中藥方劑奈米化技術開發及安全性研究(2-1)

張淑貞
中國醫藥大學
奈米技術已成為21世紀的關鍵技術之一，可應用於醫學、藥學、中草藥等醫療用途。有關微（奈）米中藥的粒徑大小，將直接影響物性、藥效、用藥安全及品質評估。爰此，衛生署中醫藥委員會為建立中草藥微奈米化之各項背景依據，以作為制定政策之參考，特於96年度「建構中藥用藥安全環境計畫」項下推行中藥與微（奈）米化技術之安全性研究。本整合型研究將進行「中藥方劑奈米化技術開發及安全性研究」，分項計畫包括：奈米化中藥方劑之指標成分分析及藥物動力學研究(子計畫一)，奈米化中藥方劑之動物安全性及功能性研究(子計畫二)，奈米化中藥方劑之細胞毒性試驗及免疫調節功能研究(子計畫三)及奈米化中藥方劑之製程開發與粒徑分析研究(子計畫四)。本研究將比較傳統與奈米化中藥方劑間之差異，選擇常用中藥方劑小柴胡湯、四逆散、茵陳蒿湯及一貫煎等作為奈米化的標的物，經過奈米化後進行粒徑分析、指標成分分析與藥物動力學、動物安全性與功能性(保肝作用)及肝細胞毒性試驗及免疫調節作用研究，作為未來中草藥奈米化製程開發之依據，並據以開發保肝中藥資源為目標，期望能完成中藥奈米製程技術之開發及安全性研究。本計畫將整合四項子計畫之成果，作為中藥奈米化製程產品之參考資訊，建立中草藥奈米製程產品之評估與技術開發平臺，並進一步探討奈米中藥之藥物動力學及建立臨床用藥之參考資訊。
關鍵字：奈米化中藥方劑；HPLC分析；安全性評估；細胞毒性

Study on Development and Safety Evaluation of Nanosizing Chinese Medicine Prescription

Shu-Jen Chang
China Medical University
Nanotechnology is one of the modern technology in 21 Century. Nanotechnology covers a wide range of industries, and therefore the potential benefits are also widespread, including Medicne, Pharmacy and Traditional Chinese Medicine. Compared with traditional substance, nanosizing substance has different properties. Nanosizing Chinese medicine have a larger surface area and easy to be absorbed. Property comparisons between the micro-(nano-)scale Chinese medicine and the Chinese medicine by conventional extraction process are then executed through chemical analysis. Therefore, Committee on Chinese Medicine and Pharmacy, DOH, Executive Yuan, Taiwan, sets the rules for nano-size chinese medicine and refer to make the policy. Under the 2007-year program of “Five-Year Plan of Establishing Medication Safety Environment of Chinese Medicine”, the Committee promotes the project on preparation of nano-Chinese medicine.
關鍵字：Nanosizing Chinese medicine prescription；HPLC analysis；Safety evaluation；Cytotoxicity