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安全性和患者获益的通用选择标准[VIII]:比较品牌名和通用名双氯芬酸钠贴剂的物理化学和药学性质。

Generic selection criteria for safety and patient benefit [VIII]: Comparing the physicochemical and pharmaceutical properties of brand-name and generic diclofenac sodium tapes.

作者信息

Nozawa Mitsuru, Goto Miho, Wada Yuko, Yotsukura Kayo, Gannichida Ako, Ishii Fumiyoshi, Shimokawa Ken-Ichi

机构信息

Triad Japan Co. Ltd.

Department of Self-medication and Health Care Sciences, Meiji Pharmaceutical University.

出版信息

Drug Discov Ther. 2019 Jul 22;13(3):150-156. doi: 10.5582/ddt.2019.01035. Epub 2019 Jun 28.

Abstract

With respect to diclofenac sodium-containing tape preparations of nonsteroidal antiphlogistic drug, we compared the pharmaceutical properties (pH, elongatedness, water-vapor permeability, adhesive force, and peeling-force) of 11 medicinal drugs (2 brand-name and 9 generic drugs) to obtain evidence for product selection in line with the needs of the patient. The elongatedness of the generic drugs Teikoku (1.39), Yutoku (1.40), and Nippon-zoki (1.43) were significantly higher than the brand-name drug Voltaren (1.22). The adhesive force was measured using the probe tack test and the inclined ball tack test. The probe tack test results of Naboal (6.8 N/cm), Teikoku (6.1 N/cm), Yutoku (5.9 N/cm), Nippon-zoki (6.2 N/cm), and Rakool (6.2 N/cm) were higher than that of Voltaren (2.0 N/cm). The inclined ball tack test results of Naboal (18.0), Teikoku (24.0), Yutoku (21.5), and Nippon-zoki (22.7) were also higher than that of Voltaren (7.2). Concerning peeling-force measurement, the 90° peeling-forces of Naboal (0.95 N), Teikoku (0.96 N), Yutoku (0.94 N), and Nippon-zoki (1.01 N) were higher than that of Voltaren (0.68 N). These results show that there were marked differences in the feeling of use of each product between the brand-name and generic drugs. The pharmacist indicates the basis for selection of a preparation according to the feeling of use desired by each patient. It has become possible to recommend products suitable for each patient, which will allow pharmacists to provide products according to the needs of each patient when a brand-name drug is changed to a generic one.

摘要

对于含双氯芬酸钠的非甾体抗炎药贴剂,我们比较了11种药物(2种品牌药和9种仿制药)的药学性质(pH值、伸长率、水汽透过率、粘着力和剥离力),以便根据患者需求获取产品选择依据。仿制药帝国(1.39)、优得酷(1.40)和日本曹达(1.43)的伸长率显著高于品牌药扶他林(1.22)。使用探针粘性测试和倾斜球粘性测试测量粘着力。纳博尔(6.8 N/cm)、帝国(6.1 N/cm)、优得酷(5.9 N/cm)、日本曹达(6.2 N/cm)和乐固(6.2 N/cm)的探针粘性测试结果高于扶他林(2.0 N/cm)。纳博尔(18.0)、帝国(24.0)、优得酷(21.5)和日本曹达(22.7)的倾斜球粘性测试结果也高于扶他林(7.2)。关于剥离力测量,纳博尔(0.95 N)、帝国(0.96 N)、优得酷(0.94 N)和日本曹达(1.01 N)的90°剥离力高于扶他林(0.68 N)。这些结果表明,品牌药和仿制药在各产品使用感受上存在显著差异。药剂师根据每位患者期望的使用感受指出制剂选择的依据。现在已能够推荐适合每位患者的产品,这将使药剂师在将品牌药更换为仿制药时能够根据每位患者的需求提供产品。

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