臺灣博碩士論文加值系統

酚酞 (phenolphthalein) 曾做為治療便秘之藥物。經動物實驗證明酚酞具有致癌性、遺傳毒性且會造成 p53 腫瘤抑制基因之損傷。因此若將酚酞作為藥劑或添加於保健食品中，可能會危害人體之健康，目前許多國家禁止含酚酞之瀉藥與保健食品之販售，包括臺灣、美國、日本、加拿大和許多歐洲國家。
本研究探討以不同條件萃取瀉藥與保健食品中之酚酞，並建立以高效能液相層析儀 (high performance liquid chromatography, HPLC) 搭配光電二極體矩陣檢測器 (photodiode array detector, PDA) 定量之最適條件，再以此條件進行市售瀉藥與保健食品中酚酞之測定，以了解市售瀉藥與保健食品中其違法添加之情形。
使用 HPLC – PDA 及 InertSustain® C18 管柱於波長 228 nm 下，使用乙腈：水= 45：55 (v/v) 進行等位沖提，酚酞之偵測極限為 0.0192 ppm，定量極限為 0.0638 ppm。
將樣品以超音波輔助萃取 (ultrasonic assisted extraction, UAE) 與微波輔助萃取 (microwave assisted extraction, MAE) 進行比較，其中酚酞片劑以超音波萃取 5 分鐘後，可得到最佳之萃取效果，其酚酞之回收率為 86.7 (± 0.1) - 95.8 (± 0.1)%。保健食品粉末 A 以功率為 200 W 之微波萃取 2 分鐘，可得到最佳之萃取效果，其酚酞之回收率為 80.43 (± 0.04) - 96.13 (± 0.03)%，保健食品粉末 B 以超音波輔助萃取 45 分鐘，可得到最佳之萃取效果，其酚酞之回收率為 84.0 (± 0.2) - 94.0 (± 0.2)%。兩種保健食品粉末 (A、B) 為我國藥局所販賣，有違法添加酚酞於保健食品之情形，應加強檢驗保健食品中酚酞之含量，以藥品及食品之安全。

Phenolphthalein has been used as a drug for the treatment of constipation. Animal experiments show that phenolphthalein is carcinogenic and genotoxic. It can cause genetic damage of p53 tumor suppressor. Using phenolphthalein as a drug or adding it to the health functional food may be harmful to the human health. At present, many countries, including Taiwan, the United States, Japan, Canada, and some European countries prohibit the sale of laxative or health functional food which contains phenolphthalein.
Different extraction conditions were tried to extract phenolphthalein from laxatives and health functional food. An optimal analytical procedure was also established for quantification of phenolphthalein by the use of high performance liquid chromatograph (HPLC) along with photodiode array (PDA) detector. Commercial laxatives and health functional food were analyzed with the procedure established in this research to see if phenolphthalein was added.
An InertSustain® C18 column was used and the detector wavelength was set at 228 nm. A mobile phase of acetonitrile/water (45:55, v/v) isocratically eluted the analyte. The limit of detection (LOD) and the limit of quantitation (LOQ) were 0.0192 and 0.0638 ppm, respectively.
Samples were extracted by ultrasonic assisted extraction (UAE) method and microwave assisted extraction (MAE) method, respectively. The optimum extraction condition for phenolphthalein tablet was to perform ultrasonic assisted extraction for 5 minutes. The recovery of phenolphthalein was 86.7 (± 0.1) ~ 95.8 (± 0.1)%. The optimum extraction condition for health functional food powder A was to perform microwave assisted extraction with the power of 200 W for 2 minutes. The recovery of phenolphthalein was 80.43 (± 0.04) ~ 96.13 (± 0.03)%. The optimum extraction condition for health functional food powder B was to perform ultrasonic assisted extraction for 45 minutes. The recovery of phenolphthalein is 84.0 (± 0.2) ~ 94.0 (± 0.2)%. The results showed that illegal addition of phenolphthalein still exists in the domestic market. Determination of phenolphthalein content of the health functional food should be strengthened in order to ensure the food safety.

摘要…………………………………………………………………………………Ⅰ
Abstract………………………………………………………………………………Ⅱ
目錄…………………………………………………………………………………Ⅲ
圖目錄………………………………………………………………………………Ⅴ
表目錄………………………………………………………………………………Ⅵ
壹、 前言……………………………………………………………………………1
貳、 文獻整理………………………………………………………………………2
一、 保健食品…………………………………………………………………2
(一) 特殊營養食品………………………………………………………2
(二) 機能性食品…………………………………………………………2
(三) 膳食補充食品………………………………………………………2
(四) 健康食品……………………………………………………………2
二、 瀉藥………………………………………………………………………3
(一) 容積性瀉藥…………………………………………………………3
(二) 刺激性瀉藥…………………………………………………………3
(三) 潤滑性瀉藥…………………………………………………………4
(四) 高滲透性瀉藥………………………………………………………4
(五) 軟化劑瀉藥…………………………………………………………4
三、 酚酞………………………………………………………………………4
(一) 酚酞之物理化學特性………………………………………………4
(二) 藥物動力學…………………………………………………………4
(二) 用途…………………………………………………………………5
四、瀉藥中及保健食品中酚酞之分析…………………………………………6
(一) 樣品前處理之方法…………………………………………………6
(二) 分析方法……………………………………………………………7
參、 材料與方法……………………………………………………………………9
一、 實驗材料……………………………………………………………………9
(一) 樣品…………………………………………………………………9
(二) 標準品………………………………………………………………9
(三) 藥品…………………………………………………………………9
(四) 層析管柱……………………………………………………………9
(五) 儀器設備……………………………………………………………9
二、 實驗流程…………………………………………………………………11
三、 實驗方法…………………………………………………………………12
(一) 建立 HPLC 分析酚酞之方法……………………………………12
(二) 市售瀉藥與保健食品中酚酞之萃取………………………………12
(三) 酚酞之偵測極限、定量極限及回收率……………………………14
(四) 統計方法……………………………………………………………15
肆、 結果與討論……………………………………………………………………16
一、 以 HPLC 分析酚酞之條件……………………………………………16
(一) 吸收波長……………………………………………………………16
(二) 移動相………………………………………………………………16
(三) 檢量線………………………………………………………………17

二、 不同萃取方法對酚酞含量之影響……………………………………17
(一) 漩渦混合器震盪與超音波輔助萃取 (ultrasonic assisted extraction, UAE)…………………………………………………………………17
(二) 微波輔助萃取 (microwave-assisted extraction, MAE)……………18
三、 樣品之分析……………………………………………………………19
四、 偵測極限、定量極限及回收率………………………………………19
(一) 偵測極限及定量極限………………………………………………19
(二) 回收率………………………………………………………………19
伍、 結論……………………………………………………………………………21
陸、 參考文獻………………………………………………………………………22
柒、 圖表……………………………………………………………………………26
捌、 附錄……………………………………………………………………………48

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