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鸡血藤饮片质量控制研究
引用本文:刘静,郭日新,王晓静,张南平,康帅,彭开锋,张鹏,戴忠,马双成. 鸡血藤饮片质量控制研究[J]. 中国药事, 2019, 33(5): 534-543
作者姓名:刘静  郭日新  王晓静  张南平  康帅  彭开锋  张鹏  戴忠  马双成
作者单位:中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,株洲千金药业股份有限公司, 株洲 412003,株洲千金药业股份有限公司, 株洲 412003,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050
基金项目:国家中药标准化项目妇科千金片/胶囊全过程质量控制标准化体系建立(编号ZYBZH-C-HUN-21)
摘    要:目的:进一步提高完善鸡血藤饮片的质量控制方法,为其综合质量评价提供科学依据。方法:在现行标准质量控制项目的基础上,进一步优化薄层鉴别方法,同时采用HPLC法对本品所含化学成分进行指纹图谱研究,并对其主要成分儿茶素和表儿茶素进行含量测定研究。结果:15批鸡血藤饮片标准检测结果显示水分为6.62%~12.51%,总灰分为2.10%~3.25%,醇溶性浸出物为8.08%~10.02%。TLC优化方法显示样品斑点清晰,分离良好,且能够区分正伪品。15批样品HPLC(UV 260 nm)指纹图谱相似度计算结果为0.84~0.99,并经对照品比对确认10个共有峰(没食子酸、原儿茶酸、原儿茶醛、儿茶素、表儿茶素、大豆苷、染料木苷、大豆苷元、染料木素和芒柄花素);同时所建立指纹图谱能够鉴别伪品。HPLC(UV 202 nm)含量测定结果显示,15批样品中儿茶素与表儿茶素含量分别为0.039%~0.068%、0.12%~0.23%,以表儿茶素含量整体较高,可作为含量测定指标。结论:建立的方法能够用于鸡血藤饮片的整体质量控制与评价。

关 键 词:鸡血藤饮片  质量控制  指纹图谱  含量测定
收稿时间:2019-01-11

A Study on Quality Control of Caulis Spatholobi Decoction Pieces
Liu Jing,Guo Rixin,Wang Xiaojing,Zhang Nanping,Kang Shuai,Peng Kaifeng,Zhang Peng,Dai Zhong and Ma Shuangcheng. A Study on Quality Control of Caulis Spatholobi Decoction Pieces[J]. Chinese Pharmaceutical Affairs, 2019, 33(5): 534-543
Authors:Liu Jing  Guo Rixin  Wang Xiaojing  Zhang Nanping  Kang Shuai  Peng Kaifeng  Zhang Peng  Dai Zhong  Ma Shuangcheng
Affiliation:National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,Zhuzhou Qianjin Pharmaceutical Co., Ltd., Zhuzhou 412003, China,Zhuzhou Qianjin Pharmaceutical Co., Ltd., Zhuzhou 412003, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:Objective:To further improve the method for quality control of Caulis Spatholobi decoction pieces and to lay a scientific basis for its comprehensive quality evaluation. Methods:Based on current standard quality control program, the TLC identification method was further optimized. At the same time, HPLC was used to carry out a fingerprint study on the chemical components contained in the products and on the content determination of the main components-catechin and epicatechin. Results:The results of standard testing for 15 batches of Caulis Spatholobi decoction pieces showed that the water contents were 6.62%-12.51%, total ashes were 2.10%-3.25%, and ethanol extractives were 8.08%-10.02%. TLC optimization method exhibited clear spots with good separation and could distinguish the counterfeits. HPLC (UV 260 nm) fingerprint indicated that the similarities of 15 batches of samples were in the range of 0.84-0.99. Ten common peaks were identified as gallic acid, protocatechic acid, protocatechuic aldehyde, (+)-catechin, epicatechin, daidzin, genistin, daidzein, genistein and formononetin by comparing with reference substances. The established fingerprint could identify the counterfeits. Moreover, the result of content determination for HPLC (UV 202 nm) showed that the contents of catechin and epicatechin in 15 samples were 0.039%-0.068% and 0.12%-0.23% respectively. The contents of epicatechin were higher, so it was more suitable to be used as the index for the content determination. Conclusion:The established method could be used for the holistic quality control and evaluation of Caulis Spatholobi.
Keywords:Caulis Spatholobi decoction pieces  quality control  fingerprint  the content determination
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