注射用丹红(粉针)HPLC指纹图谱研究  

RP-HPLC fingerprint of Danhong Injection

作　　者：刘静 刘向国 李国强[2] 郑毅 郑燕青 

机构地区：[1]德州市药品检验所,山东德州253000 [2]中国海洋大学,山东青岛266003

出　　处：《中成药》2010年第1期10-12,共3页Chinese Traditional Patent Medicine

摘　　要：目的:探讨丹红(丹参、红花)中药注射剂指纹图谱质量控制方法。方法:运用Agilent1100 DAD-HPLC高效液相色谱仪,采用大连依利特Sino Chrom ODS-BP(250mm×4.6mm,5μm)色谱柱,甲醇-0.1%磷酸水梯度洗脱,柱温30℃,流速1.0mL/min,检测波长280nm,进样量20μL。结果:在10批丹红注射剂基础上建立了有20个共有峰的注射用丹红粉针的HPLC色谱图,各峰分离度较好,指纹信息完整,符合指纹图谱技术规范。结论:可作为注射用丹红(粉针)质量控制的重要依据之一。AIM： To explore the fingerprint method for quality control of Danhong sterile powder for injection （Radix et Rhizoma salviae miltiorrhizae, Flos carthami）. METHODS： The samples were determined by Agilent 1100 DAD-HPLC with SinoChrom ODS-BP column （250 mm ×4.6 mm, 5 μm） , by gradient elution using methanol-0.1% phosphoric acid, as mobile phase 30 ℃ column temperature, flow rate of 1.0 mL/min, detection wavelength was set at 280 nm, and inject volume 20 μL. RESULTS ： Its fingerprint exhibited better separation for each peak, revealing amount of finger information, Based on the ten batches of Danhong sterile powder for injection, according to the technical requirements of fingerprint on injection of Chinese traditional medicine. CONCLUSION ： Proposed HPLC fingerprint can be used as the important evidences for the quality control of Danhong Injection.

关 键 词：丹红沣射刺 丹参 红花 指纹图谱 HPLC 

分 类 号：R944.27[医药卫生—药剂学]