Study on Quality Control Standard of Intermediate Products of Xingshen Nasal Drops by GC-MS / 中成药

ABSTRACT

Objective: To establish the quality control standards of two intermediate products of Xingshen Nasal Dropsmusk aromatic water and volatile oil of Acorus tatarinowii Schott so that the content of main components and composition of the different batches of ultimate products remained stable.Methods: The content limit of muskone of musk aromatic water was ascertained by GC-MS. And the characteristic finger print of volatile oil of Acorus tatarinowii Schott was established. Results: The content of muskone of musk aromatic water should be controlled at the range of 0.166～0.202mg/mL. RSD of muskone content of 3 batches of ultimate products was 4.49%, not larger than 10%. The characteristic finger point of volatile oil of Acorus tatarinowii Schott was composed of 6 main component peaks Methyleugenol, cis-Methylisoeugenol, trans-Methylisoeugenol, Elemicin, ?-Asarone and ?-Asarone. This characteristiz finger print could be repeated when the ultimate product was determined. Conclusion: The establishment of quality control standard of intermediate product can raise the product quality of compound preparations. And GC-MS is one of effective determination methods.