| 毕福钧,位翠杰,林彤,江英桥.童康片质量标准的研究[J].中国药品标准,2020,21(1):62-68 |
| 童康片质量标准的研究 |
| Quality standard for Tongkang Tablets |
| 投稿时间：2019-05-20 修订日期：2020-02-04 |
| DOI： |
| 中文关键词: 童康片 黄芪甲苷 TLC HPLC-ELSD |
| 英文关键词: Tongkang Tablets astragaloside TLC HPLC-ELSD |
| 基金项目:国家药典委员会《中国药典》2016年度药品标准提高任务(中药17号) |
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| 中文摘要: |
| 目的 对童康片的质量标准进行提高,完善其质量评价方法。方法 采用显微鉴别法对童康片中山药和陈皮进行鉴别,采用薄层色谱法对童康片中黄芪、白术、防风和陈皮进行定性鉴别,采用HPLC-ELSD法,Thermo Hypersil Gold C18色谱柱(250×4.6mm,5μm),以乙腈-水(35︰65)为流动相,流速1.0 mL.min-1,对童康片中黄芪甲苷进行了含量测定。结果 山药和陈皮粉末显微特征明显；黄芪、白术、防风和陈皮薄层鉴别斑点清晰,专属性强,阴性无干扰。黄芪甲苷在0.026618～1.703526μg范围内线性关系良好(r=0.9993,n=7)；平均加样回收率为：96.5%,RSD为1.9%。测定样品11批，黄芪甲苷的含量在58～106μg·片-1之间。结论 建立的质量分析方法简便可靠,重现性良好,提高后的质量标准可更全面有效地用于童康片的质量控制。 |
| 英文摘要: |
| Objective：To optimize and improve the quality of Tongkang Tablets. Methods：Microscopic identification was used to identify Dioscoreae Rhizoma and Citri Reticulatae Pericarpium. Astragali Radix, Atractylodis Macrocephalae Rhizoma, Saposhnikoviae Radix and Citri Reticulatae Pericarpium were identified by TLC. The content of astragaloside in Tongkang Tablets was determined by HPLC-ELSD, a Thermo Hypersil Gold C18 column(250×4.6mm,5μm) was adopted, with the mobile phase consisting of acetonitrile-water(35︰65)at a flow rate of 1.0 mL.min-1. Results：The microscopic characters of Dioscoreae Rhizoma and Citri Reticulatae Pericarpium were obvious. The spots of Astragali Radix, Atractylodis Macrocephalae Rhizoma, Saposhnikoviae Radix and Citri Reticulatae Pericarpium in Tongkang Tablets were distinct and specific, could be identified by TLC without the blank interference. The linear range of astragaloside was 0.026618～1.703526μg(r=0.9993,n=7), the average recovery was 96.5%(RSD=1.9%, n=6).The content range of astragaloside in 11 batches of samples was 58～106μg per tablet. Conclusion：The established methods are simple and reliable, can be used for the comprehensive and effective quality control of Tongkang Tablets. |
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