丹红注射液多元指纹图谱及多成分定量分析研究  

Multiple fingerprints and multi-comonent quantitative analysis of Danhong Injection

作　　者：汪悦[1] 邵青[1] 瞿海斌[1] 刘宇峰[1] 

机构地区：[1]浙江大学药物信息学研究所,浙江杭州310058

出　　处：《中草药》2014年第4期490-497,共8页Chinese Traditional and Herbal Drugs

基　　金：国家自然科学基金资助项目(81273992)

摘　　要：目的采用HPLC-UV-MS法建立丹红注射液多元指纹图谱，并对其中9种主要药效成分同时定量分析。方法采用AtiantisT3色谱梓（250mm×4．6mm，5μm），流动相为0．05％甲酸水溶液-50％乙蜻水溶液，梯度洗脱；质谱检测采瑚负离子选择离子（SIM）模式。结果该多元指纹图谱较全面地体现了制剂中2味处方药材片参与红化的化学信息，11批制剂指纹蚓讲相似度均在0．988以上。5-羟甲基糠醛、丹参素钠、原几茶醛、香豆酸、丹酚酸D、迷迭香酸、丹酚酸B、丹酚酸A、山奈酚-3-O-苷香糖9种成分在各自质量浓度范围内呈良好线性关系，r≥0．9990：9种化合物的平均加样回收半分别为（99．0±1．4）％、（102．0±1．7）％、（99．3±1．6）％、（97．6±1．6）％、（100．0±1．8）％、（97．9±1．6）％、（100．5±4．4）％、（100．6±2．0）％、（106．0±4．7）％（n=9）；方法重复性的RSD均小于1．45％；测定的11批制剂中9种成分总量在2．61～3．06mg／mL。结论该方法简单、准确、重复性好，多元指纹图谱结合定量测定能更全面地反映丹红注射液的质量，可用于制剂的质量控制。Objective To establish the multiple fingerprints of Danhong Injection （DI） using HPLC-UV-MS method and to simultaneously determine nine kinds of the medicinal components in DI. Methods Separation was performed on Atlantis T3 analytical column （250 mm ×4.6 mm, 5 μm） with the mobile phase of 0.05% formic acid-50% acetonitrile by gradient elution, and negative-ion SIM mode was selected for mass spectrometric detection. Results The multiple fingerprints reflected the chemical information of Salvia miltiorrhiza and safflower in DI. The similarity of the fingerprints was higher than 0.988 in all 11 batches of D1.5-Hydroxymethyl furfural, sodium danshensu, protocatechuic aldehyde, coumaric acid, salvianolic acid D, rosmarinic acid, salvianolic acid B, salvianolic acid A, and kaempferol-3-O-rutinoside showed the good linearity in their respective ranges of concentration, r ≥0.999 0. The average recovery of low-, mid-, and high-dose medicinal components （n = 9） was （99.0 ± 1.4）%, （102.0 ± 1.7）%, （99.3 ± 1.6）%, （97.6 ± 1.6）%, （100.0 ± 1.8）%, （97.9 ± 1.6）%, （100.5 ± 4.4）%, （100.6 ± 2.0）%, and （106.0 ± 4.7）%, respectively. The relative standard deviation for the method reproducibility was lower than 1.45%. The total contents of nine medicinal components in the 11 batches of DI were 2.61--3.06 mg/mL. Conclusion This method is simple, accurate, and with good reproducibility, and the multiple fingerprints combined with the quantitative analysis could reflect the quality of DI better, which could be used to control the quality of Dl.

关 键 词：丹红注射液 多元指纹图谱 HPLC-UV-MS 5-羟甲基糠醛 丹参素钠 原儿茶醛 香豆酸 丹酚酸D 迷迭香酸 丹酚酸B 丹酚酸A 山柰酚-3-O-芸香糖苷 

分 类 号：R286.02[医药卫生—中药学]