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| 盐酸左西替利嗪滴眼液的质量标准研究 |
| 朱娜1,聂李亚1,张达1,王婷2,陈姝茗3,张全丽1,牟岚1,范卫平1 |
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| (1. 北京汇恩兰德制药股份有限公司,北京 101106;
2. 北京农学院动物医学院,北京 102206;3. 重庆医科大学国际医学院,重庆 400016) |
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| 摘要: |
| 目的:建立盐酸左西替利嗪滴眼液的质量标准。方法:根据《中国药典》相关标准,参考人用药品注册技术国际协调会议
(ICH)规定,对1 批中试样品和3 批工艺验证样品进行检验,并对有关物质和含量的分析方法进行验证。结果:建立的质量标
准中,pH 限度为6. 4~7. 6,渗透压摩尔浓度限度为260~320 mOsmol/ kg,可有效保障产品质量和用药舒适性。中试和工艺验证
样品的检验结果均符合拟定的限度要求,且分析方法验证结果符合《中国药典》规定。结论:本研究建立的质量标准可用于控
制盐酸左西替利嗪滴眼液的产品质量。 |
| 关键词: 盐酸左西替利嗪滴眼液 质量标准 过敏性结膜炎 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.11.004 |
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| 基金项目: |
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| Study on Quality Standard of Levocetirizine Dihydrochloride Eye Drops |
| Zhu Na1, Nie Liya1, Zhang Da1, Wang Ting2, Chen Shuming3, Zhang Quanli1, Mou Lan1, Fan Weiping1 |
| (1. Beijing
Huonland Pharmaceutical Co. , Ltd. , Beijing 101106, China; 2. College of Veterinary Medicine, Beijing University of Agriculture,
Beijing 102206, China; 3. International Medical College, Chongqing Medical University, Chongqing 400016, China) |
| Abstract: |
| Objective: To establish the quality standard for levocetirizine dihydrochloride eye drops. Methods: In accordance with the
relevant general rules of the Chinese Pharmacopoeia, and by referring to the regulations of the International Conference on Harmonization
of Technical Requirements for Pharmaceuticals for Human Use (ICH), one batch of pilot-scale samples and three batches of process
validation samples were tested, and the analytical methods for related substances and content were validated. Results: The established
quality standards included pH, osmolality, related substances, and content determination. The pH limit was from 6. 4 to 7. 6, and the
osmolarity limit was from 260 to 320 mOsmol/ kg, which could effectively ensure the medication comfort. The results of pilot-scale and
process validation samples all met the specified limit requirements, and the validation results of analytical methods conformed to the
provisions of the Chinese Pharmacopoeia. Conclusion: The established quality standards can be used to control the product quality of
levocetirizine dihydrochloride eye drops. |
| Key words: levocetirizine dihydrochloride eye drops quality standard allergic conjunctivitis |
