麻杏甘石湯之傳統水煎劑劑型和科學濃縮製劑劑型之指標成分藥物動力學研究

水煎劑及濃縮製劑在臺灣中醫臨床使用上已是常見主要中藥劑型，但仍少有研究去探討濃縮製劑是否與傳統水煎劑具相等療效。故本篇論文為評估麻杏甘石湯水煎劑及濃縮製劑之生體可用率及生體相等性之研究，經由透過HPLC來進行分析並需做HPLC的靈敏度試驗、精確性試驗、相對回收率試驗、安定性試驗等確效試驗。實驗採用交叉設計，分別給予雄性紐西蘭大白兔麻杏甘石湯水煎劑與濃縮製劑後測定血漿中指標成分，最後將收集數據代入WinNonlin藥物動力學軟體，以Student’s t-test評估。結果顯示經迴歸分析求得之檢量線其相關係數r 2值均達0.9993以上，具有良好定量性。同日間與異日間的分析結果之C.V. %值皆小於5%。偵測極限分別為甘草酸1.46 μg/ml; 麻黃鹼0.05μg/ml與定量極限分別為甘草酸為4.42 μg/ml; 麻黃鹼0.16μg/ml。回收率均達95-108%之間。安定性試驗濃度無明顯下降。此方法是快速的，具專一性的，具準確和精確性的，從而發現適合用於確定兔子血中的藥物濃度，它可用於水煎劑和濃縮製劑在動物體內的藥物動力學研究。

關鍵字

麻杏甘石湯；傳統水煎劑；科學濃縮製劑

並列摘要

Traditional decoction and commercial extract were usually used of clinic traditional Chinese medicine in Taiwan. The investigations of bioequivalence between traditional decoction and commercial extract were still rarely. This study is to assess the bioequivalence between traditional decoction and commercial extract of Ma Xing Gan Shi Tang. The active contents of Ma Xing Gan Shi Tang in male New Zealand rabbit plasma samples collected throughout the trial were assayed using HPLC with UV detection. Development and validation of HPLC method for determination of Ma Xing Gan Shi Tang in these two dosage forms. The pharmacokinetic software Winnolin 4.0 was used for evaluating bioequivalence between traditional decoction and commercial extract. Student’s t-test was used for statistical comparison. All calibration curves were in good linear correlation with correlation coefficient r 2 > 0.9993. The intraday and interday precisions showed coefficient of variation was less than 5%. The LOD (limit of detection) of Glycyrrhizic acid and Ephedrine were 1.46 μg/ml and 0.05μg/ml, respectively. The LOQ (limit of quantitation) of Glycyrrhizic acid and Ephedrine were 4.42 μg/ml and 0.16 μg/ml, respectively. The recovery was 95-108%. The method was rapid, specific, accurate and precise and thus found to be suitable for determining the drug concentration in rabbit blood that it can be used for studying pharmacokinetics between traditional decoction and commercial extract in animals.

並列關鍵字

Ma– Xing– Gan– Shi Tang ； Traditional Decoction ； Commercial Extract

參考文獻

1. Tang S, Huang L, Huang L, Yang H, Zhou C. Studies and reports of questionnaire on Chinese cut crude drug's dosage. Zhongguo Zhong Yao Za Zhi. 2010; 35(4): 539-543.