- 學位論文
以藥物分析探討傳統中藥酒之製程最適化
Optimization of the Preparation Process for a Traditional Chinese Tonic Wine: on the Perspective of Pharmaceutical Analysis
摘要
在許多東方國家，以傳統中藥酒來作為治療疾病的另一種選擇或保健營養補充品已有悠久之歷史。然而，包括製造所用之藥材的品質管控及製造過程，仍需足夠的科學證據來證明產品的穩定性及安全性。因此，本研究的主要目的即是開發一種穩定可靠的分析方法並應用來最佳化中藥酒製造之過程。 本研究的對象為行政院衛生署中醫藥委員會所公告之"馬祖"萬壽藥酒，其處方中含有十二種中藥材，分別是龍眼肉、廣木香、什開（白豆蔻）、沉香、山梔子、黨參、當歸、川芎、玉竹、肉桂、陳皮、五加皮。 以液相層析結合photodiode array偵測器來測定藥酒中4種藥材之指標成分─當歸與川芎中的ferulic acid、肉桂中的cinnamic acid及cinnamaldehyde、陳皮中的hesperidin的含量，此方法經確效後，結果在同日間與異日間之RSD值與RE值分別小於5.0%及4.0%，顯示此方法的精密度及準確度良好，並可有效地應用於藥酒之品質管控。 接著進行最適化製程條件探討，包括不同藥材粉碎粗細程度與萃取時間、不同萃取溶媒體積、不同酒精含量之萃取溶媒及不同溫度萃取條件等各項製程變因。由結果可知，當陳皮的粉碎為0.84 mm（#20篩）；當歸、川芎、肉桂為2.36 mm（#8篩）的情形下，以10-12倍之溶媒體積量，使用50%酒精溶媒於45℃加熱24小時後可得最適化製程。並應用此最適化製程進行產品試製，試製品執行6個月安定性試驗結果顯示，其為一穩定性之製品。 最後，為增添產品風味且增加藥酒功效，希望加入具潛力天然植物對中藥酒進行處方改良－初選為土樟（Cinnamomum reticulatum Hay.）。土樟葉在過去的研究中，發現有可供利用的成分，而對其莖作研究，分離及鑑定出14種成分，其中有些是屬於新發現之成分，未來可對這些成分作進一步活性之研究，並期望能有具體之發現能應用於配方改良。
並列摘要
Traditional Chinese medicinal wine has been used for a long history in many oriental countries and use for alternative therapies or as nutritional supplement. However, the quality control of Chinese medicinal materials and the process of decoction are all need to provide scientific evidence showing that the product is consistency and safety. The aim of study is to develop a stable and reliable analytical method to optimize the preparation process of traditional Chinese tonic wine. According the officially issue from Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan, Taiwan, Ma-Zu-Wan-Show-Yao-Jyo consist of 12 Chinese medicinal materials of Longan Arillus, Aucklandiae Radix, Amomi Rotnudus Fructus, Aquilariae Resinatum Lignum, Gardeniae Fructus, Codonopsis Radix, Angelicae Sinensis Radix, Chuanxiong Rhizoma, Polygonati Odorati Rhizoma, Cinnamom Cortex, Citir Reticulatae Pericarpium, Acanthopanacis Cortex. A liquid chromatography coupled with photodiode array detector was use to determine the market compounds of cinnamaldehyde, cinnamic acid, ferulic acid and hesperidin in the herbal wine. The method validation results indicated that the relative standard deviation and relative standard error were less than 5 and 4%, respectively, for intra-and inter-day assay of the analyses. This method can be used to standardize the quality control of the herbal wine to ensure their accuracy and efficiency. To optimize the preparation process, several factors have been considered, such as the pulverization extent of the medicinal materials, the extraction time, the extraction temperature. The results showed that the optimal process for the herbal wine occurred when Citri Reticulatae Pericarpium was pulverized to 0.84 mm (# 20 mesh), Angelicae Sinensis Radix, Chuanxiong Rhizoma and Cinnamomi cortex was cut to 2.36 mm size (# 8 mesh), extracted with 50% alcohol solution, while volume was 10-12 times equivalent to the medicinal materials, then heat at 45℃ for 24 hours. Then the herbal wine product has passed 6 months stability test. Finally, in order to improve the flavors of the herbal wine and strengthen it effect, a Cinnamonum reticulatum Hay. was choiced. In the past research, its leaf has been found some available ingredients. Through isolation and identification of the chemical constituents of the stem, we got 14 compounds. Among them, some were new compounds and some were isolated for the first time from this species. We expected these chemical compounds could be research in the future and discover the potential activity to enhance effect of Chinese tonic wine.