杨婵;徐冰;张志强;王馨;史新元;付静;乔延江;
YANG Chan;XU Bing;ZHANG Zhi-qiang;WANG Xin;SHI Xin-yuan;FU Jing;QIAO Yan-jiang;Research Center of Traditional Chinese Medicine Information Engineering,Beijing University of Chinese Medicine;Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine;Beijing Tcmages Pharmaceutical Co.,LTD;

• 1:北京中医药大学中药信息工程研究中心
• 2:中药生产过程控制与质量评价北京市重点实验室
• 3:北京康仁堂药业有限公司

摘要(Abstract)：

混合均匀度是保证中药配方颗粒产品批内质量一致性的关键。该文以乌梅配方颗粒中乌梅提取物粉末-糊精体系(糊精比例10%)为研究对象,在其混合过程中设计多个取样位点,将采集的粉末样品进行近红外(near infrared,NIR)漫反射光谱分析,并结合移动窗F检验(moving window F test,MW-F test)法对混合过程均匀度进行判断。同时采用HPLC对混合过程中枸橼酸的含量变化进行分析,以验证MW-F test法的有效性。结果显示乌梅配方颗粒混合过程在200~300 r达到混匀状态,300~400 r出现脱混现象,400 r后又趋于稳定,移动窗F检验分析结果与HPLC分析结果基本一致。移动窗F检验算法通过F界值设定均匀度判别阈值,避免了常规移动窗标准偏差法中阈值设定的随机性和模糊性,可推广应用于其他中药粉末混合过程的在线监控。
Blending uniformity is essential to ensure the homogeneity of Chinese medicine formula particles within each batch. This study was based on the blending process of ebony spray dried powder and dextrin( the proportion of dextrin was 10%),in which the analysis of near infrared( NIR) diffuse reflectance spectra was collected from six different sampling points in combination with moving window F test method in order to assess the blending uniformity of the blending process. The method was validated by the changes of citric acid content determined by the HPLC. The results of moving window F test method showed that the ebony spray dried powder and dextrin was homogeneous during 200-300 r and was segregated during 300-400 r. An advantage of this method is that the threshold value is defined statistically,not empirically and thus does not suffer from threshold ambiguities in common with the moving block standard deviatiun( MBSD). And this method could be employed to monitor other blending process of Chinese medicine powders on line.

关键词(KeyWords)： 中药配方颗粒;混合均匀度;近红外;移动窗F检验法;过程分析技术
Chinese medicine formula particles;blending homogeneity;near infrared;moving window F test method;process analytical technology

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81403112);; 北京市自然科学基金项目(7154217);; 中药生产过程控制与质量评价北京市重点实验室2015年度科技创新基地培育与发展专项(Z151100001615065);; 北京中医药大学自主选题项目(2016-JYB-XS110)

作者(Author): 杨婵;徐冰;张志强;王馨;史新元;付静;乔延江;
YANG Chan;XU Bing;ZHANG Zhi-qiang;WANG Xin;SHI Xin-yuan;FU Jing;QIAO Yan-jiang;Research Center of Traditional Chinese Medicine Information Engineering,Beijing University of Chinese Medicine;Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine;Beijing Tcmages Pharmaceutical Co.,LTD;

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DOI:

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