藥材鑑定及品質條件建立－－以補氣單複方為例

Identification of Medicinal Materials and Establishment of Quality Conditions on Single Drug Prescription and Compound of Qi Tonifying Drug

目的：目前單味中藥基源鑑定多利用生藥學上「組織切片法」或「粉末鏡檢法」以形態特徵來區分；而單複方中藥成分則以高效能液相層析(high-performance liquid chromatography, HPLC)檢驗。但鏡檢牽涉檢測人員主觀判斷標準；而HPLC判斷成分時因數據多而難以對所有資訊做整體判讀。因此本篇研究希望建立另一鑑定模式，以達到中藥品質管控之目的。方法：本研究以單方的黃耆及複方的寬心飲作為預設的檢測目標。黃耆及其類似藥材紅耆分別進行核醣體內轉錄區間(internal transcribed spacer,ITS)鑑定；而寬心飲及預設缺方組成則用high-performance liquidchromatography-principal component analysis (HPLC-PCA)方式對所有成分資訊整體分析。結果：單方黃耆序列經ITS比對之後可確認所採用之藥材基源正確。而寬心飲藉由HPLC-PCA方式視覺化呈現HPLC結果，可判定正確複方組成和各種缺方間有明顯差異。結論：經本研究所採用方式，可對黃耆或寬心飲之藥材與品質達到一良好鑑定標準。預期能推廣至其他單複方藥材相關的品質鑑定。

Traditional Chinese Medicine (TCM) formulas are commonly prescribed nowadays. Due to the multiple ingredients, it's hard to control the quality and the efficacy of a compound formula. In order to establish good quality control methods, we set up quality accreditation standards on Astragalus membranaceus and Kuan-Sin-Yin (KSY) decoction which are qi-tonifying single and compound formulas. Standards contains two aspects: internal transcribed spacer (ITS) sequencing technic for the botanical origin identification and high performance liquid chromatography-principal component analysis (HPLC-PCA) technic for the inclusions content identification. ITS sequencing technology clearly identified the single-nucleotide polymorphism (SNP) sites between Astragalus membranaceus and Hedysarum polybotrys. Further, HPLC-PCA showed the differences among KSY and the control groups by visual presentation. The standard qualities of Astragalus membranaceus and KSY have been established and the new manufactured decoctions will be qualified by these standards.