摘要
目的:采用HPLC方法对注射用益气复脉(冻干)指纹图谱进行研究。方法:采用Waters Symmetry C18柱(4.6 mm×250 mm,5μm),乙腈-0.05%磷酸梯度洗脱,流速为1.0 mL.min-1,检测波长203 nm。结果:按"中药色谱指纹图谱相似度评价系统的操作规范(版本2004B)"计算,10批注射用益气复脉(冻干)的相似度均在0.90以上,确定了23个共有峰,建立了该制剂的HPLC指纹图谱。结论:方法简单可行,可以有效地控制益气复脉的质量。
Objective： To establish the HPLC fingerprint for the quality control of Yiqifumai injections. Method： A Waters Symmetry C18 column （4.6 mm×250 mm, 5μm） by stepwise gradient elution with water （0.05% Phosphoric acid, v/v） and acetonitrile as the mobile phase was used. The flow rate was 1.0 mL·min^-1, and the detection wavelength was at 203 nm. Results： The operating standard of similarty evaluation system for chromatographic fingerprint of Chinese Materia Medica （Version 2004B） was used to calculate. Similarity of 10 batches of injections was higher than 0.90, the fingerprint of Yiqifumai injections was established, and 23 common peaks were indicated. Conclusion： This method is simple, accurate, and can be applied to the quality control of Yiqifumai injections.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第11期1900-1904,共5页
Chinese Journal of Pharmaceutical Analysis
