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在葡萄糖注射液的制备过程中,常因溶液的pH调节不当或灭菌的温度和时间控制不好而导致成品发黄。这是由于葡萄糖受热分解产生5-HMF及其相关性物质所致。5-HMF对人体有害,日、英等国药典均在葡萄糖注射液项下对5-HMF的量作了规定。中国药典也对此作了限量规定。
In the preparation of glucose injection, often due to improper adjustment of the pH of the solution or sterilization temperature and time control is not good and lead to the finished product yellowing. This is due to the thermal decomposition of glucose to produce 5-HMF and its related substances. 5-HMF harmful to human body, Japan, Britain and other countries Pharmacopoeia in glucose injection under the provisions of the amount of 5-HMF. Chinese Pharmacopoeia also made a limited provision.