18色譜柱(250 mm×4.6 mm,5μm),以乙腈–0.1%磷酸為流動相,梯度洗脫,檢測波長分別為220 nm(檢測天麻素、對羥基苯甲醇)、280 nm(檢測洋川芎內(nèi)酯H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A、柚皮苷、橙皮苷、新橙皮苷);體積流量0.8 mL/min;柱溫25 ℃;進樣量10 μL。采用統(tǒng)計軟件對小兒抗癇膠囊中8種成分質(zhì)量分數(shù)進行聚類分析和主成分分析。結果 天麻素、對羥基苯甲醇、洋川芎內(nèi)酯H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A、柚皮苷、橙皮苷、新橙皮苷在各自線性范圍內(nèi)均呈良好的線性關系;加樣回收率96.89%~100.10%,RSD值0.81%~1.77%;聚類分析和主成分分析結果顯示,同一藥品生產(chǎn)企業(yè)的產(chǎn)品質(zhì)量較為穩(wěn)定,不同企業(yè)間的樣品質(zhì)量存在一定差異。結論 該方法操作簡單,結果準確,重現(xiàn)性好,為評價小兒抗癇膠囊的質(zhì)量提供了參考依據(jù)。;Objective To establish an HPLC multi-components method for the quantitative determination of gastrodin, 4- hydroxbenzyl alcohol, senkyunolide H, senkyunolide I,senkyunolide A, naringin, hesperidin, and neohesperidin in Xiaoer Kangxian Capsules, and chemometrics analysis was used to comprehensive evaluation the quality of samples from different pharmaceutical manufacturing enterprises. Methods The Agilent Eclipse XDB-C18 column (250 mm×4.6 mm, 5 μm) was used as the chromatographic column with acetonitrile - 0.1% phosphoric acid solution as the mobile phase with gradient elution. The detection wavelength were set at 220 nm for gastrodin and 4-hydroxbenzyl alcohol, and 280 nm for senkyunolide H, senkyunolide I, senkyunolide A, naringin, hesperidin, and neohesperidin. The column temperature was 25 ℃, the flow rate was set at 0.8 mL/min, and the injection volume was 10 μL. The cluster analysis and principal component analysis were conducted for the content results of eight constituents in Xiaoer Kangxian Capsules by statistical software. Results Gastrodin,4-hydroxbenzyl alcohol, senkyunolide H, senkyunolide I, senkyunolide A, naringin, hesperidin, and neohesperidin showed good linear relationships within their own ranges,whose average recoveries were 96.89% — 100.10% with the RSD values of 0.81% — 1.77%. The cluster analysis and principal component analysis showed that there were more consistent among the samples from the same pharmaceutical manufacturing enterprises, and the samples from different pharmaceutical manufacturing enterprises were some differences. Conclusion The method is simple and reproducible which can be used for the quality control of Xiaoer Kangxian Capsules."/>

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首頁 > 過刊瀏覽>2021年第36卷第6期 >2021,36(6):1132-1137. DOI:10.7501/j.issn.1674-5515.2021.06.006
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基于HPLC多指標成分定量控制和化學計量學的小兒抗癇膠囊質(zhì)量評價研究

Quality evaluation of Xiaoer Kangxian Capsules based on HPLC multi- components quantitative determination and chemometrics analysis

發(fā)布日期:2021-06-26