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中药标准煎液科学问题的探讨
引用本文:张水寒,梁雪娟,刘浩,万丹,户田光胤,陈林,周融融,黄璐琦.中药标准煎液科学问题的探讨[J].中国中药杂志,2017,42(17):3275-3281.
作者姓名:张水寒  梁雪娟  刘浩  万丹  户田光胤  陈林  周融融  黄璐琦
作者单位:湖南省中医药研究院 中药研究所, 湖南 长沙 410013;湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,湖南省中医药研究院 中药研究所, 湖南 长沙 410013;湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,湖南省中医药研究院 中药研究所, 湖南 长沙 410013;湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,湖南省中医药研究院 中药研究所, 湖南 长沙 410013;湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,日本国株式会社津村, 东京 107-8521,湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,湖南省中药原料质量监测技术服务中心, 湖南 长沙 410013,中国中医科学院 中药资源中心, 北京 100700
摘    要:该文在梳理中药配方颗粒发展历程与存在不足的基础上,提出中药标准煎液的概念,将其作为中药配方颗粒的模式标准,标化配方颗粒的生产过程及质量标准。按照"药材标准化、工艺规范化、生产智能化、质量标准化、包装规格化、仓储信息化"的原则统一标准;通过标准煎液和传统汤剂的化学成分、药理活性及临床疗效的研究进行一致性评价,阐释科学问题,旨在保证中药配方颗粒质量稳定、均一,临床应用安全、有效。

关 键 词:中药标准煎液  配方颗粒  模式标准  稳定  均一  有效
收稿时间:2017/7/28 0:00:00

Discussion on scientific problems in standard decoction of traditional Chinese medicine
ZHANG Shui-han,LIANG Xue-juan,LIU Hao,WAN Dan,Koin Tod,CHEN Lin,ZHOU Rong-rong and HUANG Lu-qi.Discussion on scientific problems in standard decoction of traditional Chinese medicine[J].China Journal of Chinese Materia Medica,2017,42(17):3275-3281.
Authors:ZHANG Shui-han  LIANG Xue-juan  LIU Hao  WAN Dan  Koin Tod  CHEN Lin  ZHOU Rong-rong and HUANG Lu-qi
Institution:Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China;Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China,Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China;Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China,Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China;Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China,Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China;Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China,Tsumura & Co., Tokyo 107-8521, Japan,Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China,Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China and National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
Abstract:Based on the reviewing of development and disadvantages of Chinese medicine formula granules, the concept of standard decoction of traditional Chinese medicine was proposed in this study, and it was used as the standard mode of Chinese medicine formula granules to standardize the production process and quality standards of formula granules. The standard was unified according to the principles of "standardization of medicinal materials, standardization of process, intellectualization of production, standardization of quality, normalization of packaging, and informatization of storage"; and consistency evaluation was carried out by the analysis of chemical components, pharmacological activities and clinical efficacy of the standardized decoction and the traditional decoction, interpreting the scientific questions to ensure the stability and uniformity of Chinese medicine formula granule as well as the safety and effectiveness of its clinical application.
Keywords:standard decoction of traditional Chinese medicine  formula granule  standard mode  stability  uniformity  effectiveness
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