Medical polyurethanes have emerged as a leading choice for biomedical applications owing to their exceptional biocompatibility and good physical and mechanical properties.Catalysts play a crucial role as additives in the synthesis of medical polyurethanes,enhancing synthesis efficiency and material properties.However,the catalysts used may affect the biocompatibility of polyurethanes and pose potential harm to human health.This review encapsulates the latest findings regarding the catalysts employed in the synthesis of medical polyurethane materials and their biotoxicity.Initially,we reviewed the prevalent types of catalysts used in the synthesis of medical polyurethane materials and described their distinctive characteristics.Subsequently,our focus shifted to exploring the potential biotoxicity associated with these catalysts.Finally,we provided a forward-looking perspective and recommendations for the future trajectory of catalyst selection in the synthesis of medical polyurethane materials.By acquiring a more profound understanding of the properties and biotoxicity of catalysts used in the synthesis of medical polyurethane materials,and by uncovering existing issues and challenges,we can better guide the design of medical polyurethane materials.This,in turn,enables us to chart the course for future development and ultimately enhance the biocompatibility and safety profiles of medical polyurethane materials.Such advancements will promote the continued development and application of medical polyurethane materials in clinical settings.

Temperature-accelerated in vitro degradation was established to estimate the longevity of polyurethane applied for long-term implantation. However, the prediction did not correlate well with the data from clinical explants and the rationality of accelerated in vitro test is still in a controversial due to the deviation. To improve the accuracy of the in vitro prediction, the influence of hydrogen bonding (HB) on the accelerated hydrolysis of silicone based polyetherurethans (SPEUs) extended with three side chains. Combining the temperature-controlled FTIR and the physical properties after temperature-accelerated in vitro degradation, it was demonstrated that side chain could increase the degree of hydrogen bond dissociation at higher temperature, resulting in the decrease of the calculated activation energy (Ea) of hydrolysis. At low temperatures, changes in surface morphology and molar mass of PEUs are minimal and HB are less easily dissociated, which had barely impact on the hydrolysis resistance. It was proposed that the Ea will not be impacted and that the accuracy of prediction will be increased if the acceleration temperature is lower than 70 °C and HB change is less than 15

电子输尿管硬镜与图像处理系统配合使用,可用于输尿管疾病的检查、诊断和治疗.此类医疗器械具有安全、术后并发症少、缩短手术及住院时间等优点[1].由于电子输尿管硬镜预期使用过程中会接触人体内部组织,因此使用前必须进行灭菌达到无菌状态.

Seeking high biological activity and osteoinductive ability has always been an urgent problem for three-dimensional-printed (3DP) bony implants. Here, a 3DP methacrylic anhydride-modified gelatin (GelMA)/hydroxyapatite (HAp) scaffold with a high solid content of 82.5% was prepared and anchored by a functionalized polyphenol hydrogel. The scaffold and hydrogel were organically integrated into a bioinspired bony implant (HGH) by phenolic hydroxyl of hyaluronan derivatives conjugating amino groups of collagen I and GelMA and further chelating calcium ions of HAp. Compared with a simplex 3DP scaffold, this freeze-dried HGH presented better water retention, delayed degradation, and mechanical stability. It could promote migration, proliferation, and osteogenic differentiation of bone marrow stem cells in vitro. One week of implantation showed that it promoted directional migration of endogenous stem cells and early osteogenesis and angiogenesis. After 15 week surgery of rabbit skull defects, the BV/TV value of HGH returned to 73% of the normal group level. This strategy provided a new research idea for bone regeneration.

Polydimethylsiloxane(PDMS) based segmented polyether urethanes (SiPEUs) suffer from poor adhesion between apolar PDMS and polar hard domains, which results in inferior mechanical properties and inadequate stability in long-term implantation. To regulate the interfacial miscibility, three chain extenders attached with different dangling side chains (fluorinated diol FDO, silicone-based diol SDO, and hexyl-based diol HDO) were used in two-step synthesis to modify the polarity of hard segments. Thermal analysis demonstrated a higher glass transition temperature of PDMS and PTMO (poly (tetramethylene oxide)) domain in SDO modified SiPEU(SSPEU) in contrast to the samples extended with FDO and HDO. Fourier transform infrared spectroscopy (FT-IR), small-angel x-ray scattering (SAXS), and dissipative particle dynamics (DPD) simulation further proved that SSPEU was achieved with optimal interfacial miscibility compared with SPEU. The intermediate layers were proposed to be functionally percolated composed of PDMS, PTMO, MDI-SDO, and MDI-BDO units, which promoted oxidative stability under accelerated test in vitro without mechanical compromise.

A green fabrication process (organic solvent-free) of artificial scaffolds is required in tissue engineering field. In this work, a series of aligned three-dimensional (3D) scaffolds are made from biodegradable waterborne polyurethane (PU) emulsion via directional freeze-drying method to ensure no organic byproducts. After optimizing the concentration of polymer in the emulsion and investigating different freezing temperatures, an aligned PUs scaffold (PU14) generated from 14wt% polymer content and processed at -196 degrees C was selected based on the desired oriented porous structure (pore size of 32.5 +/- 9.3 mu m, porosity of 92%) and balanced mechanical properties both in the horizontal direction (strength of 41.3 kPa, modulus of 72.3 kPa) and in the vertical direction (strength of 45.5 kPa, modulus of 139.3 kPa). The response of L929 cells and the regeneration of muscle tissue demonstrated that such pure material-based aligned 3D scaffold can facilitate the development of orientated cells and anisotropic tissue regeneration both in vitro and in vivo. Thus, these pure material-based scaffolds with ordered architecture have great potentials in tissue engineering for biological anisotropic tissue regeneration, such as muscle, nerve, spinal cord and so on.

NIR-light triggered shape memory process involving PU/gold-nanorod composites is shown.

Nerve injuries in the central or peripheral nervous system threaten human health and hinder social development, and effectively repairing or regenerating nerve tissues remains a huge challenge. The rise of tissue engineering strategies has brought new light for this. Similar to the extracellular matrix, biomimetic three-dimensional (3D) porous scaffolds can provide biophysical and biochemical cues to guide cell behaviors and support tissue growth. Here, we prepared a hybrid cobalt-doped alginate/waterborne polyurethane 3D porous scaffold with nano-topology of a "coral reef-like" rough surface via two-step freeze-drying. The experimental results demonstrated that the "coral reef-like" rugged surface topology and bioactive cobalt dopant synergistically promote the neurite outgrowth and up-regulate the synaptophysin expression of neuron-like cells PC12 on the scaffold. Furthermore, the scaffold notably relieved the inflammatory response of microglial cells BV2 with the transformation from pro-inflammatory (M1) to anti-inflammatory (M2) phenotype. We believe that this 3D porous scaffold offers bright design inspiration for neural tissue engineering scaffolds and holds potential applications in nerve repair.

目的 比较3种方法测定一次性使用输血器中邻苯二甲酸二乙酯(DEHP)溶出量的效果.方法 采用紫外-可见分光光度法、气相色谱法、气相色谱-质谱联用法测定国内8家企业生产的一次性使用输血器中DEHP溶出量.结果 紫外-可见分光光度法测得的数值较高,气相色谱法与气相色谱-质谱联用法结果基本一致.结论 该研究可为建立一次性使用输血器中DEHP溶出量测定方法提供参考.

本文通过对遴选出的9种创新医疗器械设备上市后的再评价,研究国产创新医疗器械在临床上的评价体系及推广模式,以期让更多的国产医疗器械产品逐步代替进口产品,推动国内医疗器械产业健康发展.

目的:探究医疗器械产品电磁兼容整改对医疗器械电气安全的不利影响.方法:结合电源滤波器实际案例,通过滤波原理和理论计算公式分析X电容对剩余电压的影响和Y电容对对地漏电流的影响;结合外壳内部喷金属粉实际案例,通过理论计算公式和分析模型分析其对电介质强度的影响.结果:理论分析结果与测试结果吻合,证明了电源滤波器中的X电容和Y电容以及外壳内喷金属粉工艺会对电气安全产生不利影响,并提出了对应的设计建议.结论:医疗器械产品的设计和整改要综合考虑电磁兼容和电气安全的相互影响,从而为用械安全提供有力保障.

目的 检测药品包装材料使用的粘合剂中甲苯二异氰酸酯(2,4-TDI)单体的残留量.方法 用乙腈提取样品后,与衍生剂1,2-吡啶哌嗪溶液进行衍生化反应,然后采用反相高效液相色谱法测定衍生物,从而计算2,4-TDI单体残留量,并进行方法学考察.结果 衍生物的线性范围为0～ 1.2 μg/mL(线性相关系数R=0.9998,线性拟合点数n=7);精密度的相对标准偏差为1.52％;24 h内稳定性的相对标准偏差为2.51％;回收率平均值为102.63％,回收率的相对标准偏差为1.79％.结论 建立的方法可靠、结果准确、稳定性好、专属性强,能够快速测定衍生物的含量,从而计算2,4-TDI单体的残留量,为药品包装材料所使用的粘合剂中2,4-TDI单体残留量的检测提供有力支持.

Objective To investigate the compatibility of packaging materials to live attenuated Japanese encephalitis vaccine and its diluents so as to evaluate the suitability of packaging container.Methods The packaged vaccines and diluents under accelerated conditions and in long-time storage were observed for the appearance of containers and adsorptivity to rubber stoppers,determined for the migration of 2,6-di-tert-butyl-4-methylphenol (BHT),an antioxidant in rubber stoppers,and harmful metal ions such as arsenic (As),antimony (Sb),lead (Pb) and cadmium (Cd) in glass containers,evaluated for the risk of abscission of inner surface of glass containers,and analyzed for the effect of containers on quality of vaccine or diluents as well as whether the containers were corroded by vaccine or diluents.Results The appearances of containers of three batches of packaged vaccines after storage at (25 ± 2) ℃,RH (60 ± 5) ％ for 6 months,at (37 ± 2) ℃,RH (75 ± 5) ％ for 4 weeks,and at (2 ～ 8) ℃ for 24 months were consistent with those before storage,while the adsorption rates of stoppers were less than 0.05％.The amounts of antioxidant BHT and harmful metal ions As,Sb,Pb and Cd migrated from packaging container to vaccine were far lower than the safety limit.The risk of abscission of inner surface of glass containers due to corrosion by the vaccine was low.However,the appearances of three batches of packaged diluents after storage at (40 ± 2) ℃,RH (75 ± 5) ％ for 12 months and at (2 ～ 30) ℃ for 42 months were consistent with those before storage.The amounts of antioxidant BHT and harmful metal ion As,Sb,Pb and Cd migrated from packaging container to diluent were far lower than the safety limit,while the risk of abscission of inner surface of glass containers due to corrosion by the diluent was low.Conclusion The risk of interaction between live attenuated JE vaccine or diluent and the containers was acceptable,indicating good compatibility.It confirmed that the current containers were suitable for the vaccine and diluent.

The requirement & testing method of the time accuracy in M-mode according to standard GB10152-2009 were analyzed, a time accuracy tester was researched and designed.

Objective To study the absorption of the bag-type infusion on 7 drugs.Methods 5 injections including 7 drugs were put into the bag-type infusion according to clinical method.The contents of the drugs in the bags were determined at different time by HPLC.The absorption ratios of the bags were calculated comparing to the zero tome.Results There were almost no absorptions to metronidazole,lincomycin,ofloxacin,ginsenoside Re,but there were some absorption to ginsenoside Rg1、soybean oil and phosphatidylcholine,especially to phosphatidylcholine for 8% absorption ratio at 8 hours.Conclusion There are strong absorptions for some drugs which should be avoided in clinical use with bag-type infusion.

Objective Purpose simulate the condition of bag transfusion apparatus for clinical use,and study its adsorption of drugs.Methods Refer to all kinds of drug testing methods.Results There is nearly no absorption of the stronger polarity drug,there is some absorption of the weaker polarity drug.Conclusion It is suggested that different drugs use different transfusion apparatus.

Objective:To establish a method for the identification of bilirubin in artificial bezoar in Niuhuangjiedu tablet by thin-layer chromatography(TLC).Method:The mixture of petroleum benzin,chloroform,ethyl formate and formic acid(20:3:5:1) was used as the developing solvent.And the samples were observed at 365 nm under viltalight lamp.Result:The spots in the chromatogram of the test solution corresponding to the position of bilirubin had the same color as the standard chromatogram.Conclusion:The method is accurate with a good sensitivity and reproducibility,can be used for the identification of bilirubin in artificial bezoar in Niuhuangjiedu tablet.

Objective: To test the HDI monomer residue of the adhesive used in the samples.Methods: The sample was extracted and derivatived with 1,2-pyridyl piperazine,then tested with RP-HPLC.Column: Waers Xterra C18 4.6×250mm 5μm.Mobile Phase: acetonitrile-water-acetic acid(58∶42∶0.15) adjusted with triethylamine to pH 4.0.Flow rate: 0.9ml·min-1.Column temperature: 35℃.Detection wavelength: 310nm.Results: The linear range is 0 ~ 0.8208μg·ml-1(r=0.9998,n=7).Precision: 0.4%.Average of negative recovery: 99.88%.Conclusion: This method is specific,sensitive,accurate,reliable,simple and can be used for testing HDI residue.

Objective:To study the method on impurities test of oxaliplatin for injection.Method:By referring to the test for oxaliplatin impurity C in EP 6.0 or BP 2005[HPLC,mobile phase was phosphoric acid solution-acetonitrile(99:1)],and screening the detection wavelength and chromatogram column,a primary method was established.Simultaneously,the degradation products and determination limit in oxaliplatin were detected by it,compa ring with the state standard in existence[HPLC,mobile phase was methanol-water(9:1),detection wavelength was 250 nm].Results:Adopting the method for oxaliplatin impurity C in EP 6.0 or BP 2005,it was found that the detection rate of impurities was higher than that of state standard.Conclusions:The impurities of oxaliplatin for injection can hardly be detected effectively by the method of state standard in existenee.Therefore a newlv efficient method was expected after the old one was argumented again.