Quality Control of Shangke Jiegu Tablets Based on Double Factors

YANG Yi; XI Hao-ying; MENG Xian-sheng; BAO Yong-rui; WANG Shuai; LI Tian-jiao

doi:10.13422/j.cnki.syfjx.2018030077

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Quality Control of Shangke Jiegu Tablets Based on Double Factors

更新时间：2024-01-04

- Quality Control of Shangke Jiegu Tablets Based on Double Factors
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 24, Issue 3, Pages: 77-82(2018)
- 作者机构：
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- DOI：10.13422/j.cnki.syfjx.2018030077
  CLC： R286.0
- Published：2018
- 稿件说明：
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YANG Yi, XI Hao-ying, MENG Xian-sheng, et al. Quality Control of Shangke Jiegu Tablets Based on Double Factors[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(3): 77-82.
DOI：

YANG Yi, XI Hao-ying, MENG Xian-sheng, et al. Quality Control of Shangke Jiegu Tablets Based on Double Factors[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(3): 77-82. DOI： 10.13422/j.cnki.syfjx.2018030077.

摘要

目的：通过HPLC和ICP-MS建立伤科接骨片有机及无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全定量检测。结果：建立10批次伤科接骨片的多波长融合指纹图谱，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，Pb，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，以有机和无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。

Abstract

Objective:To establish a comprehensive quality control method for Shangke Jiegu tablets based on organic and inorganic double factors by using HPLC and ICP-MS

in order to improve its quality control standard. Method:The fingerprint of 10 batches of the Shangke Jiegu tablets was established by HPLC

and their similarity was calculated with the similarity evaluation system. Semi-quantitative analysis of the inorganic elements was done for 10 batches of the Shangke Jiegu tablets by ICP-MS. In the process of data analysis

MPP software was employed for principal component analysis (PCA) to screen difference elements. Combining with related literature

full-quantitative analysis was done for the difference elements and heavy metals associated with efficacy as well as harmful elements. Result:The HPLC fingerprint of the Shangke Jiegu tablets was set up based on multi-wavelength fusion. 27 common peaks were marked and the similarity among samples was over 0.92.Combining with the results of semi-quantitative analysis and related literature

full-quantitative analysis was done for 12 inorganic elements

including common elements (Ca

Na)

trace elements (Fe

Mn)

and heavy metals and harmful elements (Cu

Cd). The quality evaluation system was set up based on organic and inorganic double factors. Conclusion:The method with good reproducibility is simple and accurate

providing foundation for the quality control of Shangke Jiegu tablets based on organic and inorganic double factors.

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