| 王艳伟.麦味地黄胶囊质量标准提高研究[J].中国药品标准,2016,17(6):411-415 |
| 麦味地黄胶囊质量标准提高研究 |
| Study on the Quality Standard of Maiwei Dihuang CapsuleWang Yanwei(Henan Institute for Food and Drug Control,zhengzhou 450003) |
| 投稿时间：2016-08-04 修订日期：2016-09-29 |
| DOI： |
| 中文关键词: 麦味地黄胶囊 质量标准 薄层色谱 高效液相色谱 |
| 英文关键词: Maiwei Dihuang Capsule quality standard TLC HPLC |
| 基金项目:2011-2012年度国家药品标准提高工作(中药) |
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| 中文摘要: |
| 目的：修订并提高麦味地黄胶囊的质量标准。方法：采用薄层色谱法鉴别处方中麦冬、酒萸肉、牡丹皮和茯苓；采用高效液相色谱法同时测定酒萸肉中的莫诺苷、马钱苷和醋五味子中的五味子醇甲的含量。结果：麦冬、酒萸肉、牡丹皮和茯苓的薄层鉴别方法专属性强；莫诺苷、马钱苷和五味子醇甲的线性范围分别为0.02～0.63μg（r=0.9999）、0.02～0.62μg（r=1）、0.01～0.24μg（r=0.9999），平均回收率分别为96.3%（RSD=0.6%）、97.7%（RSD=0.3%）、100.6%（RSD=1.9%）。 |
| 英文摘要: |
| Objective：To revise the quality standard of Maiwei Dihuang Capsules. Methods： Ophiopogonis Radix,Corni Fructus,Moutan Cortex and Poria were identified by TLC and the contents of morroniside ,loganin and schisandrin were determined by HPLC. Results： The TLC spots of Ophiopogonis Radix,Corni Fructus,Moutan Cortex and Poria were fairly clear. The linear ranges of morroniside, loganin and schisandrin were 0.02-0.63μg（r=0.9999）, 0.02-0.62μg（r=1）and 0.01-0.24μg(r=0.9999),the average recoveries were 96.3%（RSD＝0.6%）, 97.7%（RSD＝0.3%）and 100.6%（RSD=1.9%）,respectively. Conclusion：The improved methods are reasonable, feasible and reproducible, which could be used for the quality control of Maiwei Dihuang Capsules. |
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