辅料对油橄榄叶提取物中橄榄苦苷与羟基酪醇稳定性的影响

    Impact of the Excipients on the Stabilities of Oleuropein and Hydroxytyrosol in Olive Leaf Extract

    • 摘要: 目的 考察辅料种类、温度和时间对油橄榄叶中橄榄苦苷和羟基酪醇稳定性和均一性的影响。方法 橄榄苦苷与羟基酪醇的检测采用SinoChrom ODS-BP色谱柱(4.6 mm×250 mm,5 μm),以乙腈-水(25∶75)为流动相,流速1.0 mL·min-1,检测波长232 nm。结果 以淀粉、羧甲基淀粉钠、微晶纤维素、低取代羟丙纤维素和滑石粉为辅料制得颗粒中的橄榄苦苷与羟基酪醇含量稳定。制颗粒过程中采用70 ℃烘干1 h即可。稠浸膏于4 ℃条件下,密闭遮光放置96 h后,其橄榄苦苷与羟基酪醇含量均一且稳定。结论 上述制剂辅料可用于油橄榄叶提取物的颗粒剂或片剂研究,且含量均一、稳定。

       

      Abstract: OBJECTIVE To investigate the influence of excipients, temperature and time on the stability and uniformity of hydroxytyrosol and oleuropein in oleave leaf extract. METHODS The contents of hydroxytyrosol and oleuropein were analyzed by high performance liquid chromatography, equipped with SinoChrom ODS-BP column(4.6 mm×250 mm, 5 μm). The mobile phases contain acetonitrile and water (25∶75). The flow rate was 1.0 mL·min-1 and detection wavelength was 232?nm. RESULTS The contents of hydroxytyrosol and oleuropein in solid particles contained starch, sodium carboxymethyl starch, microcrystalline cellulose, low substituted hydroxypropy cellulose and talcum powder were stable. During the course of preparation, the best condition of 70 ℃ and 1 h should be chosen. Besides, under 4 ℃ and 96 h, the contents of hydroxytyrosol and oleuropein were still stable and uniform. CONCLUSION The above excipients can be used in the pharmaceutics studies and the main compounds in extract are stable.

       

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