Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet

Anyi Zhao; Lukun Xiao; Sha Chen; Hong Yi; Jipeng Di; Cong Guo; Jintang Cheng; Jun Zhang; Jinzhu Jiang; Jing Zhang; Yan Liu; An Liu

doi:10.1016/j.jpba.2022.114951

Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet

J Pharm Biomed Anal. 2022 Sep 20:219:114951. doi: 10.1016/j.jpba.2022.114951. Epub 2022 Jul 19.

Authors

Anyi Zhao¹, Lukun Xiao¹, Sha Chen¹, Hong Yi¹, Jipeng Di¹, Cong Guo¹, Jintang Cheng¹, Jun Zhang¹, Jinzhu Jiang¹, Jing Zhang¹, Yan Liu², An Liu³

Affiliations

¹ Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
² Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China. Electronic address: yliu1980@icmm.ac.cn.
³ Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China. Electronic address: aliu@icmm.ac.cn.

PMID: 35908413
DOI: 10.1016/j.jpba.2022.114951

Abstract

The compositions of traditional Chinese medicines are extremely complex,as a result, exploring consistent quality is demanded and challenging. Quality consistency of products obtained from the same manufacturer has received little attention. The strategy of quality consistency evaluation (QCE) has been proposed as a novel method for quality control of Traditional Chinese Medicine Patent Prescription (TCMPP). This study aimed to establish a comprehensive QCE strategy for Compound Danshen Tablet (CDT). High Performance Liquid Chromatography-Diode Array Detector and Gas Chromatography-Mass Spectrometry were separately applied to determinate the content of seven and two index components, which representing the quality actuality of different raw medicines. The dissolution test was designed to obtain the dissolution ratios of CDT samples. QCE can provide the intra-batch content consistency difference (P_A), inter-batch content consistency difference (P_B), and dissolution ratio consistency difference (P_R) values. The consistency of CDT samples from 15 different manufacturers (75 batches) was evaluated by principal component analysis (PCA), which showed that the total content (nine index components) of the 75 batches of samples obtained from 15 manufacturers ranged from 22.11 to 38.45 mg·tablet^-1. The dissolution ratios ranged from 74.8% to 116.4%. The P_A values of 15 manufacturers ranged from 2.4% to 12.2%, and the P_B (11.1-45.1%) values were higher than the P_A values. The P_R values reflecting the various dissolution ratios in vitro ranged from 8.1% to 57.5%. The three consistency factors were ranked by PCA, and products of the 15 manufacturers were classified into three categories. The P_A, P_B, and P_R values provided a comprehensive and effective approach for monitoring the quality consistency of CDT and can serve as an example of QCE for other TCMPP.

Keywords: Compound danshen tablet; Dissolution ratio consistency difference; Inter–batch content consistency difference; Intra–batch content consistency difference; Quality consistency evaluation.

MeSH terms

Chromatography, High Pressure Liquid / methods
Drugs, Chinese Herbal* / chemistry
Medicine, Chinese Traditional
Quality Control
Salvia miltiorrhiza* / chemistry
Tablets

Substances

Drugs, Chinese Herbal
Tablets