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Overall control herbal medicine in best consistency
Hui Yan1, Guoxiang Sun1, Jing Zhang1
1College of Pharmacy, Shenyang Pharmaceutical University, 110016, China.
Journal of Pharmaceutical and Biomedical Analysis
|January 8, 2021
Summary
A new standard preparation (SP) method using quantitative fingerprints effectively controls compound licorice tablet (CPLT) quality. This systematic approach ensures consistent, high-quality CPLTs across manufacturers.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Quality Control
Background:
- Traditional Chinese Medicine quality control presents challenges in ensuring consistency.
- Compound licorice tablets (CPLTs) require robust methods for quality assurance.
- Existing methods may not fully capture the complexity of CPLT quality.
Purpose of the Study:
- To develop and validate a standard preparation (SP) method for controlling CPLT quality.
- To establish a systematically quantified fingerprint method (SQFM) for CPLT evaluation.
- To assess the quality consistency of CPLTs from multiple manufacturers.
Main Methods:
- High-Performance Liquid Chromatography (HPLC) for fingerprint analysis.
- Systematically Quantified Fingerprint Method (SQFM) using five marker compounds.
- Quantitative Analysis of Multi-Components by Single-Marker (QAMS) method.
- Ultraviolet (UV) full fingerprint dissolution analysis.
Main Results:
- All 145 batches of CPLTs from 9 manufacturers met quality standards.
- SQFM demonstrated effective quality control and consistency.
- QAMS results showed minimal deviation compared to standard curve methods.
- Correlation analysis between raw materials and preparation predicted quality intelligently.
Conclusions:
- The proposed SP and SQFM provide an integral and effective approach for CPLT quality control.
- This method ensures high consistency in CPLT production.
- The findings support intelligent quality prediction and rational preparation evaluation.
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