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| Study on the Material Basis and Quality Standard Improvement of Zhuangyao Jianshen Tablets |
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| DOI： |
| KeyWord:Zhuangyao Jianshen tablets UPLC－Q－TOF MSE material basis quality standard fingerprint content determination |
| Author | Institution |
| QIAO Wei-lin，ZHANG Li-hang，PENG Li-hua，SHI Jun-jie，HUANG Li-tao，
CHEN Wei-xuan，LAO Yue-fu |
1. Zhongshan Zhongzhi Pharmaceutical Group Co.，Ltd.，Zhongshan ，China; 2. Zhongshan Hengsheng Pharmaceutical Co.，Ltd.，Zhongshan ，China |
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| Abstract: |
| An ultrahigh performance liquid chromatography－quadrupole time-of-flight mass spectrometry（UPLC－Q－TOF MSE） with UNIFI software analysis was used to analyze the chemical components in Zhuangyao Jianshen tablets．The active components were screened by ADMETlab and TCMSP database，of which 55 potential active components were found．The galic acid，protocatechuic acid and protocatechuic aldehyde were determined as the content determination index，based on the comprehensive evaluation of active components and the pharmacological activity literature related to the function of Zhuangyao Jianshen tablets．Meanwhile，a high performance liquid chromatography（HPLC） method was established to detect the contents of galic acid，protocatechuic acid，protocatechuic aldehyde in 15 batches of samples，which were 0.135 3－0.344 8 mg/g，0.430 8－0.946 3 mg/g and 0.042 4－0.107 7 mg/g，respectively．The HPLC fingerprints for 15 batches of Zhuangyao Jianshen tablets were established，15 common peaks were calibrated and attributed to the Chinese medicine of the prescription with their similarities between 0.988 and 1.000，which showed that the inter-batch consistency of ingredients were high．Compared with those in the original standard，the newly established analytical indexes in this paper could more comprehensively characterize and evaluate the quality of Zhuangyao Jianshen tablets，and provide a scientific basis for the effective material analysis and the improvement of the quality standard．It is of great significance to improve the quality controllability of the product. |
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