ICP-MS法分析脑震宁颗粒无机元素组成
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摘要
目的采用电感耦合等离子体质谱(ICP-MS)法对脑震宁颗粒无机元素组成进行分析,为其产品质量均一性和安全性评价奠定基础。方法脑震宁颗粒样品进行微波消解处理,采用ICP-MS法定量测定10批样本中18种无机元素的含量,通过Heatmaps图谱、Pearson相关系数图对结果进行分析;通过无机元素指纹图谱、主成分分析(PCA)结合聚类分析对质量均一性进行评价。结果脑震宁颗粒中无机元素以K、Ca、P、Na、Mg、Fe为主,且不同元素含量之间存在着一定正相关性。As、Hg、Cd、Pb、Cu这5种重金属元素的限量符合《中国药典》2015年版限度规定。采用平均数和中位数法分别建立无机元素对照指纹图谱,从指纹图谱相似度、聚类分析、PCA结果来看,脑震宁颗粒无机元素的质量均一性较好。PCA结果显示,K、Mg、Sr、Mn、P、Pb等元素可能是影响脑震宁颗粒无机元素质量波动的特征元素。结论本研究初步明确了脑震宁颗粒的无机元素组成,为其质量均一性和安全性评价奠定了基础。
Objective To analyze the inorganic elements composition of Naozhenning Granules(NG) by inductively coupled plasma spectrometer(ICP-MS), in order to evaluate the uniformity and safety of NG. Methods The sample of NG was prepared using the microwave digestion method, and the levels of 18 inorganic elements in 10 batches of NG were determined by ICP-MS. Then the results were analyzed by Heatmaps and Pearson Correlations. The uniformity of the products was evaluated by Inorganic elemental fingerprint, principal components analysis, and Cluster analysis. Results The main inorganic elements in NG were K, Ca, P, Na, Mg,Fe, and there was positive correlations among the different elements. The contents of five heavy metal elements, including As, Hg, Cd,Pb, and Cu, were below the limit of Chinese Pharmacopoeia 2015. The inorganic elements reference fingerprint of NG was generated using the average and median methods. The results of fingerprint similarity, cluster analysis, and principal component analysis showed that the inorganic elements of NG showed good uniformity. The results of principal component analysis showed that K, Mg, Sr, Mn, P,and Pb may be the characteristic elements influencing the quality fluctuation of inorganic elements of NG. Conclusion This study determined the inorganic element composition of NG, which laid a foundation for its uniformity and safety evaluation of NG.
Objective To analyze the inorganic elements composition of Naozhenning Granules(NG) by inductively coupled plasma spectrometer(ICP-MS), in order to evaluate the uniformity and safety of NG. Methods The sample of NG was prepared using the microwave digestion method, and the levels of 18 inorganic elements in 10 batches of NG were determined by ICP-MS. Then the results were analyzed by Heatmaps and Pearson Correlations. The uniformity of the products was evaluated by Inorganic elemental fingerprint, principal components analysis, and Cluster analysis. Results The main inorganic elements in NG were K, Ca, P, Na, Mg,Fe, and there was positive correlations among the different elements. The contents of five heavy metal elements, including As, Hg, Cd,Pb, and Cu, were below the limit of Chinese Pharmacopoeia 2015. The inorganic elements reference fingerprint of NG was generated using the average and median methods. The results of fingerprint similarity, cluster analysis, and principal component analysis showed that the inorganic elements of NG showed good uniformity. The results of principal component analysis showed that K, Mg, Sr, Mn, P,and Pb may be the characteristic elements influencing the quality fluctuation of inorganic elements of NG. Conclusion This study determined the inorganic element composition of NG, which laid a foundation for its uniformity and safety evaluation of NG.
引文
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[13]迟鸿悦,李文影,李乐乐,等.ICP-MS法测定人参中6种重金属元素[J].吉林中医药,2018,38(8):954-957.
[14]康玉,刘先华,王斌.基于ICP-MS法的桂枝茯苓胶囊中无机元素分析[J].中草药,2018,49(14):3292-3297.
[15]丁华永,彭华毅,林绥.基于ICP-MS法的麝香保心丸中26种无机元素分析[J].中草药,2018,49(4):847-852.
[16]王宝丽,李志,荆淼,等.微波消解ICP-MS法测定清血八味片中32种无机元素[J].中草药,2017,48(10):1983-1990.
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[21]王守军,阎庆华,朱美丽,等.颅脑损伤后脑脊液、血液中碳酸氢根、糖、电解质、微量元素含量的研究[J].中华神经医学杂志,2004,3(1):31-34.
[22]徐素萍.微量元素铁与人体健康的关系[J].中国食物与营养,2007(12):51-54.
[23]杨心乐,王桂兰,张忠诚.锰与人体健康[J].医学综述,2006,12(18):1134-1136.
[24]陈文强.微量元素锌与人体健康[J].微量元素与健康研究,2006,23(4):62-65.
[25]黄海霞,黄学梅,徐海涛,等.七种安神类中草药Zn、Fe含量的测定[J].广东微量元素科学,2015,22(2):33-36.
[26]张文玲,孙瑞香,魏洪芹,等.某些微量元素与人体健康的关系[J].山东地质,2003,19(S1):40-43.
[2]于舒婷,刘海霞,李昆,等.采用UHPLC-QExactive轨道肼高分辨质谱快速识别脑震宁颗粒的化学成分[J].药学学报,2018,53(4):609-620.
[3]卢紫娟,刘海霞,李昆,等.基于网络药理学的脑震宁颗粒治疗脑外伤的机制分析[J].中草药,2018,49(15):3531-3540.
[4]李献玉,郝少君,王希东,等.高效液相色谱法同时测定脑震宁颗粒中丹酚酸B和橙皮苷的含量[J].中国医院药学杂志,2010,30(17):1508-1510.
[5]李军,李献玉.HPLC法测定脑震宁颗粒中阿魏酸和橙皮苷的含量[J].解放军药学学报,2009,25(3):264-265.
[6]江建军.脑震宁等治疗脑外伤后综合征疗效观察[J].现代中西医结合杂志,2008,17(9):1371.
[7]Niu X X,Chen X W,Su H,et al.Changes of secondary metabolites and trace elements in Gentiana macrophylla flowers:A potential medicinal plant part[J].Chin Herb Med,2014,6(2):145-151.
[8]张秀娟,芦清,何春阳.药材中微量元素测定方法的研究进展[J].药物评价研究,2017,40(4):566-570.
[9]谭绿贵,傅先兰,张鑫,等.微量元素·人体健康·环境变化[J].微量元素与健康研究,2005,22(4):49-51.
[10]张亚丽,王东青,尹晓峰.微量元素与中药功效关系探讨[J].国医论坛,2012,27(6):20-21.
[11]张柯瑶,郭惠,王媚,等.扶正固本类中药中微量元素含量测定及药效关系研究[J].陕西中医,2017,38(3):398-400.
[12]田柱萍,何邦平,王小燕,等.中药材的药效与其所含微量元素关系的研究进展[J].微量元素与健康研究,2005,22(4):54-56.
[13]迟鸿悦,李文影,李乐乐,等.ICP-MS法测定人参中6种重金属元素[J].吉林中医药,2018,38(8):954-957.
[14]康玉,刘先华,王斌.基于ICP-MS法的桂枝茯苓胶囊中无机元素分析[J].中草药,2018,49(14):3292-3297.
[15]丁华永,彭华毅,林绥.基于ICP-MS法的麝香保心丸中26种无机元素分析[J].中草药,2018,49(4):847-852.
[16]王宝丽,李志,荆淼,等.微波消解ICP-MS法测定清血八味片中32种无机元素[J].中草药,2017,48(10):1983-1990.
[17]闫德祺,王刚,高玉松,等.脑震荡的诊疗研究进展[J].华南国防医学杂志,2018,32(2):133-136.
[18]韩银.微量元素与人体健康[J].乡村科技,2015(5):45-45.
[19]李淑芹,翟俊民.微量元素与人体健康的关系[J].中国地方病防治杂志,2008,23(6):433-434.
[20]耿华田.镁元素与人体健康[J].中学生物学,2005,21(6):7-8.
[21]王守军,阎庆华,朱美丽,等.颅脑损伤后脑脊液、血液中碳酸氢根、糖、电解质、微量元素含量的研究[J].中华神经医学杂志,2004,3(1):31-34.
[22]徐素萍.微量元素铁与人体健康的关系[J].中国食物与营养,2007(12):51-54.
[23]杨心乐,王桂兰,张忠诚.锰与人体健康[J].医学综述,2006,12(18):1134-1136.
[24]陈文强.微量元素锌与人体健康[J].微量元素与健康研究,2006,23(4):62-65.
[25]黄海霞,黄学梅,徐海涛,等.七种安神类中草药Zn、Fe含量的测定[J].广东微量元素科学,2015,22(2):33-36.
[26]张文玲,孙瑞香,魏洪芹,等.某些微量元素与人体健康的关系[J].山东地质,2003,19(S1):40-43.