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安全性和患者获益的通用选择标准[IX]:使用用于评估触觉行为的触觉技能记录器(HapLog)可穿戴传感器评估透明质酸钠滴眼液的“使用感受”。

Generic selection criteria for safety and patient benefit [IX]: Evaluation of "feeling of use" of sodium hyaluronate eye drops using the Haptic Skill Logger (HapLog) wearable sensor for evaluating haptic behaviors.

作者信息

Goto Miho, Nozawa Mitsuru, Wada Yuko, Shimokawa Ken-Ichi, Ishii Fumiyoshi

机构信息

Triad Japan Co. Ltd., Kanagawa, Japan.

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

出版信息

Drug Discov Ther. 2020;14(1):14-20. doi: 10.5582/ddt.2020.01004.

Abstract

We compared the pharmaceutical properties, such as surface tension, drop volume, nozzle inner diameter, and force to push the drug product out of the container (squeeze force), of purified sodium hyaluronate eye drops preparations of one brand-name (Hyalein) and 11 generic drugs used for treatment of keratoconjunctiva epithelial disorders, and examined product selection based on the needs of the patient. The surface tension of Nissin (51.0 dyn/cm) and Nitten (52.3 dyn/cm) was significantly lower than that of Hyalein (62.8 dyn/cm), whereas Nitten PF (69.5 dyn/cm) was significantly higher than Hyalein. The drop volume of Tearbalance (42.4 mg), Nissin (43.7 mg), and Nitten (42.7 mg) was significantly lower than that of Hyalein (50.4 mg). We compared the squeeze force using a wearable touch sensor (Haptic Skill Logger: HapLog) and digital force gauge (DF). The squeeze force of HapLog showed values of about 1.7- to 3.5-fold higher than that of DF. Moreover, the squeeze force of Eyecare (34.0 N), Kyorin (35.4 N), and Nitten PF (44.3 N) by HapLog was significantly higher than that of Hyalein (10.5 N). In contrast, the squeeze force of Kyorin (20.8 N) and Nitten PF (25.0 N) by DF was significantly higher than that of Hyalein (12.2 N). Two questionnaire surveys on the feeling of instillation of eye drops revealed a strong negative correlation between feeling of use and squeeze force.

摘要

我们比较了一个品牌(海露)的透明质酸钠纯化眼药水制剂和11种用于治疗角膜结膜上皮疾病的仿制药的药学性质,如表面张力、滴体积、喷嘴内径以及将药品推出容器的力(挤压力),并根据患者需求研究了产品选择。参天(51.0达因/厘米)和日典(52.3达因/厘米)的表面张力显著低于海露(62.8达因/厘米),而日典PF(69.5达因/厘米)显著高于海露。泪然(42.4毫克)、参天(43.7毫克)和日典(42.7毫克)的滴体积显著低于海露(50.4毫克)。我们使用可穿戴触摸传感器(触觉技能记录器:HapLog)和数字测力计(DF)比较了挤压力。HapLog的挤压力显示出比DF高约1.7至3.5倍的值。此外,通过HapLog测得的爱眼康(34.0牛)、杏林(35.4牛)和日典PF(44.3牛)的挤压力显著高于海露(10.5牛)。相比之下,通过DF测得的杏林(20.8牛)和日典PF(25.0牛)的挤压力显著高于海露(12.2牛)。两项关于滴眼药水感觉的问卷调查显示,使用感觉与挤压力之间存在很强的负相关。

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