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地龙舒腰胶囊的质量标准研究
引用本文:杨骏,李婷,张彤,蔡贞贞,陶建生.地龙舒腰胶囊的质量标准研究[J].中国医药工业杂志,2012,43(6):471-474.
作者姓名:杨骏  李婷  张彤  蔡贞贞  陶建生
作者单位:1. 上海中医药大学,上海201203;香山中医医院,上海200020
2. 上海中医药大学,上海,201203
基金项目:上海市卫生局中药新药及院内制剂研发项目(2010Y009A);上海市创新团队及重点学科(J50302)
摘    要:建立了HPLC法测定地龙舒腰胶囊中薯蓣皂苷的含量.采用C18色谱柱,以乙腈-水(50∶50)为流动相.结果表明,薯蓣皂苷在7.2~720 μg/ml范围内线性关系良好,平均加样回收率为103.4%.以亮氨酸和缬氨酸为对照,采用薄层色谱法鉴别了胶囊中的地龙,结果色谱斑点清晰,阴性无干扰.采用UV法对其中双酯型生物碱进行限度检查.结果3批胶囊中双酯型生物碱均低于0.15%(以乌头碱计).

关 键 词:地龙舒腰胶囊  质量标准  薯蓣皂苷  地龙  乌头碱

Quality Standard of Dilong Shuyao Capsules
Authors:YANG Jun  LI Ting  ZHANG Tong  CAI Zhenzhen  TAO Jiansheng
Institution:1(1.Shanghai University of Traditional Chinese Medicine,Shanghai 201203;2.Xiangshan Hospital of TCM,Shanghai 200020)
Abstract:An HPLC method was established for the determination of dioscin in Dilong Shuyao capsules.A C18 column was used with the mobile phase of acetonitrile-water(50∶50).The calibration curve of dioscin was linear in the range of 7.2-720 μg/ml.The average sample recovery was 103.4%.The Pheretima aspergillum in capsules was qualitatively identified by TLC with leucine and valine as the control.The TLC spots were clearly detected with no interference from negative sample.The limit of the diester-diterpenoid alkaloids were determined by UV method.The results showed that the diester-diterpenoid alkaloids content of three batches of capsules were less than 0.15%(based on aconitine).
Keywords:Dilong Shuyao capsule  quality standard  dioscin  Pheretima aspergillum  aconitine
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