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科捷仪器：六味地黄胶囊中熊果酸的含量测定
2017/11/24 20:02
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方案摘要：
产品配置单：
科捷仪器LC600C 梯度液相色谱仪
型号： KJ LC600C
产地： 江苏
品牌： 南京科捷
¥10万 - 20万
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方案详情：
六味地黄胶囊是由熟地黄、山茱萸、牡丹皮、山药、茯苓、泽泻6味中药材组成的复方制剂，具有滋阴补肾之功效，用于治疗肾阴亏损、头晕耳鸣、腰膝酸软、骨蒸潮热、盗汗遗精等症。对其主药山茱萸中熊果酸的含量测定，是控制该药品质量的主要手段之一，《中国药典》采用薄层扫描法测定，操作较为烦琐、复杂，且耗时费力，准确性和重现性差。笔者采用高效液相色谱法测定其含量，该法具有操作简单、快速，准确性、重现性好的特点。
检测仪器：高效液相色谱仪，包括溶剂输液泵、!紫外-可见检测器、手动进样器，色谱数据工作站。
色谱条件：柱温：室温；流动相：甲醇-水-甲酸（90：10：0.02）；流速：1.0mL/min；检测波长：220nm；进样量：10µL。
溶液的配制
对照品溶液：精密称取熊果酸对照品10mg，置10mL容量瓶中，加甲醇适量，使溶解，用甲醇稀释至刻度，摇匀，作为对照品溶液（每1mL甲醇约含熊果酸1mg）。
供试品溶液：精密称取本品2g，置索氏提取器内，加乙醚适量，加热回流至无色，约5h，提取液回收乙醚至干，残渣加适量甲醇使溶解，并用甲醇转至10nL容量瓶中，用甲醇稀释至刻度，离心（1200r/min）10min。取上清液作为供试品溶液。
阴性对照溶液：按处方比例称取除山茱萸以外的其他药材，按生产工艺方法制得阴性样品后，按供试品溶液的制备方法，制得阴性对照溶液。
在上述仪器工作条件下进行样品溶液测定。
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