活骨丸质量标准研究
投稿时间:2017-06-13  修订日期:2017-11-14  点此下载全文
引用本文:叶盛英,郭琪,雷虹,杨莹.活骨丸质量标准研究[J].药学实践杂志,2018,36(2):156~161
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作者单位E-mail
叶盛英 解放军254医院药剂科, 天津 300142  
郭琪 北京军区联勤部药品仪器检验所, 北京 100071 guoqi_yjs@sina.com 
雷虹 北京军区联勤部药品仪器检验所, 北京 100071  
杨莹 北京军区联勤部药品仪器检验所, 北京 100071  
基金项目:军队医疗机构制剂标准提高科研专项课题(13ZJZ10)
中文摘要:目的 对活骨丸进行质量标准研究。方法 采用薄层色谱法,对制剂中丹参、地黄、当归、川芎、三七、土鳖虫、制草乌进行专属性鉴别;采用高效液相色谱(HPLC)法对处方三七有效成分人参皂苷Rg1、Rb1和三七皂苷R1进行含量测定。以乙腈和水按不同比例混合后进行梯度洗脱,流速每为1.0 ml/min;柱温30℃;检测波长为203 nm;进样量为10 μl。结果 丹参、地黄、当归、川芎、三七、土鳖虫、制草乌等的薄层图谱特征斑点清晰,分离度好,阴性对照无干扰。三七皂苷R1、人参皂苷Rb1和Rg1分别在39.92~399.2、84.28~842.8 μg/ml和135.86~1 358.6 μg/ml范围内有良好的线性关系;三七皂苷R1、人参皂苷Rb1和人参皂苷Rg1的平均回收率分别为102.35%、103.84%、102.97%,RSD均小于2.0%。结论 所建立的质量标准准确、重复性良好,可用于活骨丸的质量控制。
中文关键词:活骨丸  人参皂苷Rg1  人参皂苷Rb1  三七皂苷R1  高效液相色谱  薄层色谱  质量控制
 
Research on quality control of Huoguwan
Abstract:Objective To establish the quality control method for Huoguwan. Methods TLC was applied to detect the component of Danshen, Dihuang, Danggui, Chuanxiong, Sanqi, Tubiechong, and Zhicaowu in this compound preparation. HPLC was used to measure the concentration of Renshenzaogan Rg1, Rb1 and Sanqizaogan R1. Unitary C18 analytical column(4.6 mm×250 mm,5 μm)was used with acetonitrile-water as the mobile phase (Flow rate:1.0 ml/min, column temperature:30℃, wavelength:203 nm). Results Each component showed distinct spots on TLC without interference. There are good linear relationship for Sanqizhaogan R1 in the range of 39.92-399.2 μg/ml, Renshenzhaogan Rb1 in 84.28 -842.8 μg/ml and Renshenzhaogan Rg1 in 135.86-1 358.6 μg/ml. The recovery was 102.35%, 103.84% and 102.97% respectively. Conclusion The above described procedure was accurate and reproducible, which can be used as a method for the quality control of Huoguwan.
keywords:Huoguwan  Renshenzaogan Rg1  Renshenzaogan Rb1  Sanqizaogan R1  HPLC  TLC  quality control
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