1.Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination
Song CHEN ; Yunrong LI ; Luwei NONG ; Li LI ; Xianzai JIANG ; Cuiqiong ZENG ; Liuping WANG
China Pharmacy 2024;35(22):2726-2731
OBJECTIVE To establish the fingerprint of the Zhuang medicine preparation Fuzheng capsules and a method for the determination of multi-ingredient content for quality evaluation. METHODS High-performance liquid chromatography (HPLC) was used in conjunction with the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine (2004A edition) to establish the fingerprint of 12 batches of Fuzheng capsules, evaluate their similarity and confirm the common peaks. Cluster analysis and principal component analysis were performed using SPSS 20.0 software with the peak areas of the common peaks in the fingerprint as variables. The same HPLC method was adopted to determine the content of liquiritin, specnuezhenide, 3,6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples. RESULTS A total of 22 common peaks were identified in the fingerprints of the 12 batches of Fuzheng capsules, with the similarities greater than 0.91. Four common peaks were identified as liquiritin (peak 8), specnuezhenide (peak 10), 3,6′-disinapoyl sucrose (peak 11), and ammonium glycyrrhizinate (peak 21). The 12 batches of samples could be clustered into 3 categories, with 200801, 200802 and 200803 as category Ⅰ, samples 1 to 8 as category , and 221101 as category Ⅲ. The sample 200802 had the highest comprehensive score (2.540). The contents of liquiritin, specnuezhenide, 3,6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples were 0.44 to 0.73, 1.28 to 2.47, 0.08 to 0.12, and 1.31 to 1.81 mg per capsule, respectively. CONCLUSIONS The main components of the 12 batches of Fuzheng capsules were similar, but the content varied, with the sample 200802 indicating the highest quality. The established fingerprint and multi-ingredient content determination method were highly specific and accurate, which can be used for the quality evaluation of Fuzheng capsules in combination with chemical pattern recognition analysis.