中藥水煎劑與濃縮方劑比較研究

詹道明
高雄醫學大學藥學系
目前臺灣中醫臨床上使用之中藥劑型主要為傳統水煎劑及濃縮製劑，少有評估濃縮製劑與傳統水煎劑在療效上相等性之研究；本計畫將以健保局常用二十個方劑為研究對象，包含疏經活血湯、川芎茶調散、銀翹散、葛根湯、麻杏甘石湯、辛夷清肺湯、芍藥甘草湯、加味逍遙散、平胃散、獨活寄生湯、小青龍湯、龍膽瀉肝湯、桑菊飲、辛夷散、蒼耳散、止嗽散、六味地黃丸、半夏瀉心湯、小柴胡湯、藿香正氣散。同時開發各種指標成分HPLC快速分析方法，HPLC的靈敏度試驗、精確性試驗、相對回收率試驗、分析安定性試驗等確效試驗之驗證。動物實驗中，雄性紐西蘭大白兔口服兩種劑型之相對生可用率研究部分，我們以水煎劑為基準，投予動物相當於化學相當量之濃縮散劑，實驗採交叉設計。運用藥物動力學軟體，評估濃縮製劑與水煎劑之間的生體相等性，提供臨床中醫師在使用濃縮製劑時的參考準則與客觀依據。
關鍵字：疏經活血湯、川芎茶調散、銀翹散、葛根湯、麻杏甘石湯、辛夷清肺湯、芍藥甘草湯、加味逍遙散、平胃散、獨活寄生湯、小青龍湯、龍膽瀉肝湯、桑菊飲、辛夷散、蒼耳散、止嗽散、六味地黃丸、半夏瀉心湯、小柴胡湯、藿香正氣散

The comparative researches between traditional herbal decoction and commercial extract

Cham, Thau-Ming
School of Pharmacy, Kaohsiung Medical University
For the time being, both traditional decoction and commercial extract were two major dosage forms of clinic traditional Chinese medicine in Taiwan. The investigations of bioequivalence between traditional decoction and commercial extract were still seldom. The purpose of this research is to study bioequivalence of twenty commercial extracts including Shu Jing Huo Xue Tang, Chuan Xiong Cha Tiao San, Yin Qiao San, Ge Gen Tang, Ma Xing Gan Shi Tang, Shin Yi Ching Fey Tang, Shaur Yaw Gan Taso Tang, Jia Wey Shiau Yau San, Ping Wei San, Du Huo Ji Sheng Tang, Hsiao Ching Lung Tang, Long Dan Xie Gan Tang, Sang Ju Yin, Shin Yi San, Cang Er San, Zhi Sou San, Liu Wei Di Huang Wan, Ban Xia Xie Xin Tang, Xiao Chai Hu Tang, Huoh Shiang Jeng Chih San. The rapid and sensitive quantitative methods for these commercial extracts are developed and validated by using HPLC. Male New Zealand rabbits are administered with traditional decoction and commercial extract in crossover design. The pharmacokinetic software, Winnolin 4.0, is utilized for evaluating bioequivalence between traditional decoction and commercial extract. The data will be provided for practitioners of Chinese medicine.
關鍵字：Shu Jing Huo Xue Tang, Chuan Xiong Cha Tiao San, Yin Qiao San, Ge Gen Tang, Ma Xing Gan Shi Tang, Shin Yi Ching Fey Tang, Shaur Yaw Gan Taso Tang, Jia Wey Shiau Yau San, Ping Wei San, Du Huo Ji Sheng Tang, Hsiao Ching Lung Tang, Long Dan Xie Gan Tang, Sang Ju Yin, Shin Yi San, Cang Er San, Zhi Sou San, Liu Wei Di Huang Wan, Ban Xia Xie Xin Tang, Xiao Chai Hu Tang, Huoh Shiang Jeng Chih San.