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机构地区:[1]苏州泽达兴邦医药科技有限公司,江苏 苏州 [2]浙江大学药学院,浙江 杭州 [3]上海上药杏灵科技药业股份有限公司,上海
出 处:《药物化学》2023年第2期108-115,共8页Hans Journal of Medicinal Chemistry
摘 要:目的:本文建立银杏叶粗提液聚酰胺层析洗脱过程轨迹,实现对洗脱过程的全程在线监控,监控中药批次间生产质量差异。方法:采集多批次银杏叶洗脱过程近红外光谱数据,结合MSPC控制技术建立过程轨迹,实现对洗脱过程的监控。结果:建立的银杏叶粗提液聚酰胺层析洗脱过程主成分得分和霍特林T2轨迹图可检测洗脱过程中的异常情况。结论:将MSPC与NIR相结合建立的轨迹图可反应洗脱全过程中的变化情况,具备中药生产全过程监控的可行性。Objective: In this paper, by establishing the polyamide chromatography elution process trajectory of ginkgo folium crude extract, the whole online monitoring of the elution process is realized, and the production quality difference between batches of traditional Chinese medicine is monitored. Methods: By collecting the nearinfrared spectral data of multiple batches of ginkgo folium elution process, combined with MSPC control technology, the process trajectory was established to realize the monitoring of the elution process. Results: The established principal component score and Hotelling’s T2 trajectory diagram of the polyamide chromatography elution process of the crude extract of ginkgo folium can detect abnormalities in the elution process. Conclusion: The trajectory map established by combining MSPC with NIR can reflect the changes in the whole process of elution, and has the feasibility of monitoring the whole process of TCM production.
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