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題名 | 中藥標準品評估、物化資料彙整與供應機制之研究=Study on Evaluation, Compilation of Physiochemical Data and Supply Mechanism of Traditional Chinese Medicine Standards |
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作者 | 張嘉銓; Chang, Chia-chuan; |
期刊 | 中醫藥年報 |
出版日期 | 20121000 |
卷期 | 光碟版1:9 2012.10[民101.10] |
頁次 | 頁1-19 |
分類號 | 414.3 |
語文 | chi |
關鍵詞 | 中藥指標成分; 物理化學資料; 供應政策; TCM standards; Physiochemical property; Supply policy; |
中文摘要 | 本研究計畫之目的在促進中藥科學化,評估中藥對照用指標成分之品質均一性,建立與彙整物理化學資料,並規劃現有指標成分之運用與供應事宜,對未來政策提出建言。 將中醫藥委員會 93-96年度委託辦理之中藥對照用指標成分開發作業所得之 82品項,在排除「中藥對照用指標成分物化學資料彙編」(91年 3月出版)一書中已收錄與市面上易大量購得之品項後,篩選出之 37項樣品進行下列純度分析、純化、資料彙整與供應規劃工作:1. 各中藥對照用指標成分以核磁共振儀及高效液相層析儀測定純度,針對純度大於或等於 95%者,進行物理化學數據與光譜測定工作。2. 純度未達95%者經由再結晶、管柱層析等方式進行純化。3. 指標成分對照參考資料收集、光譜訊號比對與實驗資料彙整,並依格式編整、校對,逐步完成編撰事宜。4. 進行分裝及研擬供應事宜之規劃。5. 依歷年委辦計畫之情形及國內指標成分通路現況,對未來「國內中藥對照用指標成分供應/販售之政策走向」提出具體建言。 結果與討論:1. 各品項中20個樣品純度已達 95%,7個樣品與記載資料不符,9個樣品純化後,純度已達 95%;1個樣品純化後純度仍未達 95%。2. 未列前冊之37品項電子檔編撰工作已大致完成。3. 分裝及供應決定: rutin (12), baicalin (3)及 glycyrrhizic acid (25)現有量多且單價高,可優先對外供應。4. 對對照用指標成分供應政策之建言:應考慮活性、純化成本、來源藥材、國內外現有供應量等因素,針對特定品項優先進行供應事宜。 |
英文摘要 | AIM: The objective of this plan is to promote the modernization of Traditional Chinese Medicine (TCM), evaluate the homogeneity of the TCM standards, establish and collect the physiochemical data, scheme out the application and supply of the existing standards, and propose suggestions for the future policy. METHOD: The TCM standards from the commissioned projects supported by Committee on Chinese Medicine and Pharmacy (CCMP) from 2004 to 2007, at a number of 82, were eliminated the published and highly commercial available items to give 37 items. After purity check and purification work, the 37 items were recorded for their physiochemical data in this plan. 1. The identification and purity of each item were determined by NMR and HPLC analysis. For the standards with a purity >95%, the physiochemical data was recorded, and their spectral data were collected for comparison and confirmation. 2. The literature search, physicochemical data collection and spectra matching for the standards were accomplished; the template used in former volume of the standard book was followed to organize and collate the data, and edit the electric data files step by step. 3. An applicable policy for standard supply was proposed. 4. According to the results of the commissioned projects in previous years and the current logistics of domestic standards, a concrete suggestion for the regulation of TCM standard in the future was proposed. RESULTS & DISCUSSION: 1. Among the 37 standard items tested, 20 items had reached a purity of 95%; 7 compounds did not matched the documented data, and 9 had reached a purity of 95% after purification; 1 compound did not reach a purity of 95% after purification. 2. The editing of the electric data files for the 37 standards not listed in the previous volume has been approximately finished. 3. Determination of the items with high dispensing and supplication priority. Rutin, baicalin and glycyrrhizic acid, rich in amount and high in unit price, are advised to be supplied in high priority. 4. The suggestions on the policy for standard supply mechanism: several factors, such as the bioactivity, cost of purification, resource of plant material and domestic and foreign supply should be considered. The specific items passed by the screening of the aforementioned factors should be supplied in high priority. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。