连花清瘟胶囊(LHQWC)由13种传统中药组成。在这项研究中,我们采用电感耦合等离子体质谱法(ICP-MS)来量化26种无机元素(Na,Mg,Al,K,Ca,V,Cr,Mn,Fe,Co,Ni,Cu,Zn,Ga,As,Se,Rb,Sr,Ag,Cd,Cs,Ba,Hg,Tl,Pb,U)跨越22批LHQWC。这些结果得到了化学计量学分析和对选定危险元素的健康风险评估的补充。化学计量学分析显示,22批LHQWC的质量差异显著,识别U,Cs,Tl,Rb,Mn,As,Mg,Al作为影响配方一致性的特征元素。此外,健康风险评估表明,虽然铜的水平,As,Cd,Pb,Cr,LHQWC中的汞在可接受的范围内,引起了对某些批次中钒含量的担忧。这些发现强调了全面的元素分析和健康风险评估的必要性,以确保LHQWC的安全和质量。我们的研究为LHQWC和类似草药配方的生产中的质量评估和监管考虑提供了有价值的见解。
Lianhua Qingwen capsule (LHQWC) is composed of 13 traditional Chinese herbs. In this study, we employed inductively coupled plasma mass spectrometry (ICP-MS) to quantify the concentrations of 26 inorganic elements (Na, Mg, Al, K, Ca, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, As, Se, Rb, Sr, Ag, Cd, Cs, Ba, Hg, Tl, Pb, U) across 22 batches of LHQWC. These results were complemented with Chemometrics analysis and health risk assessment of selected hazardous elements. Chemometric analysis revealed significant quality variations among the 22 batches of LHQWC, identifying U, Cs, Tl, Rb, Mn, As, Mg, and Al as characteristic elements influencing formulation consistency. Moreover, the health risk assessment indicated that while levels of Cu, As, Cd, Pb, Cr, and Hg in LHQWC were within acceptable limits, concerns arose regarding vanadium levels in certain batches. These findings underscore the necessity of comprehensive elemental analysis and health risk assessment to ensure the safety and quality of LHQWC. Our study provides valuable insights for both quality evaluation and regulatory considerations in the production of LHQWC and similar herbal formulations.