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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 HPLC fingerprints of brain protein hydrolyzate solution and its injection, and to provide an effective method for the quality control and process evaluation of brain protein hydrolyzate solution and injection. Methods The chromatographic separation was carried out on an Agilent Zorbax SB-C18 column with a mobile phase of 0.1% trifluoroacetic acid and 0.085% trifluoroacetic acid in acetonitrile. The gradient elution was performed at a wavelength of 276 nm with a flow rate of 0.8 mL · min -1. Similarity analysis was conducted by using the similarity evaluation system of chromatographic fingerprints of traditional Chinese medicines (version 2.0). Results The established HPLC fingerprinting could separate the components of brain protein hydrolyzate and its injections well, and identified seven common peaks. Has good precision, repeatability and stability. Conclusion The fingerprint method established by HPLC is simple and reproducible. It can analyze the substance composition of brain protein hydrolyzate and its injection and can be used for quality control and process evaluation of brain protein hydrolyzate and its injection.