中国药物警戒 ›› 2022, Vol. 19 ›› Issue (11): 1174-1180.
DOI: 10.19803/j.1672-8629.20220398

• 生物模型方法在药品安全研究中的应用专栏 • 上一篇    下一篇

葡萄籽低聚原花青素作为新型眼用抑菌剂的可行性研究

尹翔1, 王晹2Δ, 史春辉1, 王宗尉1, 汪麟3,*, 姚尚辰4#, 许明哲4   

  1. 1黑龙江省药品检验研究院,黑龙江 哈尔滨 150080;
    2哈尔滨医科大学附属第四医院,黑龙江 哈尔滨 150001;
    3哈尔滨职业技术学院,黑龙江 哈尔滨 150076;
    4中国食品药品检定研究院,北京 102629
  • 收稿日期:2022-07-11 发布日期:2022-11-17
  • 通讯作者: *汪麟,男,博士,副主任药师,药物分析。E-mail：3599688@qq.com;#为共同通信作者。
  • 作者简介:尹翔,男,硕士,工程师,药品与医疗器械检验研究。Δ为并列第一作者。
  • 基金资助:
    国家重点研发计划（SQ2022YFC3400054）

Feasibility study on grape seed proanthocyanidins as a new ophthalmic antibacterial agent

YIN Xiang1, WANG Xi2Δ, SHI Chunhui1, WANG Zongwei1, WANG Lin3,*, YAO Shangchen4#, XU Mingzhe4   

  1. 1Heilongjiang Institute for drug control, Harbin Heilongjiang150080, China;
    2The Fourth Affiliated Hospital of Harbin Medical University, Harbin Heilongjiang 150001, China;
    3Harbin Vocational and Technical College, Harbin Heilongjiang150076, China;
    4Institute for Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2022-07-11 Published:2022-11-17

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摘要： 目的 考察葡萄籽低聚原花青素在滴眼剂型中的抑菌能力,为开发新型滴眼液用抑菌剂提供实验基础。方法 参照《中华人民共和国药典》（2020年版）四部通则1121测定葡萄籽原花青素的抑菌效力,参照国家卫生和计划生育委员会颁布的《新药（西药）临床前研究指导原则汇编》评价其对健康家兔眼部刺激作用。采用MTT比色法,考察葡萄籽原花青素对人角膜上皮细胞（HCEC）的毒性和对甲型流感病毒H1N1的抑制作用。结果 以葡萄籽低聚原花青素为抑菌剂,最低有效添加量为0.10 mg·mL-1,抑菌效力可达到A级。0.10 mg·mL-1的葡萄籽低聚原花青素对兔眼无刺激、对HCEC抑制率较低、对甲型H1N1流感病毒有一定抑制作用。结论 葡萄籽低聚原青花素可做为滴眼液抑菌剂选择之一。

关键词: 葡萄籽低聚原花青素, 抑菌效力, 滴眼液, 抑菌剂, 可行性

Abstract: Objective To investigate the bacteriostatic ability of grape seed proanthocyanidins in eye drops and provide experimental basis for the development of new antibacterial agents for eye drops. Methods The antibacterial ability and antibacterial efficacy of the original antibacterial agents and grape seed proanthocyanidins in eye drops were determined with reference to the general rule 1121 of the Ⅳ volume of the Chinese Pharmacopoeia, 2020 edition, and the ocular irritation of healthy rabbits was evaluated with reference to the compilation of guiding principles for preclinical research of new drugs (western medicines) issued by the national health and Family Planning Commission. In addition, in order to study the advantages of grape seed oligoprocyanidins as bacteriostatic agents, the cytotoxicity of grape seed procyanidins on HCEC cells and the inhibition of influenza A virus H1N1 were investigated by MTT colorimetry. Results With grape seed oligomeric proanthocyanidins as antibacterial agent, the reasonable addition was 0.10 mg·mL-1, and the antibacterial ability could reach grade 0.10 mg·mL-1 grape seed procyanidins aqueous solution had no irritation to rabbit eyes and had a certain inhibitory effect on influenza A (H1N1) virus. Conclusion Grape seed proanthocyanidin can be used as one of the antibacterial agents in eye drops.

Key words: grape seed proanthocyanidins, bacteriostatic efficacy, eye drops, bacteriostatic agents, feasibility

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