冠心宁注射液中活性成分的质量控制研究

Study on the Quality Control of the Active Components in Guanxinning Injection

目的建立采用高效液相色谱法(HPLC)同步测定冠心宁注射液中丹参素、迷迭香酸、原儿茶醛、阿魏酸、丹酚酸B等5种活性成分含量的方法。方法采用Agilent Zorbax SB-C18(4.6mm×250 mm,5μm),以乙腈0.05%三氟乙酸水溶液为流动相,流速0.8 ml/min,柱温40℃,检测波长288 nm;梯度洗脱。分别计算不同批次注射液的提取率。结果建立的HPLC含量测定方法线性关系良好,5种成分的加样回收率在98.3%~101%之间,RSD在0.69%~1.6%,不同批次的冠心宁注射液中5种测定成分含量存在差异。结论该测定方法简便、快速、重现性好,可用于冠心宁注射液生产过程中质量控制与评价,保证中药注射液质量的稳定可控。

Objective To set up the method for the determination of five active component levels, named dantin, rosemary acid, protocatecha aldehyde, ferulic acid and danphenate B in guanxlnning injection together with HPLC method. Methods Agilent Zorhax SB - C18 （ 4.6 mm ×250 mm, 5 μm） was adopted. 0.05% acetonitrile trifuocoacetic acid aqueous solution was taken as mobile phase ,0.8 ml/min at flow rate, 40℃ as column temperature and 288nm as the detection wavelength. The gradient elution was applied. The extraction rates of different batches of the injection were calculated. Results The linear relationship was good for HPLC content determination method. The recovery rates of the 5 components were in the range from 98.3% to 101% and RSD was from 0.69% to 1.6%. The contents of the 5 components in guanxinning in- jection of different batches were different. Conclusion This determination method is simple, rapid and good in reproducibility. It is applicable for the quality control and evaluation during the manufacture of guanxinning injection and ensures the stable and controllable quality of Chinese herbal injection.