Quality evaluation of Xinmai'an tablets based on fingerprint and multi-component determination

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Author: WU Shuangfeng ^1, ²  ZHANG Wei ^1, ³ SUN Xiaobo ³ WANG Deqin ¹ GUO Haibiao ¹  LIU Xiaoqiu ²

Affiliation: 1.Hutchison Whampoa Guangzhou Bai Yunshan Chinese Medicine Co., Ltd., Guangzhou 510515, China 2. School of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang 110016, China 3. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100193, China

Keywords: Xinmai'an tablets High performance liquid chromatography Fingerprint Chemometrics Content determination Paeoniflorin Calycosin-7-O-β-D-glucoside Salvianolic acid B Cryptotanshinone Tanshinone Ⅰ Tanshinone ⅡA

DOI: 10.12173/j.issn.2097-4922.202410047

Reference: WU Shuangfeng, ZHANG Wei, SUN Xiaobo, WANG Deqin, GUO Haibiao, LIU Xiaoqiu. Quality evaluation of Xinmai'an tablets based on fingerprint and multi-component determination[J]. Yaoxue QianYan Zazhi, 2025, 29(3): 406-415. DOI: 10.12173/j.issn.2097-4922.202410047.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To establish HPLC fingerprint and multi-component determination method of Xinmai'an tablets.

Methods The HPLC fingerprints of 11 batches of Xinmai'an tablets were established and the similarity evaluation was conducted. The chemometric analysis was performed on the data to identify the different components of Xinmai'an tablets. The contents of six chemical components, including paeoniflorin, calycosin-7-O-β-D-glucoside, salvianolic acid B, cryptotanshinone, Tanshinone Ⅰ and Tanshinone Ⅱ_A were also determined.

Results The HPLC fingerprints of 11 batches of Xinmai'an tablets showed 37 common peaks, among which 19 chromatographic peaks were identified, including paeoniflorin, calycosin-7-O-β-D-glucoside, cryptotanshinone, etc, representing four herbs in the formula: Ginseng radix et rhizoma, Salviae miltiorrhizae radix et rhizoma, Astragali radix, and Paeoniae radix rubra. The similarity indices of 11 batches of Xinmai'an tablets were all above 0.90. The 11 batches of Xinmai'an tablets were divided into two categories by cluster analysis and principal component analysis. S1-S3 were in one group and S4-S11 were in the other group. 18 different components in Xinmai'an tablets were screened by orthogonal partial least-squares discrimination analysis. The components with large differences and high concentrations of Xinmai'an tablets were determined. Six components showed a good linear relationship with the peak area in the range of 4.864-194.600, 0.490-19.590, 40.330-1 613.000, 4.980-199.200, 1.221-48.880 and 12.560-502.400 μg/mL (r≥0.999 9), respectively. The contents of paeoniflorin (Paeoniae radix rubra), calycosin-7-O-β-D-glucoside (Astragali radix), salvianolic acid B (Salviae miltiorrhizae radix et rhizoma), cryptotanshinone (Salviae miltiorrhizae radix et rhizoma), tanshinone Ⅰ (Salviae miltiorrhizae radix et rhizoma), and tanshinone Ⅱ_A (Salviae miltiorrhizae radix et rhizoma) were 1.63-1.68, 0.19, 19.18-19.42, 1.44-1.46, 0.98-1.02 and 2.21 2.29 mg/g in 3 batches of Xinmai'an tablets, respectively.

Conclusion The established HPLC fingerprint combined with chemical pattern recognition method and the multi-component determination method for Xinmai'an tablets are comprehensive, systemic, stable, and workable, providing a reference for the overall quality evaluation and improvement of quality standards for Xinmai'an tablets.

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