中藥基準方製劑品管規格之制定研究

溫國慶 
行政院衛生
中藥製劑申請查驗登記之處方內容常因依據之典籍不同，雖同一方名而其藥材組成與份量卻不儘相同，加上藥材均來自天然物，其所含成分差異頗大，故中藥製劑之各品管項目之規格範圍亦有很大之差異。

行政院衛生署為求減少上述同方名之差異，近年來進行中藥基準方之訂定，並已公告 100個基準方，希業者持有該等方劑許可証者於八十六年八月三十一日以前辦理變更。為了解基準方之濃縮製劑其浸膏率，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，以作為嗣後基準方製劑品管審核之參考依據。擬透過中藥濃縮製劑業者提供即將依基準方試製之產品指導其測試各品管項目，實施前並對廠商實施精準度測試；以及本局自行依基準方組成與分量試製產品，測試各品管項目。綜合本局與廠商之數據統計分析，探討各項品管項目之範圍，供作嗣後查驗登記之審核內規。


關鍵字：中藥製劑、基準方、品質管制

Study on the criteria of the quality control items in the unified formula of traditional Chinese Medicines

In this study, 20 formulated prescriptions of the traditional Chinese medicines prepared by 15-20 pharmaceutical factories and 3 lots of home-made by National Laboratories of Foods amd Drugs will be collected. The items of loss on drying, total ash, acid-insoble ash, water-extract and ethanol-soluble extract of products mentioned above will be determined. The data will be analysed by t-test. According to the results of data, the distributin range for each item of 20 formulated prescriptions will be suggested. The distribution ranges of each item mentioned above will be provided for products approval.

關鍵字：Traditional Chinese medicine, Uniform formula, Quality control