多孔镍钛合金牙种植材料的体外生物安全性检测

目的检验多孔NiTi合金牙种植材料的生物相容性。方法分别通过溶血试验、细胞毒性试验（MTT法）评价多孔NiTi合金材料的生物安全性。结果多孔NiTi合金材料无溶血现象，不影响凝血功能；MTT试验显示L929细胞在多孔NiTi合金牙种植材料浸提液中生长良好，细胞毒性为1级。结论多孔NiTi合金材料具有较好的生物安全性。     

多孔NiTi合金种植材料的细胞毒性实验研究

目的:检验多孔NiTi合金与灌注羟基磷灰石多孔NiTi合金牙种植材料的生物相容性,为进一步进行动物实验及临床应用提供实验依据。方法:通过细胞毒性实验(MTT法),评价多孔NiTi合金牙种植材料的生物安全性。结果:MTT实验显示L929细胞在多孔NiTi合金牙种植材料浸提液中生长良好,细胞毒性为0级。结论:多孔NiTi合金与灌注羟基磷灰石多孔NiTi合金牙种植材料具有良好的生物安全性。     

低贵金属合金体外生物相容性评价

目的：对自行研制的牙科低贵金属合金Au-Pd-Ag合金、Ag-Pd合金的体外生物相容性进行评价。方法：使用细胞毒性试验（MTT法）、溶血试验、口腔粘膜刺激试验3种方法。结果：①培养的L929小鼠成纤维细胞经Au-Pd-Ag和Ag-Pd合金材料浸渍液处理后形态良好，增殖旺盛，材料毒性评级0－1级；②Au-Pd-Ag合金和Ag-Pd合金的溶血程度分别为1．43％和0．75％。③病理观察与正常组织比较无明显改变，两种合金对口腔粘膜无刺激。结论：Au-Pd-Ag和Ag-Pd合金具有良好的生物相容性。     

磷灰石骨水泥材料的生物学性能评价

本研究对自行研制的磷灰石骨水泥材料按生物学性能测试标准进行了细胞毒性、热原、急性全身毒性和溶血试验，以及动物体内种植试验。试验结果表明：磷灰石骨水泥材料具有良好的生物相容性，能与骨组织形成紧密结合，材料可逐渐为新骨组织置换。显示了磷灰石骨水泥作为新型医用骨水泥材料应用的良好前景。     

羟基磷灰石涂层处理的多孔镍钛合金溶血性及细胞黏附性评价

目的通过研究经羟基磷灰石(HA)涂层处理后多孔镍钛(NiTi)合金的溶血率及成骨细胞在其表面的附着、增殖及分化情况,评价其体外生物相容性。方法测定经HA涂层处理的圆盘状多孔NiTi合金(NiTi-HA组;直径10mm,厚2mm)的生物相容性,未经涂层处理的多孔NiTi合金(NiTi组)及致密纯钛(Ti组)试样设为对照组。采用分光光度法分析其溶血性能;将成骨细胞接种于试样表面,用扫描电镜(SEM)观察成骨细胞黏附形态,MTS法及碱性磷酸酶(ALP)试剂检测细胞附着、增殖情况及ALP活性,对数据进行重复测量方差分析。结果 NiTi-HA组、NiTi组及Ti组试样的溶血率分别为(0.30±0.11)%、(0.51±0.07)%及(0.27±0.06)%,均低于国家标准(YY/T0127.1)规定的5%。SEM观察显示,NiTi-HA组及NiTi组试样细胞黏附形态良好。NiTi-HA组试样表面细胞附着及增殖数量均高于NiTi组试样(P值分别为0.000与0.001)。NiTi-HA组及NiTi组试样表面细胞ALP活性无差异(P=1),但均高于Ti组试样(P值分别为0.001与0.0004)。结论 NiTi-HA组、NiTi组及Ti组试样均无溶血作用;NiTi-HA组较NiTi组更有利于成骨细胞附着和增殖,且ALP活性均高于纯钛。     

齿科修复用Zr-Cu-AL-Ag合金的生物安全性评价

目的：评价新型口腔修复用Zr-Cu-AL-Ag合金的生物安全性.方法：对Zr-Cu-AL-Ag合金进行细胞毒性试验、血液相容性试验以及急性全身毒性试验.结果：细胞毒性试验显示Zr-Cu-AL-Ag合金细胞毒性反应为0级,无细胞毒性;血液相容性试验Zr-Cu-AL-Ag合金溶血率数值小于5％,达到了生物材料对溶血率的要求.全身毒性试验显示无明显短期全身毒性.结论：Zr-Cu-AL-Ag合金拥有良好的细胞相容性、良好的血液相容性并且无急性全身毒性,可以初步满足其作为口腔植入材料的基本要求.     

经微弧氧化钛铌锆锡合金的生物安全性评价

目的：评价低弹性模量钛铌锆锡合金（TNZS）表面应用微弧氧化技术进行改性后的生物安全性。方法：参照ISO7405-1997（E）/GB16886-1997最新标准,对该材料分别进行细胞毒性试验、溶血试验、口腔黏膜刺激试验、短期全身毒性试验。结果：体内外生物学试验结果表明：细胞毒性试验显示TNZS合金经微弧氧化处理后无细胞毒性;溶血率小于5%,有良好的血液相容性;口腔黏膜刺激试验未见异常组织学反应;短期全身毒性试验显示无明显短期全身毒性。结论：钛铌锆锡合金经微弧氧化技术改性后,显示了良好的生物安全性。     

PLGA/HA支架材料生物相容性的动物实验研究

目的:通过动物实验评价新型多孔聚乳酸乙醇酸/羟基磷灰石(polyaiticglycolic acid/hydroxyapatite,PLGA/HA)支架材料的生物相容性。方法:分别将5%和10%HA掺量的PLGA/HA支架材料注射到昆明小鼠腹腔内、植入到新西兰大白兔体内,选择全身毒性试验、亚急性毒性试验、血液相容性试验、肌肉刺激试验等,对其生物相容性进行评价。结果:全身急慢性毒性试验显示材料种植到小鼠及兔子体内后,动物一般情况良好,2周后体重、红细胞计数、白细胞计数等生理参数未见明显变化;实验显示两种材料对兔混合血浆凝血功能无影响;溶血试验结果显示5%和10%的PLGA/HA的溶血率分别为2.67%和3.62%,均小于5%,完全符合医用材料对溶血试验的要求;肌肉刺激试验结果显示两种材料埋植后局部未见红肿,4周时部分PLGA/HA材料开始降解,降解部分有大量的纤维结缔组织生长;HE染色结果显示PLGA/HA基本不存在抗原性,植入机体4周后,材料周围未见明显炎症细胞浸润。结论:5%和10%HA掺量的PLGA/HA均具有良好的生物相容性和体内安全性。     

新型羟基磷灰石涂层钛种植材料生物安全性的初步评价

目的 评价表面诱导矿化(SIM)法羟基磷灰石涂层钛种植材料的生物安全性。方法 本实验共选择了三种体内外试验,即短期全身毒性试验(经口途径)、静脉注射急性全身毒性试验和溶血试验。结果经口毒性试验中试验组大白鼠都无明显毒性体征,其食物利用率、体重相对增长率等指标均与对照组无明显差别(P>0.05),内脏组织无病理性改变;急性全身毒性试验:试验组小白鼠无明显毒性表现,体重分别增加了2.8～4.8g,其体重变化量同对照组无显著性差异(P>0.05),内脏组织均未见病理性改变;体外急性溶血率为1.16％。结论 SIM法羟基磷灰石涂层钛种植材料对动物无急性全身toxic action,也无体外溶血作用,可初步认为其具有良好的生物安全性。     

新型钛铌锆锡合金生物安全性评价

目的：评价新型钛铌锆锡合金（Ti-24Nb-4Zr-7.9Sn）的生物安全性。方法：按照国标GB16886.5-1997,GB16886.4-1997,GB16886.10-2005、医药行业标准YY-T0279-1995以及YY-T0244-1996所规定的方法,分别进行细胞毒性试验、溶血试验、口腔黏膜刺激试验以及短期全身毒性试验。结果：细胞毒性试验结果显示该合金无细胞毒性,溶血试验结果显示该合金溶血率〈5%,口腔黏膜刺激试验结果显示该合金无刺激性,短期全身毒性试验显示该合金无短期全身毒性。结论：新型的钛铌锆锡合金具有良好的生物安全性,可满足卡环、支架等口腔表面接触器械的应用要求。     

Étude de la colonisation par des ostéoblastes humains de métaux poreux à base de nitinol ou de tantale dans un modèle de culture cellulaire tridimensionnelle

Acting as scaffolds for cell spreading and new tissue ingrowth once implanted into living tissues, porous materials have been used for several years for reconstructive surgery. In the field of dentistry and orthopedics, the biomechanical requirements for the implants have lead to an extensive use of biocompatible alloys. However, in a solid form these alloys have always exhibited inadequate fixative properties in the surrounding bone. Recent technologies allow the manufacturing of highly porous metallic open cell structures, biologically and biomechanically compliant. Two of these porous metals appeared particularly interesting for the design of novel dental implants: a porous titanium-nickel alloy (NiTi) and a porous tantalum structure. The purpose of the present study was to assess in vitro the invasion level of these porous materials by human osteoblasts, by the use of a three-dimensional cell culture system. Bone cell growth was measured by the MTT test, whereas cell infiltration and morphology throughout the porous scaffolds were examined by confocal microscopy. Our results indicate that porous NiTi and porous tantalum behave as suitable substrates for the attachment and ingrowth of human osteoblasts. Furthermore, the tantalum porous structure appeared more favorable to bone cell morphology and infiltration. These in vitro results are predictive for a good in vivo osseo-integration of implants made with these porous metals, as already reported in several orthopedic applications.     

牙科全瓷材料3Y-TZP生物相容性初步评价

目的：初步评价牙科全瓷材料3Y—TZP生物相容性。方法：根据ISO标准通过急性溶血实验、体外细胞毒实验（MTT法）及急性致敏实验分别测试不同浓度和浸提时间的材料浸提液对兔血细胞、L-929小鼠结缔组织成纤维细胞的影响,以及对豚鼠皮肤有无致敏反应,从而初步评价材料的生物相容性。结果：急性溶血实验结果：实验材料3Y—TZP吸光度0．32％,达到小于5％的安全标准。体外细胞毒实验各浓度组OD值均与阴性对照无显著性差异（P〉0．05）,与阳性组差异显著（P〈0．01）,材料毒性级别0级,而且强化致敏与激发期对豚鼠均无致敏反应发生。结论：实验材料3Y—TZP急性溶血实验阴性,体外细胞毒实验阴性,致敏反应阴性,初步认为3Y—TZP作为牙科全瓷修复材料对人体是安全的。     

新型牙体修复用合金—镓合金的生物学性能评价

新型牙体修复用合金——镓合金是一种能取代银汞合金的口腔修复材料。长期以来,银汞合金已在临床上广泛应用。由于金属汞的存在,给病人及医务人员均带来危害。本文就新研制成的镓合金进行了生物学性能试验,包括细胞毒性试验、溶血试验、皮肤致敏试验、口腔粘膜刺激试验、皮下埋植试验、鼠伤寒沙门氏菌回复突变试验-Ames试验和经口急性全身毒性试验。结果显示了良好的生物学性能。     

Cytotoxicity of dental alloys, metals, and ceramics assessed by millipore filter, agar overlay, and MTT tests

STATEMENT OF PROBLEM: Biocompatibility of dental materials is dependent on the release of elements from the materials. In addition, the composition, pretreatment, and handling of the materials influence the element release. PURPOSE: This study evaluated the cytotoxicity of dental alloys, metals, and ceramics, with specific emphasis on the effects of altering the composition and the pretreatment. MATERIAL AND METHODS: By using cells from a mouse fibroblast cell line and the agar overlay test, Millipore filter test, and MTT test, cytotoxicity of various metals, metal alloys, and ceramics for dental restoration were studied. Effects of altering the composition of a high noble gold alloy and of pretreatment of a ceramic-bonding alloy were also studied. In addition, the release of elements into the cell culture medium by the materials studied was measured using an inductively coupled plasma optical emission spectrophotometer. The results of the MTT test were analyzed statistically using ANOVA and Scheffé test at a significance level of P <.05. RESULTS: Specimens manufactured from materials intended for dental restorations and handled in accordance with the manufacturers' instructions were ranked from "noncytotoxic" to "mildly cytotoxic" according to the agar overlay and Millipore filter tests. For the MTT test, no significant differences were observed between these materials and controls, with the exception of JS C-gold and unalloyed titanium. The modified materials were ranked from "mildly cytotoxic" to "moderately cytotoxic" in the agar overlay and Millipore filter tests and from "noncytotoxic" to "moderately cytotoxic" in the MTT test. Thus, cytotoxicity was related to the alloy composition and treatment. The release of Cu and Zn seemed to be important for the cytotoxic effect. CONCLUSION: Alterations in the composition and the pretreatment can greatly influence the cytotoxicity, and the results stress the importance of carefully following the manufacturers' instructions when handling dental materials.     

口腔修复非贵金属材料对L-929细胞毒性的研究

目的：评价5种口腔修复非贵金属材料的细胞毒性。方法：采用细胞培养法、MTT法和流式细胞仪检测细胞周期的方法,研究5种合金的细胞毒性。结果：MTT比色法结果揭示：纯钛、钛合金具有良好生物相容性,而钴铬合金、镍铬合金、铜基合金抑制了细胞的生长。细胞周期所测各组细胞G2期比例与MTT结果相符。结论：不同金属合金的细胞毒性不同。     

牙科镍钛形状记忆合金的表面改性

镍钛形状记忆合金(NiTi SMA)具有形状记忆能力、超弹性和弹性模量可调等独特的力学性能,已成为一种新型牙科修复和种植的材料。但NiTi SMA中高含量镍的离子析出问题对其临床应用有很大影响。表面改性、涂层可使材料表面形成具有生物活性的薄膜,有效地抑制镍离子的析出,增强其抗腐蚀性和改善生物相容性,方法包括表面氧化法、表面涂层法和离子注入法等。本文对NiTi SMA表面改性方法的类型、生物力学性能和生物相容性评价等方面进行综述。     

Cytotoxicity of oxide anodized titanium alloy evaluated by cell and organic culture study

The cytotoxic effects of an oxide-anodized titanium alloy were investigated by cell and organic culture studies. Toxicity was estimated based on cell survival and growth rates compared with those of control materials (glass) after cultivation of cells (L 929) and chicken embryonic femurs expose to alloy plates. The oxide-anodized titanium alloy showed no cytotoxicity with respect to survival or growth rates in either cells or chicken embryonic femurs. Furthermore, the oxide-anodized titanium alloy was more acid and alkali resistant than intact titanium alloys. The results suggest that oxide-anodized titanium has greater stability and its metallic ions may be leachedless under various conditions following dental implantations. Therefore, this alloy should be suitable for use as a dental implant material.     

钴-铬-钼铸造合金对牙龈细胞毒性的研究

本文选用人牙龈细胞,对牙科常用的钴-铬-钼铸造合金进行细胞毒性的研究。将金属材料与细胞直接接触48小时,于去除后2小时和4天评定细胞增殖率,并作形态学观察(倒置显微镜和扫描电镜)和溶出金属离子的定量分析。实验结果表明,无论是从细胞形态的观察还是根据细胞毒性级的判断,均显示了该金属材料具有良好的体外生物相容性。