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目的:建立刺五加注射液中紫丁香苷、绿原酸含量的快速测定方法,并对86批刺五加注射液的质量进行分析。方法:采用超快速液相色谱(UFLC)法,选用shim-pack XR-ODS色谱柱(75 mm×3.0 mm,2.2μm);流动相A为乙腈-0.2%甲酸溶液(30:70),流动相B为0.2%甲酸溶液,梯度洗脱;检测波长254 nm。结果:紫丁香苷、绿原酸分别在73.35～1 173.60μg·ml~(-1)(r=0.999 4)和53.32～853.20μg·ml~(-1)(r=0.999 8)的浓度范围内线性关系良好;平均加样回收率分别为101.3%、99.5%。结论:本方法简单易行、重复性和精密度良好,可快速测定刺五加注射液中紫丁香苷和绿原酸的含量。不同厂家、不同批次刺五加注射液紫丁香苷和绿原酸的含量有差异。
Objective: To establish a rapid method for the determination of syringin and chlorogenic acid in acanthopanax senticosus injection, and analyze the quality of 86 acanthopanax senticosus injection. METHODS: Ultrashort liquid chromatography (UFLC) was used with shim-pack XR-ODS column (75 mm × 3.0 mm, 2.2 μm). Mobile phase A consisted of acetonitrile-0.2% formic acid Phase B 0.2% formic acid solution, gradient elution; detection wavelength 254 nm. Results: The concentrations of syringin and chlorogenic acid in the range of 73.35 ~ 1 173.60μg · ml -1 (r = 0.999 4) and 53.32 ~ 853.20μg · ml -1 (r = 0.999 8) Within a good linear relationship; average recovery rates were 101.3%, 99.5%. Conclusion: This method is simple, reproducible and accurate, and can quickly determine the contents of syringin and chlorogenic acid in acanthopanax senticosus injection. Different manufacturers, different batches Acanthopanax injection content of syringin and chlorogenic acid are different.