| 复方虎杖酊的质量标准研究 |
| 投稿时间：2018-04-27 修订日期：2018-08-01 点此下载全文 |
| 引用本文：于基志,鲍佳妮,杨松.复方虎杖酊的质量标准研究[J].药学实践杂志,2018,36(5):430~432 |
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| 基金项目:解放军原总后勤部卫生部军队医疗制剂质量标准提高基金重点课题（2013ZJZ01-4） |
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| 中文摘要:目的 建立复方虎杖酊的质量控制标准。方法 采用薄层色谱法对复方虎杖酊中虎杖、蜂房和冰片进行定性鉴别；采用HPLC法测定虎杖中虎杖苷的含量，色谱柱为Agilent Eclipse XDB-C18柱（4.6 mm×250 mm，5 μm），流动相：乙腈-水（23：77），检测波长306 nm，流速1.0 ml/min，柱温40℃。结果 复方虎杖酊中虎杖、蜂房和冰片的薄层色谱图斑点明显，阴性对照无干扰；虎杖苷的定量测定在8.25~66.0 μg/ml范围内与峰面积呈良好的线性关系（r=0.999 9），平均回收率为100.1%，RSD为0.2%。结论 本实验建立的方法快速简便，准确可靠，可作为该制剂的质量控制方法。 |
| 中文关键词:复方虎杖酊 虎杖 蜂房 冰片 质量标准 |
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| Quality standards of Fufang Huzhangding |
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| Abstract:Objective To establish quality standard for Fufang Huzhangding. Methods Qualitative identification of Polygonum cuspidatum,Apis mellifeta and Borneolum in Fufang Huzhangding by thin layer chromatography;The mobile phase was acetonitrile-water(23:77).The detection wavelength was 306 nm,and the flow rate was 1.0 ml/min.The mobile phase consisted of Agilent Eclipse XDB-C18 column (250 mm×4.6 mm,5 μm), and the column temperature was maintained at 40℃. Results Polygonum cuspidatum,Apis mellifeta and Borneolum in Fufang Huzhangding appeared distinguishing characteristic of TLC,spots were clear,and showed the same reacts with a reference standard.There was a good linear relationship between the concentration of polydatin and the peak area in the range of 8.25-66.0 μg/ml(r=0.999 9).The average recoveries was 100.1%,RSD was 0.2%. Conclusion The method is simple, accurate and reliable, and can be used as a quality control method of the preparation. |
| keywords:Fufang Huzhangding Polygonum cuspidatum Borneolum Apis mellifeta quality standard |
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