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目的:建立多组分胸腺肽注射剂的反相HPLC特征图谱。方法:采用反相HPLC/UV法分离胸腺肽注射剂的主要成分。色谱柱为Shimadzu Shim-pack XR-ODS(100 mm×3.0 mm,2.2μm);以流动相A:0.1%(v/v)三氟醋酸水溶液,流动相B:0.085%(v/v)三氟醋酸乙腈溶液-0.1%(v/v)三氟醋酸水溶液(80:20),进行梯度洗脱,流速0.5 mL.min-1;检测波长为280nm。用中药色谱指纹图谱相似度评价系统软件对所得色谱特征图谱进行评价。结果:同企业样品的特征图谱与均谱的相似度多数保持在0.9以上,批间一致性良好;不同企业产品的特征图谱与均谱的相似度较低。结论:所建立的反相HPLC方法具有较强的分离能力,线性、精密度良好,为胸腺肽注射剂的质量控制提供了有效的方法。
Objective: To establish a reverse phase HPLC profile of multi-component thymosin injection. Methods: The main components of thymosin injection were separated by reverse phase HPLC / UV. The chromatographic column was Shimadzu Shim-pack XR-ODS (100 mm × 3.0 mm, 2.2 μm); the mobile phase A was consisted of 0.1% (v / v) trifluoroacetic acid in water and mobile phase B Fluoroacetic acid in acetonitrile-0.1% (v / v) trifluoroacetic acid (80:20) gradient elution at a flow rate of 0.5 mL.min-1; detection wavelength was 280 nm. The chromatographic fingerprint of the obtained chromatographic fingerprint was evaluated by using the similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine. Results: The similarity between the feature spectrum and the average spectrum of the same sample was maintained above 0.9, and the consistency among the batches was good. The similarity between the feature map and the average spectrum of the products of different enterprises was low. Conclusion: The established reversed-phase HPLC method has strong separation ability, good linearity and good precision, and provides an effective method for the quality control of thymosin injection.