国家药品抽检茜草饮片质量问题分析

Quality analysis of Madder decoction pieces based on National drug sampling inspection

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  statutory examine  exploratory research

摘要:

目的： 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。方法：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。结果：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.。结论：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:

Objective:Through the national drug sampling inspection, the overall quality of Rubiae Radix et Rhizoma and the main existing problems were analysed to provide the technical support for drug regulation. Methods: Rubiae Radix et Rhizoma samples were collected from different circulation links in the country and were tested according to the current statutory standards, and exploratory research was carried out. Results: A total of 173 batches of Rubiae Radix et Rhizoma samples were checked and tested according to the current quality standard.11 batches were unqualified. The unqualified items were traits, microscopic identification, total ash and extract. It was found by exploratory research that the main adulterants of Rubiae Radix et Rhizoma were Rubia magna P.G. Xiao and Rubia schumanniana Pritz. Conclusion: The overall quality of Rubiae Radix et Rhizoma samples was "medium". The main quality problems were adulteration and excessive limit of non-medicinal parts.