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目的针对市场上复方丹参片质量差异较大的现状,探索能够全面反映复方丹参片质量信息并能快速检测其产品均一性的方法。方法以5个厂家55个批号的复方丹参片为样本,选用便携式AOTF第五代近红外光谱仪采集光谱,通过TheUnscrambler分析软件,以主成分分析法对样本进行分析。结果无论同批号还是不同批号的复方丹参片间均具有质量均一性差异,利用该技术可实现复方丹参片的快速无损质量均一性分析。结论可借鉴AOTF-NIR的技术优势构建复方丹参片快速质量控制系统,规范产品质量。
Aim To investigate the quality difference of compound Danshen Tablets in the market, to explore a method that can comprehensively reflect the quality information of compound Danshen Tablets and quickly detect the homogeneity of its products. Methods 55 batches of compound Danshen tablets from 5 manufacturers were selected as samples. The portable AOTF fifth generation near-infrared spectrometer was used to collect the spectra. The analysis software of TheUnscrambler was used to analyze the samples by principal component analysis. Results No matter whether the same or different batches of compound Danshen tablets have a difference in quality between the homogeneity, the use of the technology can be achieved quickly and without loss of quality compound Danshen quality analysis. Conclusion The technical advantages of AOTF-NIR can draw lessons from the rapid quality control system of Compound Danshen Tablets to standardize product quality.