Assy Carry out for the method for high performance liquid
chromatography (0512)
Chromatographic system and system suitability — Use
‘octadeeylsilane bonded silica gel es the stationary phase and
mixture of acetonitrile nd 0.05 mol/L. potassium dihyelrogen
phosphate (50 #50) (4 Sodium Dodecyl sulfate per
100 ml of stationary phosey adjust pH to 4.0. with
phosphoric acid) as the mobile phase. As detector a
spectrophotometer set ct 345 nm. The number of theoretical
plates of column i€ not less than 5000. caleulnted with the
reference to the peak of berberine hydrochloride.
Reference solution
hydrochloride CRS,
solution containing 80 ax of berberine hydrochloride per mal
ts the reference solution.
Weigh accurately a quantity of berberine
fissalve in methanol to produce a
Test solution To 0.25 g of powder, sceurately weighed. in
4a stopper conical flasks add accurately 25 ml of mixture of
hydrochloric acid and methanol (1 1009+ weighs beat
tunder reflux at 85% for 40 minutes. Cool and weigh agains
replenish the loss of stcigh with » mixture of hydrochloric
scid and methanol (1 #100)+ mix wells centeifges filter the
supernatant. use the suceessfal filtrate as the test solution.
Procedure Inject accurately 5 yl of each of the reference
solution and the test solution into the column, respectively
taleulate the contents,
It contains not less 2.0 mg of berberine bydrochloride
(Cy Hy NO, * HCD por gram, referred to Phellodendet
Chinensis Cortex
Actions To clear heat snd dry dampness.
Indications Bi disorders due to dampnesshest pouring
downward, manifested as reddened. swollen and painfal feet
and knees. heaviness ir the lower limbs» yellow and seanty
Administration and Dosage For oral sdministeation, 6-9
per times twice oF three times dy.
Precautions and Warnings Use with caution du
1 pregnancy:
Storage Preserve in vihily elosed containers,
Sangi Pian
(th)
Sapai Tablets
Ingredients Notoginseag Radix et Rhizoma 100 g,
Procedure Pulverize Notoginseng Radix ot Rhizoma 10 fine
powder. add a quantity of exceipient. make geanules.
compress into 1000 tabietsy or cout with fla hig tablets
‘or compress into 2000 tablets (small tabl
Description Greyish-ysllow to brownish-yellow tsbletss or
film coated tablets with greyist-yellow to lrownish-yellow
tastes bitter snd slightly sweet
Mentification C1) Microscopieals Fragments of resin
canals containing yellow secretion « Notoginseng Radix et
Rhizoma).
(2) Macerate 0.5 of powders in 10 ml of methanol by
hoking for 0 minutes. filters evaporate the filtrate to
and dissolve the residue in 1 al of methanol as the
test solution, Dissolve notoginsenoside Ry CRS+ ginsenoside
Rb, CRS nd ginsenoside Ry CRS in methanol 10 produce a
rmixture containing 0.5 mg of each per ml as the reference
solution. Carry out the method for thin layer chrome
dryness
tography (0502), using silica gel G as the costing substance
and a mixture of chloroform. methanol and water (7 = 3
0.5) as the mobile phase. Apply separately 5 pl of each of the
tow0 solutions to the plate, After developing anil removal of the
plate. dey in air, Spray with « 10% solfure acid in ethanol and
Theat at 105°C to the spots clear, Examine in daylight the spots
inthe chromatogram obtined with the fest solution correspond
in postion and colour to the spots in the chromatogram obtained
with the reference solution, Examine ander ultzaviolet light at
365 am, the fluorescent spors in the chromatogram obtained
with the test solution correspond in position and colour to the
spots in the chromatogram obtained with the reference solution,
‘Other requirements
for tablets (0101).
Assay Carry out the method for high performance liquid
chromatography 0512).
Comply with the general requirements
Chromaiogra phic
detadecylsilane bonded silica gel as the stationary phases
acetonitrile as the mobile phase Ay water as the mobile
phase B, elute in gradient as the following.
system and syntem suitabitiry — Use
Time Mobile phase A Mobile phase B
Gminutes) (per eent V/V) (per cont V/V)
paz 19 8
12-60 19-36 roa
As detector a speetruphotometer set at 203 nm. The number of
theoretical plates of the column ie not less thin 4000, caleulated
with the reference to the pek of notogin senoside R,
Reference solution Dissolve a quantity of gintenoside
Rg, CRS. ginsenoside Rb, CRS. and notoginsenoside Ry
CRS. weighed accurately. in methanol to produce a mixture
solution containing 0.4 mg, 0.4 mg. and 0.1 mg per ml
respectively as the reference solution
Take 10 tablets» grind imo fine powder. weigh
accurately 0.8 g in a stopper conical flasky avd 50-ml of
methanol. weigh, allow to stand overnights heat unser reflux,
fon a water hath at 80°C for 2 hours, cooly weigh again,
Test solution
replenish the loss of seeight with methanols shake sells fier
tnd use the successive filtrate as the test solution,
Procedure Inject aceurately 10 y of the reference solution
tnd the test solution into the columns respectively. and
caleulate the content,
1k contains ot less than 10,0 mg of yer small tablets or
20.0 my of por big tablet» of the total amount of ginsenoside
Ray (Cy Hye Oy) ginsenoside Rb) (Cy Hyy On) and
rotogin-senoside Ry (Cir Hy» Ou)+ refereed to Notoginseng,
Radix e¢ Rhizome,
Actions To dissipate stasis.
swellings and relieve pain
stop bleeding. disperse
Indications Hemoptysis. hematemesiss epitaxis. bloody.
stool, mensteual flooding and spotting traumatic bleeding
abdoroinal pains swelling and pain due to traumatie injuries.
Administration and Dosage For oral administrations «
12 pills or 2-5 large pills per timey three times a day.
Precautions and Warnings Contisindiated during preguaney.
Strength (1) 0.25 g of erude drug per small tablet
(2) 0.8 g of erude drug per big tablet
Storage Preserve in tightly closed containers