臺灣博碩士論文加值系統

含麻黃的中藥濃縮製劑常被用於治療感冒所引起之相關症狀，中藥麻黃 (Ephedrae Herba) 含有六種麻黃生物鹼，其中麻黃鹼 (ephedrine)、偽麻黃鹼 (pseudoephedrine)、甲基麻黃鹼 (methylephedrine)、去甲基麻黃鹼 (norephedrine)和去甲基偽麻黃鹼 (norpseudoephedrine) 屬世界反運動禁藥機構 (World Anti-Doping Agency, WADA) 所公告運動禁藥中第六類 (S6)-興奮劑類，過去曾有研究令人體服用含麻黃之中藥濃縮製劑後發現，若中藥濃縮製劑之單次建議用量內含ephedrine量達2.98 mg，則尿液中ephedrine平均最高濃度為4.67 μg/mL，經推算後可知若濃縮中藥製劑內ephedrine含量高於6.38 mg者，則經代謝後尿液中ephedrine的濃度可能達WADA規定的閾值10 μg/mL以上。因此，本研究目的是利用HPLC分析治療感冒的中藥濃縮製劑之單次建議用量內ephedrine、pseudoephedrine、methylephedrine、norpseudoephedrine和norephedrine的含量，期望可作為國內選手服用中藥濃縮製劑時的參考依據，以降低違規的風險。蒐集國內三家GMP藥廠製造之製劑並加以分析後，測得34%的治療感冒之含麻黃的中藥濃縮製劑超出6.38 mg，如A廠之麻杏甘石湯 (10.269 mg)、麻黃湯 (9.018 mg) 及麻黃附子細辛湯 (6.578 mg)；B廠之大青龍湯 (10.008 mg)、麻杏甘石湯 (7.215 mg)、麻黃湯 (7.614 mg)、麻黃附子細辛湯 (15.818 mg) 及葛根湯 (10.518 mg)；C廠之小青龍湯 (9.514 mg)、金沸草散 (20.792 mg)、麻杏甘石湯 (8.663 mg)、麻黃湯 (34.970 mg) 及麻黃附子細辛湯 (31.262 mg) 中ephedrine含量超出6.38 mg，因此單次服用後可能有違規的情形的狀況，故上述方劑建議選手避免使用以降低違規的風險。

Ephedrae Herba is one of the prescriptions in Traditional Chinese Medicine (TCM) preparations for releasing symptoms due to cold. The major ingredients of Ephedrae Herba, ephedrines, including ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine, and methylephedrine are banned/monitoring substances by the World Anti-Doping Agency (WADA). In previous study, the amount of ephedrine per therapeutic single-dose of Sho-seiryu-to was 2.98 mg and the mean of maximum urinary concentration (Cmax) of ephedrine was 4.67 μg/mL following individuals took single dose of the preparation. Based on this result, it is speculated that an individual who takes a single-dose of TCM preparation that contains 6.38 mg of ephedrine may lead to anti-doping rule violation. The purpose of this study was to determine the amounts of ephedrines per therapeutic single-dose in TCM preparations for colds by HPLC. We collected the TCM preparations from three GMP pharmaceuticals companies in Taiwan, and determinted the content of ephedrines n these preparations. The results show that 34% of those TCM preparations had more than 6.38 mg ephedrine in a therapeutic single-dose, such as Ma-hsing-kan-shih-to (10.269 mg), Mahwang-to (9.018 mg) and Ma-huang-fu-tzu-hsi-hsin-to (6.578 mg) from A company, Dah-ching-long-to (10.008 mg), Ma-hsing-kan-shih-to (7.215 mg), Mahwang-to (7.614 mg), Ma-huang-fu-tzu-hsi-hsin-to (15.818 mg) and Kakkon-to (10.518 mg) from B company, Sho-seiryu-to (9.514 mg), Chinfeitsao-san (20.792 mg), Ma-hsing-kan-shih-to (8.663 mg), Mahwang-to (34.970 mg) and Ma-huang-fu-tzu-hsi-hsin-to (31.262 mg) from C company. Therefore, the excretion of ephedrine in urine might exceed 10 μg/mL after taking only a single dose of these TCM preparations. In conclusion, it is estimate that all the TCM preparations for cold that contain E over 6.38 mg may cause a positive ephedrine test result, which violates the WADA rules. We suggest that athletes should avoid take these TCM preparations for cold.

第壹章 研究動機 1
第一節 研究背景 1
第二節 研究目的 2
第貳章 文獻探討 3
第一節 麻黃的簡介 3
第二節 運動與麻黃 5
第三節 麻黃生物鹼的檢測 6
第四節 非蓄意使用含麻黃的產品 9
第伍節 中藥麻黃與運動禁藥 10
第參章 材料與方法 12
第一節 材料 12
第二節 方法 15
第肆章 結果 18
第一節 滯留時間 18
第二節 標準品之線性迴歸與再現性測試 19
第三節 中藥濃縮製劑內麻黃生物鹼之含量 24
第四節 三家藥廠間各中藥濃縮製劑內麻黃生物鹼含量的比較 28
第伍章 討論 30
第一節 中藥濃縮製劑內麻黃生物鹼之含量 30
第二節 三家藥廠間各中藥濃縮製劑內麻黃生物鹼含量的比較 34
第陸章 結論與未來展望 38
參考文獻 39

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