葡萄糖注射液评价抽验中发现的问题及修改建议-中国药房.PDF

·药品监督· 葡萄糖注射液评价抽验中发现的问题及修改建议 ＊ 刘 娜 ，张昌戎，盖 静，苟林宏（兰州军区联勤部药品仪器检验所，兰州 730050） 中图分类号 R927.11；R977.7 文献标志码 A 文章编号 1001-0408（2013）17-1590-04 DOI 10.6039/j.issn. 1001-0408.2013.17.20 摘 要 目的：促进葡萄糖注射液临床用药安全的提高。方法：对39个厂家的130个批次、9种规格的葡萄糖注射液按2010年版 《中国药典》（二部）“葡萄糖注射液”项下内容进行检验，对检测结果中的渗透压摩尔浓度和5-羟甲基糠醛（5-HMF）含量进行评价 和分析。结果：5％的葡萄糖注射液渗透压摩尔浓度均低于血浆等渗范围，同厂家不同批次中5-HMF 的含量差异较大。结论：建 议《中国药典》等药品标准中收载等渗葡萄糖注射液质量标准，并在其他规格包装上注明渗透压摩尔浓度；注射液灭菌后迅速采取 降温措施。 关键词 葡萄糖注射液；渗透压摩尔浓度；5-羟甲基糠醛；评价抽验 Problems and Suggestions for Selective Evaluation of Glucose Injection LIU Na ，ZHANG Chang-rong ，GAI Jing ，GOU Lin-hong （Insititute for Drug and Instrument Control of Logistics Division of Lanzhou Military Region ，Lanzhou 730050，China ） ABSTRACT OBJECTIVE ：To improve the safety of Glucose injection in the clinic. METHODS ：The determination of 130batch- es of Glucose injection of 9 specifications from 39 manufacturers was performed by Chinese Pharmacopeia Ⅱ（2010 edition）. The osmolality and 5-HMF were evaluated and analyzed. RESULTS ：The osmolality of 5％Glucose injection was lower than isotonic range of plasma ，and there was significant difference in the contents of different batches of 5-HMF from same manufacturer. CON- CLUSIONS ：It is suggested to include the quality standards of isoosmotic Glucose injection in Chinese Pharmacopeia and clarify the osmolality in package inserts of other specifications ，the injection should be cooled quickly after sterilization. KEY WORDS Glucose injection ；Osmolality ；5-HMF ；Selective evaluation 克力树脂的交联剂。在搅拌条件下向丙烯酸酯类压敏胶中添 tin ：ST-1435[J]. Int J Fertil ，1976（2）：103. 加乙酰丙酮铝，有利于增加基质的内黏力，防止出现溢胶现象， [ 4] Lähteenmäki PL.Intestinal absorption of ST- 1435in rats 同时能提高丙烯酸酯类压敏胶在底材上的附着力。乙酰丙酮铝 [J].