CN114425034A - 一种光固化口腔凝胶及其制备方法与应用 - Google Patents
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Abstract
本发明涉及一种具有光固化性质的,用于治疗放化疗等引起的口腔黏膜炎的口腔修复凝胶。口腔凝胶的基体采用高生物相容性的凝胶材料,通过接枝甲基丙烯酸(MA)与黏附剂获得光交联与黏附性能。该口腔凝胶具有紫外光快速固化、潮湿环境下高黏附特性,用于口腔黏膜炎治疗中具有方法简单、成膜时间短、不易脱落,无生物毒性的特点。另外,本口腔凝胶可搭载治疗药物,实现药物的长期可控释放,有助于口腔黏膜炎的康复。
Description
技术领域
本发明属于生物医药技术领域,公开了一种光固化口腔凝胶及其制备方法以及该光固化口腔凝胶在制备治疗口腔黏膜炎药物中的应用。
技术背景
口腔黏膜炎(oral mucositis,OM)是放化疗常见的不良反应之一。头颈部肿瘤放疗患者中80%以上会出现OM,接受同期放化疗者超过90%会出现OM。OM主要表现在口腔粘膜的红斑、溃疡并伴随疼痛,患者难以进食,显著降低生活质量,影响癌症治疗的进行。并且易引发感染,严重者威胁生命。
目前应用于口腔黏膜炎的药物作用相对单一,主要分为粘膜保护剂、口腔护理液和镇痛剂。黏膜保护剂能够在伤口表面建立一层保护层,阻挡了病毒和细菌的入侵,并且能够缓解疼痛。但是这种粘膜保护剂只能起到屏障的作用,无法加速口腔黏膜炎的愈合。口腔护理液能够清洁口腔,起到抑制细菌生长的作用,并且降低了伤口感染几率。但是口腔护理液在口腔中存留的时间较短,只能起到短时间治疗的目的,治标不治本。镇痛剂可以有效降低患者因口腔黏膜炎造成的疼痛感,但长期使用镇痛剂会出现不同程度的副作用。
基于此,针对口腔黏膜炎,我们迫切需要一种能够长时间作用于患处,缓解疼痛并加速口腔黏膜炎的愈合,同时起到隔离屏蔽外界细菌作用的光固化口腔凝胶。
发明内容
鉴于上述不足,本发明提供了一种治疗口腔黏膜炎的光固化口腔凝胶,该口腔凝胶具有紫外光快速固化、潮湿环境下高黏附特性,用于口腔黏膜炎治疗中具有方法简单、成膜时间短、不易脱落,无生物毒性的特点。
为了实现上述发明目的,本发明提供了如下技术方案:
一种光固化口腔凝胶材料,按质量百分比计,包括:
口腔凝胶基体70%~99.9%;黏附剂0.1~30%;偶联剂0.1~20%;治疗药物0.5%~30%。
进一步的,所述口腔凝胶基体包括明胶,丝素蛋白,透明质酸,多巴胺中一种或多种复合物或共聚物。
进一步的,所述黏附剂包括壳聚糖,多巴胺中的一种或多种。
进一步的,所述偶联剂包括N-羟基琥珀酰亚胺,1-(3-二甲氨基丙基)-3-乙基碳二亚胺,N'-(乙基羰基亚氨基)-N,N-二甲基丙烷-1,3-二氨基氯化物中的一种或多种。
进一步的,所述治疗药物抗炎药物;该抗炎药物包括但不限于生长因子、甲硝锉、庆大霉素、头孢菌素类、地塞米松、乙醇中任意一种。
本发明还公开了一种制备如上述任意一项光固化口腔凝胶材料的方法,包括:
(1)称取水凝胶基体,水浴条件下溶解30min后,与甲基丙烯酸反应,得到接枝甲基丙烯酸的水凝胶基体;
(2)称取偶联剂,偶联剂与水凝胶基体在水浴加热反应,再加入黏附剂,在氮气保护下,37℃水浴10h,得到接枝黏附剂的水凝胶;
(3)将接枝黏附剂的水凝胶在37℃条件下溶解于磷酸盐缓冲液中,加入0.5%的光引发剂后充分搅拌30min,再加入抗炎药物,搅拌30min,即得光固化口腔凝胶材料。
进一步的,步骤(1)所述水凝胶接枝甲基丙烯酸在30~60℃下反应。
进一步的,步骤(2)所述偶联剂与水凝胶基体水浴温度为30~60℃,反应时间30min,反应pH值4~6。
本发明还公开了一种根据上述任一制备方法制得的光固化口腔凝胶材料。
本发明还公开了一种根据上述任一光固化口腔凝胶材料在治疗口腔黏膜炎中的应用,包括:
将口腔凝胶材料涂抹于患处,紫外灯照射5~300s。
本发明的有益效果在于:
(1)本发明制备的光固化口腔凝胶能够实现紫外光快速固化成膜,不易脱落,实现可控药物缓释。
(2)本发明采用的水凝胶基体,是可以接枝甲基丙烯酸的高生物相容性的复合物/共聚物。在接枝后通过透析的方式将多余的甲基丙烯酸单体去除,既保证了生物相容性,又使制备的口腔凝胶能够长时间附着在潮湿的口腔中,达到高效的隔离和治疗效果。
附图说明
图1为口腔凝胶成膜效果;
图2为口腔凝胶在干燥物体(枪头)上黏附效果;
图3为口腔凝胶在潮湿物体(兔股骨)上黏附效果;
图4为口腔凝胶黏附力学测试(兔上皮组织);
图5为本发明制备流程图。
具体实施方式
为进一步公开而不是限制本发明,以下结合实例对本发明作进一步的详细说明。
实施例1
将2g的GelMA(甲基丙烯酸酐化明胶)溶解到100ml PBS溶液中,在37℃水浴条件下加入0.3g N-羟基琥珀酰亚胺(NHS),0.5g 1-(3-二甲氨基丙基)-3-乙基碳二亚胺(EDC),然后将溶液pH调节为5,反应30min后将溶液倒入双颈烧瓶中,在37℃水浴条件下抽真空并通入氮气保护,再向双颈烧瓶中加入2g多巴胺(黏附剂),在氮气氛围中反应10h。反应后,在酸性条件下透析纯化一周并冻干。材料可于干燥的-20℃环境中长期保存。
将上述制得的口腔凝胶材料加入到PBS中制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入5%(w/v)的庆大霉素,混匀后放入喷壶中,喷涂在干燥和潮湿的物体上,用405nm紫外光照射10秒,成膜。
采用具有干性条件的物品(枪头)和潮湿条件的物品(骨组织)进行黏附测试。从图1可以看出,水凝胶成膜情况良好。如图2和图3显示,本口腔凝胶同时具有干燥条件和潮湿条件下黏附的能力。将口腔凝胶做黏附力学测试(图4),最大载荷约0.75N。
实施例2
将2g的甲基丙烯酸酰化素蛋白溶解到100ml PBS溶液中,在37℃水浴条件下加入0.3g N-羟基琥珀酰亚胺(NHS),0.5g 1-(3-二甲氨基丙基)-3-乙基碳二亚胺(EDC),然后将溶液pH调节为5,反应30min后将溶液倒入双颈烧瓶中,在37℃水浴条件下抽真空并通入氮气保护,再向双颈烧瓶中加入2g多巴胺(黏附剂),在氮气氛围中反应10h。反应后,在酸性条件下透析纯化一周并冻干。材料可于干燥的-20℃环境中长期保存。
将上述制得的口腔凝胶材料加入到PBS中制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入5%(w/v)的庆大霉素,混匀后放入喷壶中,喷涂在干燥和潮湿的物体上,用405nm紫外光照射10秒,成膜。
实施例3
将2g的甲基丙烯酸酰化透明质酸容解到100ml PBS溶液中,在37℃水浴条件下加入0.3gN-羟基琥珀酰亚胺(NHS),0.5g 1-(3-二甲氨基丙基)-3-乙基碳二亚胺(EDC),然后将溶液pH调节为5,反应30min后将溶液倒入双颈烧瓶中,在37℃水浴条件下抽真空并通入氮气保护,再向双颈烧瓶中加入2g多巴胺(黏附剂),在氮气氛围中反应10h。反应后,在酸性条件下透析纯化一周并冻干。材料可于干燥的-20℃环境中长期保存。
将上述制得的口腔凝胶材料加入到PBS中制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入5%(w/v)的庆大霉素,混匀后放入喷壶中,喷涂在干燥和潮湿的物体上,用405nm紫外光照射10秒,成膜。
实施例4
采用实施例1的制备方法,与实施例1不同之处在于,基体水凝胶的浓度增加一倍。将制得的口腔凝胶材料制成20mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入5%(w/v)的庆大霉素,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例5
采用实施例1的制备方法,与实施例1不同之处在于,基体水凝胶的浓度增加两倍。将制得的口腔凝胶材料制成40mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入5%(w/v)的庆大霉素,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例6
采用实施例1的制备方法,与实施例1不同之处在于,口腔凝胶负载了甲硝唑作为治疗口腔黏膜炎的药物。将制得的口腔凝胶材料制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入8%(w/v)的甲硝唑,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例7
采用实施例1的制备方法,与实施例1不同之处在于,口腔凝胶负载了头孢霉素作为治疗口腔黏膜炎的药物。将制得的口腔凝胶材料制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入2%(w/v)的头孢霉素,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例8
采用实施例1的制备方法,与实施例1不同之处在于,口腔凝胶负载了生长因子作为治疗口腔黏膜炎的药物。将制得的口腔凝胶材料制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入1%(w/v)的生长因子,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例9
采用实施例1的制备方法,与实施例1不同之处在于,将壳聚糖作为口腔凝胶的黏附剂。将制得的口腔凝胶材料制成10mg/ml(w/v)的溶液,加入0.5%(w/v)苯基-2,4,6-三甲基苯甲酰基膦酸锂光引发剂,并加入1%(w/v)的生长因子,混匀后放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射10秒,成膜。
实施例10
采用实施例1的制备方法,与实施例1不同之处在于,紫外光照射时间增加。将混匀后的口腔凝胶放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射20秒,成膜。
实施例11
采用实施例1的制备方法,与实施例1不同之处在于,紫外光照射时间减少。将混匀后的口腔凝胶放入喷壶中,喷涂在潮湿的组织上,用405nm紫外光照射5秒,成膜。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种光固化口腔凝胶材料,按质量百分比计,包括:
口腔凝胶基体70%~99.9%;黏附剂0.1~30%;偶联剂0.1~20%;治疗药物0.5%~30%。
2.根据权利要求1所述的口腔凝胶材料,其中:
所述口腔凝胶基体包括明胶,丝素蛋白,透明质酸,多巴胺中一种或多种复合物或共聚物。
3.根据权利要求1所述的口腔凝胶材料,其中:
所述黏附剂包括壳聚糖,多巴胺中的一种或多种。
4.根据权利要求1所述的口腔凝胶材料,其中:
所述偶联剂包括N-羟基琥珀酰亚胺,1-(3-二甲氨基丙基)-3-乙基碳二亚胺,N'-(乙基羰基亚氨基)-N,N-二甲基丙烷-1,3-二氨基氯化物中的一种或多种。
5.根据权利要求1所述的口腔凝胶材料,其中:
所述治疗药物抗炎药物;
该抗炎药物包括生长因子、甲硝锉、庆大霉素、头孢菌素类、地塞米松、乙醇中任意一种。
6.一种制备如权利要求1~5任意一项所述的光固化口腔凝胶材料的方法,包括:
(1)称取水凝胶基体,水浴条件下溶解30min后,与甲基丙烯酸反应,得到接枝甲基丙烯酸的水凝胶基体;
(2)称取偶联剂,偶联剂与水凝胶基体在水浴加热反应,再加入黏附剂,在氮气保护下,37℃水浴10h,得到接枝黏附剂的水凝胶;
(3)将接枝黏附剂的水凝胶在37℃条件下溶解于磷酸盐缓冲液中,加入0.5%的光引发剂后充分搅拌30min,再加入抗炎药物,搅拌30min,即得光固化口腔凝胶材料。
7.根据权利要求6所述的制备方法,其中:
步骤(1)所述水凝胶接枝甲基丙烯酸在30~60℃下反应。
8.根据权利要求6所述的制备方法,其中:
步骤(2)所述偶联剂与水凝胶基体水浴温度为30~60℃,反应时间30min,反应pH值4~6。
9.一种根据权利要求6~8所述任一制备方法制得的光固化口腔凝胶材料。
10.一种根据权利要求1~5、9所述任一光固化口腔凝胶材料在治疗口腔黏膜炎中的应用,包括:
将口腔凝胶材料涂抹于患处,紫外灯照射5~300s。
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