摘要
目的:及时有效监测银杏叶提取物柱层析洗脱液的生产过程,减少人员操作间的差异,提高生产效率。方法:利用近红外光谱在线监控技术监测银杏叶提取物柱层析洗脱液中总黄酮成分,并通过HPLC离线分析所得的多指标成分含量变化趋势图进行对比分析,验证可否用于生产状况实时监测,指导柱层析洗脱液收集起点和终点。结果:定量模型预测含量与液相色谱检测含量相关性良好,可以快速判断柱层析起点和终点。结论:该方法使柱层析生产操作简便、快捷,提高了生产效率。有利于产品质量的均一、稳定、可控。
Objective： To timely and effectively monitor column chromatography of Ginkgo biloba extract,reduce the difference between the operating staff,and improve production efficiency. Methods： The total flavonoid content in collected liquid was monitored by near- infrared spectroscopy. The online trend curves of adaptive moving window standard deviation function and similarity function obtained by the proposed method were validated by a comparison with the content variation curves of multiple indicative components analyzed by HPLC,and these trend curves demonstrated their potential for real- time process status monitoring,accurately determining the beginning point,the peak point,the end point of the elution,and the phase change from water solution to ethanol solution. Results： The content predicted by quantitative model and liquid chromatography had good correlated,which can quickly determine the chromatography beginning point and the end point. Conclusion： The method is proved to be simple and accurate,which is helpful to improve the production efficiency and achieve uniform,stable,and controllable product quality.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第11期2098-2101,共4页
Chinese Journal of Pharmaceutical Analysis
基金
中药注射剂质量标准化高技术产业化示范工程(发改办高技〔2007〕2490号)
关键词
近红外光谱技术
生产过程在线监控
银杏叶提取物
银杏总黄酮
柱层析
起点终点判断
near-infrared spectroscopy technology
online monitoring of the production process
Ginkgo biloba extract
total ginkgo flavonoids
column chromatography
starting point to end point judgment
