Herbal Medicine Formulation Research Group, Korea Institute of Oriental Medicine, Daejeon, 305-811, Republic of Korea,
Arch Pharm Res. 2015 Jan;38(1):52-62. doi: 10.1007/s12272-014-0363-z. Epub 2014 Mar 8.
This study was designed for quality assessment of Gyejibokryeong-hwan (GBH) preparations using the simultaneous determination of 11 marker compounds such as gallic acid, oxypaeoniflorin, amygdalin, albiflorin, paeoniflorin, benzoic acid, coumarin, cinnamic acid, benzoylpaeoniflorin, cinnamaldehyde, and paeonol using HPLC-PDA and chemometric analysis. The correlation coefficient of linear regression was >0.9993. The LOD and LOQ values were in the ranges of 0.02-2.11 and 0.06-7.34 μg/mL, respectively. The intra-day and inter-day precision was 0.07-4.76 and 0.04-5.08 %, and the recovery range was 92.19-103.24 %, with RSD values <4.5 %. The repeatability of the 11 marker compounds was <2.5 % of the RSD values. The results of quantification indicated that there was much variation in the content of the 11 marker compounds among the GBH preparations. Amygdalin and paeoniflorin were detected in high quantities in all GBH samples, whereas some compounds such as cinnamaldehyde and paeonol were not detected in GBH samples from the Korean manufacturers. The content of marker compounds in the laboratory GBH water extract was different to the commercial preparations. Results of analyses carried out with the method indicate the need for quality control of GBH preparations.
本研究旨在使用 HPLC-PDA 和化学计量学分析同时测定 11 种标记化合物（如没食子酸、氧化芍药苷、苦杏仁苷、白芍苷、芍药苷、苯甲酸、香豆素、桂皮酸、苯甲酰芍药苷、肉桂醛和丹皮酚），对 Gyejibokryeong-hwan（GBH）制剂进行质量评估。线性回归的相关系数>0.9993。LOD 和 LOQ 值的范围分别为 0.02-2.11 和 0.06-7.34μg/mL。日内和日间精密度分别为 0.07-4.76%和 0.04-5.08%，回收率范围为 92.19-103.24%，RSD 值<4.5%。11 种标记化合物的重复性<2.5%的 RSD 值。定量结果表明，11 种标记化合物在 GBH 制剂中的含量存在很大差异。所有 GBH 样品中均检测到苦杏仁苷和芍药苷的含量较高，而一些化合物，如肉桂醛和丹皮酚，在韩国制造商的 GBH 样品中未检测到。实验室 GBH 水提取物中标记化合物的含量与商业制剂不同。该方法的分析结果表明，需要对 GBH 制剂进行质量控制。
