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注射用辅料安全性分析及其管理系统的建立 被引量:10

Safety analysis and establishment of regulatory system of excipients for parenteral use
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摘要 注射剂是临床上广泛应用的剂型,在危重病人的治疗中发挥了重要作用。注射用辅料是注射剂的重要组成部分,可用于增加或维持有效成分的溶解度(增溶剂)或稳定性(缓冲剂、抗氧剂、螯合剂、冻干保护剂等),增加注射剂的安全性(抑菌剂、等张调节剂),还可以减小注射时疼痛与刺激(止痛剂、等张调节剂),控制并延长药物在体内传递等。注射用辅料是一类影响面大、涉及面广并具有特定用途的药用辅料,应有明显区别于非注射途径药用辅料的管理制度。笔者通过对注射用辅料的安全性进行论述,结合我国药用辅料管理现状,提出了适合我国注射用辅料的管理思路。 Parenteral formulations are widely used in the clinical treatments, particularly for those used in the treatment of the critically ill patients. Excipients for parenteral use are vital components of parenteral products , which can be used to increase or maintain the solubility (solubilizer)and stability(buffering agents, antioxidants, chelating agents, cryoprotectants) of the active ingredients increasing safety of injection (antibacterial agents, isoosmotic adjusting agents) , and can also reduce injection pain and irritation (analgesic ,isoosmotic adjusting a- gents) , as well as controlling and prolonging the drug delivery in vivo. For excipients included in injectable prod- ucts with the intended functions, a new management system should be established and be clearly distinguished from non-injected formulations and common pharmaceutical excipients . Combined with of safety and management status of pharmaceutical excipients for injection,a suitable management idea is proposed to minimize the potiential risk of excipients used in injectable dosage forms.
出处 《中国新药杂志》 CAS CSCD 北大核心 2014年第16期1912-1917,共6页 Chinese Journal of New Drugs
关键词 注射剂 注射用辅料 安全性 辅料管理 parenteral formulations excipients for parenteral use safety excipients managements
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