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[克拉霉素干糖浆与羧甲司坦制剂混合后的苦味——品牌药与仿制药的差异]

[Bitterness of the mixture of clarithromycin dry syrup and carbocisteine preparation--difference between brand name and generic drugs].

作者信息

Matsuo Ritsuko, Tanaka Syouko, Kanou Michiko, Isono Kimiko, Tanaka Yasuha, Taura Tomoko, Asada Yuki, Akamine Yukiko, Sawai Hashimu, Kinosita Masakazu, Sudou Tomomi, Kunoki Yoshiko, Miki Akiko, Hori Satoko, Satoh Hiroki, Ohtani Hisakazu, Sawada Yasufumi

机构信息

Incorporated Foundation of Wadoukai Pharmacy, Tokyo, Japan.

出版信息

Yakugaku Zasshi. 2008 Mar;128(3):479-85. doi: 10.1248/yakushi.128.479.

Abstract

The purpose of this study was to assess the bitterness intensity and pH of the solutions of clarithromycin dry syrup (CAM-DS), carbocisteine preparation (CC), and the concomitant use of both drugs. We conducted 6 types of human gustatory sensation tests with 6 healthy male volunteers. As a result, there was almost no difference in the bitterness intensity of CAM-DS between the branded (the latest and former preparations) and the generic formulations. The bitterness intensity of CAM-DS (the latest and former preparations of the branded as well as the generic formulations) was almost equally enhanced by mixing it with either the branded CC-DS or the branded and the generic carbocisteine granule (CC-Gr). On this occasion, the enhancing the bitterness of the branded CAM-DS (latest and former preparation) was nearly avoided safely by dosage form's changing CC-DS or CC-Gr to the branded CC-Sy. However, unlike the branded CC-Sy, some generic CC-Sy failed to suppress the bitterness. Furthermore, it was proven that some generic CAM-DS were shown to exhibit bitterness when mixed with even branded CC-Sy. In conclusion, it should be noted that the extent of bitterness of the mixture of CAM-DS and CC highly varies among the generic formulations.

摘要

本研究的目的是评估克拉霉素干糖浆(CAM-DS)、羧甲司坦制剂(CC)以及两种药物联合使用时溶液的苦味强度和pH值。我们对6名健康男性志愿者进行了6种类型的人体味觉测试。结果显示,品牌药(最新和以前的制剂)与仿制药的CAM-DS苦味强度几乎没有差异。将CAM-DS(品牌药的最新和以前制剂以及仿制药)与品牌CC-DS或品牌及仿制药的羧甲司坦颗粒(CC-Gr)混合后,其苦味强度几乎同等增强。在此情况下,通过将CC-DS或CC-Gr剂型改为品牌CC-Sy,几乎可以安全地避免品牌CAM-DS(最新和以前制剂)苦味增强。然而,与品牌CC-Sy不同,一些仿制药CC-Sy未能抑制苦味。此外,已证明一些仿制药CAM-DS与品牌CC-Sy混合时也会出现苦味。总之,应注意CAM-DS和CC混合物的苦味程度在仿制药配方中差异很大。

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