Yang Yan-Ling, Liu Cai-Feng, Huang Jia-Yi, Yang Hai-Ju, Zhong Wan-Ling, Li Hua-Hua, DU Shou-Ying, Bai Jie
School of Chinese Materia Medica,Beijing University of Chinese Medicine Beijing 102488,China.
Zhongguo Zhong Yao Za Zhi. 2021 Feb;46(4):801-809. doi: 10.19540/j.cnki.cjcmm.20200925.301.
By preparing 15 batches of substance benchmarks of Taohong Siwu Decoction, the methodology of the characteristic spectrums of substance benchmarks was established. The paste-forming rate range, the contents and the transfer rate range of the index components, hydroxy safflower yellow A, ferulic acid and paeoniflorin, the characteristic peaks and the similarity range of the characteristic spectrums of Taohong Siwu Decoction were determined to define key quality attributes of substance benchmarks of Taohong Siwu Decoction.In the 15 batches of substance benchmarks of Taohong Siwu Decoction, the similarity of characteristic spectrums was higher than 0.9. Furthermore, based on summarization of the characteristic peak information, there were 13 characteristic peaks in the whole decoction. Baishao had three characteristic peaks, Honghua had seven characteristic peaks, and Chuanxiong and Danggui had three characteristic peaks. The paste-forming rate of the 15 batches of substance benchmarks was controlled at 33.11%-40.62%. The content of hydroxy safflower yellow A was 0.129%-0.203%, with the average transfer rate of 16.596%±0.669%.The content of ferulic acid was 0.043%-0.055%, with the average transfer rate of 20.489%±1.772%.The content of paeoniflorin was 0.676%-0.943%, with the average transfer rate of 29.112%±3.273%.The quality value transfer of substance benchmarks of classical prescription Taohong Siwu Decoction was analyzed by the combination of characteristic spectrums, paste-forming rate and the content of index components. The established substance benchmark quality evaluation method was stable and feasible, and could provide a basis for quality control and subsequent development of relevant preparations of Taohong Siwu Decoction.
通过制备15批桃红四物汤物质基准,建立了物质基准特征图谱的方法学。确定了桃红四物汤物质基准的成膏率范围、指标成分羟基红花黄色素A、阿魏酸和芍药苷的含量及转移率范围、特征图谱的特征峰及相似度范围,以界定桃红四物汤物质基准的关键质量属性。在15批桃红四物汤物质基准中,特征图谱相似度均高于0.9。此外,基于特征峰信息总结,全方共有13个特征峰,其中白芍有3个特征峰,红花有7个特征峰,川芎和当归各有3个特征峰。15批物质基准的成膏率控制在33.11%-40.62%。羟基红花黄色素A含量为0.129%-0.203%,平均转移率为16.596%±0.669%;阿魏酸含量为0.043%-0.055%,平均转移率为20.489%±1.772%;芍药苷含量为0.676%-0.943%,平均转移率为29.112%±3.273%。结合特征图谱、成膏率和指标成分含量,分析经典名方桃红四物汤物质基准的质量值传递。所建立的物质基准质量评价方法稳定可行,可为桃红四物汤相关制剂的质量控制及后续开发提供依据。