论雄黄的安全性以及对其监管的建议

Safety of Realgar and Recommendations on its Supervision

雄黄药用历史悠久,临床应用广泛,很多传统中药名方包括儿科方剂中含有雄黄。由于雄黄为含砷矿物药,人们常以含砷的砒霜类推其毒性,对其安全性缺乏客观认识。临床上雄黄基本以炮制品入药,而不用生品。《中国药典》2020年版记载的炮制方法为水飞法,研究证明水飞炮制的雄黄毒性较低。“雄黄”被列入《医疗用毒性药品管理办法》,然而其名称“雄黄”未分“生”“制”,致使目前雄黄炮制品也按照该管理办法监管,其科学性和合理性值得商榷,亦不利于临床合理使用。本文结合古代本草有关雄黄的品质论述、古今炮制方法、现代安全性研究以及本研究团队的部分研究工作等,对雄黄的安全性进行客观评述,并对雄黄的监管提出建议。

Realgar has a long medicinal history and has been widely used in clinic.Realgar is used in many famous traditional Chinese medicine prescriptions,including pediatric prescriptions.Because realgar is a mineral medicine containing arsenic,people always use arsenic to analogize its toxicity,and there is a lack of objective understanding of realgar’s safety.Clinically,processed realgar is used rather than the raw products.The processing method of realgar recorded in Chinese Pharmacopoeia(2020 Edition)is Shuifei.Studies have shown that the toxicity of realgar processed through Shuifei is relatively low.Realgar was listed in Measures for Administration of Toxic Drugs for Medical Use,which did not make a distinction between“raw”and“processed”realgar.As a result,processed realgar products are also regulated in accordance with this provision at present.The scientificity and rationality of this method are questionable,and is not conductive to the rational clinical use of realgar.In this paper,we discussed the quality of realgar combined with ancient Chinese herbal medicine,ancient and modern processing methods,modern safety research and part of the research works of our team,which to evaluate objectively the safety of realgar and put forward suggestions on the supervision of realgar.