摘要
本文通过文献查新、阅读在线资料和国内外市售质子泵抑制剂PPIs产品说明书等资料,从辅料、稀释溶媒、室温稳定性等方面,对比各种注射用PPIs体外配伍稳定性和使用安全风险。发现我国上市销售的注射剂用PPIs产品包括奥美拉唑、兰索拉唑、泮托拉唑、埃索美拉唑;四种产品在葡萄糖注射液中的稳定性均不佳,配制后数小时内可发生颜色变化、有效成分降低和有关物质含量增加的情况;静脉滴注用和静脉注射用的PPIs剂型的辅料不同,混用会产生稳定性和血管刺激问题。在市售PPIs产品中,除商品名为"洛赛克"的奥美拉唑之外,均只能使用生理盐水稀释;不能混用静脉滴注用和静脉注射PPIs制剂,建议静脉滴注兰索拉唑时加用1.2μm过滤器。
A variety of proton pump inhibitors （PPIs） were compared considering their in vitro compatibility and safety risks. Dilution solvent, room temperature stability, and clinical use of different PPIs were collected by searching through literatures, reading online data and comparing instructions of domestic and foreign commercial PPI products. The PPI products available in China include omeprazole, lansoprazole, pantoprazole, and esomeprazole, which were all unstable in glucose injection. A few hours after preparation, their color changed, the content of active ingredients reduced, and impurities increased. The excipients in PPI injection for intravenous drip and intravenous push were different. Stability would change and irritation would arise if misused. Commercially available PPI products, except the trade name ＂Losec＂ of Omeprazole, can only use 0.9% sodium chloride injection as the solvent. Misuse of intravenous drip and intravenous push PPI formulations should be avoided. It is recommended 1.2μm filter be used when intravenous lansoprazole were injected.
出处
《药品评价》
CAS
2012年第14期24-27,共4页
Drug Evaluation
