Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (12): 1362-1367.
DOI: 10.19803/j.1672-8629.20230614

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Preliminary study on extraction technology of tea extract used for Xinnaojian preparation

WANG Zhao1, LIU Yue2, ZAN Ke1, LI Hailiang1, JIN Hongyu1#, MA Shuangcheng1,*   

  1. 1Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes for Food and Drug Control, Beijing 100050, China;
    2School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2023-09-27 Online:2023-12-15 Published:2023-12-15

Abstract: Objective To study the extraction technology of tea extract under Xinnaojian Tablet in ChP2020, and compare the related preparations. In order to undertake an initial investigation of the product at current situation. And provide reference for the drug quality control and safe usage. Methods According to the requirements of ChP2020, 8 batches of tea from different sources were extracted by means of decocting them with water, filter, combine the filtrate and add alkali, adjust the extract to be alkaline, and allow to stand. And then add acid to the precipitate and adjust to be acidic, filter, extract the filtrate with ethyl acetate by shaking, and finally, recover the solvent in vacuum. And then the extraction rate was calculated. Tea raw materials, tea extracts prepared in our laboratory, 7 batches of tea extracts collected from the market, tea extracts provided by enterprises and corresponding batches of Xinnaojian capsules were analyzed by visualized analysis with the fingerprint method which including 9 omponents of gallate, epigallocatechin, catechins, caffeine, epicatechin, epigallocatechin-3-gallate, gallocatechin gallate, epicatechin-3-gallate, epicatechin-3-gallate. And the differences were compared. Results The extraction rate of tea extract prepared in the laboratory according to the ChP2020 method is about 0.3-0.5%, and the extraction rate of tea extract produced by a company that we investigated is about 5%, while it is said that the extraction rate of tea extract purchased on the market can be as high as 20~30%. The fingerprint results showed that the fingerprint of tea extracts from different sources varied greatly, especially for the extracts purchased on the market. Conclusion In this study, the extraction technology of tea extract was preliminarily discussed, and the possible problems of existing methods and products were pointed out, which provided scientific basis for improving the extraction technology of tea extract and ensuring the quality and safety of products.

Key words: Xinnaojian preparation, tea extract, extraction technology, ultra-performance liquid chromatography fingerprint, visualized analysis, similarity evaluation, quality control

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