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藥物食品分析 MEDLINESCIEScopus

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篇名 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
卷期 4:1
並列篇名 HPLC Analysis of Morphine in Tablet Mixture Glycyrrhizin Composite
作者 張秀圭王肇陳家楨秦福壽李志恆
頁次 041-048
關鍵字 複方甘草合劑錠抽提法HPLC法配對試驗相關係數 rTablet Mixture Glycyrrhizin Compositemorphineextraction methodHPLC methodquantita-quantitative analysiscorrelation coefficientMEDLINEScopusSCIE
出刊日期 199603

中文摘要

爲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I抽提法j定量其嗎_含量;該法樣品量爲400錠,約需60個檢驗工時,耗材費 時。爲改善此缺點,本處乃研發該製劑之嗎_高效液相層析定量方法。本方法係將檢體以驗 液抽提後經Inertsil 5 0DS-2管柱(4.6mmX150mm),以75%含2.5mM sod. 1-dodecanesulfonate 之1%錯酸落液與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。其結果之平均値經平均値檢定無顯著差異;標準偏差分別爲±1.98 %及±1.94% ;其相對標準偏差均爲0.016。計算10組成對檢驗結果之相關係數得r=0.8093 ; 該相闋係數經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,檢驗工時降低爲約8小時,明顯地減低檢驗成本。

英文摘要

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 X 150mm), and a mobile phase consisting of 75% 2.5mM sod. 1-dodecane-sulfonate in 19{; acetic acid and 25% acetonitrile. In order to compare the HPLC method with extraction method, the morphine content of 1 0 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.

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