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目的:采用HPLC建立健胃消食片的指纹图谱,为其质量控制提供有效的方法。方法:采用XDB C18柱,以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,流速1.0 mL.min-1,检测波长220 nm,运用国家药典委员会指纹图谱相似度计算软件,确定指纹图谱共有峰,计算相似度,并与市场上4批假冒江中健胃消食片的指纹图谱进行比较。结果:根据13批江中健胃消食片指纹图谱,确定了17个共有峰,其相似度均大于0.97,而假冒产品指纹图谱相识度均<0.90。结论:所建立HPLC指纹图谱具有较好的精密度和重现性,可以有效表征江中健胃消食片的质量特点,能够有效控制产品质量。
Objective: To establish the fingerprint of Jianweixiaoshi tablets by HPLC and to provide an effective method for its quality control. METHODS: A gradient of acetonitrile-0.1% phosphoric acid in water was used as the mobile phase at a flow rate of 1.0 mL · min-1 on a XDB C18 column with a detection wavelength of 220 nm. The software was used to calculate the similarity of the fingerprints of the National Pharmacopoeia Commission Peak, calculate the similarity and compare with the fingerprints of four batches of Jiangzhongweiwei Xiaoshi tablets on the market. Results: Based on 13 fingerprints of Jiangzhong Jianwei digestion tablet, 17 common peaks were identified, their similarity were all higher than 0.97, while the fake fingerprints were all <0.90. Conclusion: The established HPLC fingerprint has good precision and reproducibility, which can effectively characterize the quality characteristics of Jiangzhong Jianwei Xiaoshi Tablets and can effectively control the quality of products.