用HPLC指纹图谱对复方甘草片信息化质量控制研究

目的采用双定性双定量相似度等46参数作为评价的信息参量，以建立复方甘草片（CLTs）HPLC指纹图谱的信息质量控制方法。方法采用反相HPLC法以Century SIL C18 BDS柱（200mm×4．6mm，5μm）；流动相为0．1％磷酸水-乙腈低压梯度洗脱，紫外检测波长203nm，柱温（30．00±0．15）℃，进样量5μL。以21批CLTS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21批CLTs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；以色谱指纹图谱指数F等42个信息参量进行超信息特征评价。结果以苯甲酸（SB）为参照物峰，确定29个指纹峰，建立了CLTs的HPLC指纹图谱。用双定性相似度和双定量的均值评价15批样品的化学成分数量、分布比例和含量都合格，1批含量明显超标，其他5批含量都明显偏低。结论在OTC中随机选择的26批CLTS，用HPLC指纹图谱鉴定完全合格品15批，不合格品6批，发现假药5批。因此所建立的CLTS的HPLC指纹图谱可用于CLTs生产质量控制。本研究证明用中药色谱指纹图谱技术结合多变量参数控制中药复方制剂的质量的信息质量控制方法可行且准确可靠。

Information quality control of compound liquoric tablets by HPLC fingerprint

Objective To determine an information quality control of compound liquoric tablets （CLTs） by HPLC fingerprints, using 46 parameters such as dual qualitative and dual quantitative similarities as assessing parameters. Methods The CFPs were determined by injecting 5μL of the sample solution each time on a CenturySIL C18 BDS column （200 mm× 4. 6 mm, 5μm） with the gradient elution solvent system consisting of 0. 1% phosphoric acid water and acetonitrile. The flow rate was 1 mL/min, the column temperature was maintained at （30.00±0. 15）℃ and the signals were acquired at 203 nm. The referential fingerprint （RFP） was produced in terms of the average model of the 21 batches of CLTs. The whole 21 batches of CLTs were evaluated by the mean values of dual qualitative similarities and dual quantitative similarities, and the 42 parameters such as the CFP index F. Results The CFPs containing 29 copossessing peaks were obtained by choosing benzoic acid peak as the referential peak. The chemical component quanti- ty, the chemical constituent distribution, and the total content of the chemical components in 15 batches of CLTs were completely qualified, the contents of 1 batch was obviously high while the other 5 batches were relatively low. Conclusion Among the 26 batches of CLTs randomly brought from drugstores, 15 batches were qualified, 6 batches were unqualified and 5 batches were inferiors judging from the HPLC fingerprints. This new HPLC method is precise and reproducible, which can be applied in the quality control of CLTs. The information quality control of Traditional Chi- nese Medicine using the fingerprint chromatogram combined with multi-parameters is feasible and reliable.