目的 建立HPLC梯度洗脱法同时测定仲景胃灵丸中茴香醛、肉桂醇、肉桂酸、桂皮醛、延胡索乙素、去氢紫堇碱、紫堇碱和四氢小檗碱，并采用化学计量学方法对其结果进行分析评价。方法 采用HPLC法，Agilent Zorbax SB C₁₈色谱柱（250 mm×4.6 mm，5μm），柱温30 ℃；乙腈–0.1%冰醋酸水溶液为流动相，梯度洗脱，体积流量0.9 mL/min；进样量10 μL；检测波长分别为248 nm（检测茴香醛）、280 nm（检测肉桂醇、肉桂酸、桂皮醛、延胡索乙素、去氢紫堇碱、紫堇碱和四氢小檗碱）。采用统计软件对仲景胃灵丸中8种成分的质量分数进行化学计量学评价。结果 茴香醛、肉桂醇、肉桂酸、桂皮醛、延胡索乙素、去氢紫堇碱、紫堇碱、四氢小檗碱分别在0.96～24.00、1.78～44.50、20.06～501.50、3.92～98.00、2.89～72.25、2.13～53.25、1.36～34.00、0.59～14.75μg/mL线性关系良好；平均加样回收率分别为96.97%、97.81%、100.04%、99.13%、98.91%、96.89%、97.58%、98.34%，RSD值分别为1.04%、1.51%、0.54%、1.01%、0.92%、1.32%、1.36%、1.41%。化学计量学表明10批仲景胃灵丸聚为3类，主成分1～4是影响仲景胃灵丸整体质量的主要因子。结论 以茴香醛、肉桂醇、肉桂酸、桂皮醛、延胡索乙素、去氢紫堇碱、紫堇碱、四氢小檗碱同步测定的HPLC法和化学计量学方法可用于仲景胃灵丸多指标质量评价。

Objective To establish an HPLC gradient elution method for simultaneous determination of 4-methoxybenzaldehyde, cinnamyl alcohol, cinnamic acid, cinnamaldehyde, tetrahydropalmatine, dehydrocorydalin, corydaline, and tetrahydroberberine in Zhongjing Weiling Pills, and the results was analyzed by chemometrics method.Methods The HPLC method was used on Agilent Zorbax SB C₁₈ column (250 mm×4.6 mm, 5 μm), and the column temperature was set at 30 ℃. The mobile phase was consisted of acetonitrile and water containing 0.1% glacial acetic acid aqueous solution in gradient elution, and the flow rate was set at 0.9 mL/min. The detection wavelengths were set at 248 nm for 4-methoxybenzaldehyde and 280 nm for cinnamyl alcohol, cinnamic acid, cinnamaldehyde, tetrahydropalmatine, dehydrocorydalin, corydaline, and tetrahydroberberine. The chemometrics evaluation was conducted for the content results of eight constituents in Zhongjing Weiling Pills by Statistical Software.Results There were good linear relationships for4-methoxybenzaldehyde, cinnamyl alcohol, cinnamic acid, cinnamaldehyde, tetrahydropalmatine, dehydrocorydalin, corydaline, and tetrahydroberberine within the ranges of 0.96 — 24.00, 1.78 — 44.50, 20.06 — 501.50, 3.92 — 98.00, 2.89 — 72.25, 2.13 — 53.25, 1.36 — 34.00, and 0.59 — 14.75 μg/mL. Those average recoveries were 96.97%, 97.81%, 100.04%, 99.13%, 98.91%, 96.89%, 97.58%, and 98.34% with the RSD values of 1.04%, 1.51%, 0.54%, 1.01%, 0.92%, 1.32%, 1.36%, and 1.41%, respectively. The chemometrics method showed that the 10 batches of Zhongjing Weiling Pills were divided into three categories. The 1 — 4 principal components were the main factor affecting the quality of Zhongjing Weiling Pills.Conclusion Simultaneous determination of 4-methoxybenzaldehyde, cinnamyl alcohol, cinnamic acid, cinnamaldehyde, tetrahydropalmatine, dehydrocorydalin, corydaline, and tetrahydroberberine by HPLC and chemometrics method can be used to evaluate the quality of Zhongjing Weiling Pills.

R284.1

河南省科技攻关项目（182102310096）