Study On Quality Of Xingnaojing Injection

Objective: To establish the fingerprint of Xingnaojing injection, to establish specialquality standard of the compound preparation, the drug safety evaluation work. To providescientific basis for the realization of Xingnaojing injection quality stability, controllable,improvement of production process of scientific, effective guidance, promote clinicalrational drug use.Method: To determine the index content of Xingnaojing injection by gas chromatography,and limited inspection. Establishing the method of GC fingerprint and quality evaluation toXingnaojing injection. Establishing the fingerprint of Radix Curcuma Wenyujin. The varietyof components in Xingnaojing injection fingerprint are studied by gas chromatography-massspectrometry (GC-MS).Results: Optimized the method for the determination of index components in theXingnaojing injection. The linear range of D-borneol was from0.0428to0.4276mg·ml(r=0.9999).The average recovery was99.86%(RSD=1.55%); Increased the determinationof the content of musk ketone, the linear range of musk ketone was from0.0082to0.4096mg·ml (r=0.9996), the average recovery was97.56%(RSD=1.50%); Established the methodof camphor, isoborneol, L-borneol limited inspection, the linear range of camphor was from0.855to42.752μg·ml(r=0.9999). The average recovery was100.72%(RSD=1.75%); thelinear range of isoborneol was from3.369to84.224μg·ml(r=0.9999).The linear range ofL-borneol was from1.7139to42.848μg·ml(r=0.9999). The average recovery was100.16%(RSD=2.38%). Established the GC fingerprint of Xingnaojing injection, and confirm the fivekinds of chemical composition By GC-MS method (Eucalyptol, camphor, D-borneol,β-elemene, musk ketone). Established10common peaks in the fingerprint of RadixCurcuma Wenyujin.Conclusion: The methods of determination Xingnaojing injection established in the indexcomponents D-borneol, musk ketone and camphor, isoborneol, L-borneol limited inspectionare simple and practicable. Improve the quality of evaluation methods of Xingnaojing injection. The established fingerprint method is simple, reliable, and can be used for qualitycontrol and evaluation of Xingnaojing injection for the production of stable quality, effective,and controllable product provides a cheap, safe and scientific basis.