Yang Aixia, Wang Xiaoxian, Xiong Chaomei, Chen Jing, Ruan Jinlan
Laboratory of Natural Medicinal Chemistry and Resource Evaluation, Department of Chinese Traditional Medicine, School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China ; Department of Pharmacy, Wuhan Integrated TCM & Western Medicine Hospital (Wuhan NO.1 Hospital), Wuhan, China.
Pharmacogn Mag. 2013 Apr;9(34):162-6. doi: 10.4103/0973-1296.111284.
The Tuirejieduling granule is a compound preparation made from four kinds of Chinese medicines. It is effective for anti-inflammation, antivirus, defervescence and anti-bacterium; however, its quality control standards have remained unknown.
To establish a simple and accurate fingerprint method for quality control of the Tuirejieduling granule.
The methanol extract of the Tuirejieduling granule was used for the fingerprint analysis and the four selected active ingredients (epigoitrin, phillyrin, saikosaponin A and glycyrrhetinic acid) in the extract were determined. The fingerprint method was performed on an Amethyst C18-P chromatography column by gradient elution with acetonitrile and aqueous phase (containing 0.5% H3PO4 (v/v), pH 3.0).
Under the optimal chromatographic condition, twenty peaks were chosen as fingerprint peaks of the Tuirejieduling granules extractions. The similarities of 10 batches of Tuirejieduling granule was more than 0.99. This indicates that the different batches of Tuirejieduling granules were under the consistent quality control. Good linear behaviors over the investigated concentration ranges were obtained with the values of R (2) higher than 0.99 for four studied active ingredients. The recoveries for spiked samples were in the range of 96.2-105.5%. The developed method was successfully applied to determine the contents of active constituents in different batches of Tuirejieduling granule.
The HPLC fingerprint was proved to be a reliable method for the quality control of Tuirejieduling granule.
退热解毒灵颗粒是由四种中药制成的复方制剂。它具有抗炎、抗病毒、退热和抗菌作用；然而，其质量控制标准尚不清楚。
建立一种简单、准确的指纹图谱方法用于退热解毒灵颗粒的质量控制。
采用退热解毒灵颗粒的甲醇提取物进行指纹图谱分析，并测定提取物中四种选定的活性成分（表告依春、连翘苷、柴胡皂苷A和甘草次酸）。指纹图谱分析采用紫晶C18-P色谱柱，以乙腈和水相（含0.5%磷酸（v/v），pH 3.0）进行梯度洗脱。
在最佳色谱条件下，选择20个峰作为退热解毒灵颗粒提取物的指纹峰。10批退热解毒灵颗粒的相似度均大于0.99。这表明不同批次的退热解毒灵颗粒质量控制一致。在所研究的浓度范围内，四种活性成分的线性关系良好，R（2）值均高于0.99。加样回收率在96.2%-105.5%之间。所建立的方法成功应用于不同批次退热解毒灵颗粒中活性成分的含量测定。
HPLC指纹图谱被证明是一种可靠的退热解毒灵颗粒质量控制方法。
