浙八味中药水煎剂中元素的生物可给性研究及其安全性评价  

Bioaccessibility Measurement and Safety Evaluation of Elements in Decoction of Zhebawei Traditional Chinese Medicines

作　　者：周玉波 曾怡 王赛男 屠晨瑶 黄思杨 ZHOU Yu-bo;ZENG Yi;WANG Sai-nan;TU Chen-yao;HUANG Si-yang(College of Pharmacy,Zhejiang Pharmaceutical College,Ningbo 315100,China)

机构地区：[1]浙江医药高等专科学校药学院,浙江宁波315100

出　　处：《中国药学杂志》2020年第14期1201-1206,共6页Chinese Pharmaceutical Journal

基　　金：宁波市自然科学基金项目资助(2018A610435);浙江省大学生科技创新活动计划暨新苗人才计划项目资助(2018R458005)。

摘　　要：目的对不同批次浙八味中药水煎剂中的无机元素进行生物可给性研究,并评价其安全性。方法基于电感耦合等离子发射光谱法(ICP-AES)对浙八味中药水煎剂进行无机元素含量测定,采用体外消化模型,研究元素在模拟人体胃肠液中的生物可给性,并参考粮农组织和世界卫生组织等机构制定的元素成人摄入推荐量,评价用药安全性。结果浙八味各中药水煎剂中各元素的生物可给性均小于1,同种药材水煎剂中的不同元素及同种元素在不同药材水煎剂之间的生物可给性存在一定差异,Cd、V、Se、Cr、Sn和As元素由于在某些药材水煎剂中存在的含量较低或未检出,导致其体外消化透析液中也未检测出含量。浙八味各中药水煎剂的安全性评价结果表明,Ni、Fe、Mn、Se、Cu、Zn、Co、V和Cr元素日摄入量均在推荐安全范围内,Cd和Sn的日摄入最大量和生物可给量均未超过粮农组织和世界卫生组织暂定的可容许摄入量标准,说明在服用期间可避免这些元素摄入过量产生的风险;延胡索药材水煎剂中As的总含量,超过了粮农组织和世界卫生组织暂定的可容许摄入量标准,但是其体外消化透析液的As未超标,元素总含量的测定和分析可能会片面夸大其危害。结论本实验结果为进一步研究浙八味中药中元素的生物可利用性和安全性提供依据,为从元素角度保证中药用药的合理性提供参考。OBJECTIVE To study the bioaccessibility and evaluate the safety of inorganic elements in decoction of“Zhebawei”traditional Chinese medicines(TCMs).METHODSE The bioaccessibility of inorganic elements in decoction of“Zhebawei”TCMs was measured based on in vitro digestion and inductively coupled plasma atomic emission spectrometer(ICP-AES)and the safety of these elements were evaluated by comparing with the safe limits issued by the FAO and WHO.RESULTS The bioaccessibility of the inorganic elements was less than 1,and varied among different elements of the same herbal medicine or for the same element among different herbal medicines.Cd,V,Se,Cr,Sn,and As were not detected in the dialysate of some TCMs′decoction after in vitro digestion because of the total content being low or undetected in decoction.The result of safety evaluation showed that the daily intakes of Ni,Fe,Mn,Se,Cu,Zn,Co,V,Cr from the decoction of“Zhebawei”TCMs were all within safe limits.The daily intakes of Cd and Sn did not exceed the level of personal acceptable daily intake instituted by the FAO and WHO.The total content in the decoction of Rhizoma Corydalis was more than the level of personal acceptable daily intake instituted by FAO and WHO,however the amount in the dislysate of“Zhebawei”TCMs′decoction after in vitro digestion were under the standard.The analysis of total content may exaggerate the risk of toxicity.CONCLUSION The results will provide the basis for further researches such as bioavailability and safety of inorganic elements in“Zhebawei”TCMs,and will provide references for ensuring the rational use of TCM according to the analysis of inorganic elements.

关 键 词：浙八味 无机元素 体外消化模型 生物可给性 安全性评价 

分 类 号：R284.1[医药卫生—中药学]