Objective:

2

To estimate the overall quality characteristics of Zhenqi Fuzheng granules (ZQFZ)

which were composed of Ligustri Lucidi Fructus and Astragali Radix and collected from different manufacturers (their final preparations included two types

contained sugar and sugar free) by established HPLC methods

in order to propose an appropriate quality-control strategy for promoting the quality control specification of ZQFZ.

Method:

2

The quantification of the 6 components (rhodioloside

calycosin-7-

O

-

β

-

D

-glucoside

specnuezhenide

ononin

calycosin and astragaloside IV) were performed on a C

18

column with two chromatographic systems. Chromatographic system Ⅰ: methanol and water were adopted as mobile phase with gradient elution

the flow rate was 1.0 mL·min

-1

and optimum detection waves were at 224

250 and 275 nm respectively. Chromatographic system Ⅱ: methanol and water (80∶20) were adopted as mobile phase with gradient elution at the flow rate of 1.0 mL·min

-1

and the detector parameters were set as follows: the drift tube temperature was 75 ℃

and the carrier gas flow rate was 1.5 L·min

-1

. Both column temperatures were at 30 ℃. All of the 80 batches of ZQFZ from different manufacturers were determined and analyzed.

Result:

2

All of the six markers could be detected in 80 batches of ZQFZ

but their contents were quite different. The results of the one-way ANOVA showed significant differences between manufacturer 4 and other three manufacturers in sugar-containing preparations (

P

<

0.05). And for sugar-free preparations

manufacturer 3 was significant different from other manufacturers (

P

<

0.05). The differences were concentrated in components of rhodioloside and specnuezhenide derived from crude maternal of Ligustri Lucidi Fructus.

Conclusion:

2

It is of great significance to increase relevant quality control markers of Ligustri Lucidi Fructus in ZQFZ

such as rhodioloside and specnuezhenide

for standardizing production and improving quality level.