Rutin NF11/EP8/DAB10 - EHP-130

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Rutin NF11/EP8/DAB10


RUTIN (Sophora japonica extract)



Rutinraw


English
name: Flos sophorae immaturus, Japanese pagodatree flower-bud Synonym:
Meletin, sophoretin Origin: The flower bud of sophora japonica L Plant
morphology: Deciduous tree with height of about 15-25meters Collecting
and processing: Collect the flower bud in summer, drying timely,
removing the branches, stems and impurities Appearance: The shape of
flower bud is oval, with length of 2-6mm, diameter of about 2mm
Odorless, slightly bitter taste Chemical composition: Contains rutin,
saponin and sterol Property and Flavor: Slightly cold in nature, bitter
taste Indications: Cooling blood and hemostasis, purging liver fire, for
the treatment of hemafecia, hemorrhoidal bleeding, blood dysentery,
uterine bleeding, hematemesis, epistaxis, conjunctival hyperemia caused
by hepatopyretic disease, headache and dizziness Dosage: 4 5-9g




Rutin Products

Product name: Rutin

Synonym: Rutoside, Vitamin P, Violaquereitrin

Chemical Name: 

3-{[6-0-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy}-2-(3, 4-dihyroxyphenyl)-5, 7-dihydroxy-4H-1-benzopyran-4-one. 

Molecular Structure: 


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M. F. & M. W.: C27H30O16; 610.51

Physical
Property: Yellowish- needle - crystal (in water); M. P.: 176-8°C, 23D:
+13.82°C (ethanol), 20D-39.43 °C (pyridine); Solubility: 1g in 7ml of
methanol, 8000ml of water, 200ml of boiling water; UVλ CH3OHmax nm:
258.361; IRνKBr max cm-1: 3400(OH), 1670(C=O), 1620, 1520, 1470(C6H5-). 

Plant
source: Ruta graveolens L., plant essential oil [2]; Sophora japonica
L., main part of fruit [3, 4]; Hypericum aseyron L., full plant;
Berchemia polyphylla Wall, var leioclada Hand. -Mazz. [5]; Mallotus
japonicus Muell. -Arg, leafs [6]; Fagopyrum esculentum Moench seedling. 

Indications: 

1.
Anti-inflammatory action: Apparent suppression of inflammation due to
planted wool when the product is injected into abdominal cavity of rat
[8]. Sodium rutin sulfate has very strong anti-inflammatory action to
edema of rat [9]. 

2. Actions like Vitamin P: Maintain the strength
of blood vessel, reduce its permeability and brittleness; Degreasing
action to liver fatty infiltration, especially together with
glutathione. 

3. Antiviral action: Best suppression to phlyctenular stomatitis virus at product concentration of 200g/ml [10, 11]. 

4.
Inhibition of aldehyde reductase: 95% inhibition at a concentration of
10-5M [12], which facilitates the treatment of diabetic cataract. 

5. Toxicity: Mice, intravenous injection, LD50 at 950mg/kg. 

6.
Clinical use: For the prevention of intracerebral hemorrhage,
hypertension, retinal hemorrhage, purpura and acute hemorrhagic
nephrosonephritis; For treatment of chronic tracheitis with effective
rate at 84.8% and 98%. Its derivative, troxerutin, or Venoruton, is
applied clinically for burn, arthritis, and all kinds of blood vessel
diseases. Commodity drug is available in abroad [14], while the drug has
been successfully developed in domestic. With Effective rate for the
treatment of cerebrovascular diseases is 87.8%; 88% for retinal edema
and hemorrhage




Specification of Rutin (NF11) 


















Product Name: Rutin

Botanical source: Sophorae Japonica

Part of plant used: Flower

CAS #: 153-18-4

TEST

NF11

TEST METHOD

Appearance

Identification

pH

Particle size

Chlorophyll

Red-pigments

Quercetin

Bluk Density

Tapped Density

Heavy metals

-Arsenic

-Mercury

-Cadmium

-Lead

Ash

Loss on drying

Assay(on dry basis)

Yellow to greenish-yellow powder

Must positive

6.0-7.0

95% pass through 60 mesh

≤0.004%

≤0.004%

≤5.0%

≥0.40GM/cc

≥0.60GM/cc

≤10ppm

≤1ppm

≤0.1ppm

≤1ppm

≤3ppm

≤0.5%

5.5%-9.0%

95.0%-102.0%

Visual

Infrared Absorption

pH Meter

US Screen

UV

UV

HPLC

CP2010

CP2010

Visual Colorimetry

AAS

AAS

AAS

AAS

CP2010

120oC

UV




Specification of Rutin (EP8.0) 


















Product Name: Rutin

Botanical source: Sophorae Japonica

Part of plant used: Flower

CAS #: 153-18-4

TEST

EP8.0

TEST METHOD

Appearance

Solubility







Identification







Particle size

Residual Solvents

Light absorbing impurities

Substance Insoluble in methanol

Related Substances

A: Isoquercetin

B. Kaempferol 3-Rutinoside

C. Quercetin

Other impurity

Total impurity

Sulphated Ash

Water

Assay(On dry basis)

Heavy metals

-Arsenic

-Mercury

-Cadmium

-Lead

Bulk Density

Tapped Density

Yellow to greenish-yellow, crystalling powder

Practically
insoluble in water, soluble in methanol, sparingly soluble in ethanol,
practically insoluble in methylene chloride, it dissolves in soluble of
alkali hydroxides


B. CRS absorbance

A. UV absorbance

C. TLC Examination

D. Color reaction with Zn

95% pass through 80 mesh

≤0.2%

≤0.10 between 450 and 800nm

≤3.0%



≤2.0%

≤2.0%

≤2.0%

≤0.1%

≤4.0%

≤0.10%

7.5%-9.5%

95.0%-101.0%

≤10ppm

≤1ppm

≤0.1ppm

≤1ppm

≤3ppm

≥0.30GM/cc

≥0.50GM/cc

Visual







Visual

CRS

TLC

UV

Visual

CP2010

HPGC

UV

CP2010



HPLC

HPLC

HPLC

HPLC

HPLC

CP2010

-Karl Fischer

Titration

Visual Colorimetry

AAS

AAS

AAS

AAS

CP2010

CP2010




Specification of Rutin (DAB10) 

















Product Name: Rutin

Botanical source: Sophorae Japonica

Part of plant used: Flower

CAS #: 153-18-4

TEST

DAB10

TEST METHOD

Appearance

Melting point

Identification(A/B/C)

Purity

Insoluble Matter

-Solution(a)

-Solution(b)

Particle size

Related Substances

Isoquercetin

Quercetin

Kaempferol 3-Rutinoside

Bluk Density

Tapped Density

Heavy metals

-Arsenic

-Mercury

-Cadmium

-Lead

Ash

Loss on drying

Assay(on dry basis)

Light greenish yellow powder

210oC melting and decompositon

Must positive

Must Conforms



Should be clarified

Should be clarified

95% pass through 80 mesh

Must Conforms

≤2.0%

≤2.0%

≤2.0%

≥0.30GM/cc

≥0.50GM/cc

≤10ppm

≤1ppm

≤0.1ppm

≤1ppm

≤3ppm

≤0.10%

5.5%-8.5%

98.0%-102.0%

Visual

Infrared Absorption

pH Meter

US Screen

UV

UV

HPLC

CP2010

CP2010

Visual Colorimetry

AAS

AAS

AAS

AAS

CP2010

120oC

UV


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