[关键词]
[摘要]
目的 对藏药佐塔中汞、砷元素形态和价态进行分析,并结合其在复方制剂中用法用量进行安全性评价,以期为佐塔临床应用提供理论依据。方法 采用高效液相色谱-电感耦合等离子体质谱(HPLC-ICP-MS)法测定佐塔在人工胃肠液汞、砷的形态和价态,并根据佐塔在藏药复方制剂中用法用量来计算可溶性汞、砷的摄入量。结果 9批佐塔在人工胃肠液中以无机汞(Hg2+)、三价砷(AsIII)和五价砷(AsV)形式存在,其质量分数分别为11.25~725.13、6.68~67.53、36.06~289.03 μg/g,未检测出甲基汞(MeHg)、乙基汞(EtHg)、砷胆碱(AsC)、砷甜菜碱(AsB)、一甲基砷(MMA)、二甲基砷(DMA)。结论 根据佐塔在藏药复方制剂最大日服量0.2 g计算,可溶性Hg、As的摄入量分别在2.3~145.0 μg和10.6~63.4 μg,在规范使用情况下,具有较高的临床安全性。
[Key word]
[Abstract]
Objective To analyze the elemental speciation and valence state of mercury and arsenic in the Tibetan medicine Zuota, and evaluate its safety combining with its preparation's usage and dosage, so as to provide theoretical basis for its clinical application. Methods The HPLC-ICP-MS method was used to detect the elemental speciation and valence state of mercury and arsenic in Zuota in artificial gastric and intestinal juice. The intake of soluble mercury and arsenic was calculated according to the usage and dosage of Zuota in its preparation. Results By detecting nine batches of Zuota, the result showed that the elemental speciation of mercury existed in artificial gastric and intestinal juice was inorganic mercury. The valence state of mercury was divalent mercury (Hg2+), and the content of it was 11.25-725.13 μg/g. The elemental speciation of arsenic existed in artificial gastric and intestinal juice was organic arsenic. The valence state of arsenic were trivalent arsenic (AsIII) and pentavalent arsenic (AsV), and the content of them were 6.68-67.53 μg/g and 36.06-289.03 μg/g respectively. What's more, methylmercury (MeHg), ethylmercury (EtHg), arsenic choline (AsC), arsenic betaine (AsB), monomethyl arsenic (MMA), and dimethyl arsenic (DMA) were not detected in it. Conclusion The maximum daily dose of Zuota in its preparation is 0.2 g. So the intake of soluble mercury and arsenic would be calculated as 2.3-145.0 μg and 10.6-63.4 μg respectively every day. Thus, the use of Zuota in clinic would be with highly safety.
[中图分类号]
R283.6
[基金项目]
国家重点研发计划项目(2018YFC1708005);四川省药品监督管理局项目(510201201810173);中央高校基本科研业务费专项资金研究类项目(2021PTJS35)