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- W2377503875 abstract "Purpose To prepare the befitting form of recombinant human bone morphogenetic protein-2(rhBMP-2)for clinical trial and to observe the stability of the products.Methods 1.The composite film was prepared by dropping suspended liquid of rhBMP-2 samples onto the collagen sponge which is used for assistive supplement in clinic.After sterilization with cobalt 60,the products were tested for biological activity and other medical indexes.2.Using serum calcium test kit,the stability of rhBMP-2 products were investigated by measuring the biological activity of the samples treated under different conditions.Results The rhBMP-2 composite with collagen film showed a satisfying biological activity.And the quality of the composite patch conformed to the clinical demands tested by National Institute for the Control of Pharmaceutical and Biological Products.The results showed that after 2 years storage at 4℃,the biological activity of rhBMP-2 was retained good.The biological activity showed a slight decrease when the sample was placed at room temperature for 6 months,compared to a marked decrease at 37℃ for 1 month.But the difference is inconspicuous between 1 month treatment and 6 month treatment under 37℃ condition.Conclusion The prepared composite film of rhBMP-2 and collagen sponge conforms to the clinical demands and is stable.It can be used in the clinical trial." @default.
- W2377503875 created "2016-06-24" @default.
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- W2377503875 date "2009-01-01" @default.
- W2377503875 modified "2023-09-26" @default.
- W2377503875 title "Preparation of the clinical form of recombinant human bone morphogenetic protein-2 and its stability research" @default.
- W2377503875 hasPublicationYear "2009" @default.
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