雷公藤根中Cu超标的原因探究及制剂安全性评价

Study on Cause of Excessive Cu in Tripterygium Wilfordii Root and Safety Evaluation of its Preparation

为探讨雷公藤根中Cu含量超标的原因,评价雷公藤制剂的安全性,分别取雷公藤种植地的土壤、生长3年的雷公藤根、青葙、雷公藤85%乙醇提取液和药渣,加硝酸微波消解。用火焰原子吸收分光光度法分别测定各样品中Cu的含量。测定结果显示,土壤、青葙、雷公藤根、药渣中Cu的含量分别为26.282 8, 23.171 6, 36.742 2, 20.883 3 mg/kg,均超出了《中国药典》标准20 mg/kg,超标原因主要是土壤含铜量过高所致,提取液中Cu的含量为6.975 0 mg/kg(<20 mg/kg),说明雷公藤制剂中Cu含量在安全范围内。

To investigate the cause of the excessive content of Cu in tripterygium wilfordii root and evaluated the safety of tripterygium wilfordii preparation,soil,3-year-old roots and celosia gathered from the planting area of Tripterygium Wilfordii,85%ethyl alcohol extract and residue of Tripterygium Wilfordii were accurately weighed,and microwave digestion with nitric acid was conducted.The content of Cu was determined by atomic absorption spectrophotometry(AAS).The results showed that the content of Cu in soil,Celosia,Tripterygium wilfordii root and dregs were 26.2828,23.1716,36.7422 and 20.8833 respectively,which exceeded the standard set by Chinese Pharmacopoeia by 20 mg/kg.The main reason for exceeding the standard was that the content of Cu in the extract was 6.9750 mg/kg(<20 mg/kg),which indicated that the content of Cu in Tripterygium wilfordii preparation was within the safe range.