Objective:

2

To establish HPLC fingerprint spectra of the pieces

standard decoction

intermediates

dispensing granules of Rehmanniae Radix Praeparata

and assess the quality correlation among them

then to evaluate the scientificity and rationality of preparation process based on the yields of dry extract and the transfer rate of acteoside.

Method:

2

Fingerprints of several batches of the pieces

standard decoction

intermediates and dispensing granules of Rehmanniae Radix Praeparata were detected by HPLC

and the content of acteoside was determined according to the method of

ChP

2015.The fingerprint chromatographic separation was carried out on Phenomenex Luna 100A C

18

(2) chromatographic column (4.6 mm×250 mm

5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid for gradient elution

with a flow rate of 1 mL·min

-1

and the detection wavelength was 330 nm. At the same time

the correlation analysis of quality transmission during the preparation of dispensing granules was carried out based on the yields of dry extract and the transfer rates of acteoside.

Result:

2

The contents of acteoside pieces

standard decoction and intermediates were basically consistent. The yield of dry extracts of intermediates and dispensing granules

and the transmission rate of acteoside were all within the range of standard decoction

and basically consistent with standard decoction. There were 7 common peaks in all fingerprint spectra of 17 batches of pieces

17 batches of standard decoction

10 intermediates and 10 dispensing granules of Rehmanniae Radix Praeparata

with a good correlation. The 13 main chromatographic peaks in the dispensing granules were identified by UPLC-Q-TOF-MS analysis

and 4 of the 7 fingerprint common peaks were identified as 5-hydroxymethyl furfural

acteoside

isoacteoside and martynoside.

Conclusion:

2

The main chemical constituents of Rehmanniae Radix Praeparata pieces

standard decoction

intermediates and dispensing granules are basically identical. The established HPLC fingerprint method can be used for the quality control of preparation process of Rehmanniae Radix Praeparata dispensing granules.