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[新型含酒精洗手液MR06B7的体外和体内疗效研究]

[Investigation of in vitro and in vivo efficacy of a novel alcohol based hand rub, MR06B7].

作者信息

Okunishi Junji, Okamoto Kazuki, Nishihara Yutaka, Tsujitani Kumiko, Miura Tsuyoshi, Matsuse Hitoshi, Yagi Toshikazu, Wada Yuji, Goto Junko, Seto Masahiko, Ikeda Masahiro

机构信息

Maruishi Pharmaceutical Co., Ltd., Osaka, Japan.

出版信息

Yakugaku Zasshi. 2010 May;130(5):747-54. doi: 10.1248/yakushi.130.747.

Abstract

Alcohol based hand rubs have been used for hand hygiene in health-care settings. Compared with hand scrubbing, using suitable alcohol based hand rub provides several advantages like usability in a ward with no tap, requiring less time and mildly-irritating. Alcohol provides immediate activity, but poor virucidal activity against certain viruses including norovirus. It is important to develop further improved alcohol based hand rubs which have characteristics of sufficient effectiveness, skin-safe and extended spectrum to non-enveloped viruses for infection control. In the study, in vitro microbicidal evaluations and in vivo efficacy evaluation study were investigated to clarify the characteristics of a novel hand antiseptic MR06B7 composed of additives with synergetic activities. MR06B7 showed bactericidal activity of more than 5 Log(10) reduction within 15 sec against 20 challenged strains. MR06B7 also demonstrated potent fungicidal activities at exposure time of 30 sec (more than 4 Log(10) reduction). Against all test viruses including non-enveloped viruses (adenovirus, feline calicivirus, murine norovirus and poliovirus), MR06B7 had excellent virucidal activity to reduce the titer of viability to the limit of detection within 30 sec exposure (more than 4 Log(10) reduction), whereas 83%(v/v) ethanol indicated the inadequate effectiveness. On the clinical study conducted in accordance with standard method for Healthcare Personnel Handwash of American Society for Testing and Materials, MR06B7 showed excellent immediate antimicrobial activity. The result surpassed the critical indices set forth in the FDA's Tentative Final Monograph. These findings suggest MR06B7 which satisfies most requirements of efficacy qualifications including potent virucidal activity against non-enveloped viruses may contribute to accomplish advanced infection control in clinical practice.

摘要

含酒精的手部消毒剂已在医疗机构中用于手部卫生。与洗手相比,使用合适的含酒精手部消毒剂具有诸多优点,如在无水龙头的病房中也可使用、所需时间更少且刺激性较小。酒精具有即时杀菌活性,但对包括诺如病毒在内的某些病毒的杀病毒活性较差。开发进一步改进的含酒精手部消毒剂很重要,这类消毒剂应具有足够的有效性、对皮肤安全且对非包膜病毒具有广谱活性,以用于感染控制。在该研究中,进行了体外杀菌评估和体内疗效评估研究,以阐明一种由具有协同活性的添加剂组成的新型手部消毒剂MR06B7的特性。MR06B7在15秒内对20株受试菌株的杀菌活性降低超过5个对数(10)。MR06B7在暴露30秒时也表现出强效的杀真菌活性(降低超过4个对数(10))。针对所有测试病毒,包括非包膜病毒(腺病毒、猫杯状病毒、鼠诺如病毒和脊髓灰质炎病毒),MR06B7在暴露30秒内具有出色的杀病毒活性,可将活力滴度降低至检测限以下(降低超过4个对数(10)),而83%(v/v)乙醇的有效性不足。根据美国材料与试验协会医疗人员洗手标准方法进行的临床研究中,MR06B7表现出出色的即时抗菌活性。结果超过了美国食品药品监督管理局暂定最终专论中规定的关键指标。这些发现表明,MR06B7满足了包括对非包膜病毒具有强效杀病毒活性在内的大多数疗效标准要求,可能有助于在临床实践中实现先进的感染控制。

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