ICP-MS研究含雄黄中成药中的砷元素在胃肠液中的溶出特性

Dissolution characteristics of arsenic in gastrointestinal fluids for realgar-containing traditional Chinese medicines by ICP-MS

目的研究含雄黄中成药的砷元素在胃肠液中的溶出特性,为临床安全用药提供参考。方法应用ICP-MS技术建立砷元素的测定方法,并用该方法对不同厂家牛黄消炎片和小儿化毒散中的砷总量、水中砷溶出率、人工胃液中砷溶出率及人工肠液中砷溶出率进行测定、比较和分析。结果测定方法中两种药品砷元素的线性相关系数(r)均大于0.999 9;牛黄消炎片和小儿化毒散总砷测定方法及溶出液中砷元素测定方法的精密度、稳定性和回收率均能满足实验要求;NIST西红柿叶标准物质(SRM 1573a)的测定值和标准值之间也有良好的一致性。测定结果显示:部分厂家的牛黄消炎片和小儿化毒散存在雄黄投药不足的问题;各厂家牛黄消炎片和小儿化毒散的砷在胃肠液中溶出率均小于5%;各厂家牛黄消炎片在胃肠液中的溶出率均小于在水中的溶出率,而各厂家小儿化毒散在水和胃肠液中的溶出特性不同。结论牛黄消炎片和小儿化毒散的胃肠液溶出砷值得进一步研究。

Objective To investigate dissolution characteristics of arsenic（ As） of realgar-containing traditional Chinese medicine（ TCM） in water and gastrointestinal fluids by inductively coupled plasma mass spectrometry（ ICP-M S）,so as to provide references for clinical safe medication. Methods An ICP-M S method for analysis of As was established,and the total As in Niuhuang Xiaoyan Pian and Xiao ＇ er Huadu San and their dissolution rates in water,artificial gastric fluids and artificial intestinal fluids were determined,compared and analyzed. Results The method validation indicated that the correlative coefficient（ r） for As was 0. 999 9; the precisions,stabilities and recoveries for As in both Niuhuang Xiaoyan Pian and Xiao ＇ er Huadu San,as well as in water,artificial gastric fluids and artificial intestinal fluids,met the determination requirements; the determined values of As in NIST tomato leaves reference materials（ SRM1573a） were in accordance with that certified. The results of sample analysis showed that insufficient realgar was formulated in some Niuhuang Xiaoyan Pian and Xiaoer Huadu San; all dissolution rates for Niuhuang Xiaoyan Pian and Xiaoer Huadu San in gastrointestinal fluids were below5%; lower dissolution rates for As were found in gastrointestinal fluids than that in water for all Niuhuang Xiaoyan Pian samples,while different dissolution characteristics for Xiao ＇er Huadu San from different manufactures were found in gastrointestinal fluids and water. Conclusions The dissolved As in gastrointestinal fluids for Niuhuang Xiaoyan Pian and Xiao ＇ er Huadu San should be deeply studied.