成都市售即食中药预包装产品重金属含量分析及健康风险评估

目的:对成都市售即食中药预包装产品重金属进行风险评估。方法:在市区药店购买了78批即食中药预包装产品,其中三七粉25批,天麻粉21批,灵芝粉16批,灵芝孢子粉16批。采用ICP-MS法测定重金属铅(Pb),镉(Cd),汞(As),砷(As)和铜(Cu)的含量,结果与2015年版《中国药典》规定的限量值进行比较分析。采用国际通用的靶标危害系数(THQ)和综合危险指数(HI)评估重金属对人体造成的非致癌健康风险。结果:按限量值计算,三七粉Pb,Cd和As超标率分别为4. 0%,76. 0%和20. 0%;天麻粉Cd超标率为23. 8%;灵芝粉Cd超标率为62. 5%;灵芝孢子粉Cd超标率为18. 8%。Cd在4种样品中均有超标,Hg和Cu没有超标样品。分别按产品推荐的每日摄入量下限和上限进行风险评估,三七粉有4%~20%的样品存在As摄入风险(THQAs 1),有12%~32%的样品存在元素综合摄入风险(HI 1)。天麻粉、灵芝粉和灵芝孢子粉样品THQ值和HI值均1,无摄入风险。结论:2015年版《中国药典》规定的中药材重金属限量标准是否适用于即食中药,应进一步探讨相关标准。

Concentration Analysis and Human Health Risk Assessment of Heavy Metals in Ready-to-use TCM Prepackaged Products in Chengdu

Objective: To assess the risks of heavy metals in ready-to-use traditional Chinese medicine (TCM) prepackaged products in Chengdu market. Method: The 78 batches of ready-to-use TCM prepackaged products were purchased from urban pharmacies, including 25 batches of Notoginseng Radix powder, 21 batches of Gastrodiae Rhizoma powder, 16 batches of Ganoderma powder and another 16 batches of Ganoderma Spore powder. The contents of heavy metals Pb,Cd,Hg,As and Cu were determined by using inductively coupled plasma mass spectrometry (ICP-MS). The results were compared with the relevant limited values in Chinese Pharmacopoeia(2015 edition); the internationally accepted target hazard quotients (THQs) and hazard index (HI) were adopted to evaluate the non-carcinogenic health risk of heavy metals. Result: The over-standard rate was Pb(4.0%),Cd(76.0%) and As(20.0%) for Notoginseng Radix powder; Cd (23.8%) for Gastrodiae Rhizoma powder; Cd (62.5%) for Ganoderma powder; and Cd (18.8%) for Ganoderma Spore powder according to the limit standard of the Chinese Pharmacopeia 2015 (ChP2015). The results showed that the contents of Cd exceeded the standard in all 4 samples, while Hg and Cu did not exceed the standard limits. According to the recommended upper or lower limits for the daily intake, As intake risk was found in 4%-20% of the Notoginseng Radix powder (THQ_As>1); and element comprehensive intake risk was found in 12%-32% of Notoginseng Radix powder (HI>1). The THQ values and HI values for Gastrodiae Rhizoma powder,Ganoderma powder and Ganoderma Spore powder were all less than 1, showing no intake risks. Conclusion: The current heavy metal standards in Chinese Pharmacopoeia 2015 are not suitable for ready-to-use TCM, so more reasonable standards shall be further discussed.