中药饮片制何首乌质量调查及监管建议

Investigation of Polygoni Multiflori Radix Praeparata Quality and Regulatory Suggestions

目的:调查市场上制何首乌质量状况,提出监管建议。方法:从市场上抽取适量制何首乌中药饮片样品,按照《中国药典》2020年版一部“制何首乌”项下的规定对样品进行检验,并开展探索性项目研究,根据检验结果分析市场上制何首乌质量状况,提出相应监管对策。结果:共检验49批制何首乌,18批样品的游离蒽醌含量测定项不符合规定,不合格率为36.7%,其中13批样品涉嫌非法使用铁盐染色。结论:需进一步完善现行质量标准,建议增加铁元素限量的检查方法和限度规定。

Objective:To investigate the quality of Polygoni Multiflori Radix Praeparata in the market and put forward regulatory suggestions.Method:Polygoni Multiflori Radix Praeparata samples were collected from the market,and tested according to the Chinese Pharmacopoeia.Then,exploratory research was conducted,and the general quality status of Polygoni Multiflori Radix Praeparata was summarized based on the testing and research results.Finally,relevant regulatory suggestions were proposed.Results:Of the 49 batches of samples tested,the content of free anthraquinone in 18 batches did not meet the requirements,reaching an unqualified rate of 36.7%.Among the 18 batches of unqualified samples,13 batches were suspected of illegal use of iron salt staining.Conclusion:The current quality standards need to be further improved by adding testing method and specifications for iron limits.