CN115569167B - 一种治疗烧烫伤的中药组合物及其制备方法和用途 - Google Patents
一种治疗烧烫伤的中药组合物及其制备方法和用途 Download PDFInfo
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Abstract
本申请公开了一种治疗烧烫伤的中药组合物及其制备方法和应用,涉及中药技术领域。所述中药组合物的组分包括:熟地黄、当归、生黄芪、生黄柏、白芷、炒白术、柴胡苗、石灰水、熟石膏、玄明粉和芝麻油。本申请配方简单、制备容易,用药方便、止痛快、创面干燥快、结痂快,疗程短,治疗费用较低,无需植皮,使用范围广,易于推广,对于热水、热油、热蒸汽及化学品等所致的烧烫伤有明显的止痛消炎、收敛、防腐、促进新生肉芽组织生长以及减少烧烫伤后疤痕增殖功效。
Description
技术领域
本申请涉及中药技术领域,具体涉及一种治疗烧烫伤的中药组合物及其制备方法和用途。
背景技术
烧烫伤的致伤原因除了常见的火、沸水等日常常见烧烫伤外,近年来已有因热、光、电及化学品等所导致的皮肤和粘膜损伤,常伤及皮下组织,多为不易痊愈的II度及III度烫伤,严重者可发展为生活中最常见且极其复杂的外伤之一。
化学品、热水、热油、热气等所致的烧烫伤创面是感染、脏器损害等并发症的源头,如何有效促进烧烫伤创面愈合,一直是烧烫伤治疗中研究的难点和热点。西医药物治疗烧烫伤主要应用抗生素等药物,而且长期使用会产生细菌耐药性并诱发二次感染,还会降低人体的免疫力,止痛慢且效果差,痊愈时间长,对于深II度至深IV度等严重烧烫伤患者,不仅需要在无菌病房中治疗,而且需植皮治疗才能痊愈,治疗费用昂贵。
中药及其制剂作为我国医学领域的一块瑰宝,在治疗烧烫伤方面,由于剂型丰富使用较广,有着西药无法比肩的优势;烧烫伤中药在抗感染、促进创面愈合方面也表现出了较为独特疗效。中药常用于治疗烧烫伤的重要剂型包含油剂、膏剂、散剂、水溶剂、喷雾剂、霜剂、成膜剂等。经药理学和临床试验证明,其中中药烧烫伤油剂、膏剂由于其方便、有效的优势一直是烧烫伤外治最常见的制剂之一。膏剂中的外用软膏和膏药在中国应用甚早,在《黄帝内经·灵枢》(素问)“痈疽篇”中已有“疏砭之,涂以豕膏”的记载。中药烧烫伤膏剂以治疗I度至深 II度烧烫伤为主,富有黏性的烧烫伤膏剂外敷患处,既可避免外来刺激和细菌感染,又可消炎止痛,改善局部血液循环,有利于创面组织的修复与再生,适用于各种烧烫伤创面的治疗。
现有治疗烧烫伤的药物较多,但存在着治疗时间长、疗效不显著、止痛效果不佳的缺点,因此,开发新的有效治疗烧烫伤的药物迫在眉睫。
发明内容
本申请的目的就是至少克服现有技术的不足之一,提供了一种治疗烧烫伤的中药组合物及其制备方法和用途,该配方制备简易,用药方便、止痛快、创面干燥快、结痂快,疗程短,治疗费用相关较低,无需植皮,使用范围广,易于推广的尤其对于热水、热油、热汽、光电及化学品引起的烧烫伤有明显的止痛消炎、收敛、防腐、促进新生肉芽组织生长以及减少烧烫伤后疤痕增殖的功效。
为此,本申请实施例至少公开了以下技术方案:
第一方面,本申请实施例公开了一种治疗烧烫伤的中药组合物,所述中药组合物的组分包括:熟地黄、当归、生黄芪、生黄柏、白芷、炒白术、柴胡苗、石灰水、熟石膏、玄明粉和芝麻油。
第二方面,本申请实施例公开了一种治疗烧烫伤的中药组合物的制备方法,包括如下步骤:
按重量份称取熟地黄、当归、生黄芪、生黄柏、白芷、炒白术和柴胡苗,加水室温浸泡20-30分钟,武火煮沸后文火继续维持沸腾30-40分钟,过滤收集药液,将所述药液浓缩至浓度为0.8-1.2g/ml的生药;
将石灰水和芝麻油混合均匀制成混悬液;
将熟石膏、玄明粉充分搅和后制成混合粉剂;
将石灰水-芝麻油的混悬液加入到生药中,充分混合后,再向混合液中加入配制好的熟石膏-玄明粉混合粉剂,充分搅拌,即得油膏。
第三方面,本申请实施例公开了中药组合物在制备治疗烧烫伤药物中的应用。
本申请中药组合物药物配伍原理说明如下:
熟地黄、当归为君药,熟地养血滋阴,当归血中气药,养血和血,二者合用,泽皮肤,养血生肌(血旺则肉长)、排脓止痛(血和则痛止);生黄芪、炒白术为臣药,炒白术培补脾胃止肌热,生黄芪生用固表止汗。利水退肿、托疮生肌,配炒白术,补脾胃止肌热,固表生机长肉芽;生黄柏、白芷为佐药,黄柏微苦性寒,清热解毒,白芷活血排脓、生肌止痛;柴胡苗为使,苦平微寒,透表泄热,和解表里,联合熟石膏、石灰水、玄明粉、芝麻油共用于烧烫伤的治疗。此外,所用熟石膏为含水硫酸钙的矿石煅烧后制得的粉末。《本草衍义补遗》:“石膏,本阳明经药,阳明主肌肉,其甘也,能缓脾益气,止渴去火,其辛也,能解肌出汗,上行至头,又入手太阴、少阳,而可为三经之主者。研为末,醋研丸如绿豆大,以泻胃火、痰火、食积”,石膏煅用(即熟石膏)具有敛疮生肌,收湿,止血、止痛之功效。
所用石灰水是由熟石灰溶于水后拌和处理48h并澄清后的上清液。其中熟石灰又称消石灰粉,是块状生石灰用适量水熟化而得到的粉末,其主要成分是氢氧化钙;《本草纲目·石部·石灰》云:“今人作窑烧之,一层柴或煤炭一层在下,上累青石,自下发火,层层自焚而散。入药惟用风化、不夹石者良”;石灰水具有解毒蚀腐,敛疮止血,杀虫止痒之功效,可用于痈疽疔疮,丹毒,瘰疬痰核,赘疣,外伤出血,水火烧烫伤等。
所用玄明粉为芒硝经风化干燥制得主要含有硫酸钠(Na2SO4)的无臭,味咸、有引湿性、易溶于水的白色粉末。《嘉佑本草》、《本草原始》、《本草经疏》等记载玄明粉:“味辛甘、性冷、无毒",入胃,大肠经。《中华本草》具有泻热,润燥,软坚的功效,及治疗实热积滞、大便不通、目赤肿痛、咽肿口疮、痈疽肿毒之症。
所用芝麻油,即麻油或又名芝麻香油。三国时《华佗神方》中的救汤火伤方,所用麻油是将芝麻籽用石臼法或木榨法生榨制得。本申请方中的芝麻油,是将芝麻尊古法木法榨制的纯芝麻油。现在药理研究显示,芝麻油富含的维生素E,具有保护血管、促进细胞分裂和延缓衰老的功能,富含易被人体分解吸收和利用的亚油酸、棕榈酸等不饱和脂肪酸,有助于消除动脉血管壁上的沉积物。因此,在本申请的中药制剂组方中芝麻油既作为基质辅料使用,同时又具有较好的治疗效果。
与现有技术相比,本申请至少具有以下有益效果之一:
1、本申请对于热水、热油、热蒸汽及化学品等所致的烧烫伤,有较为显著地止痛消炎、收敛、防腐、促进新生肉芽组织生长以及减少烧烫伤后疤痕增生的效果。
2、本申请配方简单、制备容易,用药方便、止痛快、创面干燥快、结痂快,疗程短,治疗费用较低,无需植皮,使用范围广,易于推广,对于热水、热油、热蒸汽及化学品等所致的烧烫伤有明显的止痛消炎、收敛、防腐、促进新生肉芽组织生长以及减少烧烫伤后疤痕增殖功效。
3、本申请中,首次将熟地黄、当归、生黄芪、生黄柏、白芷、炒白术、柴胡苗、石灰水、熟石膏、玄明粉、芝麻油等中药组合物联合用于治疗烧烫伤的中药复方制剂中,既可以将芝麻油作为基质使用,同时对于缓解伤后疼痛、防止烧烫伤部位的感染、促进伤口愈合均有一定帮助,尤其芝麻油富含维生素E、亚油酸、棕榈酸等不饱和脂肪酸易被人体分解吸收和利用,具有保护血管、促进细胞分裂、延缓衰老、消除动脉血管壁上的沉积物的功效,共同应用,可以促进疗效。
附图说明
图1为本申请实施例提供的药物对烧烫伤模型小鼠治疗前后的效果对比图;其中,左侧为烫伤模型对照组小鼠,右侧为本发明方治疗组小鼠皮肤组织;与正常对照组比较,*P<0.05;与模型对照组比较,#P<0.05;
图2为本申请实施例提供的药物对烫伤模型小鼠的皮肤治疗前后的模型小鼠皮肤病理切片的组织形态学变化图;其中,Ki67染色图(50×);(1)正常皮肤组织,(2)对照组烫伤皮肤组织,(3)用药7天后皮肤组织;与正常对照组比较,**P<0.01;与模型对照组比较,*P <0.05;
图3为本申请实施例提供的药物对烫伤患者治疗前后的效果对比图;
图4为本申请实施例提供的药物对热油烫伤患者治疗前后的效果对比图。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白,以下结合实施例对本申请进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本申请,并不用于限定本申请。本申请中未详细单独说明的试剂均为常规试剂,均可从商业途径获得;未详细特别说明的方法均为常规实验方法,可从现有技术中获知。
需要说明的是,本申请的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别类似的对象,而不必用于描述特定的顺序或先后次序,也不对其后的技术特征起到实质的限定作用。应该理解这样使用的数据在适当情况下可以互换,以便这里描述的本申请的实施例能够以除了在这里图示或描述的那些以外的顺序实施。此外,术语“包括”和“具有”以及他们的任何变形,意图在于覆盖不排他的包含,例如,包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元,而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。
为解决现有技术中,针对烧烫伤治疗手段的局限性,本申请实施例公开了一种治疗烧烫伤的中药组合物,所述中药组合物的组分包括:熟地黄、当归、生黄芪、生黄柏、白芷、炒白术、柴胡苗、石灰水、熟石膏、玄明粉和芝麻油。
在一些实施例中,所述中药组合物由以下重量体积配比的组分组成:熟地黄20-30份、当归10-15份、生黄芪10-12份、生黄柏8-10份、白芷6-10份、炒白术10-15份、柴胡苗10-12 份、石灰水30-60份、熟石膏20-30份、玄明粉20-30份、芝麻油30-60份。
在一些实施例中,所述中药组合物由以下重量配比的组分组成:熟地黄25份、当归10 份、生黄芪10份、生黄柏8份、白芷10份、炒白术15份、柴胡苗12份、石灰水30份、熟石膏20份、玄明粉20份、芝麻油30份。
其中,重量体积比表示,当固体重量为1g时,使用的液体体积为1ml。
在一些实施例中,所述石灰水为生石灰加水崩解,搅拌均匀,静置48h后收集的上清液,所述生石灰与所述水的重量比为1:7-10。
在一些实施例中,所述芝麻油为生芝麻按传统物理压榨方法获得的芝麻油。
在一些实施例中,所述芝麻油可以用具有烧烫伤作用的植物油脂或动物油脂或由植物油脂或动物油脂制备而成的药物制剂代替。
在一些实施例中,所述中药组合物为油膏。
基于上述的治疗烧烫伤的中药组合物,本申请实施例还提供了一种治疗烧烫伤的中药组合物的制备方法,包括如下步骤:
按重量份称取熟地黄、当归、生黄芪、生黄柏、白芷、炒白术和柴胡苗,加水室温浸泡 20-30分钟,武火煮沸后文火继续维持沸腾30-40分钟,过滤收集药液,将所述药液浓缩至浓度为0.8-1.2g/ml的生药;
将石灰水和芝麻油按照重量比1:1混合均匀制成混悬液;
将熟石膏、玄明粉按重量比1:1充分搅和后制成混合粉剂;
将石灰水-芝麻油的混悬液加入到生药中,充分混合后,再向混合液中加入配制好的熟石膏-玄明粉混合粉剂,充分搅拌,即得油膏。
基于上述的治疗烧烫伤的中药组合物,本申请实施例还提供了该中药组合物在制备治疗烧烫伤药物中的应用。
在一些实施例中,所述烧烫伤为由热水、热气、热油及化学品引起的I度和II度烧烫伤及溃后久不收口的疮疡。
实施例
在一个具体的实施例中,采用如下的中药组合物及方法制备了一种中药组合物,主要包括如下步骤:
配方:熟地黄25g、当归10g、生黄芪10g、生黄柏8g、白芷10g、炒白术15g、柴胡苗12g、石灰水30ml、熟石膏20g、玄明粉20g、芝麻油30ml。
制法:
(1)首先称取熟地黄25g、当归10g、生黄芪10g、生黄柏8g、白芷10g、炒白术15g、柴胡苗12g中药组合物,加水800-1000ml室温浸泡20-30分钟后,武火煮沸后文火继续维持沸腾30-40分钟后,过滤药液并浓缩至浓度为1g/ml生药量;
(2)1份生石灰加8份水,待石灰崩解后开始轻轻匀速搅拌,然后静置48h,收集上清液,即为所用石灰水;
(3)生芝麻按传统物理压榨方法获得芝麻油,即为所用芝麻油;
(4)将步骤(2)所获得澄清石灰水和步骤(3)物理压榨所得芝麻油按重量比1:1充分混合制成混悬液;
(5)取20g熟石膏和20g玄明粉,按重量比1:1充分搅和后制成混合粉剂;
(6)将配制好的石灰水30ml和芝麻油30ml的混悬液加入步骤(1)所得的中药组合物浓缩药液后,充分混合后,再向混合液中加入配制好的熟石膏-玄明粉混合粉末,并充分拌和成油膏,存储在无菌容器常温保存即可。
试验例
烧烫伤动物造模及应用本申请方治疗实验
2.1实验对象和实验材料
6-8周龄BALB/c小鼠(雌雄各半,18-22g),饲养于SPF级饲养。恒温水浴锅,小动物手术镊子、剪刀、10g金属砝码,计时器,医用棉棒、细棉线、脱毛器。
2.2动物造模
待小鼠经检疫后,恒温水浴箱加热至100℃并保持恒温状态,将用细棉线系住的砝码置于水浴锅中预热15min,小鼠后背部用脱毛器脱毛、经乙醚麻醉后,用水浴预热的10g砝码对小鼠背部进行热烫5sec,在小鼠背部同一位点连续应用预热砝码热烫2次,烫出直径约为1cm 的圆形烫伤区,即为小鼠深II级烫伤模型。
2.3模型动物分组及给药方法
将造模成功的动物随机分为模型对照组、本申请方提供的药物组共2组,分别用医用棉棒在烫伤部位涂药,并应用医用纱布覆盖包扎,分别于每日早上、下午各用药一次。对照组操作同用药组小鼠背部皮肤每天涂抹辅料芝麻油。7天后应用CO2麻醉法处死小鼠,分别经小鼠腹主动脉取血、收集各组小鼠的烫伤损伤皮肤及周围正常皮肤,应用10%福尔马林溶液于室温固定48h,石蜡包埋并切片后进行H&E染色用于组织形态学观察。
2.4组织标本的制备及免疫组化Ki67染色实验
组织标本的制备主要包含脱水、透明、包埋、切片、染色、封片等步骤,具体如下:
(1)脱水:将质量分数4%多聚甲醛固定好的小鼠皮肤组织,自来水冲洗后,应用梯度浓度乙醇对组织进行脱水处理(50%,2h、70%,2h、80%,2h、95%,1h、95%,1h、100%,1h、100%,1h);
(2)透明:脱水完成后,应用二甲苯对组织进行透明处理(1h/次,2次);
(3)包埋:将透明处理后的皮肤组织浸入55℃石蜡后应用组织包埋模具盒进行石蜡包埋;
(4)切片:对包埋好的组织蜡块进行厚度为4μm的组织切片、(水浴)摊片和载玻片捞片、烘片(60℃,2h);
(5)脱蜡:对切片应用二甲苯(20min/次,共2次)处理,梯度乙醇(100%、95%、80%、 70%、50%),5min/次,去离子水处理5min;
(6)免疫组化Ki67染色:枸橼酸钠缓冲液于高压锅内进行抗原修复处理、0.1%TritonX-100 打孔、血清封闭后,应用Ki67的一抗于湿盒内孵育过夜(4℃避光)和对应的生物素标记二抗及HRP标记链霉卵白素常规孵育,DAB显色、苏木素复染、自来水冲洗返蓝、梯度乙醇洗脱、二甲苯脱水透明。
(7)封片:应用中性树胶对染色完成的切片进行封片后,于显微镜下观察小鼠组织切片的病理变化并拍照。
2.5结果
2.5.1模型动物体内治疗效果
图1所示为应用本申请方实施例提供的药物对烧烫伤模型小鼠治疗前后的效果图。结果发现,对照组模型小鼠的皮肤创伤部分出现烫伤后溃烂样病变,且有烫伤创伤组织部位的周围有炎症性肿胀现象,组织细胞形态结构出现异常改变,4-7天后在烫伤创伤部位仍有部分组织呈白色及红肿的坏死现象,并与周围正常皮肤组织形成鲜明对比;应用本申请方提供的药物治疗4天后,小鼠皮肤创面出现了一层呈红紫色的干痂;本申请方提供的药物治疗6天后,结了一层较厚的深紫红色干痂;本申请方提供的药物治疗7天后,创伤区域的伤口范围逐渐缩小,而且在其四周出现了肉芽组织向内生长的现象,创伤部位的组织愈合面仍呈现一层厚厚的结痂。
图2所示为应用本申请方实施例提供的药物对烫伤模型小鼠的皮肤治疗前后的模型小鼠皮肤病理切片的免疫组织化学变化图。
与小鼠的无损伤皮肤的正常部位比较,模型对照组小鼠烫伤部位的皮肤组织结构有凝固性坏死样病变发生,而且其皮肤的表皮及真皮层基本组织结构都被严重损伤;部分损伤部位的组织脱落,且烫伤损伤到真皮组织的深层,具有深II度烫伤的典型表征;本申请方提供的药物治疗小鼠7天后,烫伤损伤部位的皮肤组织结构恢复趋于正常,观察到肥大细胞、巨噬细胞聚集同时,免疫组化染色结果显示,与小鼠的无损伤皮肤的正常部位、模型对照组小鼠烫伤部位的皮肤组织比较,本申请方提供的组合物治疗小鼠7天后可以较好的诱导皮肤组织细胞的增殖,有利于烧烫伤皮肤的愈合恢复,与实验过程中观察到成纤维细胞和胶原物质生成的变化,烫伤损伤皮肤部位的深层结构逐渐趋向恢复完整正常形态,烫伤损伤部位的表皮结构层次逐渐恢复完好,烫伤皮肤组织处于向完好状态持续恢复等现象具有一致性。
临床应用例
图3所示为应用本申请方提供的药物对烫伤患者治疗前后的效果图。
患者于冬天使用热水袋置于被窝里取暖不慎造成腿部慢性烫伤造成至表皮、真皮层及肌肉组织严重损伤并形成凹陷样伤口,应用本申请方提供的药物涂于患者烧烫伤受伤部位,并应用医用纱布覆盖包扎进行治疗,用药10-30min后,患者因热水袋慢性烫伤至表皮、真皮和肌肉组织深部(呈凹陷状)损伤部位的疼痛感与灼热感消失、亦有清凉湿润感;本申请方提供的药物治疗2天,烫伤部位的皮肤表面观察到有轻微的红肿、淤血、局部溃烂的出现,皮肤渗出液趋于减少;本申请方提供的药物治疗7天,烫伤部位的皮肤逐渐有结痂形成,而且与烫伤损伤的未结痂皮肤部位比较,未观察到烫伤部位的皮肤渗出液,但在烫伤部位依然存有边沿症状现象;本申请方提供的药物治疗10天,观察到烫伤部位的皮肤结痂趋于形成完整稳定的皮肤结构后停止用药,而且应用本申请方提供的药物治疗过程中未观察到患者烫伤部位的感染等不良现象;21-24天后,观察到烫伤部位的结痂逐渐脱落,而且脱落结痂周围皮肤的小伤口逐渐恢复正常,34-56天后,观察到患者的烫伤损伤皮肤的表皮、真皮层恢复正常。
图4所示为应用本申请方提供的药物对热油烫伤患者治疗前后的效果图。
患者于夏天做饭是时不慎被刚烧开的热油烫伤左腿部造成腿部严重烫伤,导致伤及腿部皮肤表皮、真皮层及肌肉组织严重损伤,并观察到烫伤部位的皮肤表面有较严重的红肿、淤血、皮肤渗出液较多并形成大范围水泡及轻微溃烂的出现(如图4中A所示);应用本申请方提供的药物涂于患者烧烫伤受伤部位,并应用医用纱布覆盖包扎进行治疗,用药10-30min后,患者腿部烫伤损伤部位的灼烧疼痛感消失、有清凉湿润感;本申请方提供的药物治疗14天,观察到烫伤部位的皮肤结痂并逐渐脱落,损伤部位皮肤趋于形成完整稳定的皮肤结构,损伤部位的皮肤表皮、真皮层恢复正常(如图4中B所示),停止用药。此外,应用本申请方提供的药物治疗过程中未观察到患者烫伤部位的感染等不良现象。
以上所述,仅为本申请较佳的具体实施方式,但本申请的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本申请揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本申请的保护范围之内。
Claims (6)
1.一种治疗烧烫伤的中药组合物,所述中药组合物由以下重量体积配比的组分组成:熟地黄20~30份、当归10~15份、生黄芪10~12份、生黄柏8~10份、白芷6~10份、炒白术10~15份、柴胡苗10~12份、石灰水30~60份、熟石膏20~30份、玄明粉20~30份、芝麻油30~60份;
其中,所述熟地黄和所述当归为君药,所述生黄芪和所述炒白术为臣药,所述生黄柏和所述白芷为佐药,所述柴胡苗为使药,联合熟石膏、石灰水、玄明粉、芝麻油共用于烧烫伤的治疗;
其中,所述熟石膏为含水硫酸钙的矿石煅烧后制得的粉末;
所述石灰水为生石灰加水崩解,搅拌均匀,静置48h后收集的上清液,所述生石灰与所述水的重量比为1:7~10;
所述芝麻油由生芝麻按传统物理压榨方法获得。
2.根据权利要求1所述的治疗烧烫伤的中药组合物,所述中药组合物由以下重量体积配比的组分组成:熟地黄25份、当归10份、生黄芪10份、生黄柏8份、白芷10份、炒白术15份、柴胡苗12份、石灰水30份、熟石膏20份、玄明粉20份、芝麻油30份。
3.根据权利要求1或2所述的治疗烧烫伤的中药组合物,所述中药组合物为油膏。
4.一种如权利要求1~3任一所述的中药组合物的制备方法,包括如下步骤:
按重量份称取熟地黄、当归、生黄芪、生黄柏、白芷、炒白术和柴胡苗,加水室温浸泡20-30分钟,武火煮沸后文火继续维持沸腾30-40分钟,过滤收集药液,将所述药液浓缩至浓度为0.8-1.2g/ml的生药;
将石灰水和芝麻油混合均匀制成混悬液;
将熟石膏、玄明粉充分搅和后制成混合粉剂;
将石灰水-芝麻油的混悬液加入到生药中,充分混合后,再向混合液中加入配制好的熟石膏-玄明粉混合粉剂,充分搅拌,即得油膏。
5.如权利要求1-3任一项所述的中药组合物在制备治疗烧烫伤药物中的应用。
6.根据权利要求5所述的应用,所述烧烫伤为由热水、热气、热油及化学品引起的I度和II度烧烫伤及溃后久不收口的疮疡。
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