Wang Lu, Xie Hui, Zhao Xiao-Li, Peng Mei-Mei, Qu Ling-Yun, Mao Chun-Qin, Li Lin, Guo Yong, Hou Jin-Cai, Lu Tu-Lin, Dai Xiao-Bin
School of Pharmacy, Nanjing University of Chinese Medicine Nanjing 210023, China.
Shineway Pharmaceutical Group Co., Ltd. Shijiazhuang 051430, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(2):306-312. doi: 10.19540/j.cnki.cjcmm.20210302.304.
A total of 18 batches of Zhuru Decoction samples were prepared. Chromatographic fingerprints were established for Zhuru Decoction and single decoction pieces, the content of which was then determined. The extraction rate ranges, content, and transfer rate ranges of puerarin, liquiritin, and glycyrrhizic acid, together with the common peaks and the similarity range of the fingerprints, were determined to clarify key quality attributes of Zhuru Decoction. The 18 batches of Zhuru Decoction samples had 25 common peaks and the fingerprint similarity higher than 0.95. Puerariae Lobatae Radix, Glycyrrhizae Radix et Rhizoma, and Zingiberis Rhizoma Recens had 21, 3, and 1 characteristic peaks, respectively. The 18 batches of samples showed the extraction rates within the range of 18.45%-25.29%. Puerarin had the content of 2.20%-3.07% and the transfer rate of 38.5%-45.9%; liquiritin had the content of 0.24%-0.85% and the transfer rate of 15.9%-37.5%; glycyrrhizic acid had the content of 0.39%-1.87% and the transfer rate of 16.2%-32.8%. In this paper, the quality value transmitting of substance benchmarks of Zhuru Decoction was analyzed based on chromatographic fingerprints, extraction rate, and the content of index components. A scientific and stable method was preliminarily established, which provided a scientific basis for the quality control and formulation development of Zhuru Decoction.
共制备了18批竹茹汤样品。建立了竹茹汤及其单味饮片的色谱指纹图谱,并测定了其含量。测定了葛根素、甘草苷和甘草酸的提取率范围、含量及转移率范围,以及指纹图谱的共有峰和相似度范围,以明确竹茹汤的关键质量属性。18批竹茹汤样品有25个共有峰,指纹图谱相似度高于0.95。葛根、甘草和生姜分别有21、3和1个特征峰。18批样品的提取率在18.45%-25.29%范围内。葛根素含量为2.20%-3.07%,转移率为38.5%-45.9%;甘草苷含量为0.24%-0.85%,转移率为15.9%-37.5%;甘草酸含量为0.39%-1.87%,转移率为16.2%-32.8%。本文基于色谱指纹图谱、提取率和指标成分含量分析了竹茹汤物质基准的质量值传递,初步建立了科学稳定的方法,为竹茹汤的质量控制和制剂研发提供了科学依据。