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POM TR. 063 362 901
(Distribution Permit Number from Board of Drug and Food Control the Republic of Indonesia)

Pharmacology

 is a freeze dried purified extract of specific part of fresh shark cartilage containing proteoglycan, hexosamine and free D-glucuronic acid. The main indication of  is to reduce pain and inflammation in osteoarthritis (OA). Bioactive substances of are chondroitin-4-sulfate, chondroitin-6-sulfate, and chondroitin-2,6-disulfate (this specific chondroitin sulfate is only found in shark cartilage) and proteoglycan as angiogenesis inhibitor.

* for detailed information, please see product application

Composition

  • Each capsule contains 400 mg proteoglycan, hexosamine and glucuronic acid

Indication

  • To maintains healthy joint

Contraindication

  • Hypersensitivity to shark cartilage

Precaution

  • Pregnancy and lactation
  • Children under 12 years old

Adverse Reaction

  • Nausea, vomiting and skin rash (allergic reaction) are rare

Dose

  • 1-3 capsules a day after meal

Administration

  • After meals

Storage

  • Keep in dry and cool place

Packaging

Box of bottle, 30 capsules @ 400 mg proteoglycan, hexosamine and free D-glucuronic acid.

Description : Each capsule contains 400 mg of glycosaminoglycan extract from shark cartilage

Active Constituent Analysis

SLH Product’s Specification/
Capsule

Method

D-Glucuronic acid

min. 100 mg

Carbazole

Hexosamines

min. 80 mg

Elson-Morgan

N-acetyl-hexosamines

min. 4 mg

Elson-Morgan

Polysaccharide

min. 20 mg

Phenol Sulfuric Acid

Heavy Metal

 

Hg

≤ 0.5 ppm

AAS

Cd

≤ 0.3 ppm

Pb

≤ 10 ppm

As

≤ 5 ppm

Typical Microbiological Analysis

 

Total bacterial count

< 30 cfu/g

USP Method 61

Total yeast and mould count

< 30 cfu/g

Salmonella Sp.

Negative

Indonesian Pharmacopeia 4th Ed. 1995

Escherichia coli

Negative

Staphylococcus aureus

Negative

Pseudomonas aeruginosa

Negative

Shigella Sp.

Negative

Culture & Identification

Physical Properties

 

Appearance

Powder

Organoleptic Test

Color

White

Odor

Fish like

Taste

Tasteless

Moisture Content

≤ 10 %

Indonesian Pharmacopeia 4th Ed. 1995

 

 

Packaging

1 bottle @ 30 capsules

Storage

Keep in dry and cool place, avoid direct sun contact

Document Number : SLH/SPESI/QC/04/005
The information contained herein is believed to be true and reliable.



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as Complementary Therapy in Osteoarthritis

Osteoarthritis (OA) is a joint inflammatory disease which limits patient’s activities. Inflammation in OA is associated with angiogenesis. Inflammation stimulates angiogenesis and angiogenesis facilitates inflammation(1) .In inflammation, inflammatory cells (macrophages and mast cells) secrete inflammatory mediators: Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α), which then stimulate matrix metalloproteinases that degrades joint proteoglycan and collagen. (1)

 is a shark cartilage extract which contains glycosaminoglycan (GAG) derivatives (chondroitin sulfate), glucosamine and anti-angiogenic factor (heat-stable proteoglycan) which have beneficial effects for joint. Chondroitin sulfate is a kind of GAG required in joint proteoglycan synthesis.(2) It is primarily formed by combining the alternative residues of glucuronic acid (both sulfated and unsulfated) and N-acetylgalactosamine into a polysaccharide chain.(3) Chondroitin sulfates in shark cartilage is different from chondroitin sulfate of other sources such as bovine and porcine. The chondroitin sulfates in shark cartilage are chondroitin 4-sulfate (Chs A), chondroitin 6-sulfate (Chs C) and chondroitin 2,6-disulfate (Chs D, present only in shark cartilage).(4) In Osteoarthritis, chondroitin sulphate will function as an anti-inflammatory and anti-degradative agent, neurite outgrowth promoting activator, and cytoprotector. Chondroitin sulfate also affect metabolic processes in joint proteoglycan synthesis. (5-9)

Fig. 13. Bioactive Substances in 

Proteoglycan is stable in heat, extreme pH and proteolytic digestion. This heat-stable proteoglycan has a molecular weight fraction of about 10 kDa that contains the majority of the antiangiogenic activity associated with shark cartilage.(10) The heat stable proteoglycan may help to reduce angiogenesis and inflammation in OA.

Free glucosamine and N-acetylglucosamine are two kinds of glucosamine that are found in . N-acetylglucosamine can reduce activity of inflammatory mediators more than free glucosamine. Free glucosamine can reduce IL-1β and Nitric oxide (NO) production also Matrix Metalloproteinases (MMPs) activity, whereas N-acetylglucosamine can reduce IL-1β, NO, TNF-α production and Cyclooxygenase-2 (COX-2) activity.(11)

Fig. 14. Mechanism of Action of Glycosaminolycan and Proteoglycan in OA



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