CN106177911A - 一种预防治疗hpv感染的生物组合物敷料 - Google Patents
一种预防治疗hpv感染的生物组合物敷料 Download PDFInfo
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Abstract
本发明提供了一种预防治疗HPV感染的生物组合物敷料，该生物组合物敷料含有PHPV蛋白、卡波姆、甘油、绿茶提取物和玉洁纯MP组分，并且该生物组合物敷料可被制备成敷料栓、凝胶敷料、洗剂、膜剂等药物剂型。本发明所提供的在治疗生殖道高危型HPV感染、高危型HPV感染引起的低级别宫颈病变、阻断生殖道HPV感染、改善阴道微环境、减轻阴道松驰干涩症状、减少阴道炎性反应，降低阴道PH值中具有明显效果。
Description
技术领域
本发明属于高新生物技术领域，具体涉及一种预防治疗HPV感染的生物组合物敷料及其临床应用。
背景技术
HPV是一种具有种属特异性的嗜上皮病毒，属双链闭环的小DNA病毒，包含约8000个碱基对。其中包括8个早期开放读码框架(E1-E8)、2个晚期读码框架和1个非编码长控区。在早期开放读码框架中，E6和E7基因对细胞生长刺激最为重要，E6、E7编码的E6、E7蛋白引起宫颈上皮细胞永生化。而晚期读码框L1和L2基因分别编码HPV的主要和次要衣壳蛋白，组装成HPV的衣壳。将HPV“解剖”开来会发现，它由蛋白衣壳这层外衣和被包裹着的核心构成。衣壳的“原料”主要是衣壳蛋白(L1)和次要衣壳蛋白(L2)；褪掉衣壳，其核心是能引起人类疾病的真身——无包膜呈现小型双链环状的DNA与少量
HIV、HSV、HPV。1949年，Strauss首先在电镜下观察到HPV颗粒，它呈球形，其20面体对称，直径约45-55nm。根据HPV基因序列结构的不同，人们将HPV分为近130种基因型，其中近HIV、HSV等百种的基因序列已被摸清。人类是HPV的唯一宿主，它最喜欢把家安在皮肤和黏膜内，因此具有高度的宿主特异亲和力。HPV病毒(人乳头瘤病毒缩写)是一种属于乳多空病毒科的乳头瘤空泡病毒A属，是球形DNA病毒，能引起人体皮肤黏膜的鳞状上皮增殖，到2013年，已分离出130多种，该病毒只侵犯人类，对其它动物无致病性，人体一旦感染会终生携带。因为HPV病毒的不同，给患者的伤害也不同，而一些病毒会给患者带来恶性肿瘤，最终导致癌变，严重威胁患者的生命，有的疾病会导致孕妇的胎儿死亡或者成为畸形儿，也有的疾病会导致男性不育。
现有的HPV的治疗包括(1)物理治疗：目的是去除肉眼可见的瘤体和亚临床感染，方法包括：激光、微波、冷冻、电灼、手术切除(妇科的LEEP刀等)、光动力疗法等；(2)药物治疗：0.5％足叶草脂毒素酊，5％咪喹莫特，50％三氯醋酸、氟尿嘧啶软膏；(3)免疫疗法在于减少复发和加快清除病灶，药物有：干扰素、白介素、胸腺肽、转移因子、卡介苗、异维A酸、自体疫苗等；(4)治疗性疫苗：临床证实HPV的疫苗几乎能100％地预防一些HPV病毒株的感染，但是它并不能预防所有类型病毒株的感染，并且价格高昂。而在治疗上由于没有特效药因而采用的免疫调节药物由于普遍存在无法有效地预防HPV感染、疗效不明确、价格昂贵等方面的缺陷而大大限制了其在临床上的使用，特别是在低收入的发展中国家。
因此，急需提供一种新的治疗方式以有效阻断HPV病毒感染，以提高临床治疗效果，改善患者症状。
发明内容
针对上述HPV治疗中所面临的问题，本发明的目的是提供一种预防治疗HPV感染的生物组合物敷料。本发明的生物组合物敷料主要成份为PHPV基因蛋白、卡波姆、辅以少量甘油、绿茶提取物，抑菌防腐剂为玉洁纯MP，该生物组合物敷料经高新生物科技交联表达而成。
本发明是采用如下技术方案实现的：
一种预防治疗HPV感染的生物组合物敷料，包含以下质量浓度的各种组份：
其中，PHPV蛋白为细胞穿膜肽ELP和寡肽-1通过重组表达方式所构建的融合蛋白。
其中，穿膜肽ELP的序列为Val-Pro-Gly-Xaa-Gly，并且Xaa优选为A。
以及，采用本发明所述的生物组合物敷料制备预防和治疗HPV感染药物治疗中的用途。
其中，所述生物组合物敷料可制备成敷料栓、凝胶敷料、洗剂、膜剂药物形式。
在本发明所述的生物组合物敷料的具体组分介绍如下：
卡波姆(Carbomer)是含有聚烯基聚醚交联的丙烯酸聚合物，是一类非常重要的流变调节剂，中和后的卡波姆是优秀的凝胶基质，有增稠、悬浮等重要用途，工艺简单，稳定性好，很低的用量下就能产生高效的增稠作用，从而制备出很宽粘度范围和不同流变性的喷剂、乳液、膏霜、凝胶和透皮制剂。且具水溶性基质的特点,外观透明美观,搽于皮肤上有特别的细腻滑爽感,与皮肤组织藕合效果很好。本发明配方中，通过胶状(膜状)卡波姆可将失活的HPV吸附、包裹排出体外，并加快受损、糜烂组织快速修复与再生，促进愈合。
绿茶提取物中含有一种比其它植物含量高得多的复合物茶多酚，其为灰白色固体或者结晶，易溶于水，易被氧化成棕色物质。常应用于洗发水、沐浴露中，气味清香。本发明配方中，通过绿茶提取物可改善阴道异味。
甘油为无色澄清黏稠液体，无臭，有暖甜味。广泛应用于医药、食品、烟草、化妆品、牙膏、油墨、涂料、国防、皮革、印染、合成树脂、农药等行业。在发明配方中用于调节敷料及隐形膜的性状。
玉洁纯是一种多效的抑菌药物，其通常被用作口腔卫生用品中的抗菌成分，具有毒性低，不经肝、肾代谢，对人体无潜在蓄积毒性的特点。玉洁纯MP是其中一种，它不仅具有广谱抗菌性，除可抑制杀死细菌外，对真菌也有何强的抑杀效果，并且其对粘膜表面具有较强的附着作用，可形成保护膜。基于上述有点，本申请的发明人突破传统观点，将玉洁纯MP大胆的应用到HPV生物组合物辅料中，除了作为抑菌防腐剂，也进一步加强了本申请组合物对HPV的杀伤作用。
本发明的生物组合物敷料主要成份中的PHPV蛋白是本申请发明团队研制的一种高效融合蛋白，该融合蛋白由细胞穿膜肽和寡肽-1组成，具有阻断多种病毒感染，修复损伤细胞，增强松驰的阴道粘膜弹性，紧致阴道内壁，提高阴道湿润度，减轻阴道炎症反应的作用。内含的穿膜肽具有较强的细胞穿透力，能快速穿透病毒包裹外壳，达到灭活细菌病毒的目的。其内含的寡肽-1具有修复损伤细胞和促进创伤愈合的功能；卡波姆是一种性质稳定、无刺激、无致敏性医用高分子材料，覆盖于受损组织，可起到隔离阻止感染，修复粘膜损伤的作用；辅料中的绿茶提取物中含有一种比其他植物含量更高的复合物茶多酚，易溶于水，易被氧化成棕色物质，气味清芳，可消除阴道异味；少量甘油能起到调节生物性状的保湿作用；玉洁纯MP是一种高效广谱抑菌防腐剂，与人体皮肤有很好的相容性。本组合物敷料无刺激、无致敏反应，每克重金属含量<20ug，细胞毒性<2级。
本发明中的各组合物敷料是按照重量份数计算。
本发明中的生物组合物敷料作用机理为通过PHPV蛋白表面的负电荷(阴离子)与人类乳头瘤病毒(HPV)颗粒上的正电荷(阳离子)相互络合，其表面所带负电荷与HPV包裹蛋白的L1区的C端和L2区的N端的正电荷区域相结合，从而阻断细菌病毒侵入宿主细胞内，致使HPV蛋白构象变化而失活，达到抵抗HPV感染的目的。同时胶状卡波姆可将失活的HPV病毒吸附包裹排出体外，玉洁纯MP可有效在阴道粘膜表面形成保护膜，进一步巩固杀毒作用，并加快溃疡损伤组织快速修复与再生，达到促进愈合的目的。
本发明的生物组合物敷料应用广泛，可用于治疗生殖道高危型HPV感染；用于高危型HPV感染引起的低级别宫颈病变(CINⅠ级)的治疗；阻断生殖道HPV感染，预防宫颈癌前病变(CIN)及宫颈癌的发生；能改善阴道微环境、减轻阴道松驰干涩症状、减少阴道炎症反应，保持阴道正常PH值。用于各类阴道炎症引起的阴道异味、瘙痒，有效改善阴道清洁度。
本发明有益效果如下：
1.本发明的生物组合物敷料组分明确，无致敏、无刺激性，质量可控；
2.本发明的生物组合物敷料适合工业化生产；
3.本发明的生物组合物敷料临床应用广泛，在预防治疗HPV感染健康女性生殖系统疾病方面效果显著。
具体实施方式
以下结合实施例对本发明做进一步的详细描述，但并非对本发明的限制，凡依照本发明公开内容所做的任何本领域的等同替换，均属于本发明的保护范围。
本发明采用以下技术方案实现的：
一种预防治疗HPV感染的生物组合物敷料，包含以下质量浓度的各种组份：
实施例1：
一种预防治疗HPV感染的生物组合物敷料，按重量份计算，PHPV蛋白0.0005％、卡波姆7％、甘油3％、绿茶提取物4％、玉洁纯MP 0.15％；以制备一百克所述组合物为例，分別取PHPV蛋白0.0005克，卡波姆7克，甘油3克，绿茶提取物4克，玉洁纯MP0.15克，加入到60克去离子水中，用高速分散机使其充分交联溶解，再用去离子水定溶至100克搅拌均匀，再按常规方法制成凝胶或临床其它所需制剂。
实施例2
一种预防治疗HPV感染的生物组合物敷料，按重量份计算，PHPV蛋白0.0001％、卡波姆5％、甘油2％、绿茶提取物1.2％、玉洁纯MP0.05％；以制备一百克所述组合物为例，分別取PHPV蛋白0.0001克，卡波姆5克，甘油2克，绿茶提取物1.2克，玉洁纯MP 0.05克，加入到70克去离子水中，用高速分散机使其充分交联溶解，再用去离子水定溶至100克搅拌均匀，再按常规方法制成凝胶或临床其它所需制剂。
实施例3
一种预防治疗HPV感染的生物组合物敷料，按重量份计算，PHPV蛋白0.0009％、卡波姆9％、甘油5％、绿茶提取物6％、玉洁纯MP0.3％；以制备一百克所述组合物为例，分別取PHPV蛋白0.0009克，卡波姆9克，甘油5克，绿茶提取物6克，玉洁纯MP 0.3克，加入到80克去离子水中，用高速分散机使其充分交联溶解，再用去离子水定溶至100克搅拌均匀，再按常规方法制成凝胶或临床其它所需制剂。
所有上述的首要实施这一知识产权，并没有设定限制其他形式的实施这种新产品和/或新方法。本领域技术人员将利用这一重要信息，上述内容修改，以实现类似的执行情况。但是，所有修改或改造基于本发明新产品属于保留的权利。
Claims (7)
1.一种预防治疗HPV感染的生物组合物敷料，其特征在于所述生物组合物敷料含有PHPV蛋白、卡波姆、甘油、绿茶提取物和玉洁纯MP。
2.根据权利要求1所述的生物组合物敷料，其特征在于所述组合物敷料包含以下质量浓度的各种组分：
3.根据权利要求1-2任意一项所述的生物组合物敷料，其中所述PHPV蛋白为细胞穿膜肽ELP和寡肽-1通过重组表达方式所构建的融合蛋白。
4.根据权利要求1-3任意一项所述的生物组合物敷料，其中所述穿膜肽ELP的序列为Val-Pro-Gly-Xaa-Gly。
5.根据权利要求1-4任意一项所述的生物组合物敷料，其中所述穿膜肽ELP中Xaa优选为A。
6.权利要求1-5任意一项所述的生物组合物敷料在制备用于预防和治疗HPV感染的药物中的用途。
7.根据权利要求7所述的用途，其中所述生物组合物敷料可制备成敷料栓、凝胶敷料、洗剂、膜剂药物形式。
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