复方芦荟胶囊配伍药物对朱砂中汞生物利用性影响探究.doc

复方芦荟胶囊配伍药物对朱砂中汞生物利用性影响探究 　 作者：庞京团 ，胡广林，韩彬，齐江宁，张化云 【摘要】 目的研究复方芦荟胶囊中汞的生物利用性及配伍药物对汞生物利用性的影响，以便认识复方芦荟胶囊中汞对人体的健康风险。方法用L8(27)正交表设计实验，体外消化透析法取得汞溶出率及生物可接受率数据。结果复方芦荟胶囊中汞含量为(11.7±0.4）%(P=0.95）；复方芦荟胶囊在胃模拟环境中汞溶出率为(1.36±0.06)%(P=0.95)，肠模拟环境下生物可接受率为(0.46±0.03)%(P=0.95)；芦荟很显著抑制了朱砂中汞的溶出率(P=0.95)，芦荟使朱砂中汞生物可接受率显著降低(P=0.90)；其他配伍药物及药物交互作用对汞生物利用性不显著。结论复方芦荟胶囊中汞含量高，生物可接受率低，长期服用会存在一定的潜在健康风险；复方芦荟胶囊配伍时可适当增大芦荟用量以降低其汞的生物利用性。 【关键词】 配伍； 复方芦荟胶囊； 生物可接受率； 汞 　　Abstract：ObjectiveTo study the bioaccessibility of mercury from Fufang Luhui Capsule，and to study the influence of different compatibility on the bioavailability of mercury. MethodsEight solutions with cinnabar were prepared using an in vitro dialysis digestion method and were analysed by L8(27)orthogonal design and the contents of mercury were determined by CV-AFS. ResultsThe content of mercury in Fufang Luhui Capsule was (11.7±0.4)%(P=0.95). The experimental results indicated that mercury dissolution rate from Fufang Luhui capsule was (1.36±0.06)%(P=0.95)，and the bioaccessibility was (0.46±0.03)%(P=0.95). As a main component of Fufang Luhui Capsule, aloe inhibited the dissolution rate of mercury in cinnabar very significantly(P=0.95), and aloe significantly reduced the bioaccessibility of mercury in cinnabar(P=0.90). Influences of the compatibility of other drugs and drug interactions was insignificant.ConclusionThe content of mercury in Fufang Luhui Capsule is high, its bioavailibility is low, and there are still some medicinal potential health risks for long-term intake.Aloe significantly influence its bioavailability, so properly increasing the content of aloe can reduce its bioaccessibility. 　　Key words：Compatibility； Fufang Luhui Jiaonang； Bioaccessibility； Mercury 复方芦荟胶囊，纯中药复方制剂，有良好的清肝泻热、润肠通便等功效，在临床上一直用于心肝火盛，烦躁失眠等症。2006年英国药物安全机构称复方芦荟胶囊汞含量超过英国标准 11.7 万倍［1］，其配方含有朱砂，是导致此次事件发生的重要原因。对于重金属，只有溶出且被利用的部分才能作用于人体而产生毒副作用，因此对重金属毒副作用的评价，不仅要测定重金属总含量，更要测定其生物可接受量（bioaccessible amount）。目前FDA和WHO均制定了类似食品、蔬菜以及茶叶等产品的重金属允许摄入量。美国、欧盟、日本等国家及我国传统中药出口的东南亚地区都制定