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肠炎宁颗粒质量标准控制研究

吴育强,吴玉菡,林果,刘萍   

  1. 海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司
  • 收稿日期:2018-08-20 修回日期:2018-10-25 出版日期:2018-10-25

Study on Quality Standard Control of Changyanning Granule

WU Yuqiang,WU Yuhan,LIN Guo and LIU Ping   

  1. Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,Hainan GuoLuwa Pharmaceutical Group Co., Ltd., Hainan Haikou
  • Received:2018-08-20 Revised:2018-10-25 Online:2018-10-25

摘要: 目的:通过调整肠炎宁颗粒的辅料种类及用量,以期通过质量控制研究提升肠炎宁颗粒质量标准。方法:采用薄层色谱(TLC)法鉴别肠炎宁颗粒中的金毛耳草、地锦草药材;采用高效液相色谱(HPLC)法测定肠炎宁颗粒中的地锦草、枫香树叶、金毛耳草中没食子酸的含量。结果:TLC法中检测出了东莨菪内酯、地锦草对照药材的特征斑点;HPLC法检测出地锦草、枫香树叶、金毛耳草中所含没食子酸呈良好的线性关系,精密度、重复性和回收率均较好,溶液在24 h内稳定,可用于本品没食子酸含量的测定。采用已验证的含量测定方法对3批样品的没食子酸含量进行测定。结论:本方法简单、专属性强,可有效控制肠炎宁颗粒的质量,提升质量标准。

Abstract: Objective:To improve the quality standard of changyanning granules through quality control research by adjusting the type and amount of excipients of changyanning granules. Methods:Thin layer chromatography (TLC) was used to identify the Hedyotis chrysotricha and Euphorbia humifusa in changyanning granules. The high performance liquid chromatography (HPLC)method was used to determine the content of gallic acid in Euphorbia humifusa, Folium Liquidambaris and Hedyotis chrysotricha in changyanning granules. Results:The characteristic spots of seopoletin and the reference crude drug of Euphorbia humifusa were detected by TLC method.The HPLC method showed that the gallic acid contained in Euphorbia humifusa, Folium Liquidambaris, Hedyotis chrysotricha had a good linear relationship.The precision, repeatability and recovery rate were all good, and the solution was stable within 24 h. The method can be used for the determination of gallic acid content of changyanning granules. The gallic acid content of three batches of samples was determined using a validated content determination method. Conclusion:This established method is simple, feasible and specific, and can effectively control the quality of changyanning granules and improve the quality standards.