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藥物食品檢驗局調查研究年報

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篇名 市售中藥濃縮製劑指標成分含量調查
卷期 15
並列篇名 Investigation into the marker constituents of Chinese herbal preparations
作者 秦玲蔡文惠黄成禹溫國慶
頁次 099-110
關鍵字 機械手臂自動化高效液相層析法TSCI
出刊日期 199709

中文摘要

本計畫利用已確立之中藥濃縮製劑指標成分之高效液相層析定量方法,與 機械手臂自動化檢體前處理步驟連接,進行37種處方之中藥濃縮製劑指標成 分定量,結果各方劑中指標成分之含量如下:當歸六黄湯中Berberine,Baicalin 之含量範圍分别爲0.03〜0.63 mg/g,16.50~76.38 mg/g。八珍湯等10方劑Paeoni-florin,Glycyrrhizin 之含量分佈範圍分别爲:八珍湯(10.58~43.58 mg/g,29.04~ 197.57 mg/g),小青龍湯(2.55〜47.37 mg/g,0.50~35.07 mg/g),當歸四逆湯 (5.68~54.44 mg/g,8.6卜57.51 mg/g),小續命湯(9.78~50.82 mg/g,6.60~47.81 mg/g),升麻葛根湯(5.29〜88.02 mg/g、8.73〜48.64 mg/g),疏經活血湯(5.42〜 23.18mg/g,6.06〜185.22 mg/g),薏苡仁湯(4.48~25.64 mg/g,8.63〜33.36 mg/g), 十全大補湯(6.0CM2.99 mg/g,9.90~89.04 mg/g),柴胡桂枝湯(1.54~21.11 mg/ g,4.95〜75.13 mg/g),小建中湯(3.38~27.67 mg/g,4.53~66.99 mg/g)。大青龍 湯等5方劑Glycyrrhizin, Cinnamic acid之含量分佈範圍分别爲:大青龍湯 (2.88〜57.60 mg/g,0.03〜0.97 mg/g),桂枝芍藥知母湯(9.24〜24.96 mg/g,0.27-1.13 mg/g),炙甘草湯(0.78〜32.76 mg/g,0.18〜11.45 mg/g),胃苓湯(4.88~ 26.52mg/g、0.11 〜2.85 mg/g),麻黄湯(11.39~156.03mg/g,0.25〜2.21mg/g)。蠲痒湯等3方劑Ferulic acid,Paeoniflorin之含量分佈範圍分别爲:蠲痒湯(0.59~ 4.92 mg/g, 16 . 88 ~ 101. 76 mg/g)血府逐瘀湯(0 . 20-0.78 mg/g, 3.99~27.04 mg/g), 補陽還五湯(0.14~ 1.74 mg/g, 5.16~50.70 mg/g)。 涼膈散,潤腸湯中 Baicalin, Glycyrrhizin之含量範圍分别爲:涼腸散(11.94〜216.32 mg/g,未檢出-3.98 mg/ g),濁腸湯(7.89~80.85 mg/g,未檢出)。荆齐連紐湯,防風通聖散中Genipo-side,Paeoniflorin 之含量範圍分别爲:荆芥連組湯(6.39~29.40 mg/g,4.27~ 24.16 mg/g),防風通聖散(16.10~165.60 mg/g、1.72〜237.45 mg/g(138 倍))。 辛夷清肺湯中Geniposide,Baicalin之含量範圍分别爲3.92~30.22 mg/g,8.30~ 96.20 mg/g。歸脾湯,消風散,養心湯中Ferulic acid, Glycyrrhizin之含量範圍 分别爲:歸脾湯(0.36~94.86 /xg/g(264 倍),6.67〜227.18 mg/g),消風散(0.58〜 6.63 mg/g,1.62〜17.47 mg/g),養心湯(0.50~3.06 mg/g,3.26〜164.2mg/g)。清暑 益氣湯,補中益氣湯,香蘇散中Hesperidin,Glycyrrhizin之含量範圍分别爲: 清暑益氣湯(9.48~78.20 mg/g,3.70〜547.20 mg/g(148 倍)),補中益氣湯(8.40〜 126.40 mg/g,3.78〜26.92 mg/g),香蘇散(8.87~63.44 mg/g,9.36〜114.3 mg/g)。 五積散中 Hesperidin,Glycyrrhizin,Magnolol 之含量範圍分别爲 5.28〜54.30 mg/g,12.00〜97.20 mg/g,0.70~31.65 mg/g。知柏地黄丸中Berberine, Paeonol 之含量範圍分别爲2.74~60.68 mg/g,未檢出-5.40 mg/g。調胃承氣湯,復元活血湯 中Glycyrrhizin, Enodin之含量範圍分别爲:調胃承氣湯(15.84~66.31 mg/g, 0.22〜1.34 mg/g)。復元活血湯(12.72〜61.17 mg/g,0.034-0.86 mg/g)。十神湯, 葛根黄連黄茶湯中Daidzein,Glycyrrhizin之含量範圍分别爲:十神湯(0.17〜 2.31 mg/g,4.03〜21.56 mg/g),葛根黄連芩湯(0.27~1.63 mg/g、5.51〜30.20 mg/ g)。桂枝获岑丸中Cinnamic acid,Paeonol之含量範圍分别爲0.24〜1.08 mg/g、 0.056〜5.87 mg/g。由結果數據顯示,不同廠牌間有未檢出者,另亦有高低差達 264倍者。同廠牌不同批號之檢體亦有高低差達45倍者。

英文摘要

In this study, sample solutions of 37 kinds of Chinese herbal medicinal preparations were prepared by Laboratory Automation System. Their marker ingredients were then determined using well-established HPLC methods. The contents of the marker constituents in these preparations were as follows: berberine and baicalin in Dang-Guei-Liow-Hwang Tang = 0.03-0.63 mg/g and 16.50-76.38 mg/g, Paeoniflorin and glycyrrhizin in Ba-Jen-Tang = 10.58-43.58mg/g and 29.04-197.57mg/g,in Sheau-Qing-Long-Tang =2.55-47.37 mg/g and 0.50-35.07 mg/ g, in Dang-Guei-Shy-Nih-Tang = 5.68-54.44 mg/g and 8.61-57.51 mg/g, in Sheau-Shiuh-Ming-Tang=9.78-50.82 mg/ g and 6.60-47.81 mg/g, in Sheng-Ma-Ger-Gen-Tang=5.29-88.02 mg/g and 8.73-48.64 mg/g, in Shu-jing-Hwo-Shiueh-Tang = 5.42-23.18 mg/g and 6.06-185.22 mg/g, in Yih-Yii-Ren-Tang =4.48-25.64 mg/g and 8.63-33.36 mg/ g, in Shyh-Chyuan-Dah-Buu-Tang = 6.00-12.99 mg/g and 9.90-89.04 mg/g, in Chair-Hwu-Guey-Jy-Tang= 1.54-21.11 mg/g and 4.95-75.13 mg/g, in Sheau-Jiann-Jong-Tang = 3.38-27.67 mg /g and 4.53-66.99 mg/g, glycyrrhizin and cinnamic acid in Da-Qing-Long- Tang= 2.88-57.60 mg/g and 0.03-0.97mg/g, in Gueihjy-Shauryauh-Jumu-Tang= 9.24-24.96 mg and 0.27-1.13mg/ g, in Zih-Gan-Cao-Tang=0.78-32.76 mg /g and 0.18-11.45 mg/g and 0.18-11.45 mg/g, in Weih-Lirng-San= 4.88-26.52 mg/g and 0.11-2.85 mg/g, in Ma-Hwang-Tang=l 1.39-156.03 mg/g and 0.25-2.21 mg/g, ferulic acid and paeoniflorin in Jyuabi-Tang = 0.59-4.92 mg/g and 16.88-101.76 mg/g, in Shiee-Fuu-Jwu-Iu-Tang= 0.20-0.78 mg/g and 3.99-27.04 mg/g, in Buu-Yang-Hwan-Wuu-Tang=0.14-1.74 mg/g and 5.16-50.70 mg/g, baicalin and glycyrrhizin in Liarn-Ger-San = 11.94-216.32 mg/g and N.D.-3.98 mg/g, in Run-Charng-Tang =7.89- 80.85 mg/g and N.D, geniposide and paeoniflorin in Ging-Jieh-Lian-Chyau-Tang= 6.39-29.40 mg/g and 4.27-24.16 mg/g, in Farng-Feng-Tong-Shewg-San= 16.10-165.60 mg/g and 1.72-237.45 mg/ g, geniposide and baicalin in Shin-Yi-Ching-Fey-Tang=3.92-30.22 mg/g and 8.30-96.20 mg/g, ferulic acid and glycyrrhizin in Guei-Pi-Tang=0.36- 94.86 m g/g and 6.67-227.18 mg/g, in Shiau-Feng-San=0.5 8-6.63 mg/g and 1.62-17.47 mg/g, in Yeang-Shin-Tang= 0.50-3.06 mg/g and 3.26-164.2 mg/g, hesperidin and glycyrrhizin in Qing-Shu Yi-Qi-Tang=9.48-78.20 mg/g and 3.70-547.20 mg/g, in Buu-Jong-Yih-Chih-Tang=8.40-126.40 mg/g and 3.78-26.92 mg/g, in Shiang-Su-San=8.87-63.44 mg/ g and 9.36-114.3 mg/g, hesperidin, glycyrrhizin and magnolol in Wuu-Ji-San=5.28-54.30 mg/g, 12.00-97.20 mg/ g and 0.70-31.65 mg/g, berberine and paeonol in Jy-Bor-Dih-Hwang-Wan= 2.74-60.68 mg/g and N.D.-5.40 mg/g, glycyrrhizin and emodin in Tyau-Wey-Cherng-Chih-Tang = 15.84-66.31 mg/g and 0.22-1.34 mg/g, in Fuh-Yuan-Hwo- Shiee-Tang=12.72-61.17mg/g and 0.034-0.86 mg/g, daidzein and glycyrrhizin in Shyr-Shern-Tang= 0.17-2.31 mg/g and 4.03-21.56 mg/g, in Ger-Gen- Hwang-Lian-Hwang-Chyn-Tang = 0.27-1.63 mg /g and 5.51-30.20 mg/g, cinnamic acid and paeonol in Guey-Jy-Fwu-Ling-Wan =0.24-1.08 mg/g and 0.056-5.87 mg/g. Quantities of marker ingredients differed markedly in different brands with nominally the same formula, and even across different batches of the same brand.

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