利福平/聚乳酸-聚羟基乙酸缓释微球的制备及特性

背景：虽然国内外有很多制备利福平/聚乳酸-聚羟基乙酸共聚物(poly lactic acid-glycolic acid copolymer,PLGA)微球的报道,但这些微球粒径多在10 μm左右,不适合与磷酸钙骨水泥复合制备成具有良好降解性的抗结核修复材料。 目的：制备大粒径利福平/PLGA缓释微球,观察其理化特性和体外缓释特性。 方法：以PLGA为载体,将利福平分散于PLGA的有机溶剂中,采用复乳溶剂挥发法制备利福平/ PLGA缓释微球。光镜和扫描电镜下观察微球的形态特征,测定微球平均直径和跨距,高效液相色谱法测定载药量和包封率,以溶出法和高效液相色谱法观察其体外释药特性,并拟合药物体外释放曲线建立曲线方程。 结果与结论：利福平/PLGA微球电镜观察呈圆球形,分散性好,粘连少,粒径分布集中,平均粒径(80.0±9.4) μm。载药量、包封率分别为(33.18±1.36)%,(54.79±1.13)%。体外缓释试验显示突释期内微球释放度为(14.66±0.18)%,前3 d累计释放度(18.09±0.45)%,到42 d体外累积释放度达到(92.17±1.23)%。提示利福平/PLGA微球具有良好的缓释效果,是一种较为理想的抗结核药物的载体材料和释放系统;PLGA是良好的药物缓释载体,可以用来制备载药缓释微球。     

载羟基喜树碱聚乳酸-羟基乙酸微球的制备及相关性能研究

目的制备一种载羟基喜树碱的聚乳酸-羟基乙酸(PLGA)缓释微球,并考察其相关性能。方法采用乳化-溶剂挥发法制备羟基喜树碱PLGA微球,用扫描电子显微镜观察载药微球表面形态,测定平均粒径及跨距,高效液相色谱检测包封率、载药率及体外释放情况,改良寇氏法计算小鼠半数致死量。结果制备的载药PLGA微球呈圆球形,表面光滑,无粘连,平均粒径30.8μm,跨距0.9,包封率为85.5%、载药率4.28%,在体外28 d累积释放药物81.4%。羟基喜树碱小鼠静脉注射的半数致死量为18.4 mg/kg,肌内注射半数致死量为71.3 mg/kg,而羟基喜树碱PLGA微球肌内注射的半数致死量为138.5 mg/kg。结论乳化-溶剂挥发法制备的羟基喜树碱PLGA微球粒径适宜,包封率、载药率高,缓释效果好,毒性低,具有潜在的临床应用价值。     

注射用雌二醇聚乳酸羟基乙酸缓释微球生物相容性研究

目的：以整体动物为研究对象，考察注射用雌二醇聚乳酸羟基乙酸缓释微球动物体内的生物降解和生物相容性。方法：肌注给药，显微镜观察组织切片，研究空白PLGA微球及载雌二醇PLGA微球的生物降解和相容性。结果：28d内，微球从规则球形降解为不规则微小颗粒，组织学观察空白微球和载雌二醇微球均未见病理改变。结论：注射用雌二醇聚乳酸羟基乙酸缓释微球具有良好的生物降解和相容性。     

乳酸-羟基乙酸共聚物缓控释微球的制备及突释成因与影响因素

背景：乳酸-羟基乙酸共聚物是一种生物可降解高分子材料,以乳酸-羟基乙酸共聚物为原料制备的载药微球和纳米粒既可提高药物的稳定性,又能实现缓释、控释和靶向释放。 目的：分析乳酸-羟基乙酸共聚物缓控释微球的制备方法以及突释的成因、影响因素和改进方法。 方法：应用计算机检索1990/2010中国期刊全文数据库和PubMed数据库与乳酸-羟基乙酸共聚物缓控释微球的制备及突释联系紧密的文章。 结果与结论：目前乳酸-羟基乙酸共聚物缓释微球制备方法主要有单凝聚法、乳化-固化法、喷雾干燥法。造成其突释的原因首先是药物分子和聚合物分子之间的相互作用太弱,导致药物很容易从微球进入释放递质中,其次是在微球释放初期,药物从微球中的孔洞和缝隙中释放出来导致突释。影响突释程度的具体因素有乳酸-羟基乙酸共聚物的相对分子质量、浓度、微球载药量、主药理化性质、微球制备方法及制备参数等。虽然国内外对突释机制以及控制突释措施的研究都还处于初步阶段,通过对各影响因素加以适当优化与控制,可在一定程度上减少微球的突释率,突释问题应该能够得到解决和控制。     

两性霉素B缓释微球的制备及缓释性能研究

为了更好地研究药物载体材料对药物微球缓释性能的影响,本研究将可完全生物降解的共聚物作为壁材以相分离法制备含抗真菌药物两性霉素B的微球,研究了不同溶剂/非溶剂、不同分子量共聚物、不同配比共聚物、不同表面活性剂及其不同用量等因素对微球的粒径大小、分布、药物包封率和药物体外释放等性能的影响。使用透射电镜（TEM）和原子力显微镜（AFM）观察微球的表面形貌,使用激光粒度分析仪测试微球的粒径大小及分布,使用紫外分光光度计测定药物的包封率。研究发现,聚合物特性粘度和分子量越大,聚合物中LA：PEG的配比越大,微球粒径越大,分布越宽;微球粒径越大,包封率也较大;AmB/PLA-PEG微球具有缓释性能,且含药微球的释放性能与微球的粒径,包封率等因素有关。     

聚乳酸-羟基乙酸共聚物-壳聚糖单向缓释膜制剂的研究

目的研制一种可以携带药物单向作用患处的膜型缓释制剂,避免对周围正常组织产生不良影响。方法昆明小鼠30只,鼠龄6周,雌性,体质量20 g左右。利用聚乳酸-羟基乙酸共聚物(PLGA)和壳聚糖分别制作外层膜和释放膜,通过交联层将2层结合,利用单向释放实验、蛋白释放、淫羊藿苷释放(测定其光密度值)确定膜的单向缓释放性。分别取不同释放时期的膜做扫描电子显微镜观察,确定其在不同释放时期膜微观结构的变化。利用降解率确定膜的物理性质,通过细胞实验和动物实验[苏木精-伊红(HE)染色],了解材料的生物相容性和载药后对治疗的有效性。结果通过释放实验、载药实验,证明单向膜可以包载不同溶解性质(水溶性、脂溶性)的药物,具有单向缓释作用。在释药过程中膜微观结构有明显变化,15 d后降解率达到96%左右。生物相容性实验和HE染色实验证明单向膜具有良好的生物相容性。细胞实验证明包载淫羊藿苷的膜可以使骨髓间充质干细胞产生一定量的碱性磷酸酶,发生分化。结论通过以上实验,确定单向膜具有良好的生物相容性、单向释放性和缓释性,载药后有一定疗效。     

盐酸万古霉素@聚乳酸-羟基乙酸共聚物-壳聚糖-透明质酸复合缓释微球的制备及体外评价北大核心

背景:局部抗生素缓释系统可解决全身应用抗生素时引发的全毒性反应与短期局部注射抗生素半衰期短的问题。目的:制备盐酸万古霉素@聚乳酸-羟基乙酸共聚物-壳聚糖-透明质酸[vaneomyeinhydroehlorid@poly(lactic acid glycolic acid)-chitosanhyaluronic acid,VA@PLGA-CS-HA]复合缓释微球,并对其性能进行评价。方法:采用乳液法制备VA@PLGA-CS-HA复合缓释微球与未载药PLGA-CS-HA复合微球,其中载药微球中万古霉素的质量浓度分别为25,50,100 g/L,检测载药微球的载药量、包封率与体外缓释性能。将3种载药微球分别与金黄色葡萄球菌菌液共培养,相应时间点内检测抑菌率。将4种微球浸提液分别与MC3T3-E1细胞和MG-63细胞共培养,培养1,3,7 d后采用CCK-8法检测细胞毒性。结果与结论:(1)含盐酸万古霉素25,50,100 g/L载药微球的包封率分别为(79.70±5.11)%,(86.41±3.91)%,(63.18±1.96)%,载药量分别为(3.98±0.26)%,(8.64±0.39)%,(12.63±0.39)%;50 g/L载药微球的包封率高于100 g/L载药微球(P<0.05),100 g/L载药微球的载药量高于其他两组(P <0.05);(2)3种载药微球在24 h内均无明显的突释,其中50 g/L载药微球不同时间点的药物释放率快于其他两组,100 g/L载药微球不同时间点的药物释放量高于其他两组,并且3组在56 d时释放的药物质量浓度均高于盐酸万古霉素最小抗菌浓度;(3)3种载药微球均能在一定时间内有效杀死金黄色葡萄球菌,在第14-28天期间3种微球的相对菌落率低于3%,说明3种载药微球能持续而有效杀灭金黄色葡萄球菌;(4)含盐酸万古霉素25,50 g/L载药微球对MC3T3-E1细胞和MG-63细胞无明显的细胞毒性,100 g/L载药微球具有一定的细胞毒性;(5)结果表明,VA@PLGA-CS-HA微球具有良好的缓释性能、抗菌能力与生物组织相容性。     

构建聚乳酸-羟基乙酸电纺丝-壳聚糖电喷微球牙周仿生膜

文题释义： 离子交联法制备壳聚糖微球：离子交联法利用酸性环境下壳聚糖呈阳离子性,向壳聚糖溶液中边搅拌边滴加三聚磷酸钠,带负电的磷酸根离子与壳聚糖分子链上带正电荷的氨基通过静电吸附,从而形成微球。 牙周膜：是连接牙齿和牙槽骨之间具有方向性的结缔组织,宽度为0.15-0.38 mm,其内含具有一定方向性胶原纤维束,其一端埋入牙骨质,另一端伸入牙槽骨内,具有固定牙根和缓解咀嚼时所产生压力的作用,又称牙周关节;牙周膜能形成牙槽骨及牙骨质,被破坏后能重建。由此可见,牙周膜不是普通的纤维结缔组织,它具有方向性、附着点、可再生牙周组织(牙骨质、牙周膜、牙槽骨)。 背景：当牙齿脱离牙槽窝后,牙周膜断裂,残留在脱位牙根表面的牙周膜由三维变成二维,丧失了支架膜的作用,导致脱位牙再植后根骨粘连。如何研发一种能黏附牙根表面具有一定厚度及强度的三维缓释支架材料,是脱位牙牙周膜再生成功的关键之一。 目的：构建可黏附脱位牙根表面的缓释生长因子的三维仿生膜。 方法：采用静电纺丝技术制备聚乳酸-羟基乙酸电纺膜,研究电纺溶剂二氯甲烷与二甲基甲酰胺混合溶液、六氟异丙醇、三氯甲烷对电纺膜的影响,筛选最佳的电纺溶剂。采用电喷技术与离子交联法制备壳聚糖微球,研究壳聚糖相对分子质量(5万、10万)与质量浓度(10,20 g/L)、接受液三聚磷酸钠浓度(2%,5%,10%)、电压(14,28 kV)对壳聚糖微球的影响,筛选最佳的参数。构建含基质细胞衍生因子1壳聚糖微球(最优参数设计),检测其体外释放基质细胞衍生因子1α的速率。首先将聚乳酸-羟基乙酸电纺膜裹在牙齿根表面,然后在其表面滴加壳聚糖微球,在其外层裹一层薄薄的聚乳酸-羟基乙酸电纺膜,从而形成聚乳酸-羟基乙酸-壳聚糖微球-聚乳酸-羟基乙酸膜。 结果与结论：①利用电纺溶剂六氟异丙醇制备的聚乳酸-羟基乙酸电纺膜平均直径最小、空隙率最大;②当壳聚糖相对分子质量为5万、质量浓度为20 g/L时,微球的大小基本一致,平均直径366.6 μm,单分散性好、饱满、稳定;28 kV电压下形成的壳聚糖微球更符合脱位牙仿生膜的要求;利用5%三聚磷酸钠制备的壳聚糖微球表面微观结构孔径居中,最有利于临床牙周膜再生;壳聚糖微球可持续释放基质细胞衍生因子1α 1个月左右;③实验创建了一种黏附牙齿表面的具有缓释效能的聚乳酸-羟基乙酸-壳聚糖微球-聚乳酸-羟基乙酸三维仿生膜并筛选出构建此仿生膜的最佳参数,可在此模型基础上进一步研究组织工程手段对脱位牙再植的效果及机制。 ORCID: 0000-0003-3957-3423(封小霞) 中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程     

乳酸-羟基乙酸共聚物多肽蛋白类药物微球控释系统的突释与控制

背景：突释问题是限制多肽蛋白类微球广泛应用的一个关键技术问题,已经成为PLGA微球控释系统面临的一个亟待解决的问题。 目的：分析近年来国内外对乳酸-羟基乙酸共聚物多肽蛋白类药物微球的突释与控制的研究,对突释的原因、影响突释的因素以及减少突释的方法与措施进行了详细的介绍。 方法：应用计算机检索CNKI和PubMed数据库中1999-01/2010-12关于乳酸-羟基乙酸共聚物多肽蛋白类药物微球控释系统研究的文章,在标题和摘要中以“聚乳酸-羟基乙酸;多肽;蛋白;微球;突释;控制”或“PLGA; peptide; protein ; microspheres; burst release; control”为检索词进行检索。通过阅读标题和摘要进行初选,排出较陈旧和重复研究文献,保留符合纳入标准的文献24篇。 结果与结论：对乳酸-羟基乙酸共聚物多肽蛋白类药物微球突释机制的理解,可以更好地实现对微球突释的控制,以扩大多肽蛋白类药物在临床上的应用。PLGA的性质、微球的制备方法、微球的制备参数都在不同程度上影响微球的突释,并且可能是多因素协同作用。通过对上述各种因素加以适当控制,可在一定程度上减少微球的突释率。通过该方面的机制研究对指导新药开发具有重要意义。     

复合壳聚糖纳米微球聚乳酸-羟基乙酸/纳米羟基磷灰石缓释载体系统对蛋白的缓释作用

背景：聚乳酸-羟基乙酸支架材料具有良好的生物相容性、无毒、可以良好的塑性,并具有一定的强度和韧性。但其降解产物为酸性,会影响局部pH值变化,不利组织生长。 目的：制备能够良好缓释蛋白类药物的复合支架。 方法：以牛血清蛋白为模型药物,以离子凝胶法制备壳聚糖微球。将微球与纳米羟基磷灰石和聚乳酸-羟基乙酸按一定比例混合,以冰粒子为致孔剂,采用粒子沥虑-冷冻干燥复合工艺制备CMs/nHA/PLGA复合缓释支架。利用扫描电镜、透射电镜、压泵仪和力学性能测试仪检测复合支架的形态和性能,并考察其在体外对蛋白类药物释放的规律。 结果与结论：制备的壳聚糖纳米微球形态良好,呈规则球形或类球形,粒径分布在220~770 nm,以380~650 nm为多。微球对药物的载药量为39.2%,包封率为68.3%,两者均与牛血清蛋白的初始量相关,载药量随牛血清蛋白初始量的增加而增加,包封率则反之。复合支架呈白色多孔状,孔径为125~355 mm,孔与孔之间联通良好,孔隙率达83.4%,压缩强度为1.4~ 2.1 MPa,10周降解率为28.6%。PLGA/nHA支架对牛血清蛋白的2 d累积释放量为85%,而壳聚糖和CMs/nHA/PLGA复合支架对牛血清蛋白的9 d累积释放量分别是为48.9%和35.7%。提示制作的壳聚糖纳米微球和CMs/nHA/PLGA支架材料对牛血清蛋白有良好的缓释作用,复合支架材料形态好,强度和降解速率合适。     

缓释重组人骨形态发生蛋白2仿生纳米纤维肝素/明胶复合支架的制备及表征

BACKGROUND: Bionic structure is one of the most important goals of scaffold design in tissue engineering. However, the majority of the bionic scaffolds do not have the capacity of sustained release of growth factors.     

高分子药用控释及缓释载体材料特点及在高血压治疗中的应用

BACKGROUND: Polymeric material, an important carrier used in the sustained-release and controlled-release system, is a major factor influencing drug efficacy; so understanding of different carrier materials contributes to obtain an ideal control-released effect. OBJECTIVE: To clarify the characters of medical polymeric materials, and analyze their application in the sustained-release and controlled-release system in the treatment of hypertension. METHODS: An online research was performed in databases of PubMed and WanFang for relative literatures published from 2006 to 2015 using the keywords of “polymers; sustained-release material; controlled-release material; chitosan; cyclodextrin; ilk fibroin; poly acid anhydride; polylactic acid” in Chinese and English, respectively. Totally 30 literatures were enrolled for analysis based on the inclusion and exclusion criteria. Analyzing the application tendency of sustained-release and controlled-release system in the treatment of hypertension was conducted by retrieving WanFang database between 2010 and 2015 in China. RESULTS AND CONCLUSION: Polymeric materials used for release carriers should be non-toxic or low toxic and hold good biocompatibility and biodegradability, including natural polymeric materials (polysaccharides and proteins) and synthetic polymeric materials (polylactic acids, polyanhydrides, polypeptides and amino acids). These new polymeric materials overcome some shortcomings of the single material and expand the range of controlled-release carriers showing a light application prospect. Studies on the sustained-release and controlled-release system have achieved satisfactory outcomes, but questions of efficiency, speed-control and intelligentization remain to be resolved. The number of literatures related to the application of sustained-release and controlled-release system in the treatment of hypertension in WanFang database between 2010 and 2015 are increased gradually, suggesting that the sustained-release and controlled-release drugs have become popular in the hypertension treatment. Nifedipine sustained-release or control-release tablets, felodipin sustained-release tablets and metoprolol sustained-release tablets are commonly used.      

非洛地平缓释片在中国高血压患者治疗中的应用

BACKGROUND: Felodipine sustained-release tablets are taken orally once daily, which not only exhibit a flat plasma-concentration curve, but also have characteristics of stable effect-acting, good absorption in vivo, high bioavailability and good compliance. OBJECTIVE: To introduce the application status of felodipine sustained-release tablets in the hypertensive treatment of China. METHODS: A computer-based research of CNKI database was performed for literatures published from January 1, 2005 to July 1, 2016. Using the keywords of “felodipine sustained-release tablets, hepertension”, 174 articles were retrieved; and when retrieving “felodipine sustained-release tablets, materials”, 22 were obtained. Thirty literatures were enrolled finally for analysis according to the exclusion criteria. RESULTS AND CONCLUSION: Felodipine sustained-release tablets have been popularized to the hypertensive treatment in our country, and obtain satisfactory treatment outcomes for mild and moderate spontaneous hepertension, which are similar with those of the nifedipine sustained-release tablets, metoprolol sustained-release tablets and benazepril hydrochloride tablets. Felodipine sustained-release tablets also induce slight adverse reactions, such as headache, flush, palpation and swelling of ankles. For patients with hypertension cannot be alleviated through single use of felodipine sustained-release tablets, combination with other types of antihypertensive drugs including beta blockers, angiotensin converting enzyme inhibitors and diuretics is advisable. Compound felodipine sustained-release tablets have been used in clinic, and numerous multicenter, double-blind, randomized control trials have proved its effectiveness and safety. Therefore, compound felodipine sustained-release tablets are another choice when single treatment shows no improvement on patients with spontaneous hypertension.       

局部定向抗结核药物缓释材料在兔桡骨内的释放及分布规律

BACKGROUND: Polylactic acid-glycolic acid polymer is a sustained-release material with relatively large drug loading and long-term release abilities that can degrade with cell growth in the body. However, its poor hydrophily easily leads to aseptic inflammation that is detrimental to the body’s recovery. OBJECTIVE: To study the release and distribution of anti-tuberculosis drug delivery materials locally oriented within the rabbit radius. METHODS: After modeling, 20 New Zealand white rabbits with distal radius bone defect were randomly divided into a control group and an experimental group, which were respectively given implantation of isoniazid-rifampicin polylactic acid-glycolic acid polymer/β-tricalcium phosphate material and isoniazid-rifampicin polylactic acid-glycolic acid polymer into the defect. Then, X-ray examination of the defect region was conducted at weeks 4, 8, 12 post implantation. Histological observation and detection of peripheral blood or local blood concentration were performed at week 12. RESULTS AND CONCLUSION: After implantation, Lane-Sandhu X-ray scores were significantly higher in the experimental group than the control group (P < 0.05). The defect in the experimental group was healed completely with less release residual among newborn bone trabeculae and osteocytes were markedly visible on the material surface, while in the control group, new bone tissues were interconnected with the surrounding bone tissues at the defect site, and less release residual was found. Both peripheral blood and local blood concentrations in the experimental group were significantly higher than those in the control group after implantation (P < 0.05). To conclude, the anti-tuberculosis drug delivery material, isoniazid-rifampicin polylactic acid-glycolic acid polymer/β-tricalcium phosphate, has ideal release effect that can stably deliver anti-tuberculosis drugs for a long term at a high bactericidal concentration.       

聚L-乳酸合成新型烧伤材料的生物相容性

背景：最近有研究表明,高分子聚合物聚L-乳酸具有很好的生物相容性,可直接参与人体代谢且无任何不良反应,是一种可用作生物支架的高分子材料。目的：验证高分子聚合物聚L-乳酸的生物相容性。方法：检测胶原复合物及聚L-乳酸的吸湿性能。分别以正常HDMEM培养基、HDMEM培养基+二甲基亚砜、HDMEM培养基+胶原复合物浸提液、HDMEM培养基+聚L-乳酸浸提液培养C3H10T1/2细胞,72 h后观察细胞形态变化。MTT法检测聚L-乳酸浸提液、二甲基亚砜、胶原复合物浸提液对C3H10T1/2细胞的毒性。在兔血中分别加入生理盐水、蒸馏水、聚L-乳酸浸提液及胶原复合物浸提液,检测溶血度。通过兔耳缘静脉分别注射生理盐水、聚L-乳酸浸提液、二甲基亚砜及胶原复合物浸提液,观察过敏反应、热源反应。将胶原复合物及聚L-乳酸分别植入兔背部皮下,4周后检测血清中炎性因子白细胞介素10和白细胞介素23的水平。结果与结论：胶原复合材料单位质量和单位面积的吸湿率均明显低于聚L-乳酸材料(P < 0.05)。在聚L-乳酸浸提液中培养的C3H10T1/2细胞生长状态良好,细胞相对增殖率高,材料毒性为1级;聚L-乳酸材料溶血率较低,无过敏反应及热源反应,植入体内后的炎症反应低于胶原复合材料(P < 0.05)。证实聚L-乳酸新型皮肤烧伤支架材料具有良好的吸收伤口液体性能及生物相容性。中国组织工程研究杂志出版内容重点：组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程     

牙种植高分子材料聚甲基丙烯酸甲酯的生物相容性

BACKGROUND: As a kind of dental implant material, the application of titanium has certain restrictions because of its higher probability of postoperative bleeding rate, infection and gingival hyperplasia. Studies have shown that polymethylmethacrylate has been used in artificial joints and artificial bones, but rarely reported to be used as dental implant material. OBJECTIVE: To explore the biocompatibility indexes such as cytotoxicity, cell adhesion rate, relative cell proliferation rate and post-implantation inflammatory response of human osteoblasts when pure titanium and polymethylmethacrylate are used as dental implant materials, so as to provide certain reference basis for the clinical usage of polymethylmethacrylate as the dental implant material. METHODS: Human osteoblasts were cultured in vitro. Three groups were divided as follows: control group (cells cultured normally), pure titanium group (cells cultured with titanium extract) and polymethylmethacrylate group (cells cultured with polymethylmethacrylate extract). RESULTS AND CONCLUSION: Compared with the control group, the cell adhesion rate was significantly decreased after 2, 4, 8 and 16 hours of culture with pure titanium and polymethylmethacrylate extracts (P < 0.05); the cell adhesion rate in the polymethylmethacrylate group was higher than that in the pure titanium group (P < 0.05). Compared with the control group, the cells were sparse and grew slowly after 2 days of culture with pure titanium and polymethylmethacrylate extracts. Cells in the polymethylmethacrylate group grew faster with fusiform distribution and obvious drawing phenomenon. Compared with the control group, the relative cell proliferation rate was significantly decreased after 2 days of culture with pure titanium and polymethylmethacrylate extracts (P < 0.05); the relative cell proliferation rate of polymethylmethacrylate group was higher than that of the pure titanium group (P < 0.05). The expression of inflammatory factors in rat serum was significantly increased after 7 days of implantation of titanium and polymethylmethacrylate materials (P < 0.05), the expression of inflammatory factors in the polymethylmethacrylate group was less than that in the titanium group (P < 0.05). There was only one rat developing allergic reaction, but no pyrogen reaction and no death in the polymethylmethacrylate group; and three rats presented with allergic reaction, one rat present with pyrogen reaction and no death occurred in the pure titanium group. These results demonstrate that as the dental implant material, polymethylmethacrylate is superior to pure titanium in the cell toxicity, inflammatory response and biocompatibility. 中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程     

高分子吸水材料宫颈扩张棒的生物相容性

背景：优美特宫颈扩张棒由高性能吸水性好的高分子生物材料制成,无毒副作用,一次性使用,可避免交叉感染。目的：观察优美特宫颈扩张棒用于置、取宫内节育器及人工流产术前扩张宫颈的临床效果。方法：将置、取宫内节育器、妊娠10周内负压吸引人工流产术需扩张宫颈的275名女性,随机分为两组,观察组137名,应用优美特宫颈扩张棒扩张宫颈;对照组138名,应用宫术宁胶棒扩张宫颈。观察两组术中宫颈软化扩张情况、镇痛效果、综合反应程度。结果与结论：两组育龄期置、取宫内节育器的宫颈扩张效果比较差异无显著性意义,观察组人流和绝经期取宫内节育器的宫颈扩张效果优于对照组(P < 0.05);观察组置入时的疼痛发生率低于对照组(P < 0.05),两组留置时的疼痛发生率均较低且无差异;两组手术结果及安全情况比较差异无显著性意义。两组均顺利取出扩张棒,无宫颈损伤发生,术中无血压下降、心率减慢等心脑综合征发生,未发生与扩张宫颈相关的不良事件。表明优美特宫颈扩张棒扩张宫颈效果安全、可靠,可显著减轻疼痛感。 中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程     

壳聚糖微球包裹幽门螺杆菌全菌蛋白抗原的制备及体外释放性能

背景：包裹幽门螺杆菌全菌蛋白抗原的研究仍处于探索阶段,有关壳聚糖微球包裹幽门螺杆菌全菌蛋白抗原的制备工艺及体外释放性能的文献甚少。 目的：探讨幽门螺杆菌全菌蛋白抗原壳聚糖微球的制备工艺及体外释放特性。 方法：采用沉淀法制备壳聚糖微球,筛选最佳制备工艺及配比、包裹时间,并在电镜下观察微球的形态和粒径。采用壳聚糖微球包裹幽门螺杆菌全菌蛋白抗原,BCA法测定幽门螺杆菌全菌蛋白抗原微球的包裹率、包裹量及体外释放率。 结果与结论：终体积分数为1%的冰醋酸、硫酸钠为交联剂、pH 5.0、滴加交联剂时不粉碎处理为壳聚糖微球最佳制备工艺,电镜观察显示微球表面光滑、形态圆整,具有良好的分散性,多数微球粒径为1.0-5.0 μm。幽门螺杆菌全菌蛋白抗原微球的包裹率为80.4%,包裹量为16.4%,48 h总释放率为19.4%,幽门螺杆菌全菌蛋白抗原微球整体呈缓慢释放状态。结果证实,实验制备的壳聚糖微球对幽门螺样菌全菌蛋白抗原具有良好的包裹率和包裹量,幽门螺杆菌全菌蛋白抗原微球整体呈缓慢释放状态。中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程      

复合左旋聚乳酸胆肠溶解支架的体外实验

BACKGROUND: The degradable poly-L-lactic acid (PLLA) biliary-enteric composite stent has been developed. OBJECTIVE: To analyze the solubility and biocompatibility of the degradable PLLA biliary-enteric composite stent. METHODS: Solubility: the PLLA composite stent was implanted into artificial gastric acid to detect the dissolution rate within 12 weeks. Pyrogen test: the PLLA composite stent extracts were injected into the rabbits via ear vein to detect the changes of body temperature. Hemolysis test: the PLLA composite stent extracts, normal saline and distilled water were added into the rabbit anticoagulant, respectively, to detect the hemolysis ratio. Cytocompatibility test: Caco-2 cells were respectively cultured in the DMEM medium containing 10% fetal bovine serum, rubber material extracts and the PLLA composite stent extracts, and the cell proliferation was detected at 12, 24, 36 and 48 hours; the lactic dehydrogenase release was detected at 2 days. RESULTS AND CONCLUSION: The PLLA composite stent showed a long stability in vivo, and approximately 80% was dissolved at about 20 weeks. No reactions of pyrogen and henolysis were observed in the pyrogen and hemolysis tests. The PLLA composite stent made no effects on the Caco-2 cell proliferation and lactic dehydrogenase release. In conclusion, the PLLA composite material holds a good solubility and cytocompatibility.     

几丁糖与聚乳酸合成生物材料修复周围神经缺损

背景：单纯几丁糖材料制成的神经导管机械强度较差,易于塌陷,不利于再生神经的生长。 目的：观察几丁糖与聚乳酸复合物修复大鼠周围神经缺损的可行性。 方法：取30只SD大鼠,制作单侧坐骨神经缺损模型,随机均分为3组,分别采用自体神经、硅胶导管及几丁糖与聚乳酸复合导管修复神经缺损,修复后12周,观察桥接神经外观、表面粘连情况及有无神经瘤生成等,检测大鼠神经传导速度、动作电位波幅及潜伏期,苏木精-伊红染色观察坐骨神经桥接物中段神经再生轴突数量及再生神经横截面积,称量大鼠完整小腿三头肌湿质量。 结果与结论：修复后12周,3组再生神经均通过5 mm神经缺损间隙,硅胶管组形成神经瘤,其余两组均未出现神经瘤;自体神经组再生神经直径大于几丁糖-聚乳酸组、硅胶管组(P < 0.05),几丁糖-聚乳酸组再生神经直径大于硅胶管组(P < 0.05);几丁糖-聚乳酸组、自体神经组可见排列整齐的高密度再生轴突,再生轴突数量多于硅胶管组(P < 0.05),且神经传导速度、动作电位波幅、小腿三头肌湿质量显著大于硅胶管组(P < 0.05),潜伏期低于硅胶管组(P < 0.05)。表明几丁糖-聚乳酸复合导管可促进缺损周围神经的再生。  中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程