| 唐筱婉,梅丹,都丽萍.关注眼用注射剂质量标准及临床应用安全性[J].中国药事,2019,33(6):630-636 |
| 关注眼用注射剂质量标准及临床应用安全性 |
| Quality Standards and Clinical Safety of Opthalmic Injections |
| 投稿时间：2019-01-30 |
| DOI：10.16153/j.1002-7777.2019.06.005 |
| 中文关键词: 眼用注射剂 质量标准 中华人民共和国药典 美国药典 日本药典 英国药典 欧洲药典 |
| 英文关键词: ophthalmic injection quality standard Chinese pharmacopoeia United States Pharmacopeia Japanese Pharmacopoeia British Pharmacopeia European Pharmacopeia |
| 基金项目:国家自然科学基金资助项目（编号81601033）；北京市自然科学基金资助项目（编号7174342）；中国医学科学院医学与健康科技创新工程项目（编号2017-I2M1-011） |
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| 中文摘要: |
| 目的：对眼用注射剂的相关质量标准进行分析汇总，为临床安全使用眼用注射剂提供建议。方法：全面检索国内外药典及近10年相关文献，比较眼用注射剂相关质量标准的变迁和异同。结果：各国药典对眼用制剂和注射剂的限定越来越严格，但仍未对眼用注射剂单独提出质量标准，且部分指标仍与国际标准存在差距。结论：建议对特定部位使用的特殊制剂（如眼用注射剂）加强管理，提高相关质量标准，以确保临床用药的安全性。 |
| 英文摘要: |
| Objective:To analyze and summarize the relevant quality standards of ophthalmic injections and provide suggestions for clinical safe use of the ophthalmic injections. Methods:Pharmacopoeias at home and abroad and the relevant literatures of the past ten years were comprehensively searched, and similarities and differences of the quality standards related to ophthalmic injections were compared. Results:Pharmacopoeias of various countries have set more and more strict restrictions on ophthalmic preparations and injections. However, no quality standard for ophthalmic injections has been put forwarded. Furthermore, some indicators are still different from those of international standards. Conclusion:It is recommended that the management of special preparations (such as ophthalmic injections) for specific sites should be strengthened, the quality standards should be improved to ensure the safety of clinical medication. |
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