From Chitin to Chitosan - Chitosan Based Hydrogels: Functions and Applications - page 31

1.6 The Standard as Biomaterials
Chitosan is a degradable material with good biocompatibility in the medical field; thus it
can be used for preparing sutures, artificial blood vessels, and artificial skin. It is effective
in treating cancer, cardiovascular disease, and wounds and can be made into intelligent
controlled release agents and slow release agents. With respect to health care, western
academia considers chitosan as the sixth key element in addition to protein, fat, sugar,
vitamin, and inorganic salt because it strengthens immunity, resists aging, prevents dis-
ease, and adjusts physiological function [109].
1.6.1 Standard of Chitosan as biomaterials
In solution, the cationic nature of chitosan gives this polymer a mucoadhesive property.
Chitosan salts can be used as a matrix or scaffold material as well as in nonparenteral
delivery systems for challenging drugs. Chitosan salts have been shown to increase the
transport of polar drugs across the nasal epithelial surface.
American Society for Testing and Materials (ASTM) F 2103-01 [110] is a standard guide
for the characterization and testing of chitosan salts as starting materials intended for
use in biomedical and tissue-engineered medical product applications. The purpose of
this guide is to identify key parameters relevant for the functionality and characteriza-
tion of chitosan salts for the development of new commercial applications of chitosan
salts for the biomedical and pharmaceutical industries. Key parameters include the
degree of deacetylation, molecular mass and viscosity in aqueous solution, dry matter
content, ash content, insolubles, endotoxin content, protein content, heavy-metal content,
and microbiological safety. This guide provides chemical and physical test methods of
these key parameters, product development considerations, and safety and toxicology
aspects of chitosan.
The People's Republic of China pharmaceutical industry standards (YY/T) 0606.7 [111]
is a standard of tissue-engineered medical products—part 7: chitosan and this standard
reference the ASTM standard mentioned above. This standard is applicable to chitosan as
starting materials intended for use in tissue-engineered medical products and surgical
implant applications. This standard provides terms and definitions of chitosan, require-
ments of chitosan products, test methods and inspection rules, packaging, transportation,
and storage of products.
SC/T (The People's Republic of China Fisheries Industry Standard) 3403 [112] is a standard
of chitin and chitosan. This standard provides detailed specifications and requirements of
chitosan products (Table 1.6).
1.6.2 Status of Chitosan Products
Golden-Shell Biochemical Co. Ltd., founded in 1994, is the largest enterprise in the line
of chitin and its ramifications in China. Major products include d-glucosamine HCl,
d-glucosamine sulfate, N -acetyl-d-glucosamine, chitosan, high-density chitosan, chitosan-
ase, oligosaccharide, and fish collagen powder. Moreover, they developed special molecular
weight chitosan, water-soluble chitosan, paper-making chitosan, sugar-refining chitosan,
pharmaceutical chitosan, cosmetic moisturizing chitosan, and so on. Table 1.7 shows the
standard of common chitosan products.