UV-VIS法和HPLC法测定医用透明质酸钠敷料中透明质酸钠含量的研究  

Study on the Determination of Sodium Hyaluronate Content in Medical Sodium Hyaluronate Dressing by Ultraviolet Visible Spectrophotometer and High Performance Liquid Chromatography

作　　者：张丽莹 薄晓文 张婷 孟强 李秋迎 ZHANG Li-ying;BO Xiao-wen;ZHANG Ting;MENG Qiang;LI Qiu-ying(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Shandong Jinan 250101;NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Shandong Jinan 250101;Shandong Key Laboratory of Biological Evaluation for Medical Devices,Shandong Jinan 250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101 [2]国家药品监督管理局生物材料器械安全性评价重点实验室,山东济南250101 [3]山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《中国医疗器械信息》2024年第3期29-32,50,共5页China Medical Device Information

摘　　要：文章阐述并验证了采用紫外-可见分光光度(UV-VIS)法和高效液相色谱(HPLC)法测定医用透明质酸钠敷料中透明质酸钠含量,并对HPLC法中透明质酸钠酶解过程中的酶解反应时间进行进一步研究。结果显示,HPLC法和UV-VIS法均可以准确高效地测定出不同类型的医用透明质酸钠敷料中透明质酸钠含量,当敷料产品中存在干扰UV-VIS法测定的成分时,应首选HPLC法,可以大幅度提高检测效率和准确度。研究同时发现,在HPLC法中,酶解反应时间对透明质酸钠含量测定结果的准确性起着关键作用,通过对酶解反应时间进行研究,最终确定了不同类型敷料产品的最佳酶解反应时间。This paper describes and verifies the determination of sodium hyaluronate content in medical dressing by ultraviolet visible spectrophotometer(UV-VIS)method and high performance liquid chromatography(HPLC)method,and further studies the enzymolysis reaction time of sodium hyaluronate in the enzymolysis process of HPLC.The results show that both HPLC method and UV-VIS method can accurately and efficiently determine the content of Sodium hyaluronate in different types of medical Sodium hyaluronate dressings.When components in the dressing product that interfere with the UV-VIS method,HPLC method can be preferred,which can greatly improve the detection efficiency and accuracy.The study also found that in the HPLC method,the enzyme reaction time plays a key role in the accuracy of the determination of Sodium hyaluronate content.By studying the enzymatic hydrolysis reaction time,the optimal enzymatic hydrolysis reaction time for different types of dressing products was ultimately determined.

关 键 词：紫外-可见分光光度法 高效液相色谱法 医用透明质酸钠敷料 透明质酸钠 酶解反应时间 

分 类 号：TB324[一般工业技术—材料科学与工程]