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10%葡萄糖注射液热压灭菌后引起的稳定性变化表现为成品的pH值、含量下降,分解产物5-羟甲基呋喃甲醛(5-HMF)增加,药液变黄,从而影响产品质量及临床使用的安全性。大量文献报道认为在严格灭菌条件和操作的情况下,把药液pH值调节至3.8～4.0时有益于产品的稳定。但笔者根据实际工作观察和统计,同时考虑到临床应用情况,认为若将pH值调节至4.5±0.1更为妥善。方法:仅就20%葡萄糖注射液半成品在pH值不同情况下热压灭菌后pH、含量下降值及分解产物5-HMF的吸收度为统计数,进行数理统计分析。热压灭菌前
The stability of 10% glucose injection after autoclave sterilization showed the change of pH, the content of 5-hydroxymethylfurfural (5-HMF) and yellowing of the product, which affected the product quality And the safety of clinical use. A large number of reports in the literature that in the case of strict sterilization conditions and operations, the liquid pH adjusted to 3.8 ~ 4.0 beneficial to the stability of the product. However, according to the actual work of observation and statistics, taking into account the clinical application, that if the pH adjusted to 4.5 ± 0.1 is more appropriate. Methods: The statistics of 20% glucose injection semi-finished products under the conditions of different pH value after autoclaving sterilization, the declining value and the 5-HMF absorbance of decomposition product were counted. Before autoclaving