Quality standards of Fufang Huzhangding
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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。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.
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Key words:
- Fufang Huzhangding /
- Polygonum cuspidatum /
- Borneolum /
- Apis mellifeta /
- quality standard
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[1] 国家药典委员会.中华人民共和国药典(一部):2015年版[S].北京:中国医药科技出版社,2015:194-195. [2] 田文涛,杨茂文,杨金琰,等.高效液相色谱法测定复方伸筋片中虎杖苷的含量[J].中国药师,2014,17(3):522-523. [3] 张国跃,刘春河. RP-HPLC法测定肝康宁片中虎杖苷的含量[J].中国医药科学,2017,7(9):39-41. -
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