探索吐温80对中药注射剂中蛋白质检查药典方法.doc

聚山梨酯80对药典方法检查中药注射剂蛋白的影响 祖金玥，冯孟鑫，李莉，徐文英，马长华*（北京中医药大学药学院，北京100102) 摘要目的：探究不同浓度的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% 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80的中药注射剂不宜采用药典方法检查其蛋白。 关键词：80；磺基水杨酸比浊法；牛血清白蛋白；刀豆蛋白A；检测限量 Influence of Polysorbate 80 on Examining Protein in Chinese Medicinal Injections with Pharmacopoeia Method Zu Jinyue, Feng Mengxin, Wang Xiaohong, Li Li, Xu Wenying, Ma Changhua* (1. College of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102) Abstract Objective: To investigate the influence of polysorbate80 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% polysorbate80 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 40μg and 50μg. After polysorbate 80 was added, the detection limits of BSA and Con A gradually increased with the concentration of polysorbate 80. When the concentration of polysorbate80 in the solution was 10%, the detection limits of BSA and Con A were up to 140μg and 100μg. Conclusion: The sulfosalicylic acid turbidimetry is not suitable for examining protein in TCM injections containing polysorbate 80. Key Words: polysorbate80; sulfosalicylic acid turbidimetry ; BSA ; Con A ; detection limit 目前中药注射剂使用的安全问题备受关注根据不良反应报告分析，的杂质蛋白是导致其发生不良反应的重要因素之一[1, 2]。《中国药典》2000年版规定对中药注射剂中有关物质——蛋白质进行检查：取注射液1ml，加新配制的30%磺基水杨酸溶液1ml，混匀，放置5分钟，不得出现浑浊。注射液中如含有遇酸能产生沉淀的成分，可改加鞣酸试液1～3滴，不得出现浑浊。 [3]，该方法一直沿用至今。 聚山梨酯80，又名吐温80，是中国药典收载的药用辅料，作为增溶剂已广泛应用于中药注射剂[4, 5]。由于聚山梨酯