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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 study the dissolution characteristics of arsenic in realgar containing realgar in gastrointestinal juice and provide references for clinical safety. Methods Arsenic determination method was established by ICP-MS. The method was used to determine the total amount of arsenic, the dissolution rate of arsenic in arsenic, the dissolution rate of arsenic in artificial gastric juice and the dissolution of arsenic in artificial intestinal juice Rates were measured, compared and analyzed. Results The linear correlation coefficient (r) of arsenic in both drugs was greater than 0.999 9 in the determination method. The determination of total arsenic in Bezoar anti-inflammatory tablets and Pedo Pharmacopoeia and the precision, stability and recovery of arsenic in the elution solution All meet the experimental requirements; there is also a good agreement between the measured and the standard values of NIST tomato leaf reference material (SRM 1573a). Measurement results show that: some manufacturers of anti-inflammatory tablets and pediatric bullish poisoning there is the problem of lack of administration of realgar; manufacturers of anti-inflammatory tablets and pediatric bullish poisoning arsenic in gastrointestinal fluid dissolution rate of less than 5%; manufacturers of anti-inflammatory Dissolution rate of tablets in gastrointestinal fluids were less than the dissolution rate in water, while the manufacturers of children’s drug toxicity in water and gastrointestinal fluid dissolution characteristics are different. Conclusion Bezoar anti-inflammatory tablets and children’s drug-toxic gastrointestinal solution of arsenic should be further studied.