天麻錠劑之配方研究; Formulation study of Gastrodia Rhizoma tablets

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題名:	天麻錠劑之配方研究;Formulation study of Gastrodia Rhizoma tablets
作者:	洪肇宏;Hung Jao-Hung
貢獻者:	中國醫藥大學藥物化學研究所
關鍵詞:	天麻;天麻素;天麻浸膏;錠劑;高效液相層析;流動床乾燥;盤式乾燥法;溶離試驗;Gastrodiae Rhizoma;Gastrodin;Gastrodiae elata Blume extracts;Tablet;HPLC;Fluid-bed drying method;Tray drying method;Dissolution test
日期:	1993
上傳時間:	2009-12-24 11:00:54 (UTC+8)
摘要:	中文摘要找尋傳統中藥來治療疾病慢慢受到重視。天麻就是一種著名的傳統中藥，主要成分為天麻素 (Gastrodin) 和非糖基天麻苷元 (p-Hydroxybenyl alcohol )，藥理可用於高血壓和阿茲海默症等。在研究過程中，先萃取天麻萃取液，再減壓濃縮成天麻浸膏，測天麻素 (Gastrodin) 的含量，以製備所需含天麻素 (Gastrodin) 25 mg的天麻錠劑。經由配方研究及不同製程，比較配方間的差異和找尋簡單、快速、低成本的製造方式。錠劑是以濕式造粒法製粒，經由加入不同比例賦型劑，包含微晶纖維素、澱粉、磷酸鈣、乳糖、硬脂酸鎂等製成十種錠劑配方產品作評估。評估項目包括比較處方間不同的物性，像錠劑的硬度、厚度、脆度、重量差異、壓縮性，以及法定的崩散度、溶離度和含量均一性試驗等。天麻素 (Gastrodin) 的溶離試驗在pH 1.2、 4.5 和 6.8溶媒中進行。由溶離數據得知，以R4 處方含有天麻浸膏 (260 mg)、微晶纖維素 (150 mg)、磷酸鈣 (5 mg)、乳糖 (5 mg)、澱粉 (80 mg) 為賦型劑製成的R4配方產品結果較佳。比較不同的顆粒乾燥方法，流動床乾燥法與盤式乾燥法。以R4配方進行測試，發現流動床乾燥，可改善錠劑的一些特性，如增加錠劑的硬度、縮短崩散時間和增加溶離速度等。; Abstrate Traditional chinese medicine (TCM) has been received increasingly as an alternative source for the treatment of human diseases. Gastrodiae elata Blume is a notable TCM. Recently, it is used for the treatment of patients with hypertension and Alzheimer’s disease. Gastrodin (GA) and p-Hydroxybenzyl alcohol (HBA) are active ingredients of Gastrodiae elata Blume. In this study, the curde extracts from Gastrodiae elata Blume were used to prepare the Gastrodiae tablets. The aim of formulation studies is to develop a useful tablet formulation and manufacturing process.Ten test formulations consist of different ratio of excipients, included avicel 102, starch, lactose, dicalcium phosphate were evaluated. These tablet formulations were prepared by wet granulation method. Physical properties such as tablet hardness, thickness, weight variation, friability and compressibility were examined. Tablet disintegration, dissolution and content uniformity were evaluated by official methods. The dissolution of gastrodin from Gastrodiae tablets were tested by the paddle method using pH 1.2, 4.5 and 6.8 media. It was found that the R4 formulation dissolved gastrodin more rapidly and completely than others. By comparing the physical properties and dissolution data, as a rapid-released Gastrodiae tablets the best formulation is composed of Gastrodiae elata Blume extracts (260 mg)、avicel (150 mg)、dicalcium phosphate (5 mg)、 lactose (5 mg)、starch (80 mg). By comparing different drying method fluid-bed drying and tray drying method on granulation process, which tested by R4 formulation, it showed that the fluid-bed drying was enhancing the crushing strength, disintegration times, therefore, increase the dissolution rate.
顯示於類別:	[藥物化學研究所] 博碩士論文

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