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香砂养胃片质量标准的改进研究

         

摘要

Objective:To improve the quality standard of Xiangsha Yangwei Tablets.Methods:Aiming at the problems existing in o-riginal standard, such as the complicated operation or weak specificity in some methods, the lack of identification or content determina-tion of main medicinal herbs, the quality standard of Xiangsha Yangwei Tablets had been improved.Results:The improved TLC meth-ods were specific and efficient, with two TLC systems, Atractylodes rhizome, Pogostemonis herbs, Citri reticulatae pericarpium, Mag-nolia officinalis and Aucklandiae radix, five kinds of medicinal herbs could be distinguished;the TLC identification of Amomi fructus rotundus had obvious negative interference, should be deleted.A HPLC detemination method of hesperidin in Citri reticulatae peri-carpium was optimized and established by orthogonal test;modified single index of magnolol in original HPLC method to two of magnol-ol and honokiol.Conclusion:The improved method is simple, fast and accurate compared to the original method, which could be bet-ter for quality control of Xiangsha Yangwei Tablets.%目的:改进并提高香砂养胃片的质量标准。方法:针对原标准存在的部分方法操作繁琐或专属性不强、缺少主要药味的〔鉴别〕或〔含量测定〕项目等问题,改进并提高其质量标准。结果:改进后的TLC鉴别方法专属性强且效率更高,用两个薄层色谱图即能鉴别苍术、广藿香、陈皮、厚朴、木香5种药材;试验发现原标准中豆蔻的TLC鉴别有明显的阴性干扰,应予删除;采用正交试验优化建立了陈皮中橙皮苷的HPLC含量测定方法;将原有的厚朴酚单指标HPLC质控方法改为测定厚朴酚、和厚朴酚双指标。结论:改进提高后的方法简便、快速、准确,能够更有效地控制香砂养胃片的质量。

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