摘要
目的建立痛宁凝胶的高效液相色谱–质谱(HPLC-MS)指纹图谱,为其质量控制提供依据。方法采用Kromasil100-5 C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈(A)–0.1%磷酸溶液(B),梯度洗脱;检测波长:240 nm;体积流量:1.0 m L/min;柱温:30℃;进样量:10μL。进行质谱分析时,流动相B用0.1%甲酸溶液替代。结果测定了10批痛宁凝胶的指纹图谱,提取18个色谱峰作为指纹图谱共有峰,采用MS法指认了12个共有峰,并将共有峰归属到各药材;10批样品相似度均大于0.9。结论该法重复性好,简便可靠,为痛宁凝胶的质量控制和评价提供了依据。
Objective To establish HPLC-MS fingerprint of Tongning Gel, and provide reference for the quality control of Tongning Gel. Methods The determination was carried out with Kromasil 100-5 C18 column （250 mm × 4.6 mm, 5 μm）. The mobile phase consisted of acetonitrile （A） - 0.1% phosphoric acid solution （B） with gradient elution. The detection wavelengths were 240 nm. The flow rate was 1.0 mL/min, and the column temperature was set at 35 ℃ with injection volume of 10 μL. 0.1% Formic acid solution was used in the MS analysis instead of the mobile phase B. Results Fingerprints of 10 batches of Tongning Gel were analyzed, and 18 common peaks were marked. Twelve Common peaks were identified by MS, and attributed to the herbs. The similarity degrees of 10 batches of the samples were above 0.9. Conclusion The method is reproducible, simple, and reliable, which can be used for the quality control and evaluation of Tongning Gel.
出处
《现代药物与临床》
CAS
2016年第4期427-430,共4页
Drugs & Clinic
基金
国家重大新药创制科技重大专项(2013ZX09402203)
江苏省科技支撑计划项目(BE2013661)
作者简介
秦建平（1979-），女（苗族），湖南邵阳人，高级工程师，从事中药质量标准研究。Tel：（0518）81152321,E-mail：qinjianping111@126．com
通信作者,萧伟（1959-），研究员级高级工程师，博士，研究方向为中药制剂和创新中药的研究与开发。
