中藥單味濃縮製劑品管規格之制定研究

張憲昌
行政院衛生
為了解單味濃縮製劑其浸膏率，以及各品管項目，包括乾燥減重、總灰分、酸不溶性灰分、水抽提物、稀醇抽提物等之分佈範圍，對單味濃縮製劑品管有加以評估之必要。
本計畫擬選定單味濃縮製劑20個，即丹參、山茱萸、續斷、百部、巴戟天、地黃、知母、陳皮、大黃、龍膽、黨參、酸棗仁、附子、山藥、膜莢黃耆、薏苡仁、半夏、茯苓、地骨皮、及芍藥，依各該單味藥材一日量之20倍製備成浸膏及濃縮製劑並進行品質測試? A另外透過製藥公會之中藥委員會，由其中藥濃縮製劑之業者，提供各廠上述20個單方濃縮成品之品管資料，加以比較統計分析，以了解各品管項目規格分佈範圍之情形。
關鍵字：中藥製劑、乾燥減重、總灰分、酸不溶性灰分、水抽提物、稀醇抽提物

Study on the criteria of the quality control in the single crude drug concentrated dosage form

Hsien-Chang Chang 
National Laboratories of Foods and Drugs. Department of Health, Executive Yuan
In order to understand the yields of extract by decoction of crude drugs and to set up the criteria of the items of quality control in concentrated preparations, twenty concentrated preparations of crude drugs will be produced in large scale by ten to fifteen factories and laboratory-scale by our laboratory. The twenty crude drugs as follows Salviae Miltiorrhizae Radix, Corni Fructus, Dipsaci Radix, Stemonae Radix, Morindae Radix, Rehmanniae Radix, Anemarrhenae Rhizoma, Citri L eiocarpae Exocarpium, Rhei Rhizoma, Gentianae Scabrae Radix, Paeoniae Radix,Codonopsitis Radix , Zizyphi Spinosi Semen, Aconiti tuber, Disocoreae Rhizoma, Astragali Radix, Coicis semen, Pinelliae tuber, Poria and Lycii radicis cortex were selected.
The items of loss on drying, total ash, acid-insoluble ash, water-soluble extract and dilute-alcohol extract of the twenty concentrated preparations by the methods of pharmacopeia. The criteria of the items of quality control in concentrated preparations will be sugg
關鍵字：quality control ,single crude drug concentrated dosage form