中藥材輻射滅菌劑量之評估研究，子計畫一：中藥材輻射滅菌劑量及包材評估研究

周鳳英
國立清華大學
本整合型計畫依據行政院衛生署中醫藥委員會九十五年度中醫藥健康安全防護網-中藥品質管制研究，重點項目1-1研定中藥材滅菌劑量技術之相關研究提出。研究目的為針對中醫藥委員會所公告需有完整包裝標示之中藥材中，選出10種進行輻射滅菌探討，研訂輻射滅菌劑量，以便標示於商品，提供民眾選擇已滅菌之優良中藥，提昇國人中藥產業之國際競爭力。本整合型計畫包括三個子計畫，總計畫與子計畫一合併。總計畫內容為邀開各子計畫間整合作業之溝通協調會議，並整合各子計畫之研究成果，召開輻射照射滅菌之產官學會議，研訂各受測中藥材之滅菌劑量，並擬訂中藥材輻射滅菌之標準作業系統（SOP）。本子計畫一內容為研訂受測中藥材之滅菌照射劑量、照射後中藥材抗氧化性、細胞毒性評估、包裝材料於輻射照射前後之物性及外觀測試以選取適當包材。95年度研究之藥材為白芍、白果、黃芩、杏仁，96年受測藥材為川芎、山楂、陳皮、柴胡、丹參、大黃。受測藥材於清華大學原科中心鈷六十照射場進行輻射照射，經不同劑量照射後分別測定中藥材之好氣菌數、真菌及酵母菌數、腸內菌數，以色差計測量照射前後中藥材色澤變化，依CNS14393-5以老鼠纖維母細胞測試對細胞毒性之變化，以測試還原力、自由基及超氧化陰離子清除力評估中藥材照射前後之抗氧化能力差異。包材研究係以文獻所載適用於食品照射之包材及目前常使用於中藥材包裝材料經滅菌所需之劑量照射後，進行拉力強度、撕裂強度、熱封性、透氣度、透濕度及顏色變化；及蒸發殘渣之溶出試驗，以選擇在特定劑量範圍照射時之中藥材最適包裝材料。
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Chou, Fong-In
National Tsing Hua University
This program project is based on the major research focuses (1-1): researches of decontamination techniques for Chinese medicines proposed by the Committee on Chinese Medicine and Pharmacy. This project focuses on the studies of 10 Chinese medicines, which are among the 27 Chinese medicines announced by Committee on Chinese Medicine and Pharmacy, in order to have the complete and proper packing label. These 10 Chinese medicines will be studied and put under various doses of gamma radiation to find the most proper decontamination conditions, which will be marked on the packing label. This service can help customers recognize and purchase good quality of Chinese medicines as well as improve the international competitiveness of traditional pharmaceutical companies in Taiwan. This program project includes three component projects. The tasks of program project are to hold meetings for rigid associations amongst component projects and to organize research results of component projects. The other goal is to hold the irradiated decontamination symposium to invite people from industry, government, and scholastic institutes in order to standardize the optimal irradiation doses and establish the Standard Operating Procedures (SOP) for irradiated decontamination of Chinese medicines. In component project (I), various irradiation doses are applied to the Chinese medicines. The antioxidant capacity and cytotoxicity of the medicines are evaluated after irradiation.
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