市售中藥濃縮製劑指標成分含量調查

Investigation into the Marker Constituents of Chinese Herbal Preparations

秦玲(Ling Chyn) ； 蔡文惠(Wen-Hui Tsai) ； 黃成禹(Cheng-Yu Huang) ； 溫國慶(Kuo-Ching Wen)

《藥物食品檢驗局調查研究年報》 15號 (1997/09) Pp. 99-110

https://doi.org/10.6946/ASRNL.199709.0099

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：當歸六黃湯中Berberine，Baicalin之含量範圍分別為0.03~0.63mg/g，16.50~76.35mg/g。八珍湯等10方劑Paeoni-florin，Glycyrrhizin之含量分佈範圍分別為：八珍湯(10.55~43.58mg/g, 29.04~197.57mg/g)，小青龍湯(2.55~47.37mg/g, 0.50~35.07mg/g)，當歸四逆湯(5.68~54.44mg/g, 8.61~57.51mg/g)，小續命湯(9.75~50.82mg/g, 6.60~47.51mg/g)，升麻葛根湯(5.29~88.02mg/g、8.73~48.64mg/g)，疏經活血湯(5.42~23.18mg/g, 6.06~185.22mg/g)，薏苡仁湯(4.48~25.64mg/g, 8.63~33.36mg/g)，十全大補湯(6.00~12.99mg/g, 9.90~89.04mg/g)，柴胡桂技湯(1.54~21.11mg/g, 4.95~75.13mg/g)，小建中湯(3.38~27.67mg/g, 4.53~66.99mg/g)。大青龍湯等5方齊Glycyrrhizin, Cinnamic acid之含量分佈範圍分別為：大青龍湯(2.88~57.60mg/g, 0.03~0.97mg/g)，桂枝芍藥知母湯(9.24~24.96mg/g, 0.27~1.13mg/g)，炙甘草湯(0.78~32.76mg/g, 0.18~11.45mg/g)，胃苓湯(4.55~26.52mg/g、 0.11~2.85mg/g)，麻黃湯(11.39~156.03mg/g, 0.25~2.21mg/g)。鐲痺湯等3方劑Ferulic acid, Paeoniflorin之含量分佈範圍分別為：鐲痺湯(0.59~4.92mg/g, 16.55~101.76mg/g)血府逐瘀湯(0.20~0.78mg/g, 3.99~27.04mg/g)，補陽還五湯(0.14~1.74mg/g, 5.16~50.70mg/g)。涼膈散，潤腸湯中Baicalin，Glycyrrhizin之含量範圍分別為：涼膈散（11.94~216.32mg/g，未檢出-3.95mg/g），潤腸湯（7.89~80.85mg/g，未檢出）。荊芥連翹湯，防風通聖散中Geniposide，Paeoniflorin之含量範圍分別為：荊芥連翹湯(6.39~29.40mg/g, 4.27~24.16mg/g)，防風通聖散(16.10~165.60mg/g、1.72~237.45mg/g（138倍）)。辛夷清肺湯中Geniposide，Baicalin之含量範圍分別為3.92~30.22mg/g，8.30~96.20mg/g。歸脾湯，消風散，養心湯中Ferulic acid，Glycyrrhizin之含量範圍分別為：歸脾湯(0.36~94.86μg/g（264倍），6.67~227.18mg/g)，消風散(0.58~6.63mg/g, 1.62~17.47mg/g)，養心湯(0.50~3.06mg/g, 3.26~164.2mg/g)。清暑益氣湯，補中益氣湯，香蘇散中Hesperidin，Glycyrrhizin之含量範圍分別為：清暑益氣湯(9.45~75.20mg/g, 3.70~547.20mg/g（148倍）)，補中益氣湯(8.40~126.40mg/g, 3.75~26.92mg/g)，香蘇散(8.87~63.44mg/g, 9.36~114.3mg/g)。五積散中Hesperidin，Glycyrrhizin，Magnolol之含量範圍分別為5.25~54.30mg/g，12.00~97.20mg/g，0.70~31.65mg/g。知柏地黃丸中Berberine，Paeonol之含量範圍分別為2.74~60.68mg/g，未檢出-5.40mg/g。調胃承氣湯，復元活血湯中Glycyrrhizin，Enodin之含量範圍分別為：調胃承氣湯(15.84~66.31mg/g, 0.22~1.34mg/g)。復元活血湯(12.72~61.17mg/g, 0.034~0.56mg/g)。十神湯，葛根黃連黃芩湯中Daidzein，Glycyrrhizin之含量範圍分別為：十神湯(0.17~2.31mg/g, 4.03~21.56mg/g)，葛根黃連芩湯(0.27~1.63mg/g、5.51-30, 20mg/g)。桂枝茯芩丸中Cinnamic acid，Paeonol之含量範圍分別為0.24~1.08mg/g、0.056~5.87mg/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。

關鍵字

機械手臂自動化 ； 高效液相層析法

並列摘要

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=11.39-156.03 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-JwuIu-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-ChyauTang=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=0.36-94.86μg/g and 6.67-227.18 mg/g, in Shiau-Feng-San=0.58-6.63 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-ChihTang=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.l7mg/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.