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    題名: 天麻膠囊劑之研究;Formulation Study of Tianma (Gastrodiae Rhizoma) Capsule
    作者: 李秀芬;LI HSIU FEN
    貢獻者: 中國醫藥學院中國藥學研究所
    關鍵詞: 天麻;膠囊劑;高效液相層析法;Tianma(Gastrodiae Rhizoma);Capsule;HPLC
    日期: 1991
    上傳時間: 2009-12-22 10:31:52 (UTC+8)
    摘要: 天麻是一種固有中藥,現代的藥理研究,發現天麻有治眩暈眼黑,頭風頭痛,肢體麻木,半身不遂,語言蹇澀,小兒驚癇動風等功效。近代則用以治療高血壓及老年癡呆症療效較為顯著。 在本研究中包含以天麻的似超氧歧化?活性測定法,發現天麻每公克具有8040 U似超氧歧化?樣活性;利用酵素免疫分析儀試驗天麻的總抗氧化力為:天麻每公克相當於約100μg/g 的L-ascorbic acid含量。進行製劑的研究,首先對天麻藥材進行建立層析指紋圖譜(HPLC雷達圖譜),在製劑的研究,是以天麻膠囊劑的配方設計本研究,本研究是從天麻膠囊劑的配方設計檢討配方對天麻成分溶離之影響,天麻藥材經抽提製成流浸膏並進一步乾燥成的粉狀,以不同的賦形劑包括澱粉、乳糖、微晶纖維素及二氧化矽等配方,進行製粒並充填入1號明膠膠囊。成品進行一般品質測定,包括重量差異度、含量均一度,外觀之形狀觀察,皆可達一般膠囊劑之要求。 以天麻素及天麻?元為天麻膠囊體外溶離之指標成份,利用本實驗開發出的HPLC定量法,移動相為氰甲烷及水(85%磷酸調pH2.83 — 2.85)之不同比例,以2:98,流速0.70 ml/min,以acetaminophene為內標準品,檢測波長分別為220nm。各處方間溶離效果最好,以指標成分之釋放率比較,天麻素及天麻?元在pH1.2的媒液中有較快的釋放,天麻素及天麻?元在pH6.8的媒液中釋放較慢,綜合相關物性及溶離數據判斷天麻膠囊劑,天麻加重質微晶纖維素處方為賦型劑者具有快速釋放的效果,為本實驗膠囊劑之最佳條件。; Si-Ni-Tang(SNT), a traditional Chinese medicine formulation containing Glycyrrhizae Radix,Zingiberis Rhizoma and Aconiti Carmichaeli Radix Praeparata, was widely used in the treatment of hypotension、shock and diarrhea. In this study, the formulations design of SNT were evaluated. The SNT decoction was prepared accorded with traditional formula, then the concentrated decoction were dried by lyopholization. The SNT tablet was manufactured by wet granulation method according to seven different tablet formulations. All tablet products were possessed good physical characteristics included hardness、 friability and the weight variation test. A simple and sensitive HPLC method involved UV detection was developed for simultaneous determination of active constituents of SNT, including Glycyrrhizic acid and 6-Gingerol. The RP-18e column with the mobile phase consisted of CH3CN and H2O-H3PO4(pH3.2-3.25)was used. The 1ml/min gradient was follow : (0-10min,40:60→40:60;10-20 min,40:60→60:40;20-25min,60:40→50:50;25-28min,50:50→40:60). The monitoring wavelength was 254 and 235 nm.. The dissolution of glycyrrhizic acid and 6-gingerol from SNT tablet was evaluated by the paddle method in both pH1.2 and pH6.8 medium. It found that, R4 formulation was dissolved both glycyrrhizic acid and 6-gingerol more rapid and completely than others. By comparing the physical properties and dissolution data, the best formulation of rapid release for SNT tablet in this study is using starch(47.5mg)、lactose(5mg)、avicel(47.5mg) as excipient .
    顯示於類別:[中國藥學研究所(已停用)] 博碩士論文

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