用HPLC指纹图谱对佩兰的信息质量控制研究

目的建立佩兰HPLC数字化指纹图谱，采用双定性双定量相似度等46个参数作为评价的信息参数，对佩兰进行信息质量控制。方法采用RP-HPLC色谱法，以CenturySIL C18 AQ（20cm×4．6mm，5μm）色谱柱，1％醋酸水-1％醋酸乙腈为流动相进行低压梯度洗脱，检测波长为265nm，柱温：（30±0．15）℃，进样量：5μL，测定不同产地佩兰药材的HPLC指纹图谱。以10批佩兰的HPLC指纹图谱按平均值法计算生成对照指纹图谱（RFP），以此RFP为标准计算10批佩兰的双定性双定量相似度的均值，据此进行宏观定性定量质量评价；并以色谱指纹图谱指数F等42个信息参数进行超信息特征评价。结果以香豆素峰为参照物峰，确立了27个共有峰，建立了佩兰HPLC数字化指纹图谱，用双定性双定量相似度的均值评价了10批样品的化学成分数量和分布比例相似性较好，但含量差异很大。结论在选取的14个产地的佩兰药材中4批与其他相比化学成分分布比例差异较大，不建议使用，推荐使用定性定量相似度均很高的S2广东清平、S4江苏东台市等产地的佩兰药材。本研究对使用佩兰药材生产制剂具有宏观质控意义，证明了中药色谱指纹图谱技术结合多变量参数控制中药质量的信息质量控制方法具可行性及实用性。

Information quality control of Herba eupatorii by HPLC fingerprints

Objective To establish an information quality control of Herba eupatorii by HPLC fingerprints, using 46 parameters such as dual qualitative and dual quantitative similarities as assessing parameters. Methods The chromatographic fingerprints were determined with reversed phase HPLC by injecting 5 μL of the sample solution each time on a CenturySIL C18 AQ （20 cm× 4.6 mm, 5 μm） with the gradient solvent system consisting of 1 acetic acid water and 1 % acetic acid acetonitrile. The flow rate was 1 mL · min ^-1 , the detection wavelength was 265 nm, and the column temperature was maintained at （30 ± 0. 15 ）℃. The referential fingerprint （RFP） was produced in terms of the average model of 10 batches of Herba eupatorii. The 10 batches of Herba eupatorii were evaluated by the mean values of dual qualitative and dual quantitative similarities, and 42 parameters such as chrom atographic fingerprint index （F） and so on. Results A total of 27 common peaks were selected as the fingerprint peaks of Herba eupatorii by taking coumarin peak as the reference peak. The quantity of chemical components, and the distribution of chemical constituents in the 10 batches of Herba eupatorii were similar, but the contents of the 10 batches varied significantly. Conclusion Among the 14 of Herba eupatorii from different areas, 4 batches which were different from the others in chemical constituents distribution were not recommended. We recommend Herba eupatorii from S2 Qingping Guangdong and S4 Dongtai Jiangsu because their qualitative and quantitative similarities were higher than the others. The study can be used to instruct preparation using Herba eupatorii, and show that information quality control of Traditional Chinese Medicine using the fingerprint chromatogram combined with multi-parameters is feasible and practical.