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. 2024 Nov 5;17(3):575-583.
doi: 10.1016/j.chmed.2024.11.001. eCollection 2025 Jul.

Research on comprehensive quality consistency evaluation strategy for TCM Granules: A case study with sugar-free Yangwei Granules produced by fluid-bed granulation

Jie Zhao  1   2 , Geng Tian  1   2 , Haibin Qu  1   2
Affiliations

Research on comprehensive quality consistency evaluation strategy for TCM Granules: A case study with sugar-free Yangwei Granules produced by fluid-bed granulation

Jie Zhao et al. Chin Herb Med. .

Abstract

Objective: To develop a quality consistency evaluation strategy for traditional Chinese medicine (TCM) granules using sugar free Yangwei Granules as a model drug, and demonstrate the effectiveness of the developed method.

Methods: The strategy integrates several methods including, HPLC fingerprint and physical fingerprint methods analyze the similarity in chemical and physical properties of the TCM granule samples. Near-infrared (NIR) spectroscopy with principal components cluster analysis method is used to monitor normal operating conditions (NOC) samples accurately and to identify different types of abnormal operating conditions (AOC) samples, particularly those that deviate from the normal range.

Results: The combined use of HPLC fingerprint and physical fingerprint provides insights into the chemical and physical properties of the samples. NIR spectroscopy, combined with principal components cluster analysis, achieves high accuracy in monitoring NOC samples and identifying AOC samples without misjudgment. The approach proves useful as a complementary method in cases where HPLC fingerprint and physical fingerprint alone lack sufficient resolution.

Conclusion: This study establishes the feasibility and utility of the integrated approach for assessing the quality consistency of TCM granules. The strategy shows a high degree of generalization and holds significant importance for enhancing the quality control processes of TCM granules.

Keywords: chemometrics; multivariate analysis; near-infrared spectroscopy; quality consistency evaluation strategy; sugar-free Yangwei Granules; traditional Chinese medicine granules.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Quality consistency evaluation strategy for TCM granules.
Fig. 2
Fig. 2
HPLC fingerprint (A) and cosine coefficients (B) of 26 samples.
Fig. 3
Fig. 3
Physical fingerprint (A) and cosine coefficients (B) of 26 samples.
Fig. 4
Fig. 4
Original (A) and preprocessed (B) NIR spectra.
Fig. 5
Fig. 5
Score plot of 26 samples for sugar free Yangwei Granules form A–E. A, PC1-PC2; B, PC1-PC3.
Fig. 6
Fig. 6
Classification results of 26 batches of Sugar-free Yangwei Granules by principal components cluster analysis.
Fig. 7
Fig. 7
Classification results of PCA cluster analysis. A, PC1-PC2; B, PC1-PC3.
Fig. 8
Fig. 8
Raw (A) and preprocessed (B) NIR spectra data for 219 collected samples.
Fig. 9
Fig. 9
PCA score of 151 batches after eliminating abnormal samples by Mahalanobis distance method based on Chauvenet rule (A), and score chart for 146 samples after outlier samples removed (B). The sample points were color-coded based on their manufacturing dates.
Fig. 10
Fig. 10
Hotelling’s T2 control chart of 146 samples. The sample points were color-coded based on their manufacturing dates.
Fig. 11
Fig. 11
Score chart of validation set.
Fig. 12
Fig. 12
Hotelling's T2 control chart of validation set.
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