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首页> 外文期刊>Journal of separation science. >Simultaneous determination of eight active components in Houttuynia cordata injection and its quality control in productive process
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Simultaneous determination of eight active components in Houttuynia cordata injection and its quality control in productive process

机译：鱼腥草注射液中8种有效成分的同时测定及其生产过程中的质量控制

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摘要

A simple, reliable and effective gas chromatography coupled with flame ionization detection method was developed for the simultaneous determination of eight components (α-pinene, β-pinene, myrcene, limonene, terpinen-4-ol, α-terpineol, bornyl acetate and methyl-n-nonylketone) in Chinese medicine Houttuynia cordata and its injection. The chromatographic separation of all eight components, including undecylene as internal standard was performed on a DB-1 column (30?m×0.25?mm, 0.25?μm). Excellent linear behaviors including herb and injection over the investigated concentration ranges were observed with the values of r2 higher than 0.9990 for all analytes. Satisfactory intra-day and inter-day precisions were achieved with RSD less than 2% and the average recoveries for all analytes at three different concentrations obtained were in the range of 93.4-104.4%, with RSD ranging from 1.3 to 4.1%. The proposed method was successfully applied in the simultaneous determination of these active components in H. cordata and H. cordata injection (HCI), including the intermediate product of HCI in productive process, from different pharmaceutical factories and different production batches, indicating that the method in this paper was particularly suitable for the routine analysis of HCI and its quality control in productive process.
机译：建立了一种简单，可靠，有效的气相色谱-火焰电离检测方法，用于同时测定八种成分（α-pine烯，β-pine烯，月桂烯，柠檬烯，萜品四醇，α-萜品醇，乙酸冰片酯和甲基-n-壬基酮）及其中药注射用鱼腥草。在DB-1色谱柱（30？m×0.25？mm，0.25？μm）上进行包括十八碳烯在内的全部八种组分的色谱分离。在所研究的浓度范围内，观察到了极好的线性行为，包括草药和注射剂，所有分析物的r2值均高于0.9990。 RSD小于2％时，可以达到令人满意的日内和日间精度，所获得的三种不同浓度的所有分析物的平均回收率均在93.4-104.4％的范围内，RSD的范围为1.3至4.1％。该方法成功地用于同时测定不同制药厂和不同生产批次的血丝虫和血丝虫注射液（HCI）中的这些活性成分，包括生产过程中的HCl中间产物，表明该方法本文特别适合于生产过程中盐酸的常规分析及其质量控制。

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