中药复方通便清火丸的质量标准提升研究

目的 建立通便清火丸薄层鉴别和药效成分含量测定方法及提升质量标准。方法 采用薄层色谱法,以黄芩苷、欧前胡素和绿原酸作为对照品进行薄层鉴别实验。采用高效液相色谱法,以黄芩苷、欧前胡素和绿原酸作为指标成分进行定量分析。结果 薄层色谱法斑点清晰且分离度和专属性好。黄芩苷、欧前胡素和绿原酸的专属性好,分别在0.08~0.38 mg·m L~(-1)、0.56~3.19μg·m L~(-1)、0.49~3.43μg·m L~(-1)范围内呈现良好的线性关系,重复性的RSD(相对标准偏差)分别为0.51%、1.22%、1.60%,平均加样回收率和RSD分别为101.10%、112.40%、99.74%,并且各供试品溶液在配置后的6 h内均呈现良好的稳定性。结论 本研究建立的方法快速简便、灵敏度高、准确性高、重复性好,可为通便清火丸质量标准提升提供一定的科学依据。

Quantification of eight components in Paeonia lactiflora and Glycyrrhiza decoction using UHPLC-MS/MS

Hao Jiang;Yushu Guo;Chao Shi;Department of Pharmacy,Medical Supplies Center of PLA General Hospital;This study aimed to utilize ultra-high-performance liquid chromatography-tandem mass spectrometry(UHPLC-MS/MS)to analyze and quantify eight therapeutic components in Paeonia lactiflora and Glycyrrhiza decoction.The goal was to establish an accurate,efficient,and applicable method for determining the composition of this formula,providing a reference for its clinical application.Methanol was employed to extract the therapeutic components from Paeonia lactiflora and Glycyrrhiza decoction,forming the test sample solution.UHPLC-MS/MS technology was applied to separate and analyze the test samples.The results indicated that upon analysis,the eight reference standards exhibited excellent linear relationships,and the test samples remained stable within 24 h.The content of paeoniflorin,paeonolide,glycyrrhizic acid A,quercetin,chebulic acid,liquiritin,naringenin,and glycyrrhetic acid was determined to be 3.530±0.124,0.139±0.006,0.245±0.008,0.779±0.026,0.433±0.021,0.388±0.018,0.617±0.013,and 0.081±0.005 mg/m L,respectively.This study established that UHPLC-MS/MS analysis demonstrated high efficiency and broad applicability,reflecting the chemical composition characteristics of Paeonia lactiflora and Glycyrrhiza decoction.This research provided a quantitative analysis method for the eight therapeutic components in Paeonia lactiflora and Glycyrrhiza decoction,applicable to its clinical use and quality control.