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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):

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Salmon ovary outer membrane hydrolysate salmon ovary based peptides l.jpg

Salmon ovary outer membrane hydrolysateSalmon Ovary-based Peptides(SOP)

KYOWA PHARMA CO. LTD.


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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


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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.


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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.


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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.


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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.


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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


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Improvement of menopausal syndrome

  • With concentrated source of nutrition's, it can improved the menopausal syndrome.

  • Make looks younger.


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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)


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SOP Safety data

Residual pesticides

Heavy metals

Hormones


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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


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Very special ingredient!

Patented product!

Extraction of amino-acid constituents from fish ovary outer membrane by enzymatic decomposition.

Patent in JapanNo. 3691497

International patents

In ChinaZC 03148699.1

In Hong-Kong04105531.1

In Korea92899/2003

In USA10/733.627


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Physical aspect


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SOP Analysis data (in 100g)

日本食品分析センター


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Amino acids profile comparative chartbetween SOP and Pig Placenta extract

(Unit: mol%)


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Amino acids profile comparisonbetween SOP and Animal origin Placenta extract

SOP profile

Human Placenta profile

Pig Placenta profile


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Safety of SOP

LD50 > 2,500mg/kg

Nothing abnormal detected on Performance status, Weight and Necropcy

Nothing abnormal detected on Biochemical examination of blood


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Clinical trial results

on the drink containing SOP

menopausal symptoms-improving effect


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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


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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.


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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 aftermenopause), 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


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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


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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


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Robo Skin Analyzer

Evaluation:

- on facial pigmentation

- on facial pores


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Skin condition analysis by Robo SkinSmall pigments on face (observed value and rank)

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


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Large pigments on face (observed value and rank) ⇒ so-called “pigmented spot”

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


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Facial pores (observed value)Visible pores number

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


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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


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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.


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Change in Menopausal Index

■Trial I

After 1 Week After 2 Weeks After 3 Weeks After 4 Weeks

17 subjects


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Change in Menopausal Index (M.I.)

Test period

Before After 1 week After 2 weeks After 3 weeks After 4 weeks

Change in M.I.

Trial I

Subjects: 17


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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


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Skin condition within 4 weeks


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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


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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


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Physical condition within 4 weeks


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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


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Physical condition


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Resume

These results show SOP effects on symptoms of menopause and skin conditionof 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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