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題名 | 中藥材毒劇藥品管理=Regulations on Poisonous TCM Herbs |
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作 者 | 張永勳; 何玉鈴; 高駿彬; 羅文佳; 蕭惠薰; 吳旻峰; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(88)1-(88)104 |
分類號 | 414.5 |
關鍵詞 | 毒劇中藥; 處方; 調劑; 製造; 管理法規; Poisonous TCM; Prescribing; Dispensing; Manufacturing regulation; |
語文 | 中文(Chinese) |
中文摘要 | 一般人常有中藥無毒、無副作用之錯誤觀念,藥即是毒,不分中西,用之得當就是藥,用之不當就是毒。目前國內對毒性中藥之管理並無特殊規範,但近幾年中藥中毒事件頻傳,因此有必要制定中藥材毒劇藥品之管理辦法。 本計畫蒐集國內外毒劇中藥之炮製、調劑、用量及相關管理辦法,成立「中藥材毒劇藥品管理」產官學諮詢小組,依委員專長,召開兩次專家座談會。第一次討論毒劇藥材品項、劑量、醫療院所毒劇中藥之管理、處方權及有毒中藥之調劑規範等議題。第二次討論中藥廠毒劇中藥之管理方式,包括毒劇藥材品項、製程管理、產品包裝、標示及行銷應注意事項等議題加以討論。 本計畫並草擬醫療院所毒劇中藥處方開立及調劑管理草案,因國內藥廠實際生產毒劇中藥品項有限,建議在優良製造管理規範( GMP)準則中加入有毒中藥相關注意事項即可。 藉由本計畫之執行,可提供衛生福利部中醫藥司將來在中藥材毒劇藥品管理之規範建議,並提供中藥材毒劇藥管理品項名單及一日建議安全劑量及中藥廠使用中藥材毒劇藥品之管理方式,希冀可提升中藥藥品品質、確保中藥藥品之有效性與安全性,進而達到國際水準,維護國民之用藥安全。 |
英文摘要 | People often had wrong impression that TCM herbs are save without toxicity. It is said that medicine is a poison no matter it is western chemical or herbs. When used properly, it is a good medicine, used improperly, it is a poison. Currently, there is no particular regulation on the use of poisonous herbs in Taiwan. Due to several poisoning cases reported in recent years, it is necessary to set up a guide line for the safe use of the poisonous herbs in herbal stores, clinic and hospitals. Similar measures should also be considered in the herbal pharmaceutical factories in manufacturing products with poisonous ingredient herbs. This project collected related references on poisonous herb, including processing, dispensing, doses and related regulations. An advisory committee on the regulation of poisonous TCM herbs were organized. Two consulting meetings had been held. The first meeting discussed the poisonous herb list, doses, regulations of poisonous herbs in herbal stores, clinics and hospitals, prescribing right and dispensing regulations on poisonous herbs. The second meeting focused on the regulation of poisonous herbs in pharmaceutical factories including poisonous herb list, manufacturing measures, packing, labeling and market selling of poisonous herbs and preparations. A draft on the regulation of prescribing, dispensing of poisonous herbs in clinics and hospitals had been proposed currently, the items of poisonous herb preparations are limited, it is recommended that a few guidelines on poisonous herbs to be added in the current GMP regulations should be sufficient. Through the efforts of this project, the conclusions acquired will provide CCMP a guide line when setting up the regulations on poisonous herb and preparations. The poisonous herb list, daily doses, and guide line for pharmaceutical factories provided. We aimed to elevate the quality level and assure the efficacy and safety of the herbs and meet the international standard to assure the safety of drugs used by the citizens. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。