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目的建立注射用活血通络的指纹图谱,并进行多成分定量分析,提升注射用活血通络质量标准。方法采用Thermo C18柱(100 mm×3 mm,1.7μm),以甲醇-0.05%甲酸水溶液梯度洗脱,体积流量0.4 m L/min,柱温20℃,检测波长为260nm。结果得到分离度和重现性良好的指纹图谱,确定21个共有峰,其中11个共有峰来自于赤芍药材,7个共有峰来自于川芎药材,3个共有峰来自桃仁药材。同时利用相似度软件对10批注射用活血通络指纹图谱进行分析,各批次样品相似度在0.98以上;通过对照品比对,指认了5个成分,分别为苦杏仁苷、羟基芍药苷、芍药内酯苷、芍药苷、阿魏酸,并对其进行定量分析。结论 UPLC建立的注射用活血通络指纹图谱检测和5个指标成分定量分析方法,快速、简便、准确,能有效评价该制剂的质量。
Objective To establish the fingerprints of Huoxuetongluo for injection and conduct multi-component quantitative analysis to improve the quality standard of Huoxuetongluo for injection. The method was performed on a Thermo C18 column (100 mm × 3 mm, 1.7 μm) eluting with a gradient of methanol-0.05% formic acid in water with a volume flow rate of 0.4 mL / min and a column temperature of 20 ° C. The detection wavelength was 260 nm. Results The fingerprints with good resolution and good reproducibility were obtained, and 21 common peaks were identified. Eleven common peaks were from Radix Paeoniae Rubra, seven common peaks were from Chuan Xiong and three common peaks were from Peach kernel. At the same time, the similarity software was used to analyze the fingerprints of Huoxuetongluo injection of 10 batches, and the similarity of samples in each batch was above 0.98. Five components were identified through comparison of the reference substance, namely amygdalin, hydroxypaeoniflorin, Paeoniflorin, paeoniflorin, ferulic acid, and their quantitative analysis. Conclusions UPLC established the method of Huoxuetongluo injection for fingerprint injection and quantitative analysis of five index components, which was rapid, simple and accurate and could effectively evaluate the quality of the preparation.