摘要
目的:研究配液温度、pH值和灭菌条件等工艺参数对羟乙基淀粉130/0.4氯化钠注射液中5-羟甲基糠醛(5-HMF)含量及pH值等产品质量属性的影响。方法:通过建立的紫外分光光度法检测不同制备工艺条件下灭菌后样品中5-HMF的含量,并采用pH计测定灭菌后样品的pH值。结果:不同配液温度对5-HMF含量无明显影响;不同pH值样品灭菌后5-HMF含量均有所增加。pH值大于5.0后,灭菌后样品pH值出现明显下降;经不同灭菌条件灭菌的样品,pH值和5-HMF含量无明显区别。结论:为确保最终产品pH值和5-HMF含量满足要求,同时保证本品无菌水平,本品生产过程注意控制溶液pH值,同时选择合适的灭菌条件。
Objective:To investigate the effects of temperature,pH and sterilization on the content of 5-hydroxymethyl furfural(5-HMF)in Hydroxyethyl Starch 130/0.4 Sodium Chloride Injection.Methods:The pH and 5-HMF content in each sample solution under different conditions were detected by pH meter and ultraviolet spectrophotometry respectively.Results:The 5-HMF content was not affected by temperature significantly.The 5-HMF content of samples with different pH values increased after sterilization.The pH decreased after sterilization significantly when the pH was greater than 5.0.There was no significant difference in the pH and 5-HMF content when the samples sterilized by different sterilization conditions.Conclusion:In order to ensure that the pH,5-HMF content and sterility level of the final product can be qualified for standard,the pH of the solution and sterilization conditions should be controlled appropriately during the production process of this product.
作者
吕秀玲
赵世娟
章晓骅
Lyu Xiuling;Zhao Shijuan;Zhang Xiaohua(Nanjing Chia-Tai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)
出处
《山东化工》
CAS
2023年第16期25-27,共3页
Shandong Chemical Industry
