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題名 | 葛根芩連新劑型開發及其藥效、安全性及安定性評估=Process Optimization of New "Gegen Qinlian Capsule" with the Evolution of Its Therapeutic Effects, Safety, and Stability |
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作者 | 溫曉薇; Wen, Hsiao-wei; |
期刊 | 中醫藥年報 |
出版日期 | 20141200 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(31)1-(31)57 |
分類號 | 414.5 |
語文 | chi |
關鍵詞 | 葛根芩連湯; 抗菌; 抗發炎; 急毒性試驗; Gegen Qinlian decoction; Antibacterial activity; Anti-inflammatory effect; Acute oral toxicity; |
中文摘要 | 葛根芩連湯為具有抗發炎及抗菌能力的中藥方劑,本研究計畫中主要探討其生產製備過程,找到最合適的水萃醇沉條件,並探討其抗菌、抗發炎能力及藥物毒性。首先找出葛根芩連湯的最適製備條件,在製備過程中有許多因數會影響有效成分(葛根素、黃芹苷、甘草酸、小檗鹼 )的含量,包括萃取水量、萃取時間、初浸膏密度及酒精濃度皆會影響結果,經過試驗後最適的製備條件為 (1) 使用 6倍水量萃取 2小時, (2) 濃縮以將初浸膏的密度調成 1.111 g/mL,(3) 加入酒精至 60%以進行醇沉並靜置 24小時, (4) 減壓濃縮去除酒精得到終浸膏, (5)終浸膏與玉米澱粉混合並烘乾得到葛根芩連粉末, (6) 將粉末裝入膠囊形成葛根芩連膠囊。而在抗菌試驗中,初浸膏及終浸膏對 Salmonella enterica和 Staphylococcus aureus都有良好抑菌能力,但對 Pseudomonas aeruginosa和 Enterococcus faecalis則無抑制作用。在抗發炎試驗中,初浸膏及終浸膏皆可降低由 LPS誘導產生的 NO及 PGE2濃度;且終浸膏抑制 PGE2生成的效果較初浸膏好。最後進行急毒性試驗,將終浸膏以管喂方式餵食給大鼠,每只大鼠餵食藥物濃度為 40 g生藥重/kg body weight,單次餵食並觀察 14天,結果顯示經餵食藥物的組別和控制組相比較,並沒有中毒症狀或死亡結果出現。另外體重、臟器重量、血液生化值、血清生化值和控制組相比亦沒有顯著性差異,以肉眼觀察臟器與病理組織切片結果也沒有病變現象,因此本研究以水萃醇沉所製成的葛根芩連終浸膏對於大鼠並沒有急毒性的傷害。本研究已完成葛根芩連湯的水萃醇沉製程的最適化研究,並確定其具有抑制 Salmonella enterica和 Staphylococcus aureus的抗菌功能,以及降低 NO與 PGE2生成的抗發炎功效,最後藉由急毒性動物試驗以確保其安全性。 |
英文摘要 | This study focused on refining the process of “Gegen Qinlian Decoction”, whose major therapeutic effects are anti-inflammatory and anti-bacteria. We worked on the optimization of “water extraction/alcohol precipitation” process, the evolution of antibacterial and anti-inflammatory effects and acute toxicity of the products. Several factors affecting the amounts of effective compounds (puerarin, baicalin, glycyrrhizic acid, and berberine) were studied, including the amount of water, the extraction time, the density of primary decoction, and ethanol concentration. The optimal processing was settled as (1) using 6 times of water to extract for 2 hours, (2) concentrate the primary decoction to the density as 1.111 g/mL, (3) using 60% ethanol to perform alcohol precipitation for 24 hours, (4) removing ethanol to get the final decoction, (5) mixing with corn starch and drying to produce “Gegen Qinlian Powder”, and (6) put powder into capsules to make “Gegen Qinlian Capsule”. In the antimicrobial evaluation, primary and final decoction presented good effects against Salmonella enterica and Staphylococcus aureus, but had no inhibitory effect on Pseudomonas aeruginosa and Enterococcus faecalis. Additionally, primary and final decoction could efficiently reduce productions of NO and PGE2, induced by LPS, and final decoction had better ability in reducing PGE2 production than primary decoction. Finally, the safety of final decoction was evaluated through the acute oral toxicity in SD rats. Rats were single given at a dose of final decoction as 40 g raw drug/kg body weight and consecutively observed for 14 days. No poison symptom or death was observed in the control and treated rats. No significant differences of body weight, organ weight, hematological parameters, and serum biochemistry between control and treated groups. No gross and histopathological change of rats was found. Conclusively, this study had optimized the process for “Gegen Qinlian Decoction”, proved its antimicrobial activity against S. enterica和 Staphylococcus aureus and anti-inflammetory effect on reducing NO and PGE production, and proved its safety based on the acute oral toxicity test on rats. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。