三七化瘀口服液高效液相色谱指纹图谱的建立

摘要

目的：探讨构建三七化瘀口服液指纹图谱的技术要点及检测条件，建立能反映该制剂整体特征的高效液相色谱（HPLC）指纹图谱质量评价方法，为提高制剂质量稳定性和保证临床用药的安全有效提供依据。方法色谱柱为Shim－pack VP－ODS柱（250 mm ×4.6 mm，5μm），流动相为（A）乙腈－（B）0.05%磷酸水( pH=5，梯度洗脱)，流速为1 mL/min，检测波长为203 nm，进样量为10μL。结果10个不同批次样品的相似度均在0.9~1.0间。结论该色谱图可作为三七化瘀口服液指纹图谱，用于三七化瘀口服液的质量评价。%Objective To investigate the fingerprinting techniques and detection conditions of Sanqi Huayu Oral Liquid,build an HPLC fingerprint quality evaluation method to reflect the overall characteristics of the preparation in order to improve the quality of prepara-tion and stability,and provide basis for the safety and effectiveness of clinical medication. Methods The chromatographic column was Shim-packVP-ODS column(250 mm × 4. 6 mm,5 μm);mobile phase was(A)acetonitrile-(B)0. 05% phosphoric acid water(pH=5, gradient elution),the flow rate was 1 mL/min,the detection wavelength was 203 nm;the injection volume was 10 μL. Results By cal-culating the similarity,the similarity of the 10 batches of samples were between 0. 9-1. 0. Conclusion The chromatographic diagram can be used as the fingerprint of Sanqi Huayu Oral Liquid,and to evaluate its quality.