When recombinant collagen liquid dressings are registered for Class Ⅱ medical devices,key performance tests should be carried out in accordance with the Guiding Principles for Registration Review of Recombinant Collagen Wound Dressings.In this paper,the identification and content of active ingredients,transdermal absorption in vitro,film formation,film microstructure,porosity and average pore size of the product were tested to evaluate the safety and effectiveness of the liquid wound dressing in the registration of Class Ⅱ medical devices.The results showed that the average content of active ingredient(based on recombinant collagen)in this wound dressing was 2.01mg/mL by 2,2'-biquinolindicarboxylic acid(BCA)method,and it could not be absorbed by human body after 0.5,1,2,6 and 12h.The liquid component in the dressing has good film formation,and a film visible to the naked eye is formed after drying at 37℃for lmin.The film thickness was controlled to be 3mm,and the film was dried at 45 ℃ for 12h.The microscopic morphology of the film was observed under Scanning electron microscope(SEM),and the surface of the film magnified 400 times and 5000 times respectively showed different physical barrier protective layers with different pore shapes.The calculated porosity was 7.645％and the average pore size was l.414μm.The liquid dressing is suitable for the nursing of non-chronic wounds such as cutting wounds,and has broad clinical application value and market prospect.
recombinant collagenwound dressingguidelines for registration examinationfilm formationidentification and contentnon-absorbable test
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