• 系統編號 RG9601-0061
• 計畫中文名稱 建立中藥境內品質管制中心(機制)
• 計畫英文名稱 --
• 主管機關 行政院衛生署 • 計畫編號 CCMP94-CP-102
• 執行機構 台北醫學大學藥學系
• 本期期間 9411 ~ 9412
• 報告頁數 22 頁 • 使用語言 中文
• 研究人員 楊玲玲；林承斌；梁文俐；林俊茂；陳立耿；王靜瓊 Ling-Ling Yang；Ling, Cheng-Bing；Liang, Wen-Li；Ling, Chun-Mao；
Chen, Lih-Geeng；Wang, Ching-Chiung
• 中文關鍵字 市售甘草；主成分；重金屬；農藥
• 英文關鍵字 --
• 中文摘要
研究目的 台灣目前所使用之中藥材以由大陸進口為主，且多數屬農作物加工炮製產品即一般所稱之飲片。所以當飲片以藥 物形式進口時，其應該如 GMP 藥品一樣，品質需要受到管制，如此國人用藥才能受到保障，同時也可減少中藥不良事件之 發生，並健全中藥界之執業環境。為配合境內管制之用藥安全計劃之審慎評估和執行之參考，本計劃進行市售中藥飲片中有 效主成分和重金屬之分析以了解市售飲片之安全性和有效性評估。 研究方法 本計畫-『建立中藥境內品質管制中心』在 95 年執行期間，由台灣各縣市針對甘草藥材進行採樣，除進行下例有效主成分和重金屬之分析檢驗並彙整相關文獻，所得結果 則經產、官、學專家會議進行討論，並研訂一套境內管制機制及建立異樣通報管制平台。 結果與討論 所收集之甘草樣品經 檢測結果如下，(1)甘草指標成分含量檢測，檢測項目包含 liquiritin, liquiritigenin, isoliquiritigene, glycyrrhizin, 18b-glycyrrhetic acid，在市售甘草中除 isoliquiritigenin 及 18b-glycyrrhetic acid 差異較小外，另外三種（liquiritin， liquiritigenin，glycyrrhizin）
含量差異均極大。(2)重金屬檢測，檢測項目為鎘、汞、鉛，在市售甘草中皆符合限量標準分別為：鎘 (Cd) 2 ppm 以下、汞 (Hg) 2 ppm、鉛 (Pb) 30 ppm 以下。(3)農藥加保扶殘留檢測，所採集 25 個市售樣品分析結果均未測得。 關鍵詞：市售甘草，主 成分，重金屬，農藥
• 英文摘要 Aim After the nephrotoxicity of aristolochic acid were found from Europen countries. Chinese Herb Nephropathy，CHNP, is a specific terminology in the medical world. Recently many of toxicity accident events were reported. In the clinic, how to purchased a
safety and high quality of Chinese herbal medicines are necessary for dispensing the prescription to consist the efficacy and prevent the drug damage and toxicity. The work is a very important to establish a rule and regulation from the government. Method In this research of ‘’Domestic Quality Control Center of Chinese Medicine in Taiwan’’, 25 crude drugs of licorice were collected from Taiwan Chinese medicinal drug’s store. The related references of its principle constituents were searched. Each crude drug was measure the heavy metal (Cd, Pb, Hg) by AA analysis and the quantitative analysis of principle constituents (liquiritin, liquiritigenin, isoliquiritigene, glycyrrhizin, 18b-glycyrrhetic acid) by HPLC. It will be also held the meeting include the experts from Chinese medicinal drug business, government and research fields and set up a domestic quality control mechanism and set up a platform for the domestic mechanism and establish the platform for peculiar reporting quality control. Results & Discussion 1.Licorice quantitative analysis of the principle constituents by HPLC Liquiritin, liquiritigenin, isoliquiritigene, glycyrrhizin, 18b-glycyrrhetic acid of each commercial licorice product was quantitativeanalysis by HPLC and the results show as the following: 1)The five principle
constituents were can detect from each crude drug of licorice. Only Isoliquiritigene was not found in all specimens of crude drugs.
2)The range of liquiritin containing on 25 crude licorice were 03~8.11 mg/g. 3)The range of Liquiritigenin containing on 25 crude licorice were 0.08~4.22 mg/g. 4)The range of Isoliquiritigen containing on 25 crude licorices were no detect~2.10 mg/g. 5)The range of Glycyrrhizin containing on 25 crude licorices were 7.28~40.72mg/g. 6)The range of 18b-Glycyrrhetic acid containing on 25 crude licorice were 0.32~1.68 mg/g. 2.Heavy metal analysis results of 25 crude licorice specimen The heavy metal of Cd, Hg and Pb were contained less 0.5ppm on the 25 kinds of licorice specimen. 3.Insecticide analysis results of 25 crude licoricespecies One of the high toxicity of insecticide-carbofuran was not found in any licorice specimen. Keywords：Licorice, heavy metal ion, principle
constituents, insecticide, analysis
