HPLC法测定眼氨肽注射液中大分子蛋白  

Determination of high molecular weight proteins in Ocular Extractives Injection by HPLC

作　　者：白海娇[1] 覃婷婷[1] 丁一[2] 

机构地区：[1]天津市药品检验所,天津300070 [2]天津药物研究院,天津300193

出　　处：《现代药物与临床》2014年第7期734-736,共3页Drugs & Clinic

摘　　要：目的：建立眼氨肽注射液中大分子蛋白的检测方法，比较不同厂家生产的眼氨肽注射剂中大分子蛋白的质量分数。方法采用高效液相色谱法测定，TSK-GEL2000SWxl分子排阻色谱柱（300 mmx7.8 mm，5μm），以三氟乙酸-乙腈-水（0.1∶10∶90）为流动相，体积流量为0.6 mL/min，检测波长214 nm，进样体积10μL。采用面积归一化法计算大分子蛋白的质量分数。结果不同厂家生产的眼氨肽注射液中的大分子蛋白质量分数普遍较低，在0.020%-0.245%。结论与原方法20%磺基水杨酸法检测蛋白质比较，本方法的准确度更好，能有效地测定眼氨肽注射液中的大分子蛋白。Objective To establish a method for the determination of high molecular weight proteins in Ocular Extractives Injection, and to compare the contents of high molecular weight proteins in Ocular Extractives Injection from different manufacturers.Methods HPLC method was carried out on a TSK-GEL2000SWxl molecular exclusion chromatography column （300 mmx7.8 mm,5μm） with trifluoroacetic acid - acetonitrile - water （0.1∶10∶90） as mobile phase. The detection wavelength was set at 214 nm. The injection volume was 20μL at the flow rate of 0.6 mL/min. Contents of high molecular weight proteins in Ocular Extractives Injection were determined by area normalization method.Results The contents of high molecular weight proteins in Ocular Extractives Injection from different manufacturers were lower, and the contents were in the range of 0.020% - 0.245%.Conclusion Compared with 20% sulfosalicylic acid method in determining high molecular weight proteins, the established method has better accuracy, and can quantify the high molecular weight proteins in Ocular Extractives Injection effectively.

关 键 词：眼氨肽注射剂 大分子蛋白 

分 类 号：R927.2[医药卫生—药学]