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本文对国内2家药厂,5家医院等7个单位配制的146批含糖输液中5-羟甲基糠醛值进行了测定。结果不合格品16批(10.96％);其中10％葡萄糖注射液115批,不合格品15批(13.04％);5％葡萄糖注射液10批,不合格品1批(10.0％);葡萄糖氯化钠注射液21批,全部合格。同时对(1) 测定时取样点的确定;(2) pH值、灭菌温度和时间对5-羟甲基糠醛值的影响;(3) 葡萄糖注射液的废品回收问题;(4) 含量测定方法的选择等进行了探讨。
In this paper, the determination of 5-hydroxymethylfurfural in 146 batches of sugar infusion in two domestic pharmaceutical factories, five hospitals and other seven units was carried out. The results were 16 batches (10.96%) of unqualified products, of which 115 batches of 10% glucose injection and 15 batches of unqualified products (13.04%), 10 batches of 5% glucose injection and 1 batches of unqualified products (10.0% Sodium injection 21 batches, all qualified. At the same time (1) determination of the sampling point; (2) pH value, sterilization temperature and time on the 5-hydroxymethyl furfural value; (3) glucose injection waste recycling problems; (4) content determination Method selection and so on were discussed.