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目的:通过1IPLC和ICP-MS两种方法建立伤科接骨片有机及兀机成分的全面质量控制方法,完善其质量控制标准、方法:采用HPLC法建立10批次伤科接骨片指纹图谱,利用软件计算其相似度:采用ICP-MS法对10批次伤科接骨片中无机元素进行半定量检测,利用MPP软件对数据进行主成分分析,筛选差异元素,结合相关文献,对与复方功能主治相关的差异元素和重金属及有害元素进行伞定量检测。结果:建立10批次伤科接骨片的多波长融合指纹图潜,确定27个共有峰,样品间相似度均>0.92。结合半定量分析结果及相关文献,对伤科接骨片中12种无机元素进行全定量检测,包括常量元素K,Ca,Na,Mg,微量元素Fe,Zn,Mn以及重金属及有害元素Cu,Hg,As,Ph,Cd,从有机和无机成分两方面建立伤科接骨片质量评价体系。结论:该方法简便,重复性好,稳定可靠,以有机和兀机成分双因子作为基础为伤科接骨片全面的质量控制提供依据。
OBJECTIVE: To establish a comprehensive quality control method for organic and inorganic components of Shang Ke Jie Gou tablets by 1IPLC and ICP-MS, and to improve its quality control standards. Methods: The fingerprints of 10 batches of Shangkejieke tablets were established by HPLC. Software to calculate the similarity: The ICP-MS method was used to detect the inorganic elements in 10 batches of injured orthopedic plates. The MPP software was used to perform the principal component analysis and the screening of the difference elements. Related differences in elements and heavy metals and harmful elements for umbrella quantitative detection. Results: The multi-wavelength fusion fingerprints of 10 batches of Shangkejieke tablets were established and 27 common peaks were identified. The similarity between samples was> 0.92. Combined with the results of semi-quantitative analysis and related literatures, 12 kinds of inorganic elements in Shangke JiaoGu tablet were detected, including K, Ca, Na, Mg, trace elements Fe, Zn, Mn, heavy metals and harmful elements Cu, Hg , As, Ph and Cd, the quality evaluation system of Shangke Jiegu piece was established from both organic and inorganic components. Conclusion: The method is simple, reproducible, stable and reliable. Based on the two factors of organic and rheumatoid factors, this method provides a basis for comprehensive quality control of Shangke Jiegu tablets.