本文關(guān)鍵詞：PU材料宮內(nèi)裝置生物相容性及物理機械性能的研究　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 動物埋植實驗 體外細胞毒性 機械性能

【摘要】：目的： 1.通過動物體內(nèi)植埋實驗及體外細胞毒性試驗評估聚氨酯(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)裝置的各項物理機械性能,評估其是否滿足宮內(nèi)裝置的設(shè)計要求。 方法： 1.根據(jù)GB/T1688.和IS010993.規(guī)定,對PU材料宮內(nèi)裝置進行動物體內(nèi)植埋及體外細胞毒性試驗。 動物體內(nèi)植埋實驗：①實驗材料：醫(yī)用PU材料宮內(nèi)裝置、T型環(huán)聚乙烯(PE)支架；②實驗分組：按體重將18只健康的SD雌性大鼠依次編號,隨機分為3組,分別將實驗材料模塊植入SD大鼠的雙側(cè)后腿部,實驗組為植入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,評估組織的炎性反應(yīng)程度,判斷兩種材料的差異性。 體外細胞毒性實驗：①實驗細胞：小鼠成纖維細胞；②實驗分組：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,在酶標450nm波長處測定吸光值,計算相對增殖率,顯微鏡下觀察各組細胞形態(tài),評估其細胞毒性。 2.物理機械性能測定：測試PU材料、PE材料及醫(yī)用硅橡膠的各項物理機械性能,包括硬度、扯斷伸長率、拉伸強度、100%定伸強度等方面和耐疲勞實驗。 結(jié)果： 1.動物體內(nèi)植埋實驗：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.體外細胞毒性試驗：CCK-8法測定細胞OD值,隨培養(yǎng)時間的延長,不同濃度的PU材料浸提液對細胞增殖有促進作用(P0.05),細胞增殖與浸提液的濃度無明顯相關(guān)(P0.05),實驗組、對照組及空白組間無明顯差異,該材料的細胞毒性為0-1級。3.物理機械性能：根據(jù)第三方檢測報告數(shù)據(jù)表明,PU材料的各項物理機械性能均優(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)位級別】：博士
【學(xué)位授予年份】：2014
【分類號】：R318.08;R169.43

【參考文獻】

相關(guān)期刊論文 前7條

1 王琴;許學(xué)先;;宮腔手術(shù)后預(yù)防宮腔粘連的研究現(xiàn)狀[J];國際婦產(chǎn)科學(xué)雜志;2011年05期

2 侯春梅;李新穎;葉偉亮;曹曦元;肖鶴;黎燕;;MTT法和CCK-8法檢測懸浮細胞增殖的比較[J];軍事醫(yī)學(xué)科學(xué)院院刊;2009年04期

3 王純忠;黃宗海;沈三弟;陸峰;史福軍;陳飛;李建國;;硅橡膠和聚氨酯制作的結(jié)腸囊管性能測試[J];中國組織工程研究與臨床康復(fù);2011年25期

4 熊小娟;丁興琳;方春霞;張小芬;楊敏;;宮腔鏡診治宮腔粘連32例臨床分析[J];中國婦幼保健;2008年08期

5 趙福杰;李妍;王敏;馬敬麗;;生物蛋白膠在宮腔鏡下宮腔粘連分離術(shù)后預(yù)防再次粘連的價值[J];中國內(nèi)鏡雜志;2008年11期

6 王昕榮;朱桂金;;子宮內(nèi)膜干細胞研究進展[J];中國優(yōu)生與遺傳雜志;2008年01期

7 王蓮蓮;曹霞;羅希;施展;;幾丁糖和透明質(zhì)酸鈉防粘連材料在婦產(chǎn)科的應(yīng)用[J];中國組織工程研究;2012年47期

，

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