聚山梨酯80对药典方法检查中药注射剂蛋白的影响  

Influence of Polysorbate 80 on Examining Protein in Chinese Medicinal Injections with Pharmacopoeia Method

作　　者：祖金玥 冯孟鑫 王小红[1] 李莉[1] 徐文英[1] 马长华[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国药品标准》2015年第1期36-38,共3页Drug Standards of China

基　　金：国家自然科学基金资助项目--探索增溶辅料对中药注射剂杂蛋白测定方法的影响(编号:81173550)

摘　　要：目的:探究不同浓度的聚山梨酯80对中药注射剂蛋白检查药典方法——磺基水杨酸比浊法检测限量的影响。方法:采用磺基水杨酸比浊法分别检查牛血清白蛋白(BSA)和刀豆蛋白A(Con A)溶液,及其含有0.5%、1.0%、1.5%、2.0%、4.0%、6.0%、8.0%、10%聚山梨酯80的溶液,得到其检测限量。结果:BSA和Con A的检测限量分别是40μg和50μg。随着聚山梨酯80的浓度增大到10%,BSA和Con A的检测限量逐渐增大至140μg和100μg。结论:含有聚山梨酯80的中药注射剂不宜采用药典方法检查其蛋白。Objective： To investigate the influence of polysorbate 80 on the protein detection limit by sulfosalicylic acid turbidimetry, a method recorded in Chinese Pharmacopoeia for protein assay of traditional Chinese medicine （TCM） injections. Methods： Bovine serum albumin （BSA） solution,concanavalin A （ Con A） solution, and their solutions containing 0.5%, 1.0%, 1. 5%, 2. 0%, 4. 0%, 6.0% , 8. 0% , 10% polysorbate 80 were measured by sulfosalicylic acid turbidimetry, respectively. The detection limit of each sample was determined. Results： The detection limits of BSA solution and Con A solution were 40 μg and 50 μg. After polysorbate 80 was added, the detection limits of BSA and Con A gradually increased with the concentration of polysorbate gO. When the concentration of polysorbate80 in the solution was 10%, the detection limits of BSA and Con A were up to 140 μg and 100 μg. Conclusion： The sulfosalicylic acid turbidimetry is not suitable for examining protein in TCM injections containing polysorbate 80.

关 键 词：聚山梨酯80 磺基水杨酸比浊法 牛血清白蛋白 刀豆蛋白A 检测限量 

分 类 号：R921.2[医药卫生—药学]