香砂养胃片质量控制标准的改进研究

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。

Improvement on the quality control standard of Xiangsha Yangwei Tablets

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 methods were specific and efficient, with two TLC systems, Atractylodes rhizome, Pogostemonis herbs, Citri reticulatae pericarpium, Magnolia 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 pericarpium was optimized and established by orthogonal test;modified single index of magnolol in original HPLC method to two of magnolol and honokiol.Conclusion：The improved method is simple, fast and accurate compared to the original method, which could be better for quality control of Xiangsha Yangwei Tablets.