消栓通络片中三七茎叶及重金属检查

Examination of Stem Leaves of Panax Notoginseng and Heavy Metals in Xiaoshuan Tongluo Tablets

目的建立消栓通络片中三七茎叶的检查方法,同时考察该制剂中重金属残留水平。方法采用薄层鉴别法对消栓通络片中三七茎叶进行筛查;运用电感耦合等离子体质谱法对样品中5种重金属有害元素残留量进行测定,并进行安全风险评估。结果置日光和紫外光(365 nm)下检视,样品色谱中在与三七茎叶皂苷对照提取物色谱相应的位置上未出现相同颜色的斑点;所有样品中有2批砷超标、1批汞超标,而安全风险评估结果显示该制剂整体上所含5种重金属的量对人体所构成的非致癌风险较低。结论所建薄层鉴别法可有效甄别消栓通络片中是否存在三七茎叶冒充三七投料现象,对重金属有害残留量的考察有助于控制该制剂的整体质量。

Objective To establish a method for the examination of stem and leaves of Panax notoginseng in Xiaoshuan Tongluo tablets,and to investigate the residual level of heavy metals in the preparation.Methods Thin layer identification was used to screen the stems and leaves of Panax notoginseng in Xiaoshuan Tongluo tablets.The inductive coupled plasma mass spectrometry was used to determine the residues of five heavy metals and assess the safety risk.Results Under sunlight and ultraviolet light(365 nm),no spots of the same color appeared in the chromatographic position corresponding to the chromatographic position of saponins from stem and leaves of Panax notoginseng.Two lots of arsenic and one lot of mercury in all samples exceeded the limit,and the safety risk assessment showed that the levels of the five heavy metals in the preparation as a whole posed a low non-carcinogenic risk to humans.Conclusion The established thin layer identification method can effectively detect whether the stems and leaves of Panax notoginseng are disguised as panax notoginseng in Xiaoshuan Tongluo tablets,and the investigation of harmful residues of heavy metals can help to control the overall quality of the preparation.