Objective:

2

To establish the quality control methods for the standard decoction of Zingiberis Rhizoma.

Method:

2

DNA barcode primitives were identified for the medicinal materials from different origins; according to the standard of Chinese herbal medicine decoction preparation principle

the identified Zingiberis Rhizoma was prepared into standard decoction for analysis. Meanwhile

the extraction method and analysis method were validated from methodologies

and the transfer rate of 6-gingerol as well as the extraction rate of standard decoction of Zingiberis Rhizoma were calculated. In addition

the quality standard of standard decoction of Zingiberis Rhizoma was also established based. The structures of main chromatographic peaks were identified by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) to clarify the main chemical constituents in the standard decoction of Zingiberis Rhizoma.

Result:

2

All the samples were identified as Zingiberis Rhizoma. Under the conditions established in this paper

the standard curve of 6-gingerol was

Y

=661.56

X

+ 2.493 3(

r

=0.999 3)

and the RSD was 0.5%in precision test

indicating that the instrument precision was good. The repeatability test showed that the RSD was 0.3%

indicating that the method had good repeatability. The stability test showed that the RSD was 0.4%

indicating that the test solution had good stability within 24h. The recovery rate was 97.2%and the RSD was 0.6%

indicating that the method was accurate and reliable. 6-gingerol's transfer rate ranged from 31.8%to 57.4%and the extraction rate was within the range of 9.6%-23.1%. The fingerprint similarity of 12 batches of Zingiberis Rhizoma standard decoction was

>

90%.

Conclusion:

2

The established quality control method for Zingiberis Rhizoma was stable and feasible; meanwhile

the standard preparation method for Zingiberis Rhizoma and its quality evaluation system were also established in this study.