活骨丸质量标准研究  

Research on quality control of Huoguwan

作　　者：叶盛英[1] 郭琪[2] 雷虹[2] 杨莹[2] 

机构地区：[1]解放军254医院药剂科,天津300142 [2]北京军区联勤部药品仪器检验所,北京100071

出　　处：《药学实践杂志》2018年第2期156-161,共6页Journal of Pharmaceutical Practice

基　　金：军队医疗机构制剂标准提高科研专项课题(13ZJZ10)

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1.0ml/min;柱温30℃;检测波长为203nm;进样量为10μl。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、84.28~842.8μg/ml和135.86~1 358.6μg/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。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,5μm)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 39.92-399.2μg/ml,Renshenzhaogan Rb1 in 84.28-842.8μg/ml and Renshenzhaogan Rg1 in 135.86-1 358.6μg/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.

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 

分 类 号：R284.1[医药卫生—中药学]