整合型計畫：中藥方劑奈米化技術開發及安全性研究(2-2)

張淑貞
中國醫藥大學
微奈米技術已成為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。本計畫申請兩年期整合型計畫，97年完成小柴胡湯與四逆散等微奈米化之製程研究，98年將進行GMP廠中藥製劑微奈米化之製程技術開發及安全性評估等，作為未來中草藥微奈米化製程開發之參考，建立中草藥微奈米製程產品之評估與技術開發平臺。
關鍵字：中藥方劑微奈米化製程；HPLC分析；安全性評估

Study on Development and Safety Evaluation of Nanosizing Chinese Medicine Prescription(2-2)

Shu-Jen Chang
Cjhina 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-)scaled 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. Nano-scaled technology development and safety evaluation of Xiao-Chai-Hu-Tang and Si-Ni-San finished in 2008. Furthermore, nano-scaled technology development and safety evaluation of commercial products will be finished in 2009.
關鍵字：Nano-scaled Chinese medicine preparations；HPLC analysis；Safety evaluation