中草藥標準品paeoniflorin與paeonol之開發及檢驗技術

王靜瓊
台北醫學大學
中藥指標成分為中藥品質管制及品質評價所必須之化學標準品，目前關於中藥指標成分並無明確之供應來源及規範，往往由研究者自行分離純化或由化學藥品供應商處購買，其品質之良劣關係中藥定量之结果，因此有賴於建立國家級之標準品，以確保定量之準確性。本研究以芍藥苷(paeoniflorin)及丹皮酚(paeonol)二種指標成分為目標，將進行中藥標準品之安定性及儲存試驗以確認各指標成分之有效保存期限及儲存方法。第一年主要進行(1)收集paeonol及paeoniflorin指標成分相關分離、分析、活性等文獻資料、(2)製備芍藥苷及丹皮酚指標成分、(3) 制定標準品分離純化之標準操作程序、(4) 指標成分之結構鑑定與純度分析、(5) 分析標準操作程序制定、(6)市售品含量分析。第二年進行安定性及儲藏試驗包括：(1)一般儲存試驗、(2)加速安定性試驗、(3)酸鹼值安定性試驗、(4)溫度安定性試驗、(5)光安定性試驗與光分解反應研究、(6)指標成分分解產物HPLC-MS及GC-MS分析條件之最適化等。本計畫製備之國家級規格中藥標準品將可落實中華中藥典之HPLC定量檢驗，提升中藥用藥之安全性，並使中草藥邁向國際化。
關鍵字：中草藥；標準品；芍藥苷；丹皮酚；標準操作程序；安定性

The development and Detection technique of paeoniflorin and paeonol Reference standard of Chinese Heral Medicines

Ching-Chiung Wang
Taipei Medical University
Reference standards are the important chemical substance for the quality evaluation and quality control of Chinese herbal medicine. Most of Traditional Chinese Medicine companys purchased the reference standards from the chemical supply company do not care about the purity and without further purified. The purity of reference standard affects the quality quantitative results of Chinese herbal medicines. Thus, it is necessary to establish the national grade of reference standard to ensure the high quality of Chinese herbal medicines. The goal of this plan is to establish the purification and analysis standard operating percedure (SOP) of paeoniflorin and paeonol and evaluate the storage stability. In first year, we will (1) collect the isolation, purification and activities reference of paeonol and paeoniflorin; (2)preparation the reference standard of paeonol and paeoniflorin; (3) establish the purification SOP of referece standard; (4) instrument analysis and purity assay of reference standard; (5) establish the HPLC analysis SOP of referece standard; (6) quatitative analysis of commercial Chinese Medicine.
關鍵字：Chinese medicines；reference standard；paeonol；paeoniflorin；standard operating procedure；stability