牛黄解毒片的安全性评价

Safety evaluation of Niuhuang Jiedu tablet

含雄黄的牛黄解毒片用于临床已有800余年历史,但由于雄黄含砷,近年来国内外对其关注度高、争议大。对含雄黄的传统中成药而言,目前存在2个认识误区,其一是把雄黄毒性与砒霜相提并论,其二将雄黄贬得一无是处,可有可无,要求从复方中将其去除。含雄黄的牛黄解毒片到底有多毒?该文结合牛黄解毒片的研究进展对此作一综述,并提出不同见解:①以总砷为标准评价含雄黄中药的安全性不妥;②雄黄的服药量和服药时间的长短决定其毒性的大小;③雄黄是中药复方中的有效成分之一,应作深入研究来决定其取舍。对诸如牛黄解毒片等所含雄黄中成药的经典方剂,应该以严谨的现代科学依据加以评价,才能指导合理、安全应用。

Realgar-containing Niuhuang Jiedu tablet （NHJD） has been applied in clinic for more than 800 years, however, because realgar contains arsenic （As） , it has aroused wide concerns and controversies both at home and abroad. Currently, there are two misunderstandings about realgar-containing Chinese patent medicines. First, some people exaggerated realgar＇s toxicity as that of arsenic. Second, they recommended to remove realgar from traditional Chinese medicine compounds. In this paper, the authors summarized the advance in studies on NHJD, and proposed different opinions： （1）It is inappropriate to take total As as the index in safety evaluation of NHJD. （2）The toxicity of NHJD is dependent on the dose and duration of administration. （3）Realgar is an active ingredient of NHJD, and shall be deeply studied. Classic realgar-containing traditional Chinese medicine prescriptions, such as Niuhuang Jiedu tablet, shall be evaluated with rigorous modern scientific basis, with the aim to guide rational and safe application.