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 Drops:musk 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.