回顧馬兜鈴酸、雷公藤、八角蓮、檳榔、仙靈骨葆膠囊、魚(yú)腥草注射劑、雙黃連注射劑等引發(fā)的中藥安全性事件，旨在探討影響中藥安全性的危險(xiǎn)因素，對(duì)中藥毒性成分、生產(chǎn)工藝、儲(chǔ)藏條件、體質(zhì)差異、給藥劑量、風(fēng)險(xiǎn)管控等方面存在的安全性問(wèn)題進(jìn)行探討，提出加強(qiáng)源頭控制以確保質(zhì)量合格、探明配伍機(jī)制以增效減毒、提高生產(chǎn)標(biāo)準(zhǔn)以推進(jìn)質(zhì)量統(tǒng)一、完善法規(guī)政策以加強(qiáng)管控、健全安全性評(píng)價(jià)體系以確保質(zhì)量達(dá)標(biāo)等建議，以期為促進(jìn)臨床合理用藥、減少中藥安全性事件提供幫助。

This paper reviews the safety incidents of traditional Chinese medicine, caused by such as aristolochic acids, Tripterygium wilfordii, Dysosma versipellis, Areca catechu, Xianling Gubao Capsule, Yuxingcao Injection and Shuanghuanglian Injection, to explore the risk factors affecting the safety of traditional Chinese medicine. This paper reviews the safety problems existing in the toxic components, production process, storage conditions, physical differences, dosage, risk management and control of traditional Chinese medicine, and puts forward suggestions such as strengthening source control to ensure that the quality is qualified, improving production standards to promote quality unification, improving laws and policies to strengthen control, and improving the safety evaluation system to ensure that the quality is up to standard, so as to provide help for promoting the rational use of clinical drugs and reducing the safety incidents of traditional Chinese medicine.

國(guó)家自然科學(xué)基金資助項(xiàng)目（82204938）