【摘要】 目的 中药颗粒剂的无机元素直接影响其药效及安全性，建立测定肾康宁颗粒中的11种微量元素含量的方法，为肾康宁颗粒质量一致性标准控制提供依据。方法 采用湿硝解法处理肾康宁颗粒后，用原子吸收分光光度法（AAS）测定肾康宁颗粒中各元素含量，使用火焰原子吸收法（FAAS）测定钾、钙、钠、镁、锌、铁、锰和铜8种元素；石墨炉原子吸收法（GFAAS）测定铅、镉和镍3种元素，在方法学验证的基础上完成含量测定。结果 肾康宁颗粒中含有丰富的无机元素，各元素方法学验证的线性、仪器精密度、样品重复性、稳定性结果良好、回收率在99.1%～102.1%之间，RSD在0.5%～2.0%之间。结论 本研究建立了肾康宁颗粒中11种元素的测定方法，可为肾康宁颗粒一致性标准控制和安全性评价提供研究思路，为中成药质量标准化建立和临床应用评价提供参考方向。更多还原

【Abstract】 Objective To provide a basis for consistency standard control of Shenkangning Granules, a method was established for determining the contents of 11 trace elements, as the inorganic elements in Chinese herbal granules directly affected their therapeutic efficacy and safety. Methods Following sample pretreatment via wet digestion, the contents of various elements in Shenkangning Granules were determined using atomic absorption spectrophotometry(AAS). Flame atomic absorption spectrometry(FAAS) was employed for the quantification of eight elements(K, Ca, Na, Mg, Zn, Fe, Mn, Cu), while graphite furnace atomic absorption spectrometry(GFAAS) was applied for the analysis of three trace elements(Pb, Cd, Ni). The content determination was completed following methodological validation. Results Shenkangning Granules were found to contain abundant inorganic elements. The methodological validation demonstrated satisfactory linearity, instrumental precision, repeatability, and stability. The recovery rates ranged from 99.1% to 102.1%, with RSD values between 0.5% and 2.0%. Conclusion This study establishes a method for determining 11 elements in Shenkangning Granules, which provides insights into consistency control and safety evaluation of the product. It also offers a reference for quality standardization and clinical application assessment of Chinese herbal medicine.更多还原