国产中成药中雄黄应用及其溶出量的研究

Application of Realgar in Chinese Patent Medicine and Arsenic Dissolution

目的了解和掌握国产中成药所含雄黄(As2S2)状况;以体外实验探讨雄黄在不同pH值溶液中可溶性砷溶出量。方法通过查阅2005年我国卫生部发布的中药保护及中药部颁标准,摘录含雄黄中药药剂总量、雄黄含量及服用方法等数据,通过对上述数据归类统计,评价我国中药成方制剂所含雄黄情况;将细粉状药用雄黄于pH值为1、3、5、7、9、11的溶液中37℃水浴4h,取上清用超低温捕集-氢化物发生-原子吸收分光光度计进行砷检测,计算砷溶出量。结果共查阅登记在录中药3860种,其中含雄黄方剂121种[包括既含雄黄又含朱砂(HgS)的74种],占总数的3.13%。在各种含雄黄方剂中,口服药物97种(80.17%),外用药物10种(8.26%),口服兼外用药物14种(11.57%);供儿童服用方剂45种(1.17%);折合砷含量质量分数<15%者108种(89.26%),>15%者6种(4.96%),范围为0.46%～27.52%;日平均折合砷摄入量<10mg者10种(8.26%),10～500mg之间者79种(65.29%),>500mg者11种(9.09%)。雄黄在体外的可溶性砷溶出实验表明,1mg雄黄在pH值分别为1、3、5、7、9、11的溶液中仅溶出无机砷(iAs),且随pH值升高iAs溶出量呈增高趋势,溶出量分别为1.58、1.24、1.57、1.62、2.28、4.76μg。结论我国中药成方中雄黄应用广泛,其所含砷化合物的健康影响应引起关注;药用雄黄所含无机砷在碱性环境中可能更易吸收。

Objective To investigate the present status of Chinese patent medicine with realgar （As2S2） and to research arsenic dissolution in different pH values. Methods Data on the amount of Chinese patent medicine with realgar, the content of realgar, the method of taking medicine and so on were collected from the Chinese traditional medicine protection and criterions issued by the Chinese Ministry of Health in 2005, and evaluated the using status of Chinese patent medicine with realgar. The realgar powder was dissolved in solutions at different pH values （1, 3, 5, 7, 9, 11） in 37℃ water for 4 h, respectively, then arsenic was determined with cold trap hydride generation atomic absorption spectrometry to calculate the amount of dissolved arsenic. Results One hundred and twenty-one （3.13%） realgar medicaments were recorded in a total of 3 860 various Chinese patent medicaments, including 74 medicaments with both realgar and cinnabar （HgS）. Of all medicaments with realgar, 97 medicaments （80.17%） were for oral application, 10 medicaments （8.26%） were for external application, and 14 medicaments （11.57%） were for both oral and external application. 45 medicaments with realgar （1.17%） could be used in children; 108 medicaments with realgar （89.26%） contained arsenic 〈15% and 6 medicaments （4.96%） contained arsenic 〉15%; The relative amount of arsenic in medicaments with realgar was from 0.46% to 27.52%. Daily intake of arsenic was 〈10 mg for 10 medicaments （8.26%）, between 10 mg and 500 mg for 79 medicaments （65.29%）, and 〉500 mg for 11 medicaments （9.09%）. Only inorganic arsenic （iAs） was detected when 1 mg realgar was dissolved in solution with pH values of 1, 3, 5, 7, 9, 11. The levels of dissolved iAs seemed increased with the pH values, which were 1.58μg, 1.24 μg, 1.57 μg, 1.62μg, 2.28μg and 4.76 μg, respectively. Conclusion Considering the common use of realgar in Chinese patent medicine and the high level of arsenic in realgar, the potential danger can not be ignored. It is possible that arsenic in realgar may be much easier to be absorbed in intestine than in stomach.