天麻丸中独活虚假投料及羌活劣药投料的检测

Detection of feeding fake Angelicae pubescentis Radix and inferior Notopterygii Rhizoma et Radix in Tianma Pills

目的对天麻丸中独活虚假投料和羌活劣药投料进行检测。方法 HPLC指纹图谱分析采用Phenomenex Kinetex C_(18)色谱柱(100 mm×4.6 mm, 2.6μm);流动相乙腈-水,梯度洗脱;体积流量1.2 mL/min;柱温30℃;检测波长320 nm。结果来自20个企业的182批样品指纹图谱中有13个共有峰,其中4个色谱峰表征羌活,6个色谱峰表征独活,1个色谱峰表征当归;1个企业1批大蜜丸样品与2个企业48批水蜜丸样品投料羌活符合2010年版《中国药典》标准,但按2015年版中国药典判断为羌活劣药投料;2个企业3批水蜜丸样品未检出独活药材对应的特征峰,虽含量测定符合《中国药典》规定,但实际为虚假投料。结论该方法简便、准确、稳定,可用于天麻丸中羌活、独活的质量控制,建议下一版《中国药典》增加天麻丸特征图谱。

AIM To detect the feedings of fake Angelicae pubescentis Radix and inferior Notopterygii Rhizoma et Radix in Tianma Pills.METHODS The analysis of HPLC fingerprints was performed on a 30 ℃ thermostatic Phenomenex Kinetex C_(18)column(100 mm×4.6 mm, 2.6 μm), with the mobile phase comprising of acetonitrile-H;O flowing at 1.2 mL/min in a gradient elution manner, and the detection wavelength set at 320 nm.RESULTS Among the 13 common peaks in the fingerprints contributed by 184 batches of Tianma Pills samples from 20 companies, four peaks came from Notopterygii Rhizoma et Radix, six came from Angelicae Pubescentis Radix, and one came from Angelicae Chinensis Radix. One batch of big honeyed Tianma Pills from one company and 48 batches of water-honeyed Tianma Pills from two companies manufactured with Notopterygii Rhizoma et Radix only satisfying the quality standard of Chinese Pharmacopeia of 2010 edition which was invalid according to the 2015 edition, within which a high stand was established. Three batches of water-honeyed Tianma Pills from two companies detected with no characteristic fingerprints of Angelicae Pubescentis Radix were identified to be made with fake Angelicae pubescentis Radix, although the samples met the requirements of Chinese Pharmacopoeia.CONCLUSION This simple, accurate and stable method can be used for the quality control of Tianma Pills. We suggest adding requirement for characteristic fingerprints in the next edition of Chinese Pharmacopoeia for the quality control of Tianma Pills.