中国中药杂志

2020, v.45(24) 5976-5981

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绞股蓝总苷提取物及总苷片的质量标准研究
Study on quality standard of gypenosides extract and Gypenosides Tablets

张子龙;李雯珊;滕菲;匡艳辉;范冬冬;王德勤;朱晶晶;王智民;
ZHANG Zi-long;LI Wen-shan;TENG Fei;KUANG Yan-hui;FAN Dong-dong;WANG De-qin;ZHU Jing-jing;WANG Zhi-min;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Shaanxi University of Chinese Medicine;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co., Ltd.;

摘要(Abstract):

该文针对目前绞股蓝药材、提取物、制剂尚无国家标准的问题,开展市场调研并收集市面上药用绞股蓝总苷提取物17批,绞股蓝总苷片剂29批,并以其专属性成分绞股蓝皂苷A为指标,建立绞股蓝提取物及其片剂的薄层色谱定性鉴别和HPLC定量评价方法。基于17个批次的绞股蓝总苷提取物和29个批次的绞股蓝总苷片的测定结果,分别制定了绞股蓝总苷提取物和总苷片制剂的质量标准,为绞股蓝提取物及其片剂质量标准的提高提出建议。与现有的部颁标准相比,增加了专属性成分的定性鉴别与定量检测,为绞股蓝总苷提取物和片制剂质量标准的修订提供科学依据与建议。
In response to no national standard for Gynostemma pentaphyllum, a market survey was carried out, and 17 batches of gypenosides extract and 29 batches of Gypenosides Tablets on the market were collected. With gypenoside A as an index, the TLC qualitative identification and HPLC quantitative evaluation method of gypenosides extract and tablets was established. Based on the determination results of 17 batches of gypenosides extract and 29 batches of Gypenosides Tablets, the quality standards of gypenosides extract and tablets were formulated respectively, so as to give suggestions for improving the quality standards of gypenosides extract and tablets. Compared with the existing ministerial standards, the qualitative identification and quantitative detection of specific components were added, in order to provide scientific basis and suggestions for the revision of the quality standard of gypenosides extract and tablet preparation.

关键词(KeyWords): 绞股蓝总苷提取物;绞股蓝总苷片;绞股蓝皂苷A;TLC;HPLC;含量测定
gypenosides extract;Gypenosides Tablets;gypenoside A;TLC;HPLC;content determination

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2017YFC1701900)

作者(Author): 张子龙;李雯珊;滕菲;匡艳辉;范冬冬;王德勤;朱晶晶;王智民;
ZHANG Zi-long;LI Wen-shan;TENG Fei;KUANG Yan-hui;FAN Dong-dong;WANG De-qin;ZHU Jing-jing;WANG Zhi-min;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Shaanxi University of Chinese Medicine;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co., Ltd.;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200922.302

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