本文關(guān)鍵詞：PU材料宮內(nèi)裝置生物相容性及物理機(jī)械性能的研究　出處：《中南大學(xué)》2014年博士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： PU材料宮內(nèi)裝置 生物相容性 動(dòng)物埋植實(shí)驗(yàn) 體外細(xì)胞毒性 機(jī)械性能

【摘要】：目的： 1.通過動(dòng)物體內(nèi)植埋實(shí)驗(yàn)及體外細(xì)胞毒性試驗(yàn)評(píng)估聚氨酯(PU)材料宮內(nèi)裝置(自主專利產(chǎn)品)的生物相容性。 2.通過測量PU材料宮內(nèi)裝置的各項(xiàng)物理機(jī)械性能,評(píng)估其是否滿足宮內(nèi)裝置的設(shè)計(jì)要求。 方法： 1.根據(jù)GB/T1688.和IS010993.規(guī)定,對PU材料宮內(nèi)裝置進(jìn)行動(dòng)物體內(nèi)植埋及體外細(xì)胞毒性試驗(yàn)。 動(dòng)物體內(nèi)植埋實(shí)驗(yàn)：①實(shí)驗(yàn)材料：醫(yī)用PU材料宮內(nèi)裝置、T型環(huán)聚乙烯(PE)支架；②實(shí)驗(yàn)分組：按體重將18只健康的SD雌性大鼠依次編號(hào),隨機(jī)分為3組,分別將實(shí)驗(yàn)材料模塊植入SD大鼠的雙側(cè)后腿部,實(shí)驗(yàn)組為植入PU材料組,對照組為植入PE材料組,而空白組僅對大鼠左側(cè)前腿做切開縫合處理。分別于術(shù)后的第7、30、90天取出植入材料的模塊周圍組織,觀察后制成HE切片。光鏡下觀察切片,評(píng)估組織的炎性反應(yīng)程度,判斷兩種材料的差異性。 體外細(xì)胞毒性實(shí)驗(yàn)：①實(shí)驗(yàn)細(xì)胞：小鼠成纖維細(xì)胞；②實(shí)驗(yàn)分組：空白組、PE浸提液組、不同濃度(100%、50%、25%)的PU材料浸提液組。于培養(yǎng)后的第 1、3、7天通過CCK-8法染色,孵育約3小時(shí),在酶標(biāo)450nm波長處測定吸光值,計(jì)算相對增殖率,顯微鏡下觀察各組細(xì)胞形態(tài),評(píng)估其細(xì)胞毒性。 2.物理機(jī)械性能測定：測試PU材料、PE材料及醫(yī)用硅橡膠的各項(xiàng)物理機(jī)械性能,包括硬度、扯斷伸長率、拉伸強(qiáng)度、100%定伸強(qiáng)度等方面和耐疲勞實(shí)驗(yàn)。 結(jié)果： 1.動(dòng)物體內(nèi)植埋實(shí)驗(yàn)：所有大鼠安全耐受麻醉及手術(shù),傷口愈合良好。術(shù)后7天、30天、90天,PU組與PE組對組織的炎性反應(yīng)程度均無明顯差異(P0.05)。 2.體外細(xì)胞毒性試驗(yàn)：CCK-8法測定細(xì)胞OD值,隨培養(yǎng)時(shí)間的延長,不同濃度的PU材料浸提液對細(xì)胞增殖有促進(jìn)作用(P0.05),細(xì)胞增殖與浸提液的濃度無明顯相關(guān)(P0.05),實(shí)驗(yàn)組、對照組及空白組間無明顯差異,該材料的細(xì)胞毒性為0-1級(jí)。3.物理機(jī)械性能：根據(jù)第三方檢測報(bào)告數(shù)據(jù)表明,PU材料的各項(xiàng)物理機(jī)械性能均優(yōu)于PE材料及醫(yī)用硅橡膠。 結(jié)論：PU材料宮內(nèi)裝置具有良好的生物相容性,其物理性能符合該專利產(chǎn)品的設(shè)計(jì)要求。
[Abstract]:Objective: 1. The biocompatibility of intrauterine devices (proprietary products) of polyurethane (pu) was evaluated by in vivo and in vitro cytotoxicity tests. 2. The physical and mechanical properties of pu intrauterine device are measured to evaluate whether it meets the design requirements of the intrauterine device. Methods: 1.According to the regulations of GB / T 1688. and IS010993., in vivo and in vitro cytotoxicity tests were carried out on the intrauterine device of pu. Animal implantation experiment: 1 Experimental material: medical pu material Intrauterine device T-type cyclic Polyethylene (PEE) scaffold; 2Experimental group: 18 healthy female SD rats were randomly divided into 3 groups according to their body weight. The experimental material modules were implanted into the posterior legs of SD rats respectively, and the experimental group was implanted with pu. The control group was implanted with PE, while the blank group only performed incision and suture on the left foreleg of the rats. The tissue around the module of the implanted material was taken out on the 7th day and 30th day 90 days after operation. After observation, HE sections were made. The sections were observed under light microscope to assess the degree of inflammatory reaction and to judge the difference between the two materials. In vitro cytotoxicity test: mouse fibroblasts; 2 Experimental group: blank group, PE extraction solution group, different concentration of Pu material extraction solution group. The cells were stained with CCK-8 for 7 days and incubated for 3 hours. The absorptivity was measured at 450 nm wavelength, the relative proliferation rate was calculated, and the morphology of each group was observed under microscope. Evaluate its cytotoxicity. 2. Determination of physical and mechanical properties: test the physical and mechanical properties of pu / PE and medical silicone rubber, including hardness, elongation at break and tensile strength. 100% tensile strength and fatigue test. Results: 1. In vivo implantation experiment: all the rats safely tolerated anesthesia and operation, the wound healed well, 7 days after operation 30 days and 90 days after operation. There was no significant difference in the degree of inflammatory reaction between pu group and PE group. 2. In vitro cytotoxicity test, the OD value of the cells was determined by the cell cytotoxicity test: with the extension of culture time, the extractions of pu with different concentrations could promote cell proliferation (P0.05). There was no significant correlation between cell proliferation and the concentration of extractant, but there was no significant difference between experimental group, control group and blank group. The cytotoxicity of the material is 0-1 grade .3.Physico-mechanical properties: according to the data of the third party testing report, the physical and mechanical properties of the pu material are superior to those of PE material and medical silicone rubber. Conclusion the device has good biocompatibility and its physical properties meet the design requirements of the patent product.
【學(xué)位授予單位】：中南大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2014
【分類號(hào)】：R318.08;R169.43

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