葛根芩連新劑型開發及其藥效、安全性及安定性評估

溫曉薇
國立中興大學食品暨應用生物科技學系
近年來，因為化學合成藥劑對生物體可產生副作用，專家學者試圖以天然植物中藥製成藥劑，因此中藥製劑的研究日益增加，且專注於找尋製備藥劑的最佳條件及作用機制。本研究將以中藥複方-葛根芩連湯為研究主題，其主要療效為清熱止瀉。計劃將劃分為兩年進行，第一年將找尋葛根芩連膠囊製程之精緻化條件，包含(1)水提醇沈製備之最適化、(2)有效成分測定與(3)抗菌及抗發炎功效評估，待製程條件最適化後，將葛根芩連粉包於膠囊中，以降低苦味易於服用。而在第二年的研究中，將第一年所製備出的葛根芩連膠囊，進行安全性試驗(致突變性與急毒性試驗)、療效評估(體內抗發炎試驗)及安定性分析(耐熱性試驗及加速試驗)。藉由此兩年計畫，促使葛根芩連湯的製程精緻化，以製備出葛根芩連膠囊，並確定此新劑型之安全性與療效，以及評估其有效保存期限。
關鍵字：中藥複方、葛根芩連膠囊、水提醇沈、抗菌、抗發炎

Process optimization of new “Gegen Qinlian Capsule” with the evalution of its therapentic effects, safety, and stability

Hsiao-Wei Wen
Department of Food Science and Biotechnology, National Chung-Hsing University
In nowadays, scientists have gradually tried to replace synthetic drugs with natural herbal medicine, due to the severe side effects of synthetic drugs on human health. Therefore, the studies about manufacture of Chinese medicine are growing and they focus on process optimization and therapeutic mechanisms. In this study, we focus on refining the process of “Gegen Qinlian Decoction”, whose major therapeutic effects are anti-inflammatory and anti-diarrhea. This proposal is a two-year study. The first-year study will focus on optimizing the refining process of Gegen Qinlian Capsule, including the optimization of “water extraction/alcohol precipitation” process, the measurement of active ingredients, and the evolution of antibacterial and anti-inflammatory effects of Gegen Qinlian Capsule. In the second year, the properties of Gegen Qinlian Capsule will be evaluated, through safety tests (Ames test and acute oral test), therapeutic test (anti-inflammatory assay), and stability tests (thermal stability exam and accelerated test). Through this study, the refining processing of Gegen Qinlian Capsule will be optimized with the evaluation of its safety and therapeutic effects, and the estimation of its shelf-life.
關鍵字：natural herbal medicine, Gegen Qinlian Capsule, water extraction/alcohol precipitation, antibacterial, anti-inflammatory