利用輻射滅菌技術處理中藥材之劑量限量標準及其量產之可行性評估

周鳳英
國立清華大學
本計畫係依照行政院衛生署中醫藥委員會99年度中藥品質研究類委託研究計畫，研究重點2-2中藥材包裝及貯存條件規範相關研究提出。研究目標為建立適當的中藥材輻射滅菌處理技術；研訂輻射照射滅菌最適劑量，評估不同種中藥材所需滅菌劑量，以及滅菌劑量照射對中藥材之指標成分及外觀之影響，研訂中藥材輻射照射之劑量限量標準與評估輻射滅菌量產之可行性。
本計畫為一年期計畫，受測藥材為大棗、五味子、芡實、蓮子、山茱萸、茯苓、山藥7種中藥材。使用包材為PE及PP二種常應用於食品照射之包材。每種受測之中藥材皆進行10批次取樣。受測藥材於清華大學原子科學技術發展中心之鈷六十照射場接受輻射照射。輻射照射處理之中藥材將進行含菌量測定（包括好氣性微生物數、酵母菌、黴菌及腸內菌數） 以評估各中藥材之所需滅菌劑量。經滅菌劑量處理之中藥材將進行指標成分、脂肪酸圖譜、及外觀顏色變化等特性分析。照射後之包材將進行拉力強度、撕裂強度、透氣度、透濕度、顏色變化及蒸發殘渣之溶出等特性測試。照射樣品並進行三個月及六個月之儲存試驗，所完成之測試結果將用以評估各中藥材照射劑量與微生物殘存量之相關性，建立以特定包材包裝情況下之最適照射條件。
本研究為針對中醫藥委員會所公告需有完整包裝標示之中藥材，選擇其中易蟲蛀或霉變之中藥材共7種做試驗，研訂輻射滅菌劑量、選擇適當包材，以便標示「輻射滅菌處理」於具包裝標示之中藥材上，提供民眾選擇已滅菌之優良中藥，並提昇國人中藥產業之國際競爭力。
關鍵字：中藥材；輻射滅菌；微生物含量

Evaluation of the standard-dose limits and the feasibility of radiation disinfection for Chinese medicine herbs in large scale

Fong-In Chou
National Tsing Hua University
This project is based on the major research focuses (2-2): the standardization of package and storage of Chinese medicine herbs (CMHs) proposed by the Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan. The aim of the research is to establish the technique for radiation disinfection of CMHs. The optimal dosage required for disinfection of different kinds of CMHs and the effects over the key ingredients, morphology of the CMHs after irradiated with disinfection dosage will be investigated. The standard-dose limits for the radiation disinfection of the CMHs and the feasibility of radiation disinfection for CMHs in large scale will be evaluated.
This is a one-year project, research will focus on the evaluation of the 7 kinds of CMHs, including Fructus Zizyphi Sativae, Fructus Schizandrae, Semen Euryalis, Semen Nelumbonis, Fructus Corni, Sclerotium Poriae, and Rhizoma Dioscoreae. The packing materials include PE and PP normally applied in food irradiation will be used in this study. All kinds of tested CMHs will be sampled for 10 batches. Gamma irradiation will be performed in a Co-60 hot cell in Nuclear Science and Technology Development center, National Tsing Hua University. After irradiation, the microbial contain including aerobic bacteria, enterobacteria, yeasts and molds in CMHs will be analyzed. Dosage required for disinfection CMHs will be evaluated. CMHs materials received the disinfection dose will be proceed characteristic tests such as key ingredient analysis, fatty acid spectrum and morphological analysis. The irradiated packing materials will be taken for the tests including tensile strength, tear strength, degree of ventilation, humidity transmittance, color changes and leaching of evaporated residue. After the completion of the storage test, we will establish the most appropriate irradiation conditions for various CMHs under specified packing condition. 
This research is focused on the declared CMHs that required complete labeling about the packing and contents. Seven kinds of CMHs easy contaminated by microbial and pests are chosen for study. We will establish the dosage for disinfection irradiation and select appropriate packing materials for the tested CMHs. Through this study, we will be able to put the "Radiation Disinfection" labels on the package and provide the general public with outstanding disinfected CMHs so as to promote the international competition ability for the domestic CMHs manufacturing business.
關鍵字：Chinese medicine herbs; radiation disinfection; microbial contain