脑蛋白水解物及其注射剂的高效液相色谱指纹图谱研究

Development of High Performance Liquid Chromatographic Fingerprints of Cerebroprotein Hydrolysate and Its Injection

目的建立脑蛋白水解物溶液及其注射剂的HPLC指纹图谱,为脑蛋白水解物溶液和注射剂的质量控制以及工艺评价提供有效的方法。方法色谱分离采用Agilent Zorbax SB-C18色谱柱,流动相为0.1%三氟醋酸溶液和0.085%三氟醋酸乙腈溶液,梯度洗脱,紫外检测器276 nm波长检测,流速0.8 mL·min-1;采用"中药色谱指纹图谱相似度评价系统"(2.0版)对其进行相似度分析。结果所建立的HPLC指纹图谱能够对脑蛋白水解物及其注射剂各组分进行较好分离,确定了7个共有峰。具有较好的精密度、重复性和稳定性。结论采用HPLC建立的指纹图谱方法简单,重复性好,能够分析脑蛋白水解物及其注射剂的物质组成,可用于脑蛋白水解物及其注射剂的质量控制和工艺评价。

OBJECTIVE To establish the specific chromatogram of cerebroprotein hydrolysate and so asto provide an effective way for the quality control and process evaluation of eerehroprotein hydrolysate and its injection. METHODS Agilent Zorbax SB-Cts column was adopted with the mobile phase consisting of 0. 1% trifluoroacetic acid solution and 0. 085% trifluoroacetic acid acetonitrile solution in gradient mode. UV detection was performed at 276 nm. The flow rate was 0. 8 mL · min 1. The methodology was validated. Several batches of cereborprotein hydrolysate and its preparation were determined by HPLC, and the similarity degree was analyzed with Similarity Evaluation System for Chromatographic Fingerprint of TCM （ Version 2. 0）. RESULTS The components of cerehorprotein hydrolysate and its injection could be separated well using HPLC method. Seven common peaks were identified. CONCLUSION The established method is simple, accurate and reproducible for determination of the components of eerebroprotein hydralysate and its preparation, which can he used for the quality control and process evaluation of cerebroprotein hydralysate and its injection.