使用HPLC-PDA進行三黃瀉心湯活性成分品質管制之研究

Quality Control of Active Components in San-Huang-Xie-Xin-Tang by Using HPLC-PDA

紀鈞真(Chun-Chen Chi)

指導教授 ： 吳永昌

高雄醫學大學/藥學院/天然藥物研究所碩士班/碩士(2012年)

摘要

本研究目的是開發了一種快速簡便利用HPLC-PDA 檢測四類化合物，包含蒽醌類(anthraquinones)、二苯乙烯類(stilbenes)、黃酮類(flavonoids)及生物鹼類(alkaloids)組合物之化學圖資分析的方法。在實驗中我們使用三黃瀉心湯做為複方製劑之驗證模式進行四類化合物成分分析的研究。三黃瀉心湯主要包括蓼科的大黃、唇形科的黃芩以及毛茛科的黃連三種中藥材所組成的，並選擇其具代表性的活性指標成分resveratroloside (1), sennoside A (2), baicalin (3), coptisine (4), palmatine (5), berberine (6), rhein (7), aloe-emodin (8) 和 wogonin (9) 等九種指標成分做為同時分析不同三黃瀉心湯產品之50%甲醇水溶液萃取物之主要活性指標成分，並利用HPLC-PDA在三十分鐘內進行九種活性指標成分之分析。
在定量分析方面，每一個化合物線性迴歸的結果皆符合R2 (coefficient of determination, 判定係數)≧0.99有良好的線性關係，且對於此方法確效，也進行了同日間精密度(Intra-day precision)與異日間精密度(Inter-day precision) 之三重複測定，以確定實驗分析方法之準確性與再現性，其(Related Standard Deviation, R.S.D.)都在可接受之範圍內。而九個標準品之最低偵測極限(LOD, Limit of Detection)及最低可定量濃度（LOQ, Limit of Quantitation）範圍介於0.01-0.55 ?慊/mL。將此確效方法進一步的分析來自八個不同台灣中藥廠之十種三黃瀉心湯產品。此分析方法提供了一個有效快速於三黃瀉心湯中藥製品中檢測四類目標化合物之品質控制平台的方法。

關鍵字

三黃瀉心湯

並列摘要

A high-performance liquid chromatography with a photodiode-array detector (HPLC-PDA) based on a chemical profiling approach to rapidly evaluate four types of chemical components, including anthraquinones, stilbenes, flavonoids, and alkaloids were proposed and tested using a model combinatorial formula, San-Huang-Xie-Xin-Tang (SHXXT). The SHXXT combinatorial formula contains three herbal medicines, which were rhizome of Rheum tanguticum Maxim. ex Balf. (Polygonaceae), root of Scutellaria baicalensis Georgi. (Labiatae), and rhizome of Coptis chinensis Franch. (Ranunculaceae). In this purpose, the nine major active constituents of four type’s chemical components, including resveratroloside (1), sennoside A (2), baicalin (3), coptisine (4), palmatine (5), berberine (6), rhein (7), aloe-emodin (8), and wogonin (9) were selected and simultaneous determined in 50% methanolic aqueous solutions of different SHXXT products by using HPLC-PDA. The optimized analytic procedure was performed within 30 minutes.
The quantitative analysis of each compound with high correlation coefficient values (R2>0.99) indicated good correlations between concentrations and peak areas within the test ranges. The relative standard deviation values in triplicate of intra and inter-day precision and accuracy were evaluated and at acceptable ranges. The limits of detection and quantification were between 0.01 and 0.55 ?慊/mL. This validation method was further applied to analyze ten different commercial products of SHXXT from eight different Taiwanese TCM companies. The present investigation provided an efficient quality control platform to estimate the differentiation from SHXXT products utilizing four classes of bioactive chemical markers.

並列關鍵字

San-Huang-Xie-Xin-Tang

參考文獻

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