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題名 | 中藥基準方製劑品管規格之制定研究=Study on the Criteria of the Quality Control Items in the Unified Formula of Traditional Chinese Medicines |
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作者 | 溫國慶; |
期刊 | 中醫藥年報 |
出版日期 | 19980500 |
卷期 | 16:2 1998.05[民87.05] |
頁次 | 頁521-592 |
分類號 | 413.95 |
語文 | chi |
關鍵詞 | 中藥基準方; 乾燥減重; 灰分; 酸不溶性灰分; 稀醇抽提物; 水抽提物; Unified Chinese herbal formulas; Loss on drying; Total ash; Acid-insoluble ash; Water-soluble extract; Diluted-ethanol soluble extract; |
中文摘要 | 為了解中藥基準方之浸膏率及探討其品管項目規格分佈範圍,就第一 階段公告之基準方進行產製及試驗結果,濃縮製劑99個方中,平均浸膏 率30%以上者有9方(9.1%),介於20∼30%者計53方(53.5%),介於 10∼20%者,有36方(30.3%),低於10者,只有1方(1.0%)。 實驗室自製之20個濃縮製劑基準方,其水抽提物浸膏百分比高於 90%者,計有百合固金湯、四物湯、獨活寄生湯、歸脾湯、八珍湯、辛夷 清肺湯、補中益氣湯、龍膽瀉肝湯、疏經活血湯、九味羌活湯、人參養榮 湯、桂枝湯、清肺湯等13方。介於80∼90%者,計有麻黃湯、六君子湯、 麻杏甘石湯、柴葛解肌湯、黃連解毒湯等五。介於70∼80%者,計有葛 根湯及定喘湯2方。其稀醇抽提物稍低於水抽提物。 基準方使用相同藥材來源,分別由實驗室與工廠規模產製之產品比 較,實驗室之產品,共稀醇、水抽提物大多高於工廠規模之產品,但大約 有85∼95%之相當性。 至於使用不同來源藥材及浸膏澱粉比不同者,其稀醇、手抽提物之差 異性大。另灰分含量項,含有礦物性藥材口石膏者其差異也大。 |
英文摘要 | In order to understand the yields of extract in concentrated dosage form of unified Chinese herbal formulas. In this study, ninety-nine formulas were carried out. Each formulas was prepared by seven to ten industries. The yields of extract of each formula were tested with triple times. The range of the mean yields of extract in ninety-nine formulas as fellows, nine formulas range form thirty to forty percents, fifty-three formulas range form twenty to thirty percents; thirty- six formulas range form ten to twenty percents, only one forumla below ten percents. In order to understand the relationship between water-soluble extract and hot water-soluble extract in concentrated dosage form of unified Chinese herbal formulas. In this study, twenty formulas were prepared in laboratory scale and the quality items were determinated. The ratio between water-soluble extracted and hot water-soluble extract in twenty formulas as fellows, thirty formulas are more than ninety percents, five formulas range form eighty to ninety percents, two formulas range from seventy to eighty. In general, diluted ethanol-soluble extracts of each formula are lower than water-soluble extracts. Thirty formulas, five formulas and two formulas mentioned above are bae-Her-Guh-Jin-Tang(百合固金湯),Syh-Wuh-Tang(四物湯), Dwu-Hwo-sheng-Tang(獨活寄生湯),Guei-Pyi-Tang(歸脾湯),Ba-Jen- Tang(八珍湯),Shin-Yi-Ching-Fey-Tang(辛夷清肺湯),Buu-Jong-Yih- Chin-Tang(補中益氣湯),Long-Daan-Shien-Gan-Tang(龍膽瀉肝湯), Shu-Jing-Hwo-Shiueh-Tang(疏經活血湯),Jeou-Wey-Chiang-Hwo-Tang(九 味羌活湯),Ren-Shen-Yeang-Rong-Tang(人參養榮湯),Guey-Jy-Tang(桂 枝湯),Ching-Fey-Tang(清肺湯);Ma-Hwang-Tang(麻黃湯),Liow- Jiun-Tzyy-Tang(六君子湯),Ma-Shing-Gan-Shyr-Tang(麻杏甘石湯), Chair-Ger-Jiee-Ji-Tang(柴葛解肌湯),Hwang-Lian-Jiee-Dwu-Tang(黃 蓮解毒湯);Ger-Gen-Tang (葛根湯),and Ding-Choan-Tang(定喘湯),in sequence. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。