利胆排毒方提取物的高效液相色谱指纹图谱研究

摘要

OBJECTIVE:To probe into the fingerprint of Lidanpaidu prescription, and provide basis for the material foundation and quality control of Lidanpaidu prescription. METHODS: Waters Cosmosil 5C18-MS-Ⅱchromatographic column(4.6 mm ×250 mm,5 μm) was adopted with the mobile phase of acetonitrile ( B)-0.1%phosphate and 2% tetrahydrofuran aqueous solution ( A) by gradient elution at flow rate of 0.8 ml/min, detection wavelength of 248 nm and column temperature of 35 ℃.Analysis was conducted on 10 batches of Lidanpaidu extraction by correlation coefficient method. RESULTS: The HPLC fingerprint of Lidanpaidu prescription was established, 19 common peaks were signed, and the similarity threshold of 10 batches of samples were between 0.984-0.997.CONCLUSIONS: The established method is accurate and reliable, and can be used for the study on the chemical material foundation of the formula and the evidence for quality control of Lidanpaidu prescription.%目的：探讨利胆排毒方提取物的指纹图谱，为利胆排毒方的物质基础和质量控制研究提供一定依据。方法：采用Waters Cosmosil 5C18－MS－Ⅱ色谱柱（4．6 mm ×250 mm，5μm），流动相为乙腈（B）－0．1％磷酸＋2％四氢呋喃水溶液（A），梯度洗脱，流速0．8 ml／min，检测波长248 nm，柱温35℃，采用相关系数法对10批利胆排毒方提取物进行分析。结果：建立了利胆排毒方提取物的高效液相色谱指纹图谱，标定了19个共有峰，10批样品的相似度在0．984～0．997之间。结论：建立的方法准确、可靠，可用于利胆排毒方的物质基础研究和其新制剂开发时的质量控制。