中药注射剂安全性的分析与思考 |
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作者姓名: | 彭国平 李存玉 |
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作者单位: | 南京中医药大学药学院,江苏 南京 210023 |
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摘 要: | 中药注射剂安全性是社会关注的热点问题,正确认识中药注射剂不良反应,将能避免社会民众产生误解或认识错位。目前中药注射剂的生产原料、生产工艺以及突出安全性的质量监控是影响中药注射剂安全性的关键所在,针对各品种临床存在的问题,加强中药注射剂安全性的基础研究,在说明书明确临床药物配伍及使用规范,强化相关物质、不溶性微粒、热原、过敏物质等注射剂安全性质控,确实保证中药注射剂用药安全。
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关 键 词: | 中药注射剂 安全性 质量提升 过敏 |
Thinking and Analysis on the Safety of Traditional Chinese Medicine Injection |
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Authors: | PENG Guo-ping LI Cun-yu |
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Abstract: | The safety of traditional Chinese medicine injection (TCMI) has become the hot question in the society. Correct understanding of the adverse reactions of TCMI can effectively avoid the misunderstanding or misperception among the public. At present, the raw materials, production process and quality control were the key points which influence the safety of TCMI injections. According to the clinical problems of various varieties, it should concentrate on strengthening basic research, standardization the instructions and drug compatibility, enhance the safety control of the related substances, insoluble particles, pyrogen and allergens to ensure the safe usage of TCMI. |
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Keywords: | traditional Chinese medicine injection safety quality improvement allergy |
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