複方甘草合劑錠中所含嗎啡之高效液相層析定量法之研發

HPLC Analysis of Morphine in Tablet Mixtute Glcyrrhizin Composite

張秀圭(Shiow-Guei Chang) ； 王肇(Chao Wang) ； 陳家楨(Jia-Jen Chen) ； 秦福壽(Fwu-Show Chin) ； 李志恆(Jih-Heng Li)

《藥物食品分析》 4卷1期 (1996/03) Pp. 41-48

摘要

為因應本處產品複方甘草合劑錠品質管理之需，本處曾自行研發經酸鹼處理後以有機溶劑抽提之『抽提法』定量其嗎啡含量；該法樣品量為400錠，約需60個檢驗工時，耗材費時。為改善此缺點，本處乃研發該製劑之嗎啡高效液相層析定量方法。本方法係將檢體以鹼液抽提後經Inertsil 5 ODS-2管柱(4.6mm×150mm)，以75%含2.5mM sod. 1-dodecanesulfonate之1%醋酸溶液與25% acetonitrile之混合移動相層析之，其他較複雜成分可由提高有機相比例沖提洗出。經取10批本處產品複方甘草合劑錠，依配對試驗(Paired Test)方式分別以抽提法及HPLC法定量其嗎啡。其結果之平約值經平均值檢定無顯著差異；標準偏差分別為±1.98%及±1.94%；其相對標準偏差均為0.016。計算10組成對檢驗結果之相關係數得r=0.8093；該相關係數經r-test及t-test均呈非常顯著相關，表示可以HPLC法取代抽提法，而使檢驗樣品量減少至20錠，檢驗工時降低為約8小時，明顯地減低檢驗成本。

關鍵字

複方甘草合劑錠 ； 抽提法 ； HPLC法 ； 配對試驗 ； 相關係數r

並列摘要

For the quality control of morphine content in Tablet Mixture Glycyrrhizin Composite, previously a so called 《extraction》 method was developed by our bureau. However, this method required acid and base treatments, repeated extraction of the sample with organic solvents, and it took about 60 working-hours. In this study, we have established an HPLC method to determine the morphine content in the product by using an Inertsil 5 ODS-2 colume (4.6×150mm), and a mobile phase consisting of 75% 2.5mM sod. 1-dodecane-sulfonate in 1% acetic acid and 25% acetonitrile. In order to compare the HPLC method with extraction method, the morphine content of 10 batches of product was quantified by both methods. The results obtained from both methods were not significantly different. The standard deviations of extraction method and HPLC method were±1.98% and±1.94%, respectively. The correlation coefficient(r) of 10 pairs data was 0.8093, showing very significant relationship between two methods in accordance with the r-and t-tests. In addition, the HPLC method reduces the analysis time to 8 hours. These results strongly suggest that the HPLC method is more efficient than the extraction method.

並列關鍵字

Tablet Mixture Glycyrrhizin Composite ； morphine ； extraction method ； HPLC method ； quantitative analysis ； correlation coefficient