CN107921049A - 用于治疗人乳头状瘤病毒皮肤感染的含乙酰水杨酸的组合物和医疗装置 - Google Patents
用于治疗人乳头状瘤病毒皮肤感染的含乙酰水杨酸的组合物和医疗装置 Download PDFInfo
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Abstract
本发明的目的是一种用于治疗乳头状瘤病毒(HPV)皮肤感染,特别是用于治疗疣和相关病症的医疗装置。具体地,本发明涉及用于局部治疗HPV皮肤感染,特别是良性感染,更特别是疣的乙酰水杨酸。可以通过膏药或贴片(两者都以固态,如片剂、粉末或颗粒,以及通过亲水或疏水凝胶)给予乙酰水杨酸。
Description
技术领域
本发明的目的是一种用于治疗乳头状瘤病毒(HPV,papilloma virus)皮肤感染、特别是用于治疗疣和相关病症的医疗装置。
背景技术
人乳头状瘤病毒(HPV)是乳多空病毒(乳多泡病毒,papovavirus)家族的小DNA病毒。尽管没有被包裹,但是HPV是抗性非常强的病毒,直径约55nm。它们的基因组由包含约8000个核苷酸碱基对的环状DNA双链组成,与组蛋白结合形成类似于小染色体的结构。
根据它们的营养作用,可以将HPV分类为皮肤和粘膜(类型)。皮肤类型分化为通常在群体中传播的那些(HPV 1、2和4)和与疣状表皮发育不良有关的那些,其中最重要的是HPV 5和HPV 8,因为关于恶性转化的倾向性较强。通常将粘膜类型划分为高风险和低风险类型。低风险类型(HPV 6和11)几乎从来不存在于侵入性鳞状细胞癌中,而高风险类型则始终存在(HPV 16和18)。
通常将良性HPV皮肤感染分类为疣(wart)、乳头状瘤(papillomata)和湿疣。乳头状瘤影响口腔,而湿疣给男性和女性的生殖器带来痛苦。
疣是由人乳头状瘤病毒(HPV)诱导的皮肤形成并且是由以下组成的良性表现:由血管供给且被上皮组织层覆盖的内部组织的核。病毒穿入表皮,将其感染。
疣的外观根据导致其的病毒株的位置而变化。疣分成:
1.寻常疣(普通疣,common wart):由乳头状瘤病毒诱发的皮肤病变(lesion),通常表现出不规则的形状且经常(而不是始终)无症状地发展。
2.足底疣(跖疣,plantar wart):典型地在脚部的脚底,这些由HPV导致的疣病变容易在泳池和健身房中传染。
3.扁平疣(flat wart):疣病变略微突出(轮廓分明,in relief);感染手、脚、脸和腿的乳头状瘤病毒可以导致这些皮肤病变,其趋向于在短时间内消失。
寻常疣表现出典型的粗糙表面,经常是起皱的以及具有无美感的外观,常常出现在手上、肘部和膝盖上。
疣是相当普遍的问题:据估计它们给大约10%的全球人口带来痛苦,并且有升高趋势。最受冲击的人群是学龄儿童、青少年和年轻人。在10和15岁之间的年龄段达到高峰。
疣经常是无症状的且即使不治疗也趋向于消失,恢复时间非常长,甚至持续若干年。考虑到这些皮肤表现的不美观外观,受折磨的患者经常依赖治疗来除去它们。
目前采用的疗法包括:
-手术切除:在于感染皮肤的全部切除。尽管该方法有效,但是其侵入性非常强且在任何情况下不能消除疣复发的问题;
-冷冻疗法:这在于用液氮冷冻所涉及的区域;
-角质层分离制剂(keratolytic preparation):这些加速疣的老化周期,导致其上升至表面并允许其自发脱离;
-病变内注射(intralesional injection):在疣自身内注射干扰素,以诱发由病毒感染的细胞的细胞凋亡;
-激光疗法:在于通过激光灼烧疣;
-应用维生素E:以油性制剂(还用作抗刺激护肤霜)局部应用维生素E导致疣消除,可能改善瘢痕形成能力。
这些治疗大部分是侵入性的,并且具有低于或等于70%的成功几率。
因此需要用于HPV皮肤感染,特别是良性皮肤感染如疣和类似表现的治疗,其是有效的并且侵入性小或完全没有侵入性。
乙酰水杨酸(ASA)属于非类固醇抗炎药物(NSAID)类。ASA是水杨酸的衍生物,与水杨酸的不同之处在于在2位上存在乙酰基基团,该基团有助于该分子的抗炎活性。ASA的作用在于通过使环氧酶(COX)的活性位点中的丝氨酸乙酰化来抑制前列腺素的合成。在低剂量(75-81mg/天)下,ASA的作用在血小板水平下是选择性的,其中其不可逆地抑制COX 1的丝氨酸530,产生抗血栓形成的效果。在高剂量(650-4000mg/天)下,ASA抑制COX 1和COX 2,阻断前列腺素合成并具有解热和镇痛效果。已经研究或提出了其他的分子作用机制来解释其多种药理特性,但是对于ASA的可能抗病毒活性却知之甚少。与其他COX2抑制剂类似,ASA可能能够作用于巨细胞病毒(CMV),疱疹病毒家族的病原体。科学证据已经表明ASA可以阻断流感病毒。
发明内容
现在发现用于局部治疗HPV皮肤感染的乙酰水杨酸对于治疗HPV皮肤感染,特别是良性感染(如疣和类似表现)是有效的,在几个小时内消除特征为这些表现的角质层。
不受特定理论的约束,尽管不存在与ASA抵抗HPV的活性有关的科学证据,但是其干扰病毒所选择的在宿主中传播的细胞通路的能力可以解释其治疗所述皮肤感染的效力。
另一个可能的机制可归因于ASA直接在皮肤表现上施加的角质层分离效果,通过加速细胞损失使表皮层从真皮分离。ASA抑制COX1的合成并影响前列腺素通路,减弱角质细胞的细胞间粘结,中断其在下面角质层中的粘附,引起上层从新形成的下层分离。
更可能地,考虑到所观察到的高治疗效力,ASA通过协同运行的各种机制的合作而发挥作用。
因此,根据所附权利要求1至19或26,本发明的一个目的是用于治疗HPV皮肤感染,特别是良性感染(如疣、乳头状瘤和湿疣)的乙酰水杨酸。
根据权利要求20至25,本发明的另一目的是用于局部应用(优选地经由受控释放)的医疗装置,其包含固体形式或嵌入在各种性质的聚合物基质中的乙酰水杨酸。
通过以下对实施方式的优选且非排他性的实施例的描述,可以得到根据本发明的方法的进一步的特征和优势。
附图说明
图1描绘了根据本发明的医疗装置的第一实施方式的示意性截面图;
图2描绘了根据本发明的医疗装置的第二实施方式的示意性截面图;
图3描绘了根据本发明的医疗装置的第三实施方式的示意性截面图。
具体实施方式
本发明涉及用于治疗HPV皮肤感染,特别是良性皮肤感染如疣(无论寻常疣或足底疣或扁平疣)、乳头状瘤、湿疣等的乙酰水杨酸。
在某些实施方式中,用根据本发明的乙酰水杨酸治疗的皮肤感染是所谓的生殖器疣,更常称为尖锐湿疣,其表现为皮肤上的赘生物或突起。所述湿疣是通过性途径传播的HPV生殖器感染的表现,但是不能排除通过其他非性途径感染的可能性。
在男性中,湿疣优先出现在腺水平(gland level)、尿道口、系带、阴茎和包皮腺的纵沟(sulcus)处;在女性中,受影响最大的区域则是外阴、子宫颈和阴道。
湿疣可以是突出的或平坦的,或大或小;有时它们可以成群在一起并呈现出类似于珊瑚虫或花椰菜的形式。在一些情况下,疣具有与皮肤相同的颜色,并且特别小且平坦以致它们不会被观察到。湿疣常常是无症状的,但是某些变化会产生烧灼感、发痒和局部刺激。
根据本发明的乙酰水杨酸(ASA)用于以固态(形式)或嵌入在聚合物基质中局部给予。
在优选的实施方式中,ASA的剂量在0.3和5g/天之间、或0.3和4之间或0.3和1.2g/天之间,优选地0.5和1g/天之间。
一般而言,ASA包含在贴片(patch)或膏药(plaster)中,贴片或膏药包括朝向待治疗的皮肤的粘合材料层和朝向外部(向外)的防渗层。
防渗层优先选自:
-聚对苯二甲酸乙二醇酯膜(PET)
-聚乙烯膜
-聚氨酯膜
-聚酰胺膜
-乙烯乙烯醇共聚物(EVA)膜
-包含两层或更多层膜的层压体(层压材料,laminate),所述膜选自以上所列的那些。
在层压体的情况下,可以通过粘结或通过共挤出制造它们。
这些膜是商购的且是技术人员(专家)众所周知的。
层或粘合材料可以是以条带的形式,例如以连续或间断路线(轨迹),沿着膏药的相对端或沿着其周边布置。在其他实施方式中,层或粘合材料采取方形或圆形的垫形式、或其他形状的形式,在膏药的朝向待治疗皮肤的面的离散区域布置。
用于本发明的目的的粘合剂是易于除去的粘合剂。在某些实施方式中,使用包含热塑性聚合物并包含氧化锌的“热熔体”类型的胶(胶水,glue),称重量优选地在5%和35%之间、更优选地10%和20%之间。
在某些实施方式中,热塑性聚合物选自:丙烯酸聚合物、丁基橡胶、乙烯乙酸乙烯酯(EVA)聚合物、天然橡胶、腈聚合物、硅橡胶、苯乙烯共聚物(优选苯乙烯丁烯共聚物(SBC、SBS)、苯乙烯-乙烯-丁烯-苯乙烯共聚物(SEBS)、苯乙烯-乙烯-丙烯共聚物(SEP)或苯乙烯-异戊二烯-苯乙烯(SIS)共聚物)或乙烯基聚合物。
在优选的实施方式中,热塑性聚合物添加有利于粘附的试剂。在优选的实施方式中,这种试剂选自:萜烯和改性萜烯、环脂族树脂、芳香族树脂、松香、氢化烃树脂、萜烯酚树脂和硅酮树脂。
在某些实施方式中,借助于以上阐述的膏药或贴片,以片剂的形式使用ASA,该片剂应用在待治疗的皮肤表现上。
在其他实施方式中,ASA以亲水或疏水凝胶的形式或以片剂的形式包含在聚合物基质中。
亲水凝胶:
凝胶化液相是水。
在优选的实施方式中,凝胶化物质(gelling substance)选自:
-其聚丙烯酸和盐,例如Carbopol-934,
-羧甲基纤维素,
-羟基丙基纤维素,
-甲基纤维素400和4000cPs,
-羟乙基纤维素,
-羟丙基甲基纤维素(HPMC)25、100、4000和15000cPs,
-黄原胶,
-阿拉伯树胶(金合欢胶),
-琼脂(agar-agar),
-瓜尔胶,
-刺槐豆胶,
-藻酸盐,
-糖蜜(molasses),
-甘露糖和半乳糖多糖,
-壳聚糖,
-改性淀粉
或它们的混合物。
在优选的实施方式中,凝胶化物质以按重量计0.5%和6%之间、更优选地1%和4%之间的量包含在凝胶的组合物中。
疏水凝胶:
疏水凝胶是无水系统,其中分散相由疏水的分散剂(hydrophobe dispersant)组成。
在优选的实施方式中,分散相选自:植物油(甘油三酯)、植物蜡如希蒙得木油(Simmondsia Chinensis oil)、液体石蜡、1-癸烯的氢化聚合物、高分子量硅酮如二甲聚硅氧烷(聚二甲基硅氧烷,dimethicone)。
优选的凝胶化试剂选自:
-胶体二氧化硅,
-脂肪酸铝盐,
-高分子量脂肪醇,优选地包含在100和450DA之间,
-地蜡(ozokerite),
-植物蜡,
-动物蜡。
亲水、疏水或脂质基质:
还可以将ASA配制在特殊的亲水、疏水脂质基质中,或配制在干燥的基质中,例如通过将药物直接压制在聚合物基质中或压制之前混合ASA的颗粒和聚合物基质。
亲水基质应当是以上针对亲水性凝胶定义的那些。
疏水基质优选是聚乙烯、聚氯乙烯、乙基纤维素、丙烯酸酯聚合物类(基质)或者基于它们的共聚物。
以这些固体形式,ASA由于蒸汽或汗液的渗透而释放到聚合物基质中。结果,缓慢的溶解作用使得随时间延迟并基本持续的释放,由此活性成分遍及压实聚合物颗粒之间存在的通道网络而分散。
脂质基质是由蜡和脂质制备的。活性成分通过分散孔以及通过腐蚀(erosion)两者释放。在某些实施方式中,将巴西棕榈蜡与硬脂酸组合使用。
还可以使用可生物降解的基质,天然聚合物如蛋白质和多糖(原样的或改性的),或者可以使用合成聚合物,例如脂肪族聚酯和聚酸酐、或源自海藻的基质如海藻酸。
在男性或女性生殖器湿疣的治疗中,以乳膏、阴道乳膏或凝胶或妇科泡沫(gynecological foam)或阴道栓剂使用ASA,用于局部应用。
可以使用技术人员熟知的常规方法和赋形剂制备这种药物形式。例如,在Remington,The Science and Practice of Pharmacy,Allen,Loyd V.,Jr编辑,第22版,2012中描述了这类方法。
还可以将乙酰水杨酸与另一种具有(抗)炎性或缓和(emollient)及镇痛活性且来自植物来源如锦葵(Malva sylvestris)、互生叶白千层(Melaleuca alternifolia)和向日葵(Helianthus annuus)的活性成分相结合。
在优选的实施方式中,ASA是微粉化的形式(微粒形式,micronized form)。
在根据本发明的贴片或膏药中,药物的延迟释放取决于多种因素。
第一个重要因素是基质的孔隙率。出于本发明的目的,可以使用大孔隙率(宏观孔隙率,macro-porosity)或微孔隙率(微观孔隙率,micro-porosity)基质或非多孔基质。
大孔隙率基质具有尺寸在0.1和1微米之间的孔。药物通过孔扩散。
微孔隙率基质可以具有尺寸在50和200埃之间的孔。在这种情况下,药物也通过孔扩散。
在非多孔基质中,药物通过网络格网分散且释放更缓慢。
其他重要因素是:
-ASA的溶解度,其足够高以允许ASA通过基质腐蚀借助于溶解而释放;
-使用的聚合物基质的水合/溶胀比(hydration/swelling ratio),
-聚合物粘度,其中增加凝胶层中的聚合物的分子量或其粘度,ASA的溶解作用减缓;
-聚合物浓度,其中其浓度增加导致凝胶粘度增加,因此药物扩散更缓慢;
-聚合物和水力分散层的厚度,其中厚度增加导致药物释放更缓慢;
-分散表面积,其中较小的分散面积加速药物的释放;
-稀释剂或添加剂的存在,其中水溶性稀释剂如乳糖加快释放速率,而不可溶的稀释剂如磷酸二钙则降低扩散并增加腐蚀。
在图1、2和3中,示出了根据本发明的用于局部给予的医疗装置的某些实施方式。在这些实施方式中,聚合物基质、外部防渗层和粘合层选自上文所描述的那些。
在一个实施方式中,如图1所示,以应用于皮肤区C的贴片或膏药1的形式给予ASA,皮肤区C上存在待治疗的HPV感染,例如疣V。
贴片1包含ASA的固体剂量(固体剂型,solid dose)2(例如片剂、粉末、颗粒或另一种常规的固体形式,其中ASA可以是纯的形式或添加有常见的赋形剂)和典型地围绕固体剂量2的粘合层3。
位于固体剂量2上方的是剂量推板(pusher plate)4。贴片1外侧被防渗层5覆盖。
在图1所示贴片1的特别优选的实施方式中,ASA的固体剂量2包含处于亲水基质(如羟乙基纤维素)和/或改性淀粉中的ASA。
在其他实施方式中,如图2所示,贴片或膏药101包括含有ASA的聚合物基质102,其中ASA分散在粘合剂聚合物中,该粘合剂聚合物通过溶剂熔融(熔化)或热熔融在防渗层105上。朝向待治疗表面的膏药101的面包含粘合层103。
在图2所示贴片101的特别优选的实施方式中,聚合物基质102包含处于凡士林-液体石蜡(7:3)和按重量计20%尿素中的ASA。
在其他形式的实施方式中,如图3所示,贴片或膏药201包括含有微球形式的ASA的聚合物基质202,其可以通过以下方式获得:将ASA悬浮在水溶性聚合物的水溶液中,然后将这种悬浮液均匀分散在亲脂性聚合物中,从而形成含有ASA的微球206。
贴片201的外面(外侧面,outer face)包含防渗层205,而贴片201朝向待治疗表面的面(侧面,face)包含围绕聚合物基质202的粘合剂边缘203。
在图3所示贴片201的特别优选的实施方式中,聚合物基质202包含处于按重量计约5%的羧甲基纤维素钠、按重量计约12%的乙醇、按重量计约20%的丙三醇、按重量计约16%的丙二醇和配足100%的适量蒸馏水中的乙酰水杨酸。
******
显然,已经描述的仅仅是本发明的某些具体实施方式,在不背离本发明的保护范围的情况下,本领域技术人员能够进行所有必要的修改来使其适合具体的应用。
Claims (26)
1.乙酰水杨酸,用于在局部治疗HPV皮肤感染中应用。
2.根据权利要求1所述的用于应用的乙酰水杨酸,其中,所述HPV皮肤感染是良性类型的HPV皮肤感染。
3.根据权利要求2所述的用于应用的乙酰水杨酸,其中,所述HPV皮肤感染是乳头状瘤、湿疣、男性或女性生殖器的湿疣、或寻常疣、足底疣或扁平疣。
4.根据权利要求1至3中任一项所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸呈固态或嵌入在聚合物基质中。
5.根据权利要求1至4中任一项所述的用于应用的乙酰水杨酸,其中,乙酰水杨酸的剂量在0.3和5g/天之间或0.3和4g/天之间、或0.3和1.2g/天之间、或0.5和1g/天之间。
6.根据权利要求1至5中任一项所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸包含在贴片或膏药中,所述贴片或膏药包含朝向待治疗的皮肤的层或粘合材料以及朝向外部的防渗层。
7.根据权利要求6所述的用于应用的乙酰水杨酸,其中,所述防渗层优先选自:
-聚对苯二甲酸乙二醇酯膜(PET)
-聚乙烯膜
-聚氨酯膜
-聚酰胺膜
-乙烯乙烯醇共聚物(EVA)膜
-包括两层或更多层选自以上所列那些的膜的层压体。
8.根据权利要求6或7所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸是片剂形式。
9.根据权利要求6或7所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸包含在聚合物基质中并且是亲水凝胶或疏水凝胶的形式或者是片剂形式。
10.根据权利要求9所述的乙酰水杨酸,其中,所述亲水凝胶包含选自以下各项的凝胶化物质:
-其聚丙烯酸盐,例如Carbopol-934,
-羧甲基纤维素,
-羟丙基纤维素,
-甲基纤维素400和4000cPs,
-羟乙基纤维素,
-羟丙基甲基纤维素(HPMC)25、100、4000和15000cPs,
-黄原胶,
-阿拉伯树胶(金合欢胶),
-琼脂,
-瓜尔胶,
-刺槐豆胶,
-藻酸盐,
-糖蜜,
-甘露糖和半乳糖多糖,
-壳聚糖,
-改性淀粉
或它们的混合物,
以及可选地水。
11.根据权利要求9所述的乙酰水杨酸,其中,所述疏水凝胶包含选自以下各项的凝胶化物质:
-胶体二氧化硅,
-脂肪酸铝盐,
-高分子量脂肪醇,优选地包含在100和450DA之间,
-地蜡,
-植物蜡,
-动物蜡,
以及可选地分散相,选自植物油(甘油三酯)、植物蜡如希蒙得木油、液体石蜡、1-癸烯的氢化聚合物、高分子量硅酮如二甲聚硅氧烷。
12.根据权利要求9所述的乙酰水杨酸,其中,所述乙酰水杨酸包含在亲水基质、疏水基质、脂质基质或者通过直接压制或粒化后干燥的可生物降解的基质中,其中,所述亲水基质在权利要求9中限定,所述疏水基质优先选自聚乙烯、聚氯乙烯、乙基纤维素、丙烯酸酯聚合物或它们的共聚物,以及所述脂质基质或可生物降解的基质分别选自蜡或脂质,以及原样的或改性的蛋白质、多糖,合成聚合物如脂肪族聚酯和聚酸酐,以及源自海藻的基质如海藻酸。
13.根据权利要求3所述的用于应用的乙酰水杨酸,其中,所述HPV皮肤感染是男性或女性生殖器的湿疣,其中以用于局部应用的乳膏、阴道乳膏或凝胶或妇科泡沫或阴道栓剂来使用乙酰水杨酸。
14.根据权利要求1至13中任一项所述的用于应用的乙酰水杨酸,与活性成分结合,所述活性成分具有抗炎或缓和及镇痛的活性且来自植物来源,锦葵、互生叶白千层和向日葵。
15.根据权利要求1至14中任一项所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸是微粉化形式。
16.根据权利要求1至15中任一项所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸是无定形或晶体形式,或是水合的或者作为笼形物。
17.根据权利要求16所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸是环糊精包合复合物的形式。
18.根据权利要求17所述的用于应用的乙酰水杨酸,其中,所述环糊精选自β-环糊精和羟丙基-β-环糊精。
19.根据权利要求17或18所述的用于应用的乙酰水杨酸,其中,由1:1和3:1之间的乙酰水杨酸/环糊精比值开始,可获得乙酰水杨酸在环糊精中的所述包合复合物。
20.一种贴片或膏药(1),包含:
-乙酰水杨酸的固体剂量(2),选自片剂、粉末、颗粒和其他常规的固体形式,其中,所述乙酰水杨酸可以是纯的形式或添加有常见的赋形剂,
-围绕所述固体剂量(2)的粘合层(3),
-位于所述固体剂量(2)上方的剂量推板(4),
-外部防渗层(5)。
21.根据权利要求20所述的贴片或膏药(1),其中,所述固体剂量(2)包含处于亲水基质如羟乙基纤维素和/或改性淀粉中的乙酰水杨酸。
22.一种包含聚合物基质(102)的贴片或膏药(101),所述聚合物基质(102)包含乙酰水杨酸,其中所述乙酰水杨酸分布在粘合剂聚合物中,通过溶剂或热使所述粘合剂聚合物熔融在防渗层(105)上,其中朝向待治疗表面的贴片(101)的面含有粘合层(103)。
23.根据权利要求22所述的贴片或膏药(101),其中,所述聚合物基质(102)包含处于7:3凡士林-液体石蜡和按重量计20%尿素中的乙酰水杨酸。
24.一种贴片或膏药(201),包含含有微球形式的乙酰水杨酸的聚合物基质(202),其这样获得:将所述乙酰水杨酸悬浮在水溶性聚合物的水溶液中,然后将这种悬浮液均匀分散在亲脂性聚合物中以形成包含乙酰水杨酸的微球(206),其中,所述贴片(201)的外面包含防渗层(205)以及所述贴片(201)朝向待治疗表面的面含有围绕所述聚合物基质(202)的粘合边缘(203)。
25.根据权利要求24所述的贴片或膏药(201),其中,所述聚合物基质(202)包含处于按重量计约5%的羧甲基纤维素钠、按重量计约12%的乙醇、按重量计约20%的丙三醇、按重量计约16%的丙二醇以及配足100%的适量蒸馏水中的乙酰水杨酸。
26.根据权利要求1至19中任一项所述的用于应用的乙酰水杨酸,其中,所述乙酰水杨酸包含于权利要求20至25中任一项所述的贴片或膏药(1、101、201)中。
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IT201700090344A1 (it) * | 2017-08-04 | 2019-02-04 | Poli Md S R L | Dispositivo medicale per il trattamento delle infezioni cutanee da hpv |
MX2019004729A (es) * | 2017-08-04 | 2019-08-21 | Poli Md S R L | Dispositivo medico para el tratamiento de infecciones cutaneas por pvh. |
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