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[Establish quality evaluation method based on standard decoction of Danshen extract]
Qing Dong1,2, Hua-Tao Yu3, Yun-Tao Dai3
1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Summary
Marketed Danshen extract granules vary in quality due to raw material differences. A systematic evaluation method using a standard decoction approach revealed raw material quality is the main factor affecting Danshen extract granule uniformity.
Area of Science:
- Pharmacognosy
- Analytical Chemistry
- Traditional Chinese Medicine
Background:
- Marketed Danshen extract granules exhibit significant quality variations.
- These inconsistencies stem from heterogeneous raw material quality, diverse manufacturing processes, and inadequate quality assessment methods.
- Ensuring the quality and efficacy of herbal medicines like Danshen is crucial.
Purpose of the Study:
- To establish a systematic quality evaluation method for Danshen decoction from a "standard decoction" perspective.
- To identify the primary factors influencing the quality uniformity of Danshen extract granules.
- To clarify the chemical composition and assess the stability of Danshen decoction preparation.
Main Methods:
- Preparation of Danshen standard decoction.
- Development of a fingerprinting method to quantify salvianolic acid B.
- Identification of key fingerprint peaks using Ultra-Performance Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometry (UPLC-QTOF/MS).
- Calculation of extraction ratio, transfer rate of index components, and pH value to assess process stability.
Main Results:
- Phenolic acids were identified as the predominant chemical constituents in Danshen decoction.
- The extraction rate, salvianolic acid B transfer rate, and pH value demonstrated relative stability throughout the preparation process.
- High similarity in the fingerprint profiles of the standard decoction indicated a stable preparation procedure.
- Significant variations in salvianolic acid B levels were observed, primarily attributed to the inherent quality differences in the raw Salviae miltiorrhizae radix et rhizoma.
Conclusions:
- The established evaluation method, based on the "standard decoction" concept, provides a reliable approach for assessing Danshen decoction quality.
- The manufacturing procedure for Danshen decoction is stable, ensuring consistent chemical profiles.
- The primary driver of quality variability in Danshen extract granules is the heterogeneity of the raw Salviae miltiorrhizae radix et rhizoma, not the preparation process itself.