1、Designation:F231511Standard Guide forImmobilization or Encapsulation of Living Cells or Tissue inAlginate Gels1This standard is issued under the fixed designation F2315;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last
2、 revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONEncapsulation in insoluble alginate gel is recognized as a rapid,non-toxic,and versatile method forimmobilization of macromole
3、cules and cells.Microencapsulated cells or tissue as artificial organs areunder study for treatment of a variety of diseases such as Parkinsons disease,chronic pain,liverfailure,hypocalcemia,and,perhaps the most well-known example,immobilization of islets ofLangerhans utilized as an artificial pancr
4、eas in the treatment of diabetes.Since alginates are aheterogeneous group of polymers with a wide range of functional properties,the success of animmobilization or encapsulation procedure will rely on an appropriate choice of materials andmethodology.This must be based on knowledge of the chemical c
5、omposition of alginate and thecorrelation between the structure,composition,and functional properties of the polymer,as well asdifferences in gelation technologies.It is also important to recognize the need for working with highlypurified and well-characterized alginates in order to obtain gels with
6、 reproducible properties.The aimof this guide is to provide information relevant to the immobilization or encapsulation of living cellsand tissue in alginate gels.1.Scope1.1 This guide discusses information relevant to the immo-bilization or encapsulation of living cells or tissue in alginategels.Im
7、mobilized or encapsulated cells are suitable for use inbiomedicalandpharmaceuticalapplications,orboth,including,but not limited to,Tissue Engineered MedicalProducts(TEMPs).1.2 This guide addresses key parameters relevant for suc-cessful immobilization and encapsulation in alginate gels.1.3 The value
8、s stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety a
9、nd health practices and determine the applica-bility of regulatory requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devic
10、es(Withdrawn 2012)3F1903 Practice for Testing For Biological Responses toParticles In VitroF1904 Practice for Testing the Biological Responses toParticles in vivoF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity(With-drawn 2011)3F1906 Practice for
11、Evaluation of Immune Responses InBiocompatibility Testing Using ELISATests,LymphocyteProliferation,and Cell Migration(Withdrawn 2011)3F2064 Guide for Characterization and Testing of Alginatesas Starting Materials Intended for Use in Biomedical andTissue-Engineered Medical Products Application1This g
12、uide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.43 on Cells and Tissue Engineered Constructs for TEMPs.Current edition approved March 1,2011.Published March 2011.Originallyapproved in 2003.Last previ
13、ous edition approved in 2010 as F2315 10.DOI:10.1520/F2315-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The
14、 last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.2 USP Document:USP Monograph USP 24/NF19 Sodium Alginate42.3 Other Referenced Documents:EN-ISO 10993 Biologi
15、cal Evaluation of Medical Devices5International Conference on Harmonization(ICH)S2BGenotoxicity:A Standard Battery for Genotoxicity Test-ing of Pharmaceuticals(July 1997)63.Terminology3.1 Definitions:3.1.1 alginate,npolysaccharide obtained from some ofthe more common species of marine algae,consisti
16、ng of aninsoluble mix of calcium,magnesium,sodium,and potassiumsalts.3.1.1.1 DiscussionAlginate exists in brown algae as itsmost abundant polysaccharide,mainly occurring in the cellwalls and intercellular spaces of brown seaweed and kelp.Alginates main function is to contribute to the strength andflexibility of the seaweed plant.Alginate is classified as ahydrocolloid.The most commonly used alginate is sodiumalginate.Sodium alginate and,in particular,calcium cross-linked alginate gels are used i
