CN109010353A - 一种治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物 - Google Patents
一种治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物 Download PDFInfo
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- CN109010353A CN109010353A CN201810828485.1A CN201810828485A CN109010353A CN 109010353 A CN109010353 A CN 109010353A CN 201810828485 A CN201810828485 A CN 201810828485A CN 109010353 A CN109010353 A CN 109010353A
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Abstract
针对癌症患者经放化疗后产生的二次粘膜组织创伤难题，本发明提供一种治疗放化疗患者口腔粘膜溃疡的生物多糖组合物，其特征在于：按照重量百分比，该组合物由以下组分构成：生物多糖材料1.3～36.1％，黏附剂0.1～15％，其余为去离子水。该组合物具有抑制病原菌、促进伤口愈合、降低炎症反应等功能，为癌症放化疗患者溃疡提供了一种有效的治疗方案。
Description
技术领域
本发明涉及医药领域，具体提供一种治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物。
背景技术
随着恶性肿瘤的发病率逐渐提高，放化疗的推广及腔内照射的普及，为了提高恶性肿瘤患者的远期生存率，放射治疗配方化学疗法逐渐成为治疗恶性肿瘤的重要方法。口腔溃疡是肿瘤患者接受系统放化疗过程中最常见、最令患者感到痛苦的毒副作用之一，临床表现为口腔黏膜的轻度感觉异常、多发红斑、融合性溃疡和出血性损伤。口腔溃疡严重影响患者的日常活动，包括进食、喝水、吞咽、说话等，降低生存质量，导致营养不良，机体免疫力下降，甚至会造成全身感染。在接受高剂量化疗药物、头颈部放疗及造血干细胞移植术前预处理的患者中发生率高达90％～100％。
口腔粘膜疾病特指口腔内粘膜的损坏，具体症状表现为口舌溃烂，舌体干裂，继而引发口腔扁平苔藓，口腔炎，复发性口疮，唇炎等口腔疾患，导致饮食困难，口腔疼痛难忍。溃疡数目由少到多，多发于口腔粘膜、牙龈、舌体上下与侧面及咽喉部，溃烂面大如黄豆，小如米粒，可导致体内多种并发症。造成肿瘤患者接受系统放化疗过程中出现口腔溃疡一般认为的主要原因是：化疗药物对粘膜上皮细胞的直接损伤作用；化疗后骨髓造血功能受抑，中性粒细胞减少，造成口腔局部感染；化疗后由于胃肠道毒副作用使患者饮水、进食减少，口腔内寄生的正常菌群大量繁殖，口腔自洁作用减弱，产生吲哚、硫氢基、胺类等破坏口腔内环境，导致口腔粘膜受损而形成溃疡；由于大量抗生素及糖皮质激素的应用，使口腔正常菌群受抑，某些致病菌、真菌异常繁殖，引起口腔溃疡感染等。
现在常用的治疗方法主要有采用2.5％碳酸氢钠、利凡诺稀释液交替漱口，或采用0.3％甲酰四氢叶酸钙漱口的漱口法；氧疗及雾化给药法；采用低强度激光治疗的激光疗法；如FDA批准的palifermin重组人角质细胞生长因子的药物疗法等。临床上还有种类繁杂的中药制剂，抗生素和激素及生物制剂等，但效果不理想，见效慢，且容易反复发生，难以有效地解决放化疗给肿瘤患者带来的二次黏膜溃疡创伤难题。
生物多糖是从生物体中提取出来的多糖类物质，由单糖通过糖苷键结合的高分子碳水化合物，在植物、动物、真菌、细菌内广泛存在，如构成植物和动物骨架的纤维素和甲壳素，作为生物体能量储存作用的淀粉和糖原，具有抗凝血作用的肝素。根据组成单糖的类别，可以将多糖划分为由同种单糖构成的同多糖、由两种以上单糖构成的杂多糖、结合蛋白质或脂类的复合多糖等；根据多糖的来源，多糖又可以被划分为植物多糖、动物多糖、真菌多糖等。多糖的结构包括一级结构和高级结构，高级结构又包括二级、三级及四级结构。主链糖单元的组成构成了多糖的一级结构，而多糖的高级结构使多糖具有特定的空间构象，也显著影响了多糖特殊的生物活性。
生物多糖是生命有机体的重要组成部分，毒性小、安全性高、功能广泛，具有许多特殊的生物生理活性，能够参与生命细胞的各种活动，对维持生命活动起着重要的作用，表现出降血糖、降血脂、抗炎症、抗氧化、抗衰老、抗肿瘤等多种活性，在保健食品、化妆品和医药领域等有广泛的应用前景。
现代医疗理论证明伤口愈合是细胞与细胞、细胞与细胞基质以及与可溶性介质间相互作用的连续动态过程。创面的修复与局部组织的营养、微环境、生长因子含量、微循环、低氧条件、感染等多种因素的相互作用有关，新型医用敷料可以起到关键性的作用。本发明的生物多糖材料组合物以香菇多糖、黄芪多糖和壳聚糖为主要活性成分，复合其它生物多糖材料，充分利用多种多糖材料复配增效的作用，实现加速组织愈合，达到快速治疗癌症患者经放化疗后产生的黏膜溃疡的目的。同时敷料毒性及组织反应轻、生物相容性好、降解迅速、使用方面。
发明内容
针对癌症患者经放化疗后产生的二次粘膜组织创伤难题，本发明提供一种治疗放化疗患者口腔粘膜溃疡的生物多糖组合物，该组合物具有抑制病原菌、促进伤口愈合、降低炎症反应等功能，为癌症放化疗患者溃疡提供了一种有效的治疗方案。
本发明技术方案如下：
一种治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：按照重量百分比，该组合物由以下组分构成：生物多糖材料1.3～36.1％，黏附剂0.1～15％，其余为去离子水。
其中，所述生物多糖材料为香菇多糖、黄芪多糖、壳聚糖以及其它生物多糖材料，其中各组分占组合物的重量百分比为：香菇多糖0.1～1.6％，黄芪多糖0.3～3.5％，壳聚糖0.4～8％，其它生物多糖材料0.5～23％。进一步优选，各组分占组合物的重量百分比为：香菇多糖0.2～0.8％，黄芪多糖0.4～1.2％，壳聚糖0.8～3％，其它生物多糖材料1～8％。
所述其它生物多糖材料选自硫酸软骨素、硫酸皮肤素、灵芝多糖、茯苓多糖、白芨多糖、银耳多糖、枸杞多糖、黑木耳多糖、海藻多糖、果胶、几丁寡糖、壳寡糖、透明质酸、昆布多糖、猪苓多糖中的一种或几种。进一步优选，所述其它生物多糖材料选自茯苓多糖、白芨多糖、壳寡糖、透明质酸；各组分占组合物的重量百分比为：茯苓多糖0.1～2.2％，白芨多糖0.2～3％，壳寡糖0.5～4％，透明质酸0.5～2.5％。
本发明所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述黏附剂选自羧甲基纤维素钠、淀粉及其衍生物、糊精、羟乙基纤维素、壳聚糖衍生物、黄原胶、卡拉胶、阿拉伯树胶、刺梧桐胶、黄耆胶、木质素磺酸钠、羧化淀粉、聚丙烯酸、聚甲基丙烯酸、聚苯乙烯磺酸、聚乙烯磺酸、聚乙烯膦酸、羧甲基壳聚糖、丙烯酸乙烯吡啶共聚物、聚维酮、卡波姆、微晶纤维素、甲壳素纳米纤维中的一种或几种。进一步优选，黏附剂选自羧甲基纤维素钠、壳聚糖衍生物、微晶纤维素、甲壳素纳米纤维，各组分占组合物的重量百分比为：羧甲基纤维素钠0.5～4％，壳聚糖衍生物0.9～5.5％，微晶纤维素0.2～3.5％，甲壳素纳米纤维0.1～1.0％。
本发明所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：该组合物中还添加有辅料，所述辅料为矫味剂、抗氧化剂、pH值调节剂中的一种或几种，添加量为组合物重量的0.5～7％。
其中：所述矫味剂为薄荷精油、甘露醇、山梨醇、玫瑰精油中的一种或几种；所述抗氧化剂为维生素C、维生素E，茶多酚，葡萄籽提取物中的一种或几种；所述pH值调节剂为盐酸、磷酸、乙酸、丙酸、丁酸、辛酸、己二酸、乙二酸、酒石酸、柠檬酸、硬脂酸、酒石酸、苹果酸、枸椽酸、抗坏血酸中的一种或几种。
进一步优选：所述矫味剂为薄荷精油；所述抗氧化剂为维生素C、维生素E；所述pH值调节剂为盐酸、乙酸、柠檬酸；各组分占组合物的重量百分比为：矫味剂0.04～2％，抗氧化剂0.3～5％，pH值调节剂0.1～3％，矫味剂+抗氧化剂+pH值调节剂≤7％。
本发明所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：将香菇多糖、黄芪多糖、壳聚糖和其它生物多糖材料在去离子水中溶解或分散后，再加入辅料和黏附剂，充分搅拌，形成具有一定粘度的液体，即为生物多糖材料组合物。
本发明所述组合物可以作为治疗口腔粘膜疾病的医用敷料应用。
本发明利用香菇多糖、黄芪多糖和壳聚糖为主要活性成分，并复合其它生物多糖材料，充分利用多种多糖材料复配增效的作用，能够快速有效地治疗口腔溃疡及舌炎、口角炎、口唇炎、急性咽炎或牙龈红肿等口腔粘膜疾病，解决现有技术无法有效快速解决的肿瘤患者放化疗后口腔粘膜疾病的难题。通过使用与口腔黏膜具有优异粘附性能和良好生物相容性的黏附剂材料使组合物在口腔溃疡部位粘附牢固，对溃疡面具有良好的粘膜屏蔽性。研究表明香菇多糖、黄芪多糖和壳聚糖等多种生物多糖复配后的效果要显著优于单一生物多糖对溃疡伤口修复的效果。
本发明的优点及有益效果是：
1.本发明组合物具有组分生物相容性好、安全可靠，同时具有杀菌消炎、提高免疫力、促进伤口愈合等功能。
2.组合物中各组份安全健康，组份间能够起到协同作用，见效快、疗效显著，起到立竿见影的作用。
3.本发明对溃疡面的刺激性低，在保护溃疡面表层的同时，对外界进行隔离，减轻疼痛，促进溃疡面组织的愈合。
4.本发明所述组合物能够快速治愈肿瘤患者放化疗后口腔粘膜疾病，同时能够提高患者免疫力，无毒副作用。
附图说明
图1动物有效性评价-小鼠创面模型。
图2动物有效性评价-小型猪创面模型。
具体实施方式
在具体实施方式中，本发明所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，按照重量配比，该组合物主要由以下组会构成：香菇多糖0.1～1.6％，黄芪多糖0.3～3.5％，壳聚糖0.4～8％，其它生物多糖材料0.5～23％，黏附剂0.1～15％，其它辅料0.1～7％，其余为去离子水。香菇多糖、黄芪多糖、壳聚糖和其它生物多糖材料在去离子水中溶解或分散后，再加入辅料和黏附剂，充分搅拌，形成具有一定粘度的液体。
为了使本发明的技术方案和优点更加清楚，下面将结合具体实施例进行详细描述。
实施例1
香菇多糖4克，黄芪多糖8克，壳聚糖13克，其它生物活性多糖共15克(包括茯苓多糖10克，壳寡糖5克)，溶于940毫升去离子水中。然后加入黏附剂羧甲基纤维素钠20克，完全溶解后，经超高压灭菌，制备出生物多糖组合物粘稠液体。
用水合氯醛将大鼠麻醉后，把大鼠俯卧于固定板上，在大鼠脊柱左右两侧大致相当的位置进行创面实验，左右各一个创面，创面直径为10mm，全层伤口(除去表皮和真皮)。左侧伤口涂抹生物多糖组合物，右侧伤口作为自身对照组。涂抹后将各组动物用纱布进行缠绕包裹，避免感染。各组动物每日涂抹药物1次，连续11日。在术后每日进行观察，采集图片和测量创面面积。如图1所示，图中左侧为对照组，右侧为涂抹生物多糖组合物组，可见生物多糖组合物能够快速显著的促进大鼠背部全层创面伤口的愈合。
实施例2
香菇多糖6克，黄芪多糖12克，壳聚糖25克，几丁寡糖25克，溶于902毫升去离子水中。然后加入黏附剂羧甲基纤维素钠25克，柠檬酸5克，完全溶解后，经超高压灭菌，制备出生物多糖组合物粘稠液体。
将小型猪进行氯胺酮(20mg/kg)静脉内给予动物麻醉。麻醉后进行动物术前准备，术中用异氟烷(1.0-1.5％)、氧气和二氧化氮用呼吸面罩经口鼻吸入进行麻醉监护，维持麻醉深度。用电推剃毛，备皮刀进行背部皮肤备皮，肥皂水和清水进行皮肤冲洗，然后用酒精和碘酒进行消毒，用11号手术刀进行切割完成直径10毫米全层皮肤切口。左侧伤口涂抹生物多糖组合物，右侧伤口作为自身对照组。涂抹后将各组动物用纱布进行缠绕包裹，避免感染。各组动物每日涂抹药物1次，连续16日。在术后每日进行观察，采集图片和测量创面面积。如图2所示，图中上部为对照组，下部为涂抹生物多糖组合物组，可见生物多糖组合物能够快速显著的促进小型猪背部全皮肤缺损创面伤口的愈合。
实施例3
香菇多糖8克，黄芪多糖10克，壳聚糖12克，其它生物活性多糖共50克(包括透明质酸25克，壳寡糖25克)，溶于898毫升去离子水中。然后加入黏附剂羧甲基壳聚糖22克，完全溶解后，经超高压灭菌，制备出生物多糖组合物粘稠液体。
志愿者为乳腺癌患者，在经过CE方案化疗三周期后出现口腔溃疡。在伤口处涂覆多糖组合物，每日早中晚各涂抹一次，共涂抹3天，可见生物多糖组合物能够快速显著的促进口腔溃疡伤口的修复。
实施例4
香菇多糖5克，黄芪多糖12克，壳聚糖30克，其它生物活性多糖共53克(包括白芨多糖20克，壳寡糖20克，茯苓多糖13克)，溶于862毫升去离子水中。然后加入羧甲基壳聚糖20克，乙酸18克，完全溶解后，经超高压灭菌，制备出生物多糖组合物粘稠液体。
志愿者为舌癌患者，经过放疗后出现的口腔溃疡。在伤口处涂覆多糖组合物，每日早中晚各涂抹一次，共涂抹3天，可见生物多糖组合物能够快速显著的促进口腔溃疡伤口的修复。
实施例5
香菇多糖10克，其它生物活性多糖共53克(包括白芨多糖25克，壳寡糖15克，茯苓多糖13克)，溶于917毫升去离子水中。然后加入羧甲基壳聚糖20克，完全溶解后，经超高压灭菌，制备出生物多糖组合物粘稠液体。该生物多糖组合物需要5天以上的时间实现口腔溃疡伤口的修复，其修复速度远低于其它实施例。
以上实施例结果表明，本发明所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，是具有一定粘度的液体，涂覆在患者口腔粘膜溃疡处能够快速在伤口表面形成一层保护膜，进而快速有效地促进口腔溃疡伤口的修复。
上述实施例只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施，并不能以此限制本发明的保护范围。凡根据本发明精神实质所作的等效变化或修饰，都应涵盖在本发明的保护范围之内。
Claims (10)
1.一种治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：按照重量百分比，该组合物由以下组分构成：生物多糖材料1.3～36.1％，黏附剂0.1～15％，其余为去离子水。
2.按照权利要求1所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述生物多糖材料为香菇多糖、黄芪多糖、壳聚糖以及其它生物多糖材料，其中各组分占组合物的重量百分比为：香菇多糖0.1～1.6％，黄芪多糖0.3～3.5％，壳聚糖0.4～8％，其它生物多糖材料0.5～23％。
3.按照权利要求2所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述其它生物多糖材料选自硫酸软骨素、硫酸皮肤素、灵芝多糖、茯苓多糖、白芨多糖、银耳多糖、枸杞多糖、黑木耳多糖、海藻多糖、果胶、几丁寡糖、壳寡糖、透明质酸、昆布多糖、猪苓多糖中的一种或几种。
4.按照权利要求2或3所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述其它生物多糖材料选自茯苓多糖、白芨多糖、壳寡糖、透明质酸；各组分占组合物的重量百分比为：茯苓多糖0.1～2.2％，白芨多糖0.2～3％，壳寡糖0.5～4％，透明质酸0.5～2.5％。
5.按照权利要求1所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述黏附剂选自羧甲基纤维素钠、淀粉及其衍生物、糊精、羟乙基纤维素、壳聚糖衍生物、黄原胶、卡拉胶、阿拉伯树胶、刺梧桐胶、黄耆胶、木质素磺酸钠、羧化淀粉、聚丙烯酸、聚甲基丙烯酸、聚苯乙烯磺酸、聚乙烯磺酸、聚乙烯膦酸、羧甲基壳聚糖、丙烯酸乙烯吡啶共聚物、聚维酮、卡波姆、微晶纤维素、甲壳素纳米纤维中的一种或几种。
6.按照权利要求1所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：该组合物中还添加有辅料，所述辅料为矫味剂、抗氧化剂、pH值调节剂中的一种或几种，添加量为组合物重量的0.5～7％。
7.按照权利要求6所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述矫味剂为薄荷精油、甘露醇、山梨醇、玫瑰精油中的一种或几种；所述抗氧化剂为维生素C、维生素E，茶多酚，葡萄籽提取物中的一种或几种；所述pH值调节剂为盐酸、磷酸、乙酸、丙酸、丁酸、辛酸、己二酸、乙二酸、酒石酸、柠檬酸、硬脂酸、酒石酸、苹果酸、枸椽酸、抗坏血酸中的一种或几种。
8.按照权利要求7所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：所述矫味剂为薄荷精油；所述抗氧化剂为维生素C、维生素E；所述pH值调节剂为盐酸、乙酸、柠檬酸；各组分占组合物的重量百分比为：矫味剂0.04～2％，抗氧化剂0.3～5％，pH值调节剂0.1～3％，矫味剂+抗氧化剂+pH值调节剂≤7％。
9.按照权利要求1所述治疗放化疗患者口腔粘膜溃疡的生物多糖材料组合物，其特征在于：将香菇多糖、黄芪多糖、壳聚糖和其它生物多糖材料在去离子水中溶解或分散后，再加入辅料和黏附剂，充分搅拌，形成具有一定粘度的液体，即为生物多糖材料组合物。
10.一种权利要求1或9所述组合物作为治疗口腔粘膜疾病的医用敷料的应用。
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