心脑健制剂用茶叶提取物提取工艺初探  

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

作　　者：王赵[1] 刘越 昝珂[1] 李海亮 金红宇[1] 马双成[1] WANG Zhao;LIU Yue;ZAN Ke;LI Hailiang;JIN Hongyu;MA Shuangcheng(Institute for Control of Chinese Traditional Medicine and Ethnic Medicine,National Institutes for Food and Drug Control,Beijing 100050,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]中国食品药品检定研究院中药民族药检定所,北京100050 [2]北京中医药大学中药学院,北京102488

出　　处：《中国药物警戒》2023年第12期1362-1367,共6页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2022YFC3501500)。

摘　　要：目的对《中华人民共和国药典》(2020年版)(简称“《中国药典》”)心脑健片项下茶叶提取物的提取工艺进行小试研究,并比较相关产品的差异,初步了解产品现状,为其药品质量控制和用药安全提供参考。方法按照《中国药典》工艺要求对8批不同来源的茶叶通过加水煎煮等步骤进行小试提取,计算提取率。建立包括没食子酸,表没食子儿茶素,儿茶素,咖啡因,表儿茶素,表没食子儿茶素没食子酸酯,没食子儿茶素没食子酸酯,表儿茶素没食子酸酯,儿茶素没食子酸酯等在内的9个指标成分的指纹图谱,并对茶叶原料、实验室制备对应茶叶提取物,从市面上收集的茶叶提取物及企业提供的茶叶提取物和心脑健胶囊进行可视化分析,比较差异。结果实验室按照《中国药典》方法制备的茶叶提取物提取率为0.3%~0.5%,据调研企业生产的茶叶提取物提取率约为5%,而从市场上购买的茶叶提取物提取率可高达20%~30%。指纹图谱结果显示,不同来源的茶叶提取物指纹图谱不同,尤其市场上购置的提取物指纹图谱差异较大。结论本研究初步探讨了茶叶提取物的提取工艺,指出现有方法和产品可能存在的问题,为完善茶叶提取物提取工艺、保障产品质量和安全提供了借鉴。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.

关 键 词：心脑健制剂 茶叶提取物 提取工艺 指纹图谱 可视化分析 相似度评价 质量管理 

分 类 号：R994.1[医药卫生—毒理学]