Direct analysis in real time mass spectrometry, a process analytical technology tool for real-time process monitoring in botanical drug manufacturing.
Direct analysis in real time mass spectrometry, a process analytical technology tool for real-time process monitoring in botanical drug manufacturing.
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DOI：
10.1016/j.jpba.2013.12.034
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发表时间：
2014-03
影响因子：
3.4
通讯作者：
Lu Wang;Shanshan Zeng;Teng Chen;Hai-bin Qu
中科院分区：
文献类型：
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作者：
Lu Wang;Shanshan Zeng;Teng Chen;Hai-bin Qu
介绍了一种用于间歇过程监控的过程分析技术（PAT）工具。采用真实的时间直接分析质谱法（DART-MS）对抗癌植物制剂的多组分渗滤过程进行了快速指纹图谱分析。进行了15个批次，其中10个正常操作和5个人为变化的异常批次。所得的多元数据进行了分析，多因素偏最小二乘（MPLS）模型。控制轨迹来自8个正常批次，并通过R2和Q2进行确认。然后通过剩余批次验证批次模型的准确性和诊断能力。通过高效液相色谱（HPLC）分析，对工艺故障进行了解释.此外，一个批次水平的模型被开发，以比较和评估模型的性能。本研究表明，DART-MS在植物生产过程监测中非常有前途。与一般PAT工具相比，DART-MS提供了对有效成分的特定解释，并可用于提高复杂基质中样品的批质量和工艺一致性。
A promising process analytical technology (PAT) tool has been introduced for batch processes monitoring. Direct analysis in real time mass spectrometry (DART-MS), a means of rapid fingerprint analysis, was applied to a percolation process with multi-constituent substances for an anti-cancer botanical preparation. Fifteen batches were carried out, including ten normal operations and five abnormal batches with artificial variations. The obtained multivariate data were analyzed by a multi-way partial least squares (MPLS) model. Control trajectories were derived from eight normal batches, and the qualification was tested byR2andQ2. Accuracy and diagnosis capability of the batch model were then validated by the remaining batches. Assisted with high performance liquid chromatography (HPLC) determination, process faults were explained by corresponding variable contributions. Furthermore, a batch level model was developed to compare and assess the model performance. The present study has demonstrated that DART-MS is very promising in process monitoring in botanical manufacturing. Compared with general PAT tools, DART-MS offers a particular account on effective compositions and can be potentially used to improve batch quality and process consistency of samples in complex matrices.