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題 名 | 建立厚朴中藥材飲片炮製基準及炮製廠規範=Establish the GMP and the Standard Processing in Decocting Pieces of Hou Po |
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作 者 | 劉崇喜; | 書刊名 | 中醫藥年報 |
卷 期 | 25:4 2007.10[民96.10] |
頁 次 | 頁89-146 |
專 輯 | 中醫藥品質管理相關研究 |
分類號 | 414.4 |
關鍵詞 | 厚朴; 炮製; 炮製規範; Hou Po; Processed; GMP for processing; |
語 文 | 中文(Chinese) |
中文摘要 | 本計畫選擇厚朴中藥材,進行炮製基準研究相關計畫及製規範制定,並分析厚朴炮製前後成分的變化,同時進行炮製前後藥理活性及毒性之比較。透過研究計畫來建立GMP炮製工廠規範模式。首先,將進行厚朴的基原鑑定,調查臺灣市售品,以傳統炮製厚朴的方式薑製,炮製成薑汁炒厚朴、薑汁煮厚朴、薑汁浸厚朴,研究並對炮製前後厚朴成分及毒性分析。在成分分析方面,將利用薄層層析法(TLC)及液相薄層層析法(HPLC)以厚朴酚(Magnolol)及和厚朴酚(Honokiol)為指標成分,對炮製前後的厚朴分別進行成分分析。本計畫中發現厚朴經炮製後,厚朴酚(Magnolol)及和厚朴酚(Honokiol)含量明顯增加,尤其以薑炒厚朴的炮製方式,magnolol和honokiol含量,分別增加5.6倍及4.1倍。在毒性分析方面,利用急性毒性試驗(LD[9274])觀測厚朴臨床上使用的安全性。發現厚朴的半致死劑量(LD[9274])>10 g/kg,並無明顯的毒性。將以上結果,與南部某GMP藥廠,制定標準作業程序書,建立炮製廠規範。 |
英文摘要 | The present study is going to investigate the changes of Hou Po with different processing methods in the chemical compounds and the pharmacological activity as well as the toxicity to help the pharmaceutical factory to establish the GMP for processing. First, the botanical of Hou Po in Taiwan was investigated. Then, Hou Po was prepared with Gan Jiang by stir-frying, boiling and steeping. The well known chemical compounds including magnolol and honokiol were used as indicators, and the other chemical compounds from these processed Hou Po were analyzed by HPLC. We observed that the magnolol and honokiol isolated from Hou Po prepared with Gan Jiang by stir-frying were increased to 5.6-fold and 4.1-fold of that from Hou Po without processing, respectively. The LD[9274] was estimated to evaluate the therapeutic index of the processed Hou Po. We observed that Hou Po could be safely used in clinic, since the LD[9274] of Hou Po was higher than 10 g/kg. The processing of Hou Po will be transported to Pharmaceutical Corporation in South Taiwan to produce the commercial products and to establish the GMP of processed Hou Po. |
本系統中英文摘要資訊取自各篇刊載內容。