Background: Compound Niuhuang Xiaoyan capsule is a realgar and cinnabar-containing traditional Chinese medicine, the contents of total arsenic and total mercury are found over regulation defined limits. However, only small amounts of arsenic in realgar and mercury in cinnabar are dissolved in the gastric juice, so the determination of soluble arsenic and soluble mercury is more significant than that of total arsenic and total mercury in Compound Niuhuang Xiaoyan capsule.

Objective: To study the contents of total arsenic, total mercury, soluble arsenic and soluble mercury in Compound Niuhuang Xiaoyan capsule.

Methods: Microwave digestion and semi-bionic extraction were used to pretreat the samples of Compound Niuhuang Xiaoyan capsule, and the inductively coupled plasma mass spectrometry method was established to determine the contents of total arsenic, total mercury, soluble arsenic and soluble mercury in Compound Niuhuang Xiaoyan capsule. The accuracy of the established method was further evaluated by using a certified standard reference material prepared from dried citrus leaves (GBW10020(GSB-11)).

Results: The spiked recoveries were within 95-105 %. The R.S.D% of repeatability (N=6) and precision (N = 6) were below 5.0 %. The correlation coefficients of linear (R) for arsenic and mercury were both above 0.998. The limits of quantification (LOQ) were below 0.1 μg/L. The contents of As and Hg were defined in the dried citrus leaves and very near to the standard values provided by the manufacturer. The established method was applied for the analysis of three batches of Compound Niuhuang Xiaoyan capsule produced by three different manufacturers successfully. Insufficient realgar or cinnabar was formulated in some Compound Niuhuang Xiaoyan capsule samples.

Conclusion: The analysis showed that the contents of soluble arsenic and soluble mercury in artificial gastric juice were significantly less than that of total arsenic and total mercury in Compound Niuhuang Xiaoyan capsule. The results provided a reference for further study on the toxicology and pharmacokinetics of Compound Niuhuang Xiaoyan capsule.

背景：复方牛黄消炎胶囊为含雄黄、朱砂的中药，总砷、总汞含量均超标。但雄黄中的砷和朱砂中的汞仅少量溶解在胃液中，因此可溶性砷和可溶性汞的测定比复方牛黄消炎胶囊中总砷和总汞的测定更显着。

目的：研究复方牛黄消炎胶囊中总砷、总汞、可溶性砷和可溶性汞的含量。

方法：采用微波消解和半仿生提取法对复方牛黄消炎胶囊样品进行预处理，建立电感耦合等离子体质谱法测定复方牛黄中总砷、总汞、可溶性砷和可溶性汞的含量。消炎胶囊。使用由干燥柑橘叶制备的有证标准参考物质 (GBW10020(GSB-11)) 进一步评估了所建立方法的准确性。

结果：加标回收率在 95-105% 之间。重复性 (N=6) 和精密度 (N=6) 的 RSD% 低于 5.0%。砷和汞的线性相关系数 (R) 均高于 0.998。定量限 (LOQ) 低于 0.1 μg/L。As 和 Hg 的含量在干燥柑橘叶中确定，非常接近制造商提供的标准值。将所建立的方法成功应用于三个不同厂家生产的三批复方牛黄消炎胶囊的分析。部分复方牛黄消炎胶囊样品中雄黄或朱砂含量不足。

结论：分析表明，人工胃液中可溶性砷和可溶性汞的含量显着低于复方牛黄消炎胶囊中总砷和总汞的含量。该结果为复方牛黄消炎胶囊毒理和药代动力学的进一步研究提供参考。