聚乙二醇 (PEG)无味、无毒、无刺激性、低免疫原性，具有良好的水溶性，不易与蛋白质、细胞结合，生物相容性好，是FDA批准的可用于人体注射的合成类高分子聚合物。
PEGNB是由聚乙二醇 (PEG)经邻硝基苄醇 (o-nitrobenzyl alcohol，NB)修饰得到的、具有光敏特性的高分子材料。其中NB可在365-405 nm波长光照射下发生光解反应，产生的醛基可与氨基反应，从而实现PEGNB与含氨基物质 (如蛋白、多肽、药物、活性因子等)的共价偶联，以及与组织的无缝整合与粘附。此外，当与含双键的光敏高分子联用时，NB的光解产物可参与自由基聚合反应，形成机械强度优异的水凝胶。
产品规格
| 组分 | 外观 | 规格 | 备注 | PEGNB
| 淡黄色至黄色粉末颗粒
| 1 g/瓶、5 g/瓶 | 避光保存 |
|
使用建议
1、PEGNB可与含氨基的高分子材料，如多聚赖氨酸、壳聚糖、羧甲基壳聚糖、明胶等联合使用，在365-405 nm波长光照射下发生交联反应形成凝胶。
2、PEGNB可与甲基丙烯基修饰的高分子，如CMCMA、HAMA、CSMA、ChMA、CMChMA联合使用，由光引发剂光照引发聚合，构建不同理化性能的水凝胶材料。
配制方法
1、与含双键的高分子及光引发剂联用时，光引发剂使用量如下：
O775165 (分子量40 kDa)）：63 mg (LAP/NAP)/1 g (PEGNB)；
N1518263 (分子量80kDa)：32 mg (LAP/NAP)/1 g (PEGNB)；
2、配制光引发剂标准液 (如有)：取一定质量的NAP或LAP配制成所需浓度的溶液，2~8 ℃避光保存；
3、取所需质量的PEGNB放入离心管，并取所需体积的引发剂标准溶液或配制液加入到上述离心管中；
4、将上述样品于室温下避光搅拌或于摇床振荡，直至完全溶解。样品如在溶液中结块，可先用药匙碾碎；若样品溶解速度偏慢，可置于50-60℃环境加热搅拌助溶。
注意事项
1、PEGNB配制的溶液浓度越大，组织粘附能力越强，但是对应的溶液阻光率越大，所需要的辐照时间越长。分子量40 kDa的PEGNB，建议使用浓度不超过30 wt%；分子量80 kDa的PEGNB，建议使用浓度不超过50 wt%。
2、PEGNB的分子量越高，与含双键的光敏高分子联用时形成的水凝胶弹性越好，韧性越强。
产品应用
3D生物打印、药物缓释、组织工程、再生医学、蛋白固定、骨/软骨修复、术后防粘连等。
灭菌方式
1、过滤灭菌 (建议)：使用0.22 μm无菌针头过滤器过滤溶液灭菌，此方法仅限于低粘度溶液使用，如溶液粘度较高时，请选用巴氏灭菌或湿热灭菌法。
2、巴氏灭菌：将溶液加热到80 ℃，保持30 min；再迅速转移至冰水混合物中冷却至常温。共循环上述操作三次；
3、湿热灭菌：将溶液于高温高压灭菌锅内，121 ℃下灭菌8 min，手动放气后，将溶液迅速转移至冰水混合物中冷却至常温。需注意，高温条件会导致凝胶性能下降，因此使用该方法灭菌时应严格遵守上述操作步骤。
注：无菌溶液可以2-8 ℃避光暂存，建议7天内使用；非无菌溶液可以2-8 ℃避光暂存，建议48小时内使用。
产品特点
1、原位、快速构建高强韧水凝胶：可与HAMA秒级构建高强韧仿生界面键合纳米复合水凝胶。
2、组织粘附与整合：PEG-NB光解产生的醛基与施用部位组织表面的氨基反应，实现凝胶与组织的共价键合。
典型应用
基于上述优势，PEGNB水凝胶被国内外的研究人员用于3D打印和药物缓释等场景，并取得一系列标志性的成果。
1、DLP打印：高结构复杂性、微米级精度的水凝胶支架、血管等器件的加工
2、医学应用：“一步法”构建泪道栓塞眼表缓释给药体系
Compos. B. Eng. (IF =13.1), 2023, 266, 111014
产品优势
1、批次稳定：采用标准化的生产工艺，保证不同批次的PEGNB在成分、理化特性和生物学方面具有高度的重复性和可控性。
2、超高纯度：采用独特的生产工艺，有效地去除NB小分子和工艺杂质，实现超低杂质水平，保证PEGNB在生物医学应用的安全性。
3、可靠的安全性：PEGNB是全球第一款经中检院和第三方机构完成双重生物相容性评价以及第三方毒理代谢研究的市售PEGNB产品，产品安全无毒性，可吸收、分布、排泄，加速下游产品从实验室到临床的转化。
4、高稳定性：参照《无源植入性医疗器械稳定性研究指导原则》，经过实时稳定性和加速稳定性试验证明：PEGNB产品在标示贮存条件下质量稳定。
Polyethylene glycol (PEG) is odorless, non-toxic, non-irritating, and has low immunogenicity. It exhibits good water solubility, low non-specific binding to proteins and cells, and excellent biocompatibility. As a synthetic polymer approved by the FDA, it can be used for human injection.
PEGNB is a photosensitive polymer material obtained by modifying polyethylene glycol (PEG) with o-nitrobenzyl alcohol (NB). The NB group can undergo photolysis under light irradiation at a wavelength of 365–405 nm, producing aldehyde groups that can react with amino groups. This enables the covalent conjugation of PEGNB with amino-containing substances (such as proteins, peptides, drugs, bioactive factors, etc.), as well as seamless integration and adhesion to tissues. Furthermore, when used in combination with photosensitive polymers containing double bonds, the photolysis products of NB can participate in free-radical polymerization to form hydrogels with excellent mechanical strength.
Product Specifications
| Component | Appearance | Specification | Remarks | PEGNB
| Pale yellow to yellow powder or granules
| 1 g/bottle, 5 g/bottle | Store in the dark
|
|
Suggestions for Use
1. PEGNB can be used in combination with amino-containing polymers such as polylysine, chitosan, carboxymethyl chitosan, gelatin, etc. Cross-linking occurs under light irradiation at 365–405 nm to form a gel.
2. PEGNB can be used in combination with methacryl-modified polymers such as CMCMA, HAMA, CSMA, ChMA, CMChMA. Polymerization is initiated by a photoinitiator under light irradiation to construct hydrogel materials with different physicochemical properties.
Preparation Method
1. When used with double bond-containing polymers and a photoinitiator, the recommended dosage of photoinitiator is as follows:
O775165 (MW 40 kDa): 63 mg (LAP/NAP) per 1 g PEGNB;
N1518263 (MW 80 kDa): 32 mg (LAP/NAP) per 1 g PEGNB.
2. Preparation of photoinitiator stock solution (if applicable):
Dissolve an appropriate amount of NAP or LAP to prepare a solution of the desired concentration. Store at 2-8 °C in the dark.
3. Weigh the required amount of PEGNB into a centrifuge tube. Add the required volume of initiator stock solution or prepared solution to the tube.
4. Stir the sample in the dark at room temperature or shake on an orbital shaker until completely dissolved. If the sample clumps in solution, crush it gently with a spatula first. If dissolution is slow, heat and stir at 50–60 °C to assist solubilization.
Precautions
1. Higher concentrations of PEGNB solution result in stronger tissue adhesion, but also higher light blocking and longer required irradiation time.
For 40 kDa PEGNB: recommended concentration ≤ 30 wt%.
For 80 kDa PEGNB: recommended concentration ≤ 50 wt%.
2. Higher molecular weight of PEGNB leads to better elasticity and toughness of hydrogels formed with double bond-containing photosensitive polymers.
Product Applications
3D bioprinting, drug sustained release, tissue engineering, regenerative medicine, protein immobilization, bone/cartilage repair, postoperative anti-adhesion, etc.
Sterilization Methods
1. Filter sterilization (recommended): Sterilize the solution using a 0.22 μm sterile syringe filter. This method is only suitable for low-viscosity solutions. For high-viscosity solutions, use pasteurization or autoclaving.
2. Pasteurization: Heat the solution to 80 °C and hold for 30 min, then quickly cool to room temperature in an ice-water bath. Repeat the cycle three times.
3. Autoclaving (moist heat sterilization): Sterilize the solution in an autoclave at 121 °C for 8 min. After manual venting, cool rapidly to room temperature in an ice-water bath. Note that high temperature may reduce gel performance; strictly follow the above procedure.
Note: Sterile solutions: store at 2–8 °C in the dark, use within 7 days. Non-sterile solutions: store at 2–8 °C in the dark, use within 48 hours.
Product Features
1. In situ, rapid formation of high-strength and high-toughness hydrogels: Can form high-strength, tough, bionic interface-bonded nanocomposite hydrogels with HAMA in seconds.
2. Tissue adhesion and integration: Aldehyde groups generated by photolysis of PEG-NB react with amino groups on the tissue surface at the application site, achieving covalent bonding between the gel and tissue.
Typical Applications
Based on the above advantages, PEGNB hydrogels have been used by researchers worldwide for 3D printing and drug sustained release, achieving a series of landmark results.
1. DLP printing: Fabrication of high-structural-complexity, micron-precision hydrogel scaffolds, blood vessels and other devices.
2. Medical applications:
“One-step” construction of lacrimal duct occlusion and ocular surface sustained-release drug delivery systems.
Compos. B. Eng. (IF = 13.1), 2023, 266, 111014
Product Advantages
1. Batch-to-batch stability: Standardized production process ensures high repeatability and consistency in composition, physicochemical properties and biological performance between different batches.
2. Ultra-high purity: Unique production process effectively removes small-molecule NB and process impurities, achieving an ultra-low impurity level and ensuring safety for biomedical applications.
3. Reliable safety: PEGNB is the first commercially available PEGNB product worldwide that has completed dual biocompatibility evaluation by NIFDC and a third-party institution, as well as third-party toxicology and metabolism studies. The product is safe, non-toxic, biodegradable, absorbable, distributable and excretable, accelerating the translation of downstream products from lab to clinic.
4. High stability: In accordance with the Guidance for Stability Study of Non-Invasive Implantable Medical Devices, real-time and accelerated stability tests confirm that PEGNB remains stable under labeled storage conditions.
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