建立厚朴中藥材飲片炮製基準及炮製廠規範

劉崇喜
大仁技術學
目的: 本計畫預計二年內完成常見厚朴中藥材之炮製基準研究相關計畫及炮製廠規範，先擬定第一年計畫，等完成第一年計畫結果後再做評估續第二年計畫。 實施方法: 本計畫為二年，先擬定第一年計畫，等完成第一年計畫結果後再做評估續第二年計畫。第一年將進行厚朴在台灣市埸之調查，基原判定，炮製(薑汁炒、薑汁煮、薑汁浸)製成研究並對炮製前後厚朴進行成分分析。在分析方面，將利用液相薄層層析法(HPLC)、與提供藥效評估用之厚朴酚(Magnolol)及和厚朴酚(Honokiol)、木蘭箭毒鹼(Magnocurarine)與其他成分包括新產生者。進一步利用液相層析/質譜與質譜/質譜(LC/MS與LC/MS/MS)對炮製前後的厚朴分別進行成分分析。同時利用LC/MS及LC/MS/MS，建立厚朴炮製前後可檢測到之每一成分的基本圖譜資料庫，亦即「指紋」(finger print)的建立。此外，比較各種炮製厚朴的護肝活性及血糖調降作用，同時長期評估各種炮製厚朴的毒副作用並將以上炮製基準結果，製成炮製廠規範。第二年，把第一年完成之炮製廠規範做後續初級產品生產技術與產品、配合廠商實務(漢聖製藥科技股份有限公司)訂定正確中藥炮製廠之GMP規範。 本計畫之完成將可建立厚朴之品質管控規範，進而建立中藥材飲片炮製廠規範及其炮製基準及相關製劑之現代化與國際化。
關鍵字：厚朴、炮製廠規範、炮製基準

Establish the GMP and the standard processing in decocting pieces of Hou Po

Liou SS
Tajen Institute of Technology
The present study is a 2 year research that will investigate Hou Po with different processing methods to help the pharmaceutical factory to establish the Good Manufacturing Practice (GMP) for processing. In the 1st year, the botanical of Hou Po in Taiwan will be investigated. Moreover, Hou Po will be prepared with Gan Jiang by stir-frying, boiling and steeping. The well known chemical compounds including magnolol, honokiol and magnocurarine, and the other chemical compounds from these processed Hou Po will be analyzed by HPLC. Then, the chemical properties of Hou Po with or without processing will be identified with LC/MS and LC/MS/MS to establish the finger print of the chemical compounds. In addition to evaluate the protective action on liver and the plasma glucose lowering activity, the long-term toxically effects of these processed Hou Po will also be clarified. Then, the 2nd year research will be followed by the 1st year research.In the 2nd year, the processing of Hou Po will
關鍵字：Hou Po；GMP；standard processing