| 摘要: | 利用代謝體學建構中藥炮製技術科學化規範－何首烏藥材炮製技術的比較 在中醫藥委員會於2004-2008年執行建構中藥用藥安全環境五年計畫中，包括從藥材的基原鑑定、炮製過程、包裝規格、藥材及製劑指標成分與活性成分的確認及檢驗規格的制定等方面。以全面提升中藥品質，以確定國人用藥安全。其中，炮製是中藥材特殊的傳統處理方式，具有悠久的歷史。炮製能降低毒性、減少副作用；增加成分溶出、提高藥效；改變藥性，應用於不同的症狀治療。炮製過程的品質優劣也會影響藥效與治療的發揮。因此，需要建立一個簡易可辨識的分析技術來掌控藥材炮製的品質。以代謝體學途徑（Metabolomic Approach）結合多變數統計（Multivariate Statistics），已廣泛地應用在中草藥藥材品質管制（QA/QC）的鑑定。利用植物代謝體學（Metabolome in Plants）的觀念對藥材進行全光譜分析，再加上藥理與活性試驗資料的整合，能補充傳統品質管制方法中，僅以中藥材主要成分的分析角度所忽略之多成分組成與複雜生物活性間的關係的不足，以及微量成分間的協同、結合或拮抗的交互作用。 何首烏（Polygonum multiflorum Thunb.）常見的炮製方法有黑豆蒸、黑豆酒煮、醋煮、水煮等九蒸九曬方法，其中黑豆拌蒸法沿用至今。臨床上用藥以製何首烏居多。本計畫將利用高效率液相層析儀（HPLC）和核磁共振儀（NMR）的操作，對何首烏藥材的主要成分進行定性、定量的分析外，我們將以所得之全光譜資料以主要組成分析法（Principle Component Analysis, PCA）進行統計分析，作為何首烏炮製品質管制的監測分析的補充參考。另外，再加上藥理，樹突細胞（Dendritic cell）免疫功能以及分子生物活性的測試資料，以系統生物學（Systems Biology）的觀點進行何首烏藥材炮製標準落點（Standard plot）的建立。希望藉此建構一套針對炮製品質，完整又快速的分析系統。進而應用於其他中藥炮製的研究，提供中藥材品質管制基準制定之參考。
Establishment of Scientific Standard Procedure for TCM Material Medica Processing Using Metabolomic Strategy－The Comparison of Polygonum multiflorum Processing Methods In order to promote the quality of Chinese material medica and certify the safety of people’s use in Chinese medicine comprehensively, “Building up a safe environment for Chinese medicine use in five years” of the Committee on Chinese Medicine and Pharmacy in 2004-2008 have involved the studies for origins identification, processing evaluation, package standard and bioactive components identification with standard examination establishment for materials and pharmaceutical products. Therein, the processing of Chinese material medica has a history as long as traditional Chinese medicine itself, and is able to reduce toxicity or side effects, improve effect, change properties or functions and preserve active constituents. Therefore, the quality of processing procedures will impact the pharmacological and therapeutic effects of Chinese material medica. A rapid and efficient analytical discipline and method for quality control of processed Chinese material medica is required. Metabolomics approach in combination with multivariate statistics has been widely applied in the QA/QC of Chinese material medica. Under plant metabolome concept, using a wide spectrum of chemical analysis techniques linking with the patterns of pharmacological and bioactive tests is able to provide the profile and correlations between complex compounds and bioactivity due to synergic or opposing effect in Chinese material medica. It can replenish the insufficiency of classic quality control methods based on the analysis of only major components. Polygonum multiflorum was processed using steaming with black beans, steaming with black beans plus wine, boiling with vinegar or boiling in water etc. The mothed of steaming with black beans is still apllied in this moment. Actually, the processed Polygonum multiflorum materials are common used in the clinic. In this study, HPLC and NMR will be applied and combined with principal component analysis (PCA), a well-established statistical method, to fingerprint the profile of processed Chinese material medica. In addition, the standard plot will be established after statistical analysis of metabolite profile in combination with activities of pharmacology, dendritic cell immune function and molecular biology under systems biology. In the purpose of this study, we try to build up a model system for scientific standard procedure of Chinese material medica processing by the study of Polygonum multiflorum. The results will contribute to a first step towards ultimate QA/QC of Chinese material medica. |
