山东省市售土鳖虫质量分析与评价

Quality Analysis and Evaluation of Eupolyphaga steleophaga in Shandong Province

目的:评价山东省市售土鳖虫质量状况。方法:收集山东省16地市市售土鳖虫样品28批,参照《中国药典》2020年版一部,分别对样品的性状、显微特征、薄层特征进行鉴别,对杂质、水分、总灰分、酸不溶性灰分、黄曲霉毒素和浸出物进行检查,对样品进行聚类及相关性分析,对重金属污染情况就行了探索研究。结果:土鳖虫的性状及显微特征均符合药典规定;薄层色谱中,供试品溶液在与对照药材色谱相应的位置上,分别显相同颜色的荧光斑点和斑点;杂质含量为0.08%~2%,水分含量为6.7%~9.4%,总灰分含量为7.7%~15.8%(合格率为96%),酸不溶性灰分含量为1.1%~9.2%(合格率为96%),28批样品中,有两批同厂家样品检出黄曲霉毒素(检出率7%),浸出物含量为25.6%~37.0%,通过聚类分析,可将样品分为三类。结论:山东省市售土鳖虫总体质量较好,现行质量标准基本能满足其质量控制,极少部分样品中发现总灰分、酸不溶性灰分以及黄曲霉毒素含量超标等问题,需要进一步加强炮制工艺优化、贮藏环境监控及质量控制和监管。

Objective:To evaluate the quality of Eupolyphaga steleophaga in Shandong Province.Methods:twenty-eight batches of samples sold in 16 cities in Shandong Province were collected.The properties,microscopic characteristics and thin-layer chromatography(TLC)characteristics of the samples were identified,the impurities,moisture,total ash,acid insoluble ash,aflatoxins and extracts were examined according to the Chinese Pharmacopoeia(2020 Edition,Volume 1).The clustering and correlation analysis of the samples was carried out and the heavy metal pollution situation are explored.Results:The properties and microscopic characteristics of the sample of Eupolyphaga steleophaga met the requirement of the Chinese Pharmacopoeia.In the TLC chromatograms the test solution showed the same color spots at the corresponding position of the reference solution.In the samples of Eupolyphaga steleophaga,the contents of impurities were 0.08%~2%,the contents of moisture were 6.7%~9.4%,the content of total ash were 7.7%~15.8%(the pass rate is 96%),the content of acid insoluble ash were 1.1%~9.2%(the pass rate is 96%);Aflatoxin was detected in two of the 28 batches of samples from the same manufacturer(detection rate 7%),the content of the extract was 25.6%~37.0%.Through cluster analysis,the samples can be divided into three categories.Conclusion:The overall quality of Eupolyphaga steleophaga in Shandong Province is good,The current quality standard can basically meet its quality control,The contents of total ash,acid insoluble ash and aflatoxins exceeded the standard in very few samples.It is necessary to further strengthen the process optimization,storage environment monitoring and quality supervision.