Full Text:   <1146>

Summary:  <1332>

CLC number: R932

On-line Access: 2020-11-05

Received: 2020-07-29

Revision Accepted: 2020-08-14

Crosschecked: 2020-10-15

Cited: 0

Clicked: 2182

Citations:  Bibtex RefMan EndNote GB/T7714


Wen-long Li


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Journal of Zhejiang University SCIENCE B 2020 Vol.21 No.11 P.897-910


A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets

Author(s):  Si-jun Wu, Ping Qiu, Pian Li, Zheng Li, Wen-long Li

Affiliation(s):  College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; more

Corresponding email(s):   wshlwl@tjutcm.edu.cn

Key Words:  Process analytical technology, Blending process, Near-infrared spectroscopy, End-point determination

Si-jun Wu, Ping Qiu, Pian Li, Zheng Li, Wen-long Li. A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets[J]. Journal of Zhejiang University Science B, 2020, 21(11): 897-910.

@article{title="A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets",
author="Si-jun Wu, Ping Qiu, Pian Li, Zheng Li, Wen-long Li",
journal="Journal of Zhejiang University Science B",
publisher="Zhejiang University Press & Springer",

%0 Journal Article
%T A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets
%A Si-jun Wu
%A Ping Qiu
%A Pian Li
%A Zheng Li
%A Wen-long Li
%J Journal of Zhejiang University SCIENCE B
%V 21
%N 11
%P 897-910
%@ 1673-1581
%D 2020
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B2000417

T1 - A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets
A1 - Si-jun Wu
A1 - Ping Qiu
A1 - Pian Li
A1 - Zheng Li
A1 - Wen-long Li
J0 - Journal of Zhejiang University Science B
VL - 21
IS - 11
SP - 897
EP - 910
%@ 1673-1581
Y1 - 2020
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B2000417

Objectives: This study is aimed to explore the blending process of Dahuang soda tablets. These are composed of two active pharmaceutical ingredients (APIs, emodin and emodin methyl ether) and four kinds of excipients (sodium bicarbonate, starch, sucrose, and magnesium stearate). Also, the objective is to develop a more robust model to determine the blending end-point. Methods: Qualitative and quantitative methods based on near-infrared (NIR) spectroscopy were established to monitor the homogeneity of the powder during the blending process. A calibration set consisting of samples from 15 batches was used to develop two types of calibration models with the partial least squares regression (PLSR) method to explore the influence of density on the model robustness. The principal component analysis-moving block standard deviation (PCA-MBSD) method was used for the end-point determination of the blending with the process spectra. Results: The model with different densities showed better prediction performance and robustness than the model with fixed powder density. In addition, the blending end-points of APIs and excipients were inconsistent because of the differences in the physical properties and chemical contents among the materials of the design batches. For the complex systems of multi-components, using the PCA-MBSD method to determine the blending end-point of each component is difficult. In these conditions, a quantitative method is a more suitable alternative. Conclusions: Our results demonstrated that the effect of density plays an important role in improving the performance of the model, and a robust modeling method has been developed.




Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article


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