Simvastatin, a traditionally recognized lipid-lowering medication, has emerged as a potent osteoinductive agent with significant potential in bone tissue engineering and regenerative medicine. Its advantages include multi-pathways enhancement of bone healing, potential application in special populations with osteoporosis (e.g., the elderly and pregnant women), high safety profile, and low cost. However, the clinical translation of simvastatin for bone regeneration has been challenged by its poor aqueous solubility, limited bioavailability when administered orally, and potential systemic side effects at higher doses. In this study, an osmotic pump system was developed as an innovative localized delivery carrier for simvastatin acid-loaded material, which could maintain therapeutic drug concentrations at the defect site for extended periods while minimizing systemic exposure. The approach mitigated the local inflammatory response caused by the burst release of simvastatin acid and enhanced the osteogenesis effect both in vitro and in vivo. This study represented the first application that loaded drugs with biomaterials through osmotic pump principle which is applicable to most materials loaded with water-soluble drugs, broadening the range of loadable drugs and their clinical application scope.

The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics. Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects. 3D printing technology can produce low-modulus titanium alloy implants with porous structures, providing a better solution to the above problems. This technology is convenient to design and has a huge advantage in making orthopedic implants. The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis, including solid structural pelvic prosthesis and porous structural pelvic prosthesis. The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa, respectively, and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa, respectively. The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples. New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted. A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole. In conclusion, the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties, biocompatibility, and the ability to promote new bone growth.

动物源医疗器械作为应用广泛的医疗器械产品,应不断完善其评价技术和方法,提升质量评价标准,以促进产业的健康发展.临床使用过程中,动物源医疗器械产品产生的可沥滤物会不同程度地对人体产生危害.因此,总结概括动物源医疗器械可沥滤物的研究进展,对于动物源医疗器械产品质量控制具有重要意义.本文介绍了动物源医疗器械可沥滤物的监管现状,对不同来源的可沥滤物进行了分类分析,并总结概括了相关浸提液的制备方法、可沥滤物的检测方法、可沥滤物允许限量的确定方法.最后,对动物源医疗器械领域的研究和质量评价现状进行了概括和展望.

Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.

With the rapid development of my country's hemodialysis industry, the application of hemodialysis machines has become more and more extensive, but at the same time, the quality control technology of hemodialysis machines is not perfect. Especially for a wide range of leachable substances in dialyzers, there are few studies and detection methods. This study first briefly describes the development of hemodialyzers, and then expounds the common types of leachables, extraction methods, and chromatography and mass spectrometry conditions. It is summarized that the research plan of leachable substances is to determine the type first, then formulate the extraction plan, and then establish the detection method. Finally, we look forward to the research prospects of hemodialyzer leachables, and point out that with the deepening and extensive development of research, it can further promote the healthy development of the hemodialyzer industry.

目的:收集整理国内外文献对于可降解冠脉支架的研究成果,对其代表性材料进行深入分析,以期对可降解支架的研发与优化提供参考.方法:采用文献研究法,检索PubMed数据库、中国知网数据库、中国万方数据库1998至2020年的文献,从可降解冠脉支架代表性材料的特性、体内外降解情况及面临的挑战方面分别论述.结果 与结论:目前的研究方向主要分为可降解金属支架和可降解聚合物支架,研究较多的冠脉支架材料是镁、铁、锌合金与聚乳酸材料.可降解金属支架支撑性好但降解时间长,且降解速率仍需改善;可降解聚合物支架生物相容性好且降解时间短,但机械性能较弱.不管是金属还是聚合物材料,研究都仅仅处于初期,以后还会有更多可降解材料的发现,可降解冠脉支架是一个持续研究的课题.

目的 通过调节液体流量、流速及周期性脉动等参数,研究新西兰家兔颈动脉体外应力培养时血管结构的变化.方法 取SPF级新西兰家兔颈动脉置于生物反应器上,构建血管体外培养模型.共分四组,静态组为静态培养,动态组(80、50、25组)在脉冲泵运行位移与频率相同的条件下,保持培养液流速分别为80、50、25 ml/min,维持应力状态培养,培养结束后通过HE、Masson、EVG染色对血管结构的变化进行评价.结果 静态组15 d血管内皮细胞保持完整,平滑肌细胞排列混乱,弹性纤维收缩剧烈,胶原纤维基本没有变化;80组弹性纤维未见明显变化,内皮细胞不可见,第8天平滑肌较第4天排列整齐,第8天胶原纤维明显减少.50组内皮细胞不可见,平滑肌排列整齐,15 d时弹性纤维疏松且趋于平直,血管胶原纤维明显减少;25组内皮细胞可见,弹性纤维和胶原纤维改变较50组轻微.结论 在模拟动物体内各参数的条件下,血管体外动态培养有助于维持血管的生理结构,培养的难点在于防止污染和补充胶原.高应力条件下,会导致血管内皮细胞受损,进而造成平滑肌细胞增殖,胶原纤维流失更为严重.

目的:建立整形手术用交联透明质酸钠凝胶产品中蛋白质含量的标准检测方法,为行业标准YY/T 0962-2014《整形手术用交联透明质酸钠凝胶》的修订提供实验依据.方法:采用酸解法处理样品,考察了酸的种类、酸解时间等影响因素,用0.5mol/L硫酸溶液且在(95±5)℃恒温干燥箱45min中将样品完全溶解,利用考马斯亮蓝G-250与蛋白质结合显色的原理,以牛血清白蛋白为对照品,采用分光光度法在波长595nm处测定样品中蛋白质的含量,且委托第三方三所实验室对方法进行验证,对数据结果进行双因子方差分析.结果:该方法专属性较高,蛋白浓度在2～10μg/ml,回归方程y=0.0125x-0.0033(r=0.9997),校正曲线的线性关系良好,样品测定重复性RSD均值为3.19％,回收率结果98.70％,检出限为0.96μg/ml,四所实验室对同批次样品进行测定,采用双因子方差分析,得到P值为0.253>0.05,认为不同实验室采用同一方法对同批次样品的蛋白测定结果不存在显著性差异.结论:该方法是一种简单、快速、准确测定整形手术用交联透明质酸钠凝胶产品中蛋白含量的检测方法.

在骨缺损治疗中通常使用生物相容性和机械性能较好的钛合金骨科医疗器械进行替换,但是传统的加工制造工艺不能满足对复杂外形医疗器械的加工要求.近年来流行的3D打印技术具有传统材料制造技术不具有的优点,其性能优良的生物医用材料结合先进的材料制造技术,在骨科医疗器械领域具有很大的发展潜力.在计算机软件的帮助下,可以按照患者的需求制造特殊外形和结构的骨科医疗器械,从而实现个性化医疗.近几年出现了很多3D打印的骨科植入物,都表现出了优良的生物学性能.但是也存在一些问题,例如钛合金材料在力学性能上不能很好地匹配人骨,产生"应力屏蔽"现象,研究者们通过3D打印制造多孔结构的钛合金来降低钛合金人体植入物的弹性模量,也有研究者通过3D打印制造低模量的新型β型钛合金,这两种途径都有效地减小了应力屏蔽现象.此外,3D打印制造的钛合金零件往往会产生空隙和未熔化的粉末缺陷,从而导致表面光滑度下降和金属离子过度析出,影响骨科植入物的生物安全性.研究者们通过对3D打印钛合金骨科植入物进行表面处理,提高了生物安全性.通过创新三维结构和改进钛合金材料的成分使骨科钛合金医疗器械的力学性能得到了较好的优化,通过一些表面处理技术提高了 3D打印钛合金骨科医疗器械的表面质量,进一步提高了其生物安全性和有效性.因此近年来出现了很多临床上使用3D打印钛合金骨科医疗器械修复骨缺损的案例,取得了良好的效果.在未来,3D打印技术将成为定制化骨科医疗器械的主流制造方法,会有更多的3D打印新工艺和新材料出现.本文主要就3D打印骨科钛合金医疗器械产品的研究进展做出简要评述.

目的 改进和优化YY/T 0962—2014《整形手术用交联透明质酸钠凝胶》行业标准中交联剂1,4-丁二醇二缩水甘油醚(1,4-butanediol diglycidyl ether,BDDE)含量的标准检测方法,为该标准的修订提供技术依据.方法 在气相色谱法中,为使BDDE更好地从凝胶内部释放出来,在测定之前增加样品的酶解处理步骤,并用乙酸乙酯对BDDE进行萃取.此外,在酶标仪检测法中研究透明质酸酶的影响,将透明质酸酶添加到标准溶液中,从而去除透明质酸酶对测定结果的影响.最后委托M、Q、X三家实验室对该方法进行验证,对同一批次样品进行BDDE含量测定,对数据结果进行双因子方差分析,以检验该方法是否具有可行性.结果 气相法专属性、精密度以及重复性良好,平均回收率为105.02％,相对标准偏差(relative standard deviation,RSD)为9.15％(n=6).酶标仪检测法精密度、重复性良好,BDDE浓度0.5～8μg/mL范围内,BDDE浓度和荧光强度有良好的线性关系,线性方程为y=36.89x+2.135(r=0.9989),检出限为0.106μg/mL,平均回收率为97.43％,RSD为8.22％;采用双因子方差分析,对M、Q和本课题组(Z)三家实验室的验证结果进行统计(P>0.05),认为不同实验室采用同一方法对同批次样品的交联剂含量测定结果不存在显著性差异.结论 对于整形手术用交联透明质酸钠凝胶中交联剂BDDE含量的测定,气相法操作简单快捷,可作为BDDE的日常测定方法;酶标仪检测法特异性更高,数据更为真实精确,可作为整形手术用交联透明质酸钠凝胶产品中交联剂含量的仲裁方法.

Three-dimensional (3D) printing technology has attracted considerable focus for preparing porous bone repair scaffolds to promote bone regeneration. Inspired by organic-inorganic components and the porous structure of natural bone, novel porous degradable scaffolds have been printed using hydroxyapatite (HA), carboxymethyl chitosan (CMCS), and polydopamine (PDA). The well-designed HA/CMCS/PDA scaffolds exhibited a porous structure with 60.5 ± 4.6% porosity and 415 ± 87 μm in mode pore diameter. The weight loss percentage (WL%) of the HA/CMCS/PDA scaffolds reached about 17% during a 10-week degradation in vitro. The degradation process between the CMCS and HA induced the release of calcium ions. Using commercial product as the contrast material, the osteogenic properties of the scaffolds were assessed in vivo. The implantation and degradation of HA/CMCS/PDA scaffolds had no adverse effects on the kidney and liver of rabbits with no inflammatory response in the implantation sites. The micro-CT and histology data suggested that the HA/CMCS/PDA scaffolds could effectively stimulate new bone formation within the femoral lacuna defect region of rabbits versus blank control at 12 weeks after implantation. Surface cortical bone was generated in the defect area in the HA/CMCS/PDA group; the defect in the blank group remained obvious. HA/CMCS/PDA scaffolds had excellent biodegradability matching the formation of new bone during implantation. In conclusion, 3D-printed HA/CMCS/PDA scaffolds have remarkable potential as a new material for repairing bone defects.

透明质酸(Hyaluronic acid,HA)是人体组织成分之一,广泛存在于人体皮肤、软骨组织、韧带以及眼睛玻璃体中,具有良好的生物相容性、亲水性、粘弹性及低免疫原性.生物工程生产的交联透明质酸钠凝胶具有相似的生物学特性,是目前最常用的注射微整手术填充材料之一.该文首先回顾了注射整形行业的发展历史,同时分析了交联透明质酸钠凝胶在整形行业的应用,包括面部除皱、隆鼻颏、瘢痕修复等部分,重点阐述了整形手术用交联透明质酸钠凝胶质量控制的方法,包括交联剂残留量、透明质酸钠含量、溶胀度、蛋白质含量、重金属含量以及分子量等.结合国内外交联透明质酸钠凝胶的研究动态,提出了今后的发展前景.

Hydroxyapatite is widely used in the field of bone repair because it is similar to bone tissue components and has excellent biocompatibility. Because single material does not have a variety of excellent biological properties, the preparation of hydroxyapatite/polymer-based composite bone repair materials with superior performance has become one of the hotspots in the field of bone repair materials. This paper reviews some key points of designing hydroxyapatite-based composite bone repair materials and summarizes the research status of hydroxyapatite/polymer-based composites at home and abroad in recent years. In addition, this paper introduces the research situation of hydroxyapatite bone repair materials for drug-loading and puts forward some prospects for the future development of hydroxyapatite-based composite bone repair materials.

牙膏是日常生活中不可缺少的清洁用品,而牙膏中的重金属铅对人体危害很大,因此本文综述了目前牙膏的多种前处理方法和牙膏中铅含量的检测方法,为在不同实验情况下,选择准确度高、精密度好、简便、快速测定牙膏中铅含量的检测方法提供理论依据.

Objective To develop a gas chromatography-mass spectrometric ( GC-MS ) method for the determination and evaluation of ethylene chlorohydrin ( ECH ) residue in PTA balloon dilatation catheter. Methods The ECH residue were extracted in acetone by ultrasonic bathing. Chromatographic column ZB-624, inlet temperature 180 ℃, split ratio 1 : 1, high purity He as carrier gas, column flow rate 1. 5 mL/min. Temperature programmed condition:50℃ (1min),5℃/min to 100℃. Mass spectrometric conditions were as follow:ion source temperature 230 ℃, the interface temperature between GC and MS was 250 ℃, electrical energy 70 eV. Qualitative analysis was carried out by retention time and mass spectrometric scan,m/z between 35 and 500,and quantified by select ion monitoring method ( SIM ) , m/z=43. The ECH was determined by external standard method under the SIM mode by GC-MS. Results The number of theoretical plates were more than 56753. A good linearity was obtained at the concentrations of 1. 44～22. 96μg/mL with a correlation of 0. 999 and the average recovery was 99. 1％ ( n=5,RSD<5％) . The minimum limit of ECH was 0. 41μg/mL. No ECH was found in the sample. Conclusions The method of GC-MS is sensitive, rapid and accurate for determination of ECH residue in PTA balloon dilatationcatheter products. It can be used for quality control of PTA balloon dilatation catheter and for peers reference.

OBJECTIVE:Evaluation of di-(2-ethylhexyl)phthalate (DEHP) as raw material for preparing DEHP reference material for medical devices tests.METHODS:Identification and determination of purity of DEHP were carried out for the raw material using the gas chromatography-mass spectrometer(GC-MS) area normalization method. The results of calculation of DEHP reference material was obtained through collaboration with several laboratories. Homogeneity and stability were also carried.RESULTS:The selected raw material had high and stable purity. DEHP reference material's purity was 99.9%±0.2%. The homogeneity determination results were:the content results between and in bottles had no statistical difference. The statisticsF was 2.20 and 0.28,which were less than the threshold value F,2.85;P>0.05. The stability determination results were:the DEHP reference material was unchanged and stable in 12 months.CONCLUSION:The above test results showed that the DEHP reference material was homogeneous,stable, and had high purity and low uncertainty. So it was proper to develop it as DEHP reference material for medical devices tests.

目的:以2-氯乙醇(Ethylene Chlorohydrin,ECH)为原料制备用于医疗器械检测用的ECH标准物质.方法:采用气相色谱质谱连用技术对原材料进行筛选和考核,采用气相色谱技术对ECH标准物质的含量进行测定,采用多家实验室协作标定的方式进行定值,并进行不确定度评定,另对ECH标准物质的均匀性和稳定性进行了考察.结果:所研制的ECH标准物质原料纯度高,量值稳定,ECH含量为97.92％±0.02％;均匀性考察结果:ECH含量的统计量F=0.70,小于F(0.05)临界值2.76;稳定性试验结果表明ECH标准物质在12个月时纯度的相对标准偏差RSD是0.46％.结论:所研制的ECH标准物质纯度高,不确定度小,均匀性和稳定性良好,适宜作为医疗器械检测用ECH标准物质.

目的:采用气相色谱-质谱联用法(GC-MS)分析同种异体骨产品中有机溶剂残留的情况,最终建立GC-MS法定性和定量测定同种异体骨产品中溶剂残留量的方法.方法:采用GC-MS扫描(SCAN)模式对同种异体骨产品进行有机溶剂残留的定性分析,并采用GC-MS选择离子(SIM)模式对其中的10种残留溶剂进行了定量分析.结果:被测对象中检出多种有机溶剂残留,如甲醇、乙醇、二氯甲烷等,多份样品中检出了苯残留,溶剂残留总量最多达167.45 μ,g/g.此方法对10种溶剂定量分析的线性相关系数均在0.99以上,平均加样回收率在90.5％～113.8％,相对标准偏差(RSD)在1.00％～3.19％.结论:所建立的检测方法准确、简便、快速,可用于同种异体骨产品中有机溶剂残留的检测与质量控制.

Objective: To establish a gas chromatographic method for simultaneous determination of ifve kinds of small molecular levels in silicone oil.Methods: Using hexane as solvent, the determination was performed on a Rtx-5MS capillary column (30 m×0.25 mm×0.25 μm). The column temperature was maintained at 60℃ for 3 min, and programmed to 160℃ at the rate of 10℃·min-1 for 1 min. After that the temperature was elevated to 280℃ at the rate of 40℃·min-1 for 2 min. The FID was used as detector. The temperature of the injection and the detector was both set at 280℃.Results: The concentrations of hexamethylcyclotrisiloxane, octamethyltrisiloxane, octamethylcyclotetrasiloxane, decamethyltetrasiloxane, and decamethylcyclopentasiloxane were ranged in 1.42-22.80, 1.60-25.62, 1.78-28.56, 1.56-24.90, and 1.77-28.32 μg·mL-1 with a good linear relationship between peak areas, respectively. The average recoveries were 105.8%, 102.6%, 103.4%, 98.21%, and 101.0%, respectively.Conclusion:The established method is accurate, reliable, and sensitive, which provides an accurate and practical method for simultaneous determination of ifve kinds of small molecular levels in silicone oil.