胸腺肽注射剂反相HPLC特征图谱研究

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,2.2 μm);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280 nm。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 specific chromatogram of thymopolypeptides injections. Method: RP-HPLC/UV was used as the reference method to separate the main components in thymopolypeptides injections.Shimadzu Shim-pack XR-ODS (100 mm×3.0 mm,2.2 μm) column was adopted;The mobile phase was A:0.1%(v/v)trifluoroactic acid solution,B:0.085%(v/v)trifluoroactic acid acetonitrile solution-0.1%(v/v)trifluoroactic acid solution(80∶ 20)with gradient elution at the flow rate of 0.5 mL·min^-1;The detection wavelength was 280 nm.The specific chromatograms were evaluated by the software of the similarity evaluation system for the chromatographic fingerprints of Chinese traditional medicines. Results: The most similarity values between specific chromatograms and their average chromatograms from same manufactures are above 0.9 that demonstrates the consistency of components of injections from same manufacturers is good;on the contrary,the results of different manufacturers' injections are not so satisfactory. Conclusion: The method established in this research provides an effective way for controlling the quality of thymopolypeptides injections with good separation,linear and precision.