扎冲十三味丸HPLC指纹图谱建立及4种成分测定

目的建立扎冲十三味丸(诃子、制草乌、石菖蒲等)HPLC指纹图谱,并测定4种成分的含有量。方法该药物甲醇提取液的分析采用Kromasil C₁₈色谱柱(250 mm×4.6 mm,5μm);流动相乙腈-水,梯度洗脱;体积流量1 mL/min;柱温40℃;检测波长225 nm。结果没食子酸、鞣花酸、木香烃内酯、去氢木香内酯分别在5.16～165.0、2.59～83.00、1.06～34.00、1.25～40.00μg/mL范围内线性关系良好(r≥0.999 5),平均加样回收率分别为102.4%、99.8%、98.4%、101.6%,RSD分别为1.84%、1.86%、1.33%、1.96%。10批样品指纹图谱中有13个共有峰,相似度均在0.98以上。结论该方法简便稳定,准确可靠,可用于扎冲十三味丸的质量控制。

Establishment of HPLC fingerprints and determination of four constituents for Zhachong Shisanwei Pills

AIM To establish the HPLC fingerprints of Zhachong Shisanwei Pills(Chebulae Fructus, Aconiti kusnezoffii Radix Cocta, Acori tatarinowii Rhizoma, etc.) and to determine the contents of four constituents. METHODS The analysis of methanol extract of this drug was performed on a 40 ℃ thermostatic Kromasil C18 column(250 mm×4.6 mm, 5 μm), with the mobile phase comprising of acetonitrile-water flowing at 1 mL/min in a gradient elution manner, and the detection wavelength was set at 225 nm.RESULTS Gallic acid, ellagic acid, costundide, dehydrocostus lactone showed good linear relationships within the ranges of 5.16-165.0, 2.59-83.00, 1.06-34.00, 1.25-40.00 μg/mL(r≥0.999 5), whose average recoveries were 102.4%, 99.8%, 98.4%, 101.6% with the RSDs of 1.84%, 1.86%, 1.33%, 1.96%, respectively. There were thirteen common peaks in the fingerprints of ten batches of samples with the similarities of more than 0.98.CONCLUSION This simple, stable, accurate and reliable method can be used for the quality control of Zhachong Shisanwei Pills.