苦参康肤搽剂的HPLC指纹图谱HPLC fingerprint of Kushenkangfu liniment
李明,曹嘉宁,闫丹彤,王淼,赵春杰
LI Ming,CAO Jia-ning,YAN Dan-tong,WANG Miao,ZHAO Chun-jie
摘要(Abstract)：
目的建立中药复方制剂苦参康肤搽剂的HPLC指纹图谱,对其进行质量控制。方法采用Inertsil C_(18)柱(250 mm×4.6 mm,5μm),以甲醇-乙腈(体积比为1:3,流动相A)-体积分数为0.2%的氨水(流动相B)为流动相进行梯度洗脱,流速:1.0 m L·min~(-1),检测波长:220 nm,柱温:35℃,建立苦参康肤搽剂HPLC指纹图谱,运用"中药色谱指纹图谱相似度评价软件"对10批制剂进行相似度评价,并对特征峰进行指认。结果建立的苦参康肤搽剂HPLC指纹图谱的精密度、专属性、重复性、稳定性均良好;10批制剂的指纹图谱的相似度值为0.993~0.999。结论上述建立的HPLC指纹图谱可以用于苦参康肤搽剂的质量评价,可以为提高苦参康肤搽剂整体质量控制方法提供依据。
Objective To establish the HPLC fingerprint of Kushenkangfu liniment for controlling the quality of this product.Methods The separation was performed on a Kromasil C_(18) column(250 mm x4.6 mm,5μm) by gradient elution with methanol-acetonitril(V:V = 1:3)-0.2%(φ) aqueous ammonia as the mobile phase,flow rate at 1.0 mL·min~(-1),detection wavelength at 220 nm and column temperature at35℃.An HPLC fingerprint of Kushenkangfu liniment was set up and the quality of 10 batches of Kushenkangfu liniment was evaluated by similarity assay.Furthermore,the main characteristic peaks in HPLC fingerprint of Kushenkangfu liniment were identified.Results The established HPLC fingerprint of Kusenkangfu liniment was specific precise,and reproducible.The similarity of 10 batches of Kushenkangfu liniment was about 0.993-0.998.Conclusions The established HPLC fingerprint can be used for quality control of Kushenkangfu liniment and provide some experimental basis to improve overall quality of Kushenkangfu liniment.
关键词(KeyWords)：
苦参康肤搽剂;高效液相色谱指纹图谱;质量控制
Kushenkangfu liniment;HPLC fingerprint;quality control
基金项目(Foundation):
作者(Author):
李明,曹嘉宁,闫丹彤,王淼,赵春杰
LI Ming,CAO Jia-ning,YAN Dan-tong,WANG Miao,ZHAO Chun-jie
DOI: 10.14066/j.cnki.cn21-1349/r.2017.03.009
参考文献(References)：
- [1]国家药典委员会.中华人民共和国药典:一部[M].北京:中国医药科技出版社,2015:202.
- [2]马丽娜,张岩,陶遵威.色谱分析技术在中药指纹图谱研究中的应用[J].药物评价研究,2012,35(1):58-62.
- [3]丘进,黎强,庞云娟,等.RP-HPLC测定复方双花藤止痒搽剂中苦参碱的含量[J].中国现代用药学杂志,2009,6(3):1155-1157.
- [4]张立庆,张娜.HPLC法测定子花洁肤搽剂中苦参碱的含量[J].齐鲁药事,2012,8(1):15-16.
- [5]熊英,邬晓鸥.RP-HPLC测定龙凤洁身纯中苦参碱和蛇床子素的含量[J].华西药学杂志,2001,16(3):213-214.
- [6]汪魏平.HPLC法测定止痒酊中苦参碱的含量[J].安徽医药,2006,10(1):27-28.
- [7]纪瑛.苦参的化学成分指纹图谱[J].中成药,2010,32(4):535-538.
- [8]赵华,宋敏,赵华,等.苦参药材的生物碱HPLC指纹图谱[J].中国药科大报,2009,40(2):139-143.
- [9]张蕾,吴迪,陈晓辉,等.建立评价苦参质量的RPHPLC指纹图谱分析方法[J].药物分析杂志,2006,26(9):1261-1265.