冠心宁注射液生产过程质量控制方法及特征成分含量变化研究

Study on Quality Control of the Production Process of Guanxinning Injection and Quantitative Change of Its Characteristic Components

目的：建立同时测定冠心宁注射液中5个特征性成分含量的方法，应用于注射液、中间体和组方药材丹参、川芎的质量控制和评价，并研究成分在生产过程中的含量变化规律。方法：采用高效液相色谱法，色谱柱为Agilent Zorbax SB—C18（3．0mm×100mm，3．5μm）；流动相为乙腈和0．4％乙酸水；进样量5μL；流速：0．5mL·min^-1；柱温：30℃；检测波长：288nm；梯度洗脱。分别计算不同批次注射液和中间体中组方药材的提取率。结果：建立的HPLC含量测定方法线性关系良好，5个成分的加样回收率在97．54％～107．24％之间，RSD〈1％，发现同个厂家生产的不同批次的冠心宁注射液中5个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，可用于冠心宁组方药材、中间体及注射液生产过程中质量控制与评价，厂家应优化生产工艺，保证中药注射液质量的稳定可控。

This study aimed to develop a simultaneous determination method of five characteristic components in Guanxinaing injection and apply this method for quality control and evaluation of Guanxinning injection, its intermediate and crude drugs. Content change rules of components during the production process were also studied. High performance liquid chromatography （HPLC） method was performed on a column of Agilent Zorbax SB-C18 （3.0mm × 100mm, 3.5μm, and it was optimized for separation at 30℃. The mobile phase consisted of acetoneitrile and 0.4% acetic acid in gradient elution with a flow rate of 0.5mL·min^-1 The detection wavelength was at 288 nm and the injection volume was 5μL. Extract efficiency of crude drugs from injections and intermediate of different batches were calculated. The results showed that the linearity of HPLC method was good, and the average recovery of five constituents were between 97.54% and 107.24% , with RSD 〈 1%. Content of five components from different batches of Guanxinning injections showed apparent difference. It is concluded that the method is simple and timesaving with good reproducibility. This method can be applied for quality control and injection preparation evaluation of the intermediate and crude drug during its production process. The production process should be further optimized to ensure the quality and stability of TCM injections.