Abstract：Objective To improve the quality control standard of Jiangzhi Shuxin Mixture. Methods Waters XB C18 (4.6 mm × 250 mm, 5 μm) was used as the mobile phase, and methanol was used as mobile phase A. The mixed aqueous solution (containing 0.6% phosphoric acid and 0.2% tetrahydrofuran) was used as mobile phase B. Gradient elution: 0-15 min, 2% A; 15-55 min, 2%-25% A; 55-90 min, 25%-40% A; 90-110 min, 40%-50% A. The detection wavelength was 280 nm, the column temperature was 30℃, the flow rate was 1.0 mL/mim, the analysis time was 120 min, and the injection volume was 10 μL. The above method was used to establish a fingerprint for Jiangzhi Shuxin Mixture. The content of the preservative in the preparation was determined by high performance liquid chromatography. Inductively coupled plasma mass spectrometry is used to detect heavy metals and harmful elements that may be contained. Results The similarity of 10 batches of samples met the requirements. The contents of benzoic acid were less than 0.3%. The contents of lead, cadmium, chromium, arsenic, nickel, copper and mercury in the samples all conform to the new general rule <232> of the American Pharmacopoeia. Conclusion The fingerprint established in this study is simple, reproducible and provides a scientific basis for the comprehensive quality evaluation of Jiangzhi Shuxin Mixture. It is suggested that more items affecting the safety of the preparation should be added in order to strictly control the quality of the preparation.
刘敏 范蕾 陈桂云 余乐 冯美玲. 降脂舒心合剂HPLC指纹图谱的建立及制剂安全性项目的影响因素检测[J]. 中国医药导报, 2019, 16(9): 117-122.
LIU Min FAN Lei CHEN Guiyun YU Le FENG Meiling. Establishment of HPLC fingerprint of Jiangzhi Shuxin Mixture and detection of influencing factors of preparation safety project. 中国医药导报, 2019, 16(9): 117-122.
2019, Vol. 16 
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