Assessment of volatile component stability in Guanxin Jieyu granules through gas chromatography in accordance with Q14 guidelines

TL;DR

This paper shows that using β-cyclodextrin improves the stability of volatile compounds in a new traditional Chinese medicine for angina and anxiety.

Contribution

The study introduces a novel β-cyclodextrin inclusion method to stabilize volatile TCM components, validated via ICH Q14-compliant gas chromatography.

Findings

β-cyclodextrin inclusion reduced the failure probability of volatile components to 1.10% over 730 days at 25°C.

Physical mixtures had an 88.50% failure probability under the same conditions.

Gas chromatography confirmed the effectiveness of cyclodextrin in preserving volatile TCM constituents.

Abstract

Guanxin Jieyu Granules, a novel traditional Chinese medicine (TCM) in development, targets stable angina pectoris with accompanying anxiety. To improve stability, its volatile oil components—including borneol—are stabilized via β-cyclodextrin inclusion. In compliance with ICH Q14 guidelines, a gas chromatography (GC) analytical method was developed, incorporating knowledge management, risk management, experimental design, and results analysis, as well as performance evaluation of the analytical method. Accelerated Destructive Degradation Tests (ADDTs) using this method revealed a dramatic stability enhancement from β-cyclodextrin encapsulation. At 25 °C over 730 days, the inclusion complex showed only a 1.10% probability of failure (defined as ≥ 5% content loss), compared to 88.50% for the physical mixture. These results underscore the critical role of cyclodextrin inclusion in preserving volatile TCM constituents.

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