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| 平胃分散片的制备及其苍术素的含量测定 |
| Preparation of Pingwei Dispersible Tablets and Content Determination of Atractylodin |
| 投稿时间：2014-06-26 修订日期：2014-09-14 |
| DOI： |
| 中文关键词: 平胃分散片 制备 苍术素 高效液相色谱法 含量测定 |
| 英文关键词:Pingwei dispersible tablets Preparation Atractylodin HPLC Content determination |
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| 中文摘要: |
| 摘 要 目的： 制备平胃分散片并建立以高效液相色谱法测定其苍术素含量的方法。方法: 以Kromasil C18250 mm×4.6 mm,5 μm）为色谱柱，流动相为甲醇-水（75∶25）,检测波长为340 nm，流速为1.0 ml·min-1，柱温为30℃，进样量是10 μl。结果: 处方中内崩解剂微晶纤维素、外崩解剂羧甲基纤维钠、羟丙甲纤维素的浓度分别是40%、9%、2%，以2%的羟丙甲纤维素的70%乙醇溶液作为黏合剂，以1.5%的硬脂酸镁作为润滑剂后压片。苍术素在0.100 6～0.503 0 μg范围内进样量与峰面积呈良好的线性关系(r= 0.999 9)，平均回收率为99.3％(RSD=0.9％,n=6）。结论: 平胃分散片制备工艺合理，定量方法简便、准确、专属性强，可用于该制剂的含量测定。 |
| 英文摘要: |
| ABSTRACT Objective: To prepare Pingwei dispersible tablets and establish a method for the determination of atractylodin. Methods: HPLC was performed on a Kromasil C18 column （250 mm×4.6 mm,5 μm）using methanol water(75∶25) as the mobile phase at a flow rate of 1 ml·min-1. The detection wavelength was at 340nm. The column temperature was 30℃ and the injection volume was 10 μl. Results: The optimized formula of the tablets was as follows: the proportion of inner disintegrant microcrystalline cellulose, outside disintegrant carboxymethyl cellulose sodium and HPMC was 40%, 9% and 2%, respectively. The adhesive was 2% HPMC in 70% ethanol, and 1.5% magnesium stearate was used as the lubricant. The linear range of atractylodin was 0.100 6-0.503 0 μg (r=0.999 9), and the average recovery was 99.3％(RSD=0.9％, n=6）. Conclusion:The formula and the preparation process of the tablets are reasonable and the content determination method is simple, accurate and specific, which can be used in the quality control of Pingwei dispersible tablets. |
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