提取方法对清咽丸中冰片含量的影响分析

Analysis of the effect of extraction methods on the content of Borneol in Qingyan pills

目的:清咽丸(大蜜丸)为中国药典2015年版一部收载的品种,现行标准对本品的冰片含量进行了控制,但方法重现性较差,且结果偏低。本次试验优化了供试品溶液的提取方法,可以使大蜜丸中的冰片提取得更完全,测定结果更真实。方法:采用GC法,色谱柱为聚乙二醇毛细管柱(WAX柱),检测器为FID,柱温为120℃。结果:冰片在0.200～4.00μg的范围内,线性关系良好(r=1.0000)。平均回收率为98.7%,RSD小于2%。通过本次试验所建立的新方法,对61批样品进行检测,检测结果均高于原标准方法。结论:建立的含量测定方法专属性强、重复性好,可以更真实的反映样品中冰片的含量,从而更有效的控制样品的质量。

Objective: Qingyan pills(big honeyed pills) is recorded in Chinese Pharmacopoeia 2015 edition. The borneol content is controlled in the present standard. However, the method reproducibility is poor and the result was lower than real data.This experiment optimized the preparation method of sample solutions to completely extract borneol in the pill with more accurate result. Method: GC method was used to analyze on polyethylene glycol capillary column(WAX column) with FID detector. The column temperature was 120℃. Result: The linear ranges of borneol was 0.200 μg ~4.00 μg with good linear relationship(r=1.0000). The detection result was higher than that detected by standard method. Conclusion: The content determination method is specific and reproducible, which can more truly reflect the content of borneol in the sample, so as to control sample quality more effectively.