含朱砂口服中成药中汞的生物利用性及安全性评价_临床医学论文.docVIP

含朱砂口服中成药中汞的生物利用性及安全性评价_临床医学论文 含朱砂口服中成药中汞的生物利用性及安全性评价_临床医学论文 作者：齐江宁，胡广林*，庞京团，韩 彬，黄维钱 【摘要】 目的从生物利用性角度评价含朱砂中成药中汞的潜在健康风险。方法火焰原子吸收法(FAAS)测定含朱砂中成药总汞含量，体外消化透析法模拟人体胃肠消化，氢化物发生—原子荧光光谱法(HG-AFS)检测得到含朱砂中成药中汞生物利用性相关数据。结果6种常用含朱砂中成药在人工胃液中汞溶出率在0.14%～1.96%范围内，小肠阶段汞可接受率为0.003 8%～0.011 7%。基于汞在人体的半衰期和蓄积中毒量，反推导出含朱砂中成药中汞元素的安全阈值为每人每天0.099 mg。结论综合考虑6种常用含朱砂中成药的汞含量水平、服用剂量、服用频次等，说明口服含朱砂中成药引起汞暴露的安全风险性较低。 【关键词】 生物利用性; 体外消化透析法; 含朱砂中成药; 安全阈值; 汞 　Abstract：ObjectiveTo introduce mercury bioaccessibility for risk assessment of Chinese patent medicines containing cinnabar. MethodsTotal mercury from Chinese patent medicines containing cinnabar was determined by FAAS. In vitro digestion and dialysis method was adopted to simulate the conditions of gastric compartment and intestinal compartment and dialysate fractions were collected and quantified by the means of HG-AFS. ResultsIn the gastric compartment, the solubility of mercury from six common Chinese patent medicines containing cinnabar ranged from 0.14%～1.96%; in the intestinal compartment, mercury bioaccessibility (0.003 8%～0.011 7%) was found for all the samples. The toxic threshold level of mercury was 0.099 mg/(person·day) for the case of Chinese patent medicines containing cinnabar on the basis of available data on mercury (cumulative toxic dose and half-life) in the body. ConclusionTaking into consideration on mercury level and intake of Chinese patent medicines containing cinnabar, the potential health risk seems to be low. 　　Key words：Bioavailability; In vitro digestion and dialysis method; Chinese patent medicines containing cinnabar; Toxic threshold; Mercury 　　朱砂又名丹砂、辰砂，是一味传统中药，主治安神定惊、明目解毒，其主要成分为硫化汞。在中成药中，含有朱砂的品种占10%;在儿科中成药中，含朱砂的品种占到了20.32%。《中国药典》(2005年版Ⅰ部)正文中收载含朱砂的内服成方制剂44种。《中国药典》对万氏牛黄清心丸、保赤散等7种含朱砂中成药附有朱砂含量测定一项(硫氰酸盐容量分析法)，并且对硫化汞的含量指标做了具体规定[1]。但是，含朱砂中成药中重金属汞含量偏高，引起了人们对此类中成药服用安全性的担忧[2～4]。矿物类中药至今没有相应的安全质量标准[5]，许多国家对中药都采用食品重金属限量标准来衡量其服用安全性。随着中药国际化进程日益加快和人们健康意识的迅速提高，如何合理科学地对传统矿物药的服用安全性进行评价已经成为当前亟待解决的问题。 　　众所周知，含朱砂中成药中汞元素主要以硫化汞形态存在，硫化汞是强化学惰性的，其