目的 近年来何首乌肝中毒事件频发,针对网络销售制何首乌大量增加及质量监测缺失的问题,检测不同批次从网络上购买(网购)的制何首乌质量和肝细胞毒性大小,并比较何首乌不同炮制工艺的减毒效果,为规范和提高何首乌临床用药的安全性提供参考.方法 采用指标成分定量测定、化学指纹图谱和肝细胞毒性评价方法,考察部分网络销售的制何首乌质量差异;比较不同炮制方法对何首乌肝细胞毒性降低效果.结果 网购的26批制何首乌二苯乙烯苷在0.004%～3.442%,其中有8批不符合《中国药典》2010年版规定;指纹图谱相似度在0.052～0.998,其中有6批差异巨大;对肝细胞毒性(IC₅₀)差异较大,其中4批网购的制何首乌样品毒性大于生何首乌对照药材.何首乌常压清蒸法减毒速度较慢,蒸制12 h毒性仅下降13.6%;高压清蒸法和高压黑豆汁蒸法减毒速度相对较快,蒸制5～6 h毒性下降22.1%左右且趋于稳定.结论 网络销售的制何首乌质量参差不齐,相当部分炮制减毒不充分,增加了何首乌肝中毒的风险,应加强何首乌炮制工艺规范化研究;何首乌高压清蒸法的炮制减毒效果较好、时间较短,建议推广采用.

Objective Recently hepatotoxicity induced by Polygoni Multiflori Radix Praeparata (PMRP) frequently happened. To aim at dealing with the problems of latest increase of online shopping PMRP and lack of quality monitoring mechanism, the quality and hepatotoxicity of various batches of online shopping PMRP were analyzed, the toxicity-attenuation effects of various processing technologies of Polygoni Multiflori Radix (PMR) were compared, and the reference for clinical safe medication of PMR was provided. Methods The quality variance of these PMRP was evaluated and the hepatotoxicity-attenuation effects of various processing technologies were compared by adopting index component content determination, chemical fingerprint, and liver cell toxicity evaluation. Results The content of diphenylethylene glycosides in 26 batches of online shopping PMRP was 0.004%-3.442%, therein eight batches could not conform to Chinese Pharmacopoeia 2010; The chemical fingerprint similarity was between 0.052 and 0.998, therein great differences among six batches existed; The hepatotoxicity difference was significant as 9.7 times, therein the toxicity of four groups of online shopping PMRP samples was higher than that of PMR medicinal material. The toxicity of PMRP attenuated slowly using atmospheric pressure steaming method, and the toxicity by steaming 12 h declined only 13.6%; The toxicity of PMRP attenuated relatively fast by high-pressure steaming and high-pressure black soya bean steaming methods, and the toxicity by steaming 5-6 h declined by 22.1% and tended towards stability. Conclusion The quality of online shopping PMRP varies greatly and inadequate processing method increases the liver poisoning risk of PMRP to some extent, which indicates that the researches on technology standardization of PMRP should be strengthened. As well, the high-pressure steaming method can ensure the safety of PMRP and shorten the processing time greatly, which should be expected as a promising processing method.

国家自然科学基金资助项目(81373984)