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Amhwa sodium hyaluronate raw material has been approved by the -CEP certificate

2024-04-15

Recently, Amhwa sodium hyaluronate API obtained the European Pharmacopeia applicability certification issued by the European Agency for Quality of Medicines EDQM, namely the EU CEP certificate.

Sodium Hyaluronate, also known as sodium hyaluronate, is a polymer polysaccharide biomaterial formed by the repeated alternation of n-acetylglucuronic acid.


Sodium hyaluronate is a physiologically active substance that widely exists in animals and humans. It is found in human skin, joint synovial fluid, umbilical cord, aqueous humor and vitreous body. It has a high degree of viscoelasticity, plasticity, and good biocompatibility, and has an obvious role in preventing adhesion and repairing soft tissue. It is clinically used in a variety of skin injuries to promote wound healing. It is effective for abrasions and lacerations, leg ulcers, diabetic ulcers, compression ulcers, as well as debridement and venous stasis ulcers.


Sodium hyaluronate is the main component of synovial fluid and one of the components of cartilage matrix. It plays a lubricating role in the joint cavity, can cover and protect the joint cartilage, improve the joint contracture, inhibit the surface of cartilage degeneration, improve the pathological joint fluid, and increase the drip slip function.


There is a large amount of sodium hyaluronate in the vitreous body of the eye, which forms the vitreous body together with collagen fiber and soluble protein. The network structure formed by collagen acts as a solid scaffold, and the macromolecular network structure of sodium hyaluronate can combine with a large amount of water to form a gel filling. The two network systems balance each other, and sodium hyaluronate in the corneal matrix plays an important role in maintaining the corneal shape. Sodium hyaluronate itself is a natural component of human body. As an ideal viscoelastic agent for ophthalmic surgery, sodium hyaluronate has good biocompatibility.


At present, the use of sodium hyaluronate as a medium is not limited to ophthalmic drugs, but also has been added to anti-tumor drugs, non-steroidal anti-inflammatory analgesics and glucocorticoids, and has obvious drug synergism and slow-release effects.


In the current situation of stricter regulatory policies and higher quality requirements in the global pharmaceutical field, Amhwa has successfully obtained the CEP certificate of sodium hyaluronate API, which shows that the European Medicines Quality Agency EDQM has recognized the biological quality of Amhwa, and fully reflects the excellent process research and development and quality control capabilities of Amhwa, which is a new milestone on the road of Amhwa's international development.

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