精制冠心片指纹图谱的建立

Establishment of fingerprints of Jingzhi Guanxin tablets

目的建立复方中药精制冠心片指纹图谱,纳入企业内控质量标准。方法采用HPLC法,ACE C_(18)色谱柱,乙腈-0.1%磷酸溶液梯度洗脱,流速1.0 m L·min^(-1),波长275 nm,柱温30℃。结果建立了20批精制冠心片指纹图谱,标定23个共有峰,指认5个,相似度均>0.9。结论所建立的色谱条件能够有效分离精制冠心片的主要成分。所建立的指纹图谱分析方法准确可靠,可用于精制冠心片的质量控制。

AIM The establish compound Chinese medicine Jingzhi Guanxin tablets fingerprints,and which were included into the enterprise internal control quality standards. METHODS The HPLC was used, chromatog- raphy conditions were ACE C18 column with mobile phase of mixed solution of aeetonitrile and 0.1% phosphoric acid for gradient elution. Flow rate was 1.0 mL·min^-1 ,detecting wave length was 275 nm, and the column tem- perature was 30℃. RESULTS HPLC fingerprints of 20 samples of Jingzhi Guanxin tablets were established. The similarity was more than 0.9. The calibrate 23 common peaks were calibrated and five were identified. CON- CLUSION The chromatographic conditions established can effectively separate the main components of Jingzhi Guanxin tablets. The established fingerprint analysis method is accurate and reliable, and can be used for quality control of Jingzhi Guanxin tablets.