.2), 39.97 min (pH 4.5) and 4.54 min (pH 6.8). Conclusion: According to the similarity factor (f2) and the efficiency of dissolution, it is concluded that the multisource drug 5 mg glibenclamide of the present study is therapeutically equivalent in vitro to the reference 5 mg Glidiabet.
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