本文關(guān)鍵詞：可降解鎂合金內(nèi)固定材料的生物相容性研究　出處：《吉林大學(xué)》2013年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 鎂合金 溶血試驗 體內(nèi)試驗 組織相容性

【摘要】：研究背景：生物醫(yī)用材料是醫(yī)學(xué)與材料科學(xué)結(jié)合的產(chǎn)物，在臨床工作尤其外科工作中，擁有相當(dāng)重要的地位。首先，金屬材料因高強(qiáng)度、韌性好及抗腐蝕性能好，更適用于修復(fù)和置換人體骨組織。醫(yī)用金屬材料應(yīng)用最為廣泛，主要包括鈦合金、不銹鋼、鈷鉻合金。但它們在應(yīng)用中面臨著一些問題，由于生理環(huán)境的腐蝕而產(chǎn)生的重金屬離子向組織內(nèi)擴(kuò)散，從而對人體健康造成損害；同時由于彈性模量明顯高于骨組織，造成應(yīng)力遮擋，導(dǎo)致內(nèi)固定失敗或造成應(yīng)力性骨折等。而且金屬內(nèi)固定多需要在骨折愈合后，取出內(nèi)固定。對于患者來說，再次增加了經(jīng)濟(jì)負(fù)擔(dān)。所以研發(fā)新型金屬基生物植入材料是基于醫(yī)學(xué)發(fā)展和人文關(guān)懷應(yīng)運而生的。尤其是與人類骨骼生物性能相近，并能發(fā)揮完美的固定功能，甚至能夠促進(jìn)骨組織修復(fù)，加速骨組織愈合的全新材料。同時其在體內(nèi)具備可降解性。鎂及鎂合金成為生物醫(yī)學(xué)材料研究的關(guān)注焦點。與現(xiàn)有醫(yī)用金屬材料相比，鎂及其合金具有明顯優(yōu)勢。首先鎂作為人體必須的營養(yǎng)元素，生物安全性高。鎂在人體內(nèi)金屬離子含量位列第四位。鎂的重要性顯而易見。鎂離子的生理功能體現(xiàn)在其為酶的組成部分，參與新陳代謝。其次鎂能夠通過泌尿系統(tǒng)排泄，人體攝入大量鎂后，血清鎂含量仍不會明顯升高。再次鎂與骨組織的密度及彈性模量相似，避免應(yīng)力遮擋。同時鎂資源豐富，是最容易獲得的金屬元素之一。鑒于上述優(yōu)點，鎂及其合金的研究成為生物材料領(lǐng)域重要的研究方向。但鎂合金缺點同樣明顯，如局部腐蝕，降解行為不可控，可塑性差，力學(xué)特性差等。近年，鎂與鋅及鈣的合金，在強(qiáng)度、可塑性上表面優(yōu)異。但生物相容性、可控性降解仍有問題。本文中Mg-Zn-Ca-Y合金采用Ca元素，Zn元素，耐腐蝕性的稀土元素Y作為合金化元素，使用傳統(tǒng)熔煉鍛造技術(shù)，合成Mg-Zn-Ca-Y合金。本人通過溶血實驗及組織相容性試驗對鎂合金進(jìn)行生物相容性評價。為鎂合金的改良提供依據(jù)。 目的：本研究對新型Mg-Zn-Ca-Y合金的溶血率與浸提液濃度之間的關(guān)系及組織相容性系統(tǒng)評價，同時觀察測量新型合金植入動物體內(nèi)后，動物局部組織與全身狀態(tài)的改變，分析其對機(jī)體的影響。為新型材料應(yīng)用于臨床做必要的試驗與準(zhǔn)備，為制成臨床安全、滿意的可降解合金材料提供科學(xué)依據(jù)。 方法：第一部分，將鎂合金浸提液制備為不同濃度：100%、75%、50%、25%、10%、5%、2.5%、1%，按照GBT16886.4-2003《醫(yī)療器械生物學(xué)評價》第4部分《與血液相互作用試驗選擇》的要求，進(jìn)行溶血試驗。第二部分，于白兔骶嵴肌內(nèi)植入Mg合金短棒，觀察、測量白兔植入后的情況：體重、飲食、離子、肝功、腎功水平，植入點組織局部反應(yīng)，肝、腎情況。分別于術(shù)前、術(shù)后1、7、14、28、54天抽取白兔耳緣靜脈血液，觀察分析白兔在植入合金材料后肝功、離子、腎功是否存在變化及變化情況；利用HE染色，分別對不同時間點取出的植入物周邊纖維膜厚度及炎性改變情況進(jìn)行觀察，分別于植入后3、6個月，利用掃描電鏡，觀察纖維膜厚度，以及電鏡觀察1周、2周、1月、3月、6月鎂合金分解、腐蝕情況，對鎂合金在動物體內(nèi)的降解情況及對白兔的影響進(jìn)行分析。結(jié)果： Mg-Zn-Ca-Y合金的浸提液在100%、75%、50%、25%、10%、5%、2.5%及1%稀釋度下的溶血率分別為64.7%、62.4%、58.0%、34.2%、10.6%，4.7%，0.7%和0.2%。隨著濃度的減少，Mg+濃度逐漸下降，而鈉離子處于基本穩(wěn)定的狀態(tài),考慮Mg+濃度是影響其體外試驗溶血的主要因素之一。植入日本大耳白兔骶棘肌肌肉內(nèi)，一般情況良好，，切口無紅腫及分泌物。HE染色觀察的結(jié)果顯示，2周后纖維膜逐漸形成。12周后纖維膜變薄。鎂合金樣品在植入后1、2周，肉眼觀察表面無明顯變化，但電鏡觀察，其表面已出現(xiàn)少量裂隙。隨著時間推移，4、8、12周的樣品中，肉眼觀察，其表面已出現(xiàn)腐蝕情況，電鏡觀察其表面腐蝕情況較前嚴(yán)重，部分出現(xiàn)較為嚴(yán)重的點腐蝕。電鏡觀察局部反應(yīng)膜結(jié)果：實驗組纖維膜切面厚度15.1μm，對照組11.4μm。4周后標(biāo)本出現(xiàn)表面氧化，粗糙，肉眼未觀察到產(chǎn)氣。 結(jié)論：Mg-Zn-Ca-Y合金的體外溶血性能有待提高，考慮其受分解的Mg+離子的影響。Mg-Zn-Ca-Y合金的組織相容性通過國家標(biāo)準(zhǔn)。植入后，動物離子、肝功及肝腎臟均未見明顯異常。
[Abstract]:Background: biomedical materials is the combination of medicine and material science, especially in clinical surgical work, has a very important position. First of all, metal materials have high strength, good toughness and good corrosion resistance, more suitable for the repair and replacement of human bone tissue. The application of Biomedical Metal materials most widely, mainly including titanium alloy, stainless steel, cobalt chromium alloy. But they are facing some problems in the application of heavy metal ions, due to corrosion of the physiological environment of diffusion into the tissue, thereby causing damage to human health; at the same time due to the elastic modulus was significantly higher than that of bone tissue, cause stress shielding, leading to the failure of internal fixation should be or cause stress fracture. And the metal internal fixation in fracture healing, removing internal fixation. For the patients, to increase the economic burden. So the research and development of new metal basal implant materials Is the development of medicine and humanistic care. Especially came into being based on biological properties are similar to human bones, and can play a perfect fixed function, can promote bone tissue repair, accelerate newbone tissue healing. At the same time in vivo with biodegradability. Magnesium and magnesium alloy has become the focus of biomedical materials. Compared with the existing medical metal materials, magnesium alloy has obvious advantages. Firstly, magnesium as nutrient elements necessary to human body, high biological safety. The magnesium ion content in the body of magnesium was ranked fourth. The importance is obvious. The physiological function of magnesium ion in part reflected in the The new supersedes the old., as enzymes. Secondly through the urinary excretion of magnesium, magnesium intake body, serum magnesium content is still not significantly elevated again. Density and elastic modulus of magnesium and bone tissue similar to avoid stress At the same time occlusion. Magnesium is rich in resources, is one of the most readily available metal elements. In view of the above advantages, magnesium and its alloys have become an important research direction in the field of biological material. But the disadvantage is equally obvious, such as magnesium alloy, corrosion, degradation behavior is not controllable, plasticity, mechanical properties are poor. In recent years, alloy. Magnesium and zinc and calcium in strength, plasticity on the surface. But excellent biocompatibility and controllable degradation still has a problem. This paper adopts Ca Mg-Zn-Ca-Y alloy elements, Zn elements, rare earth elements Y corrosion resistance as alloying elements, the use of traditional melting forging technology of Mg-Zn-Ca-Y Alloy Synthesized by hemolysis test. I and tissue compatibility test of magnesium alloy for biocompatibility evaluation. Provide the basis for the improvement of magnesium alloy.
Objective: To study the hemolysis rate of the Mg-Zn-Ca-Y alloy and the model of relationship between leaching solution concentration and tissue compatibility evaluation system, at the same time to observe and measure the new alloy implanted in animal, animal tissue and body condition change, analyze the effects on the body. As the application of new materials to do clinical test and prepare the necessary that made the clinical safety, provide scientific basis for the satisfaction of the degradable alloy material.
Methods: in the first part, the magnesium alloy extract preparation for different concentrations: 100%, 75%, 50%, 25%, 10%, 5%, 2.5%, 1%, fourth part evaluation > < interactions with blood test requirements in accordance with the Select > GBT16886.4-2003< medical biology, hemolytic test. In the second part, the white rabbit sacral crest intramuscular implantation of Mg alloy rods, observation, measurement of white rabbits after implantation: body weight, diet, ion, liver function, renal function level, local reaction, implantation of liver, kidney. At preoperative, postoperative 1,7,14,28,54 days from rabbit ear vein blood in rabbits, to observe and analyze the alloy material after implantation liver function, renal function and ion, whether there are changes and changes; using HE staining, the thickness of fibrous membrane around the implant and inflammation at different time points out changes were observed respectively in 3,6 months after implantation, using scanning electron microscope, to observe the thickness of fibrous membrane, And the electron microscope observation of 1 weeks, 2 weeks, January, March, June, magnesium alloy decomposition, corrosion, analysis of magnesium alloy in the degradation of animal body and influence on rabbits. Results: the extracts in 100%, 75%, 50%, 25%, 10%, 5%, 2.5% and 1% of Mg-Zn-Ca-Y alloy, hemolytic dilution the degree of the rate were 64.7%, 62.4%, 58%, 34.2%, 10.6%, 4.7%, 0.7% and 0.2%. with the concentration decreased, the concentration of Mg+ decreased gradually, while the sodium ion in stable state, consider the concentration of Mg+ is one of the main factors affecting the haemolysis test in vitro. Implantation of Japanese white rabbits in the sacral spine muscle generally, in good condition, no incision swelling and secretion of.HE staining showed that the fibrous membrane gradually formed after 2 weeks.12 weeks after the fiber membrane thinning. Magnesium alloy samples at 1,2 weeks after implantation, observed no obvious change on the surface, but the electron microscope, the surface has small cracks. With time Time, visual observation to 4,8,12 weeks in the sample, the surface has been corrosion, electron microscope observation of the surface corrosion was serious, some of the more severe corrosion. Local reaction membrane electron microscope results: the experimental group fiber membrane slice thickness of 15.1 m, the control group 11.4 m.4 weeks after the specimen surface oxidation, rough, naked eye was not observed in the gas production.
Conclusion: the in vitro hemolytic properties of Mg-Zn-Ca-Y alloy should be improved, considering the Mg+ ion decomposition effect of.Mg-Zn-Ca-Y alloy biocompatibility by national standards. After implantation, animal ion, liver function and liver and kidney showed no obvious abnormalities.

【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：R318.08

【參考文獻(xiàn)】

相關(guān)期刊論文 前7條

1 張永君,嚴(yán)川偉,王福會,曹楚南;鎂的應(yīng)用及其腐蝕與防護(hù)[J];材料保護(hù);2002年04期

2 李龍川,高家誠,王勇;醫(yī)用鎂合金的腐蝕行為與表面改性[J];材料導(dǎo)報;2003年10期

3 高家誠,李龍川,王勇,喬麗英;表面改性純鎂的細(xì)胞毒性和溶血率[J];稀有金屬材料與工程;2005年06期

4 啟明;利用高溫滲氮法生產(chǎn)適合作生體醫(yī)用材料用的無鎳不銹鋼[J];金屬功能材料;2003年04期

5 劉江;;醫(yī)用金屬材料的研制與應(yīng)用[J];金屬功能材料;2007年06期

6 張素潔;張忠誠;徐祗云;;微量元素氟與人體健康[J];微量元素與健康研究;2007年02期

7 劉凌;李年豐;周厚吾;孔華;;生物可吸收鎂合金膽道內(nèi)支架應(yīng)用前景[J];中國實用外科雜志;2010年03期

本文編號：1370215