水蛭及炮制品、标准汤剂、中间体和配方颗粒总砷、无机砷量值传递研究  

Study on the quantity value transfer of total arsenic and inorganic arsenic in Hirudo,Hirdo processed product,Standard Decoction,Intermediates and Formula Granules

作　　者：刘华明 马名利 林小钰 张辉 谭沛 Liu Huaming;Ma Mingli;Lin Xiaoyu;Zhang Hui;Tan Pei(Huarun Sanjiu Pharmaceutical Co.,Ltd.,Shenzhen 518110,China;Huarun Sanjiu Modern Traditional Chinese Medicine Pharmaceutical Co.,Ltd.,Huizhou 516000,China)

机构地区：[1]华润三九医药股份有限公司,深圳518110 [2]华润三九现代中药制药有限公司,惠州516000

出　　处：《国际中医中药杂志》2025年第3期372-379,共8页International Journal of Traditional Chinese Medicine

基　　金：深圳市创新项目(JSGG20191129093418578)。

摘　　要：目的研究水蛭药材、烫水蛭饮片、标准汤剂、中间体及配方颗粒中总砷、无机砷含量及含量转移率,评价烫水蛭配方颗粒安全性。方法采用电感耦合等离子体质谱和HPLC-电感耦合等离子体质谱法检测水蛭、烫水蛭样品中的总砷、无机砷含量,并对含量、含量转移率、无机砷在总砷中的占比进行分析,确定炮制、煎煮后水蛭中总砷、无机砷的变化规律。对15批不同产地的水蛭药材进行聚类分析,确定产地之间的差异。结果水蛭炮制成烫水蛭饮片后,总砷含量基本不变,2种无机砷盐呈不同变化规律,其中亚砷酸盐含量及其在总砷中的占比均降低,而砷酸盐含量及其在总砷中的占比均升高。烫水蛭饮片经水煎煮制成标准汤剂、中间体和配方颗粒后,总砷含量易超标,总砷含量转移率处于较高水平,2种无机砷盐含量转移率均超过100%,无机砷在总砷中的占比均升高。聚类分析结果显示,产地对水蛭药材中砷含量有一定影响。结论本研究揭示了总砷、无机砷在水蛭饮片炮制、标准汤剂、中间体和配方颗粒制备后的变化规律,可为烫水蛭配方颗粒生产制备和质量标准制定提供参考。Objective To evaluate the contents and transfer rates of total arsenic and inorganic arsenic in Hirudo,decoction pieces,standard decoction,intermediates,and formula granules;To provide a basis for the safety evaluation of formula granules of Hirudo.Methods The inductively coupled plasma mass spectrometry(ICP-MS)and high-performance liquid chromatography-Inductively coupled plasma mass spectrometry(HPLC-ICP-MS)were employed for determining the contents of total arsenic and inorganic arsenic in Hirudo and its scald product.Then the contents,transfer rates,and proportions of inorganic arsenic in total arsenic were analyzed to inform the change rules of total arsenic and inorganic arsenic after processing and decocting.Clustering analysis(CA)was applied by analyzing fifteen batches of Hirudo for identifying the distinction among different producing areas.Results After processing the Hirudo into Hirudo scald product,the content of arsenic was basically unchanged,arsenite and arsenate were presenting a different variation,the content of arsenite and its proportion in total arsenic decreased,while the content of arsenate and its proportion in total arsenic increased.The total arsenic content was exceeding the standard easily,meanwhile the transfer rate of total arsenic was at high level.The transfer rates of arsenite and arsenate were more than 100%,and the proportions of arsenite and arsenate in total arsenic increased since the decoction pieces were decocted into standard decoction,intermediates and formula granules.CA results showed that producing areas have a certain impact on the arsenic content in Hirudo.Conclusion This study revealed the change rules of total arsenic and inorganic arsenic in Hirudo after processing and decocting into standard decoction,intermediates,and formula granules,which can providing reference for the production and quality standard formulation of formula granules of Hirudo.

关 键 词：水蛭(中药) 含量测定(中药) 砷 转移率 中药产地 

分 类 号：R28[医药卫生—中药学]