国家药品抽检茜草饮片质量问题分析
Quality Analysis of Rubiae Radix et Rhizoma Based on National Drug Sampling Inspection
张明童 1马潇 1宋平顺 1王娟弟 1李冬华1
作者信息
- 1. 甘肃省药品检验研究院(甘肃省中藏药检验检测技术工程实验室,国家药品监督管理局中药材及饮片质量控制重点实验室),兰州 730070
- 折叠
摘要
通过国家药品抽检,分析茜草饮片的总体质量和存在的主要问题,为药品监管提供技术支持.从全国不同环节抽取茜草样品,依据现行法定标准进行检验,并进行探索性研究.共抽检173 批茜草样品,按现行质量标准检验,不合格11 批,不合格项目为性状,显微鉴别、总灰分和浸出物;经探索性研究发现,掺混品主要为大茜草 Rubia magna P.G.Xiao 和大叶茜草 Rubia schumanniana Pritz..茜草样品的总体质量状况为"一般",存在的问题主要为掺伪和非药用部位超标.
Abstract
To analyze the overall quality and main problems of Rubiae Radix et Rhizoma pieces through national drug quality inspection,and to provide technical support for drug supervision,Rubiae Radix et Rhizoma samples were collected from different circulation links across the country and were tested according to the current legal standards,and exploratory research was carried out.A total of 173 batches of Rubiae Radix et Rhizoma samples were checked and tested,and 11 batches were unqualified according to the current quality standards.The unqualified items were traits,microscopic identification,total ash and extract.It was found that the main adulterants were Rubia magna P.G.Xiao and Rubia schumanniana Pritz.through exploratory study.The overall quality of Rubiae Radix et Rhizoma was evaluated as"general".The main quality problems were adulteration and non-medicinal parts exceeding the standard.
关键词
茜草/质量分析/法定标准检验/探索性研究Key words
Rubiae Radix et Rhizoma/quality analysis/the legal standard inspection/exploratory research引用本文复制引用
基金项目
中药材及饮片质量控制重点实验室项目(2022GSMPA-KL12)
中药材及饮片质量控制重点实验室项目(2022GSMPA-KL10)
中药材及饮片质量控制重点实验室项目(2022GSMPA-KL75)
甘肃省药品科研项目(2022GSMPA0017)
兰州市科技计划(2022-3-41)
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据