目的 建立眼氨肽注射液中大分子蛋白的檢測方法，比較不同廠家生產(chǎn)的眼氨肽注射劑中大分子蛋白的質(zhì)量分?jǐn)?shù)。方法 采用高效液相色譜法測定，TSK-GEL2000SWxl分子排阻色譜柱（300 mm×7.8 mm，5 μm），以三氟乙酸-乙腈-水（0.1：10：90）為流動相，體積流量為0.6 mL/min，檢測波長214 nm，進樣體積10 μL。采用面積歸一化法計算大分子蛋白的質(zhì)量分?jǐn)?shù)。結(jié)果 不同廠家生產(chǎn)的眼氨肽注射液中的大分子蛋白質(zhì)量分?jǐn)?shù)普遍較低，在0.020%～0.245%。結(jié)論 與原方法20%磺基水楊酸法檢測蛋白質(zhì)比較，本方法的準(zhǔn)確度更好，能有效地測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 mm×7.8 mm, 5 μm) with trifluoroacetic acid-acetonitrile-water (0.1:10:90) as mobile phase. The detection wavelength was set at 214 nm. The injection volume was 20 μL 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.