Quality Transfer Characteristics of Gardenia jasminoides Ellis in Xingnaojing Injection

Xingnaojing injection (XNJ) is a botanical neuroprotective formulation composed of Gardenia jasminoides Ellis (GJE), Radix Curcumae, musk, and borneol. A critical pharmacopeial standards review reveals no validated chemical markers for monitoring GJE quality within the formulation. To bridge this gap, a combined steam distillation and liquid-liquid extraction method was developed for accurate analysis of GJE components during manufacturing. Gas chromatography–mass spectrometry (GC-MS) profiling unambiguously identified the sesquiterpene derivative 4-methyleneisophorone as a consistent and traceable component throughout all key manufacturing stages: raw material processing, intermediate formulation, and final product assembly. These findings provide a scientifically grounded method to strengthen quality control in botanical injections such as XNJ.