SOP - GFI2U

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Salmon ovary outer membrane hydrolysate
Salmon Ovary-based Peptides
(SOP)
KYOWA PHARMA CO. LTD.
History of Placenta ①
Ancient Greece (BC 400): Hippocrates (Father of Medicine) confirmed
natural healing power of Placenta
Ancient China (Tang period – 4000 years ago):
Placenta presented in a ancient Chinese medical book
China (Ming period):
A Chinese herbalism book presented Human Placenta curative
properties such as tonicity, menstrual regulation effect, postpartum
disorder improvement and lactogenic action
USSR in 1933
Dr. Filatov developed tissue therapy with Placenta
History of Placenta ②
Japan (Kaga region)
Placenta was deemed as drug conferring immortality
Medical application of Placenta in Japan:
Dr. K. MITSUBAYASHI (Gynecology professor of Kyoto University):
Development of Placenta formulation “Vita-X” (drug improving forcing, galactopoiesis,
hematopoietic function, etc.)
Dr. K. HIEDA (Pathology professor of Kurume University):
Development of
Placenta injectable solution “Laennec”: For neuralgia, rheumatism, sirrhosis, chloasma,
frozen shoulder, menopausal syndrome and tonicity
Medical application of Placenta covered by insurance in Japan:
For hepatic dysfunction, menopausal syndrome, agalactorrhea, etc.
Background of development ①
Beneficial effects of Placenta
- Concentrated source of nutrition
- Human growth factor
- Cellular stimulant activity
- Improvement of menopausal syndrome
Example of human placenta:
After BSE problems, placenta derived from pigs
is used for cosmetic and medicinal products.
Concentrated source of nutrition


Provides nutrition to the baby & the mother itself.
The child’s brain, eyes, muscles, bones, organs, glands,
nerves, skin, tissues and fluids are entirely make from
the nutrients taken from its mother’s bloodstream via the
placenta.
Human growth factor




The hormone can promotes tissue repair.
Create cell regeneration in the bones.
Re-generate tissue for muscle & vital organs.
Can support immune system in combating
infection and disease.
Cellular stimulant activity



placenta also has metabolic and endocrine activity.
produces, among other hormones, progesterone's which
is important in maintaining the pregnancy.
maintain the uterine lining as well as inhibit the
production
Improvement of menopausal syndrome


With concentrated source of nutrition's, it can
improved the menopausal syndrome.
Make looks younger.
Background of development ②
- Avoidance of animal ingredient’s use (quadruped) for
health and cosmetic products in Europe
- Safety issue (diseases characteristic of animal)
- Shifting to marine-derived ingredients for the safety
- Use of biomass in a positive manner (for environmental
care)
↓
Focus on salmon ovary outer membrane (disposal part
of salmon) for its “baby protective action” similar to
placenta action
↓
Development of Salmon ovary outer membrane
hydrolysate = Salmon Ovary Peptides (SOP)
SOP Safety data
Residual
pesticides
Heavy
metals
Hormones
BHC
Not detected
DDT
Not detected
Aldrin & Dieldrin
Not detected
Endrin
Not detected
Arsenic
Not detected
Cadomium
Not detected
Total mercury
Not detected
Tin
Not detected
Total chromes
Not detected
Cyanogens
Not detected
Progesterone
Not detected
Estragiol
Not detected
Physical aspect of SOP
Origin and production: SOP is freeze-dried
salmon (Salmonidae) ovary-based peptides,
obtained by enzymatic decomposition
Aspect: Slightly yellow-brown powder having a
characteristic odor
Molecular weight distribution:
600~1500
Mean molecular weight:
600~800
Very special ingredient!
Patented product!
Extraction of amino-acid constituents from fish
ovary outer membrane by enzymatic decomposition.
Patent in Japan
No. 3691497
International patents
In China
ZC 03148699.1
In Hong-Kong
04105531.1
In Korea
92899/2003
In USA
10/733.627
Physical aspect
SOP Analysis data (in 100g)
< Nutritional data>
<Minerals>
<Vitamins>
Other amino acids
Analysis Item
Result
Water
5。2g
Total nitrogen
14。9g
Lipid
0。1g
Ash
5。5g
Sodium
1。7g
Dietary fiber
0。5g
Fe
3。37mg
Ca
497mg
Mg
39。4mg
Cu
127mg
Zn
0。09mg
Mn
0。51mg
Se
172μg
B2
0。61mg
B6
0。31mg
B12
2。4mg
Biotin
26。4μg
Niacin equivalent
11。2mg
Niacin (nicotine acid equivalent)
0。16mg
Triptophan
660mg
Amino acids
Pig Placenta
Human Placenta
Salmon Collagen
Asparagine acid
7.25
7.29
4.91
5.25
Threonine
4.00
4.74
3.39
2.13
Serine
5.96
7.32
4.09
4.86
Glutamine acid
10.11
14.01
5.84
8.27
Proline
7.49
4.42
4.58
9.27
Glycine
21.38
11.52
9.34
36.52
Alanine
10.58
13.38
5.18
11.35
Cysteine
0.55
Valine
3.59
6.53
3.00
1.73
Methionine
2.06
1.97
1.16
1.58
Isoleucine
2.79
1.91
Leucine
5.13
3.88
4.23
1.95
Tyrosine
1.81
0.71
1.19
0.28
Phenylalanine
1.90
1.52
1.29
Histidine
1.32
1.91
1.30
0.98
Lysine
5.34
7.71
3.61
2.62
Arginine
5.44
3.89
2.88
5.22
Hydroxyproline
3.08
0.45
Tryptophan
0.32
Carnosine
0.33
0.43
Ornithine
0.39
0.65
1.8
Phosphoserine
0.25
0.66
5.00
0.45
Taurine
Hydroxyrysine
1.05
Amino acids profile comparative chart
between SOP and Pig Placenta extract
SOP
(Unit: mol%)
Amino acids profile comparison
between SOP and Animal origin Placenta extract
SOPのアミノ酸組成
SOP
profile
Lys
Pse
Orn
His
Phe
Arg
Hyp Trp
Hyl
Asp
Thr
Tyr
Ser
Glu
Leu
Ile
Pro
Met
Val
Ala
Gly
Cyt
His
Orn
Pse
Trp
Phe
Tyr
Leu
ヒトプラセンタエキスのアミノ酸組成
Human
Placenta profile
豚プラセンタエキスのアミノ酸組成
Pig
Placenta profile
Hyp
Lys
Arg
Hyl
Asp
Phe
Thr
Ser
Hyp
Lys
Arg
Orn
Hyl
Pse Asp
Tyr
Thr
Ser
Leu
Ile
Met
Glu
Val
Cyt
Trp
His
Ala
Gly
Pro
Ile
Glu
Met
Val
Cyt
Ala
Pro
Gly
Safety of SOP
LD50 > 2,500mg/kg
Nothing abnormal detected on Performance
status, Weight and Necropcy
Nothing abnormal detected on Biochemical
examination of blood
Clinical trial results
on the drink containing SOP
menopausal symptomsimproving effect
Various effects of Placenta
- Activation of cell division
- Activation of metabolism
- Hormonal adjustment
- Improvement of immunity/resistance
- Improvement of metabolism/blood circulation
- Suppression of inflammation
- Regulation of autonomic nerves (ataractic effect)
- Improvement of menopausal syndrome
- Elimination of radical oxygen
Activation and regulation of physical
function and detoxification
Placenta-like function of SOP
Composition: Similar to human or pig placenta
Function: Similar to Animal Placenta
- Inhibition of functional decline for liver and
pancreas (antitoxic effect)
- SOD-like function
- Inhibition of tyrosinase activation
- Inhibition of visceral fat accumulation
On the base of this function, we realized a clinical trial.
Summary of trial ①

Object:
Validation of SOP efficacy on improvement of Skin condition,
anti-fatigue action and improvement of menopausal syndrome

Subjects:

- 17 women aged between 35 and 55 (just before or after
menopause), having symptoms of menopause such as rough
dry skin, insomnia, fatigable, stiff shoulder, etc.
- Menopausal Index between 25 and 55 (They have some
symptoms of menopause, but not so serious. Medical treatment
is not required.)
Exclusion criteria: Subjects hormonally treated
Summary of trial ②
Methods
Taking a drink containing SOP 500mg per day
・For 17 subjects: during 4 consecutive weeks
・For 4 subjects of them: during 4 consecutive
weeks + 1 week of time-out +1 week for retaking

SOP drink
・For 4 subjects of them: during 4 consecutive
weeks + 1 week of time-out +1 week for retaking
Placebo drink
Summary of trial ③

Measurement
Measurement timing:
Before trial – After 1 week – After 4 weeks – (1 week
of time-out) – After 5 weeks (just after time-out) –
After 6 weeks
Summary of measurement:
・Skin condition was measured in 15 minutes after
face-washing by Robo Skin Analyzer
・Menopausal index
・Skin condition questionnaire
Robo Skin Analyzer
Evaluation:
- on facial pigmentation
- on facial pores
Skin condition analysis by Robo Skin
Small pigments on face (observed value and rank)
平均
色素沈着数(小)(実測値)
2007C01
平均
色素沈着総面積(
小)
(
ランク)
2007C 01
6
2007C02
2007C 02
2007C03
40
0.05<P<0.1
0
0.05<P<0.1
0
35
2007C04
2007C 03
5
2007C 04
2007C05
2007C06
2007C 05
2007C 06
4
2007C07
30
2007C 07
2007C08
2007C09
25
2007C 08
3
2007C 09
2007C 10
2007C10
2007C11
2007C 11
2
2007C 12
2007C12
20
2007D 01
2007D01
2007D03
15
2007D 03
1
2007D 05
2007D05
2007D 06
2007D06
10
0
試飲前
1週間後
1ヵ月後
2007D09
試飲前
1週間後
1ヵ月後
2007D 09
We observed significative diminution of small pigments number and its surface
after 1 week and at 4th week.
This result shows improvement effect of Ocean Placenta on small pigments.
Dr. Y. NOMURA: Director of
Nomura Dermatological Clinic
Dr. S. HIRASAWA: Director of My
City Clinic
Large pigments on face (observed value and rank)
⇒ so-called “pigmented spot”
平均
色素沈着数(大)(実測値)
2007C01
2007C02
90
2007C03
P>0.10
2007C04
P>0.10
80
2007C05
2007C06
70
2007C07
2007C08
60
2007C09
2007C10
50
2007C11
2007C12
40
2007D01
2007D03
30
2007D05
2007D06
20
試飲前
1週間後
1ヵ月後
2007D09
We observed slight diminution of large pigments after 1 week and at 4th week,
but not significant. According to these results, SOP should have diminution
effect of facial pigments in small and large cases.
Dr. Y. NOMURA: Director of
Nomura Dermatological Clinic
Dr. S. HIRASAWA: Director of My
City Clinic
Facial pores (observed value)
Visible pores number
平均
毛穴数(実測値)
2007C01
2007C02
0.02<P<0.05
1700
2007C03
0.02<P<0.05
2007C04
1500
2007C05
2007C06
1300
2007C07
2007C08
1100
2007C09
2007C10
900
2007C11
2007C12
700
2007D01
2007D03
500
2007D05
2007D06
300
試飲前
1週間後
1ヵ月後
2007D09
We observed slight diminution of visible pores number after 1 week and at
4th week. This result shows tighten effect of Ocean Placenta on visible pores.
Dr. Y. NOMURA: Director of
Nomura Dermatological Clinic
Dr. S. HIRASAWA: Director of My
City Clinic
Self-evaluation: Change in Menopausal Index
and Skin & Physical conditions
① Menopausal Index
Self-evaluation by scoring
Trial I: 17 subjects
Trial II: 8 subjects from them (4 subjects for Placebo group)
② Change in skin and physical conditions
<Skin condition>
Inscribing subjective symptom
<Physical condition>
Inscribing subjective symptom
Change in Menopausal Index
Trial I
 Improvement of Menopausal Index on 16 of 17 subjects after 1
week, on 17 of 17 after 2 weeks, on 15 on 17 after 3 weeks and
on 17 of 17 after 4 weeks
Trial II
 During 1 week of time-out: Aggravation of Menopausal Index
on 8 of 8
 1 week after the resumption: Improvement on 4 of 4 for SOP
group (for Placebo group: improvement on 2 of 4,
aggravation or no change on 2 of 4)
This result shows menopausal index improvement effect of
SOP after 1 week of use.
Change in Menopausal Index
0
-5
-10
-15
■Trial
I
試験Ⅰ
-20
-25
-30
After
1 Week After2週間後
2 Weeks
1週間後
After
3 Weeks After
4 Weeks
4週間後
3週間後
17 subjects
Change in Menopausal Index (M.I.)
Test period
試飲期間
Before
week After 2
weeks After3週間後
3 weeks After
4 weeks
試飲前After 1 1週間後
2週間後
4週間後
Change in M.I.
更年期指数変化
0
-5
Trial
I
試験Ⅰ
被験者17名
Subjects:
17
-10
-15
-20
-25
-30
-35
-19.4
-20.5
-22.2
-29.0
Change in Skin and physical conditions
<Skin condition ①>
Trial I (during 4 weeks) (Remarks from the subjects)






Skin dryness was improved after 1 week of use.
During face-washing, skin became smooth at 2nd week.
Skin became velvety at 4th week.
Good blood circulation of face in the morning and clear
facial skin at 4th week.
One subject got a cold during the test and took a drug, but
she didn’t have any skin problem, such as skin roughness
or drug eruption.
Improvement of skin roughness during menstruation
Skin condition within 4 weeks
NO. OF WEEK
REMARK
WEEK 1
Skin dryness improved
WEEK 2
Skin became smooth
WEEK 3
Skin became smoother
WEEK 4
- Good blood circulation
- Improvement of skin roughness
Change in Skin and physical conditions
<Skin condition ②>
Trial II (Remarks from the subjects)
At 5th week ‘time-off period”:
 Sensation of itching and skin dryness
 Not easy to make-up
At 6th week: Ocean Placenta group
 Improvement of skin brilliance
 Improvement of dullness skin color
At 6th week: Placebo group
 Skin still dried
 But skin remains satiny from 4th week
Change in Skin and physical conditions
<Physical condition ①>
Trial I (during 4 weeks)





Easy to sleep from 3rd day
Fatigue reduced after 1 week
Intolerance to cold reduced after 1 week
Improvement of impatience at 4th week
Augmentation of menstrual bleeding
Physical condition within 4 weeks
NO. OF WEEK
REMARK
WEEK 1
Easy to sleep
WEEK 2
Fatigue reduced after 1st week
WEEK 3
Intolerance to cold reduced
WEEK 4
- Improvement of impatience
- Augmentation of menstrual
bleeding
Change in Skin and physical conditions
<Physical condition ②>
Trial II
At 5th week ‘time-off period”:

Feeling bleu due to time-off period

Easily-fatigued with shoulder hurt

Difficulty of falling sleep

Sensation of impatience

Intolerance to cold
At 6th week: Ocean Placenta group

Good view and shoulder hurt reduced from 3rd day.

Sensation of fatigue reduced

Keeping good mental condition during ill health
At 6th week: Placebo group

Sensation of impatience (same as 5th week)

Intolerance to cold

Difficulty of falling sleep
Physical condition
5th week time of
period
Oceanta Placenta
Group at 6th week
Placebo Group at 6th
week
Difficulty of falling
sleep
Improved to a good
sleep
Difficulty of falling
sleep
Sensation of
impatience
Sensation of fatigue
reduced
Sensation of
impatience (same as
5th week)
Intolerance to cold
Keeping good mental
condition during ill
health
Intolerance to cold
Resume
These results show SOP effects on symptoms of
menopause and skin condition of women of
menopausal age. Nearly all of the subjects had a gut
feeling of SOP effects on their skin and physical
condition from first week. Nearly all of and physical
condition from only first week. So, we observed
immediate action of SOP and its continuous effect
during the dosing.
Thanks to SOP’s efficacy, we can hope a wide variety
of SOP application, such as beauty supplement or
drink, anti-fatigue supplement or drink for women
of menopausal age.
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