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目的建立痛安注射液的指纹图谱,更有效地控制该产品的质量。方法采用HPLC法对痛安注射液指纹图谱进行研究。色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),保护柱:Phenomenex C18(4 mm×3 mm,5μm);流动相:0.02 mol/L磷酸二氢钾-乙腈,线性梯度洗脱;体积流量:1 mL/min;进样量:10μL;柱温:30℃;检测波长为230 nm。采用国家药典委员会推荐的中药色谱指纹图谱相似度评价系统的操作规范软件(版本2004A)进行评价。结果制剂中选定的共有峰分离良好。结论该方法为痛安注射液的质量控制提供了较全面的信息,利于产品的质量控制。
Objective To establish the fingerprint of Tongan injection and to control the quality of the product more effectively. Methods HPLC method was used to study the fingerprint of Tongan injection. The chromatographic column was Diamonsil C18 column (250 mm×4.6 mm, 5 μm). The guard column was Phenomenex C18 (4 mm×3 mm, 5 μm). The mobile phase was 0.02 mol/L potassium dihydrogen phosphate-acetonitrile. The gradient elution was linear. Volume flow: 1 mL/min; injection volume: 10 μL; column temperature: 30°C; detection wavelength 230 nm. The operation specification software (version 2004A) of the chromatographic fingerprint similarity evaluation system of traditional Chinese medicine recommended by the National Pharmacopoeia Commission was used for evaluation. The selected common peaks in the formulation were well separated. Conclusion This method provides more comprehensive information for the quality control of Tongan injection, which is conducive to product quality control.