葡萄糖注射液评价抽验中发现的问题及修改建议

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。

Problems and Suggestions for Selective Evaluation of Glucose Injection

OBJECTIVE： To improve the safety of Glucose injection in the clinic. METHODS： The determination of 130 batches 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. CONCLUSIONS： 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.