Issue 17, 2020

Evaluation of a multiple and global analytical indicator of batch consistency: traditional Chinese medicine injection as a case study

Abstract

This paper evaluates a multiple and global analytical indicator of batch consistency in traditional Chinese medicine injections (TCMIs) via a chemometrics tool, which is more comprehensive to appraise quality consistency of different batches of injections than the traditional method of fingerprint similarity. A commonly used TCMI, Salviae miltiorrhizae and ligustrazine hydrochloride injection (SLI), was employed as a model. With the aid of a chemometrics tool (principal component analysis, PCA), evaluation of multiple and global analytical indicators of batch consistency, which included saccharides, phenolic acids and inorganic salts (18 indicators in total), was carried out to appraise the quality consistency of 13 batches of injection provided by the Guizhou Baite Pharmaceutical Co., Ltd. (Guizhou, China). Compared with the traditional HPLC-UV fingerprint similarity evaluation, the method proposed in the paper can more comprehensively and correctly reflect the quality consistency of different batches of injections. In this paper, the multi-index evaluation result showed poor batch consistency, which was more consistent with the determination results, while the fingerprint similarity evaluation results still showed good batch consistency. The HPLC-UV fingerprint reflects only substances with UV absorption, but it is not able to reflect substances without UV absorption or weak UV absorption, which leads to inappropriate conclusions. Therefore, quality consistency of injections can be effectively appraised by evaluation of multiple and global analytical indicators, instead of HPLC-UV fingerprint only. For visualizing the batch consistency of the multiple and global analytical indicators, a heat map was used to represent the fluctuation. Furthermore, critical indicator identification was also applied to select several indicators that should be paid more attention during the process of quality control of injection. And the analysis result showed that Na+, fructose (Fru), glucose (Glc), manninotriose (Man), danshensu (DSS) and salvianolic acid B (SAB) are the indicators that should be given more attention when controlling the quality of injections, also called critical quality control indicators. The proposed method provides a reference for the quality control of TCMIs and has broad application potential.

Graphical abstract: Evaluation of a multiple and global analytical indicator of batch consistency: traditional Chinese medicine injection as a case study

Supplementary files

Article information

Article type
Paper
Submitted
02 Dec 2019
Accepted
27 Feb 2020
First published
11 Mar 2020
This article is Open Access
Creative Commons BY-NC license

RSC Adv., 2020,10, 10338-10351

Evaluation of a multiple and global analytical indicator of batch consistency: traditional Chinese medicine injection as a case study

L. Chen, F. Zhao, W. Li, Z. Chen, J. Pan, D. Xiong, B. Li, Q. Zhang and H. Qu, RSC Adv., 2020, 10, 10338 DOI: 10.1039/C9RA10065B

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