CN112891516A - 一种祛除扁平疣精华液及制备方法 - Google Patents
一种祛除扁平疣精华液及制备方法 Download PDFInfo
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- CN112891516A CN112891516A CN202110105157.0A CN202110105157A CN112891516A CN 112891516 A CN112891516 A CN 112891516A CN 202110105157 A CN202110105157 A CN 202110105157A CN 112891516 A CN112891516 A CN 112891516A
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Abstract
本发明提出了一种祛除扁平疣精华液及制备方法,涉及扁平疣技术领域。该祛除扁平疣精华液,包括如下重量百分数的原料,PHPV融合因子4~8%和茶多酚0.5~1%,余量为溶剂。本发明的优点在于,此祛除扁平疣精华液可有效去除扁平疣,温和不刺激、无残留且不容易复发。本发明还提供一种前述祛除扁平疣精华液的制备方法,该制备方法通过预混再混合,使得PHPV融合因子和茶多酚可以较好的溶解并稳定存在于溶剂中,便于提升药效。
Description
技术领域
本发明涉及扁平疣技术领域,具体而言,涉及一种祛除扁平疣精华液及制备方法。
背景技术
疣是一种由人类乳头瘤病毒即HPV感染引起的以皮肤良性赘生物为特征的皮肤病,HPV可通过皮肤黏膜微小破损进入上皮细胞,特别是基底层细胞内,并复制、增殖,导致上皮细胞异常分化和增生,间接接触污染物也会导致病毒传播。不同类型疣的组织病理学表现和临床表现有差异,一般表现为皮肤部疣状凸起,常见的有寻常疣、扁平疣、跖疣和生殖器疣。
其中,扁平疣主要侵犯青少年故称青年扁平疣,好发于颜面、手背及前臂,皮损数目往往是较多的扁平丘疹,芝麻或米粒大小,边界清楚,颜色不定,这种病症严重影响青少年的自信和心理健康,需要进行有效的治疗。目前,对于扁平疣主要有以下几类治疗方式:
1、中医治疗,采用中药中的扁平疣煎剂进行治疗,6周为一疗程,疗效相对较好,同时副作用不大,但煎剂服用难度高、药量大同时不便携带,给连续用药带来极大的阻碍;
2、西医治疗,西医多采用抗病毒、免疫调节治疗,严重者联合手术治疗,比如冷冻、激光或外涂维A酸类药膏等。这类治疗一般花费较大,同时容易留疤,治疗成本较高;
3、治疗用祛疣膏,这类产品使用起来有痛感,同时其中的祛疣成分容易残留在皮肤表面,造成二次伤害,或者造成一定程度的白斑。
因此,需要研发一种温和不刺激、无残留且不容易复发的产品。
发明内容
本发明的目的在于提供一种祛除扁平疣精华液,此祛除扁平疣精华液可有效去除扁平疣,温和不刺激、无残留且不容易复发。
本发明的另一目的在于提供一种前述祛除扁平疣精华液的制备方法,该制备方法通过预混再混合,使得PHPV融合因子和茶多酚可以较好的溶解并稳定存在于溶剂中,便于提升药效。
本发明解决其技术问题是采用以下技术方案来实现的。
一方面,本申请实施例提供一种祛除扁平疣精华液,包括如下重量百分数的原料,PHPV融合因子4~8%和茶多酚0.5~1%,余量为溶剂。
本发明提供的祛除扁平疣精华液所用原料如下:
PHPV融合因子:PHPV融合因子是由穿膜肽与人寡肽-1(EGF)经高新层析技术修饰交联融合而成,PHPV融合因子表面构象中的正电荷(阳离子)C端与人乳头瘤病毒HPV颗粒上的N端负电荷(阴离子)相互络合,通过其表面所带负电荷的N端与中间疏水区含有肽酶的识别区位点的C端正电荷相结合,将膜转位信号ELP与核定位信号肽NLS偶联,通过正负电荷相亲和的物理作用,来阻断人乳头瘤病毒侵入宿主细胞内,通过穿膜肽的穿透作用达到快速破坏病毒胞膜外壳来灭活病毒。
茶多酚:是茶叶中多酚类物质的总称,包括黄烷醇类、花色苷类、黄酮类、黄酮醇类和酚酸类等。主要为黄烷醇类,占60~80%,是茶叶中有保健功能的主要成份之一。
另一方面,本申请实施例提供一种前述祛除扁平疣精华液的制备方法,包括如下步骤:(1)将PHPV融合因子、茶多酚、消炎剂、美白剂和/或保湿剂分别溶于溶剂,制备成工作液;(2)将各工作液混合,并向其中加入促渗透剂,搅拌混匀,得到祛除扁平疣精华液。
综上,相对于现有技术,本发明的实施例至少具有如下优点或有益效果:
本发明提供的祛除扁平疣精华液,采用PHPV融合因子和茶多酚联用,在PHPV融合因子精准治疗的基础上,以茶多酚调节免疫球蛋白的活性,提高人体免疫力,同时阻断各种病菌的进攻,阻断抗体、肾上腺素等的过敏反应,保证机体内环境的稳定,进而达到标本兼治的目的,保证一次治疗后无反复,避免像其他治疗方式或药物出现反复影响患者身心健康的情况。
此外,本发明的另一目的在于提供一种前述祛除扁平疣精华液的制备方法,通过将各成分制备为工作液,再将工作液制备搅拌混合即得,先制备工作液再混合,使得PHPV融合因子等成分,可以较好的溶解并稳定存在于溶剂中,使得后续搅拌混匀难度降低,利于祛除扁平疣精华液中各成分的稳定。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对本发明实施例中的技术方案进行清楚、完整地描述。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
本申请实施例提供一种祛除扁平疣精华液,包括如下重量百分数的原料,PHPV融合因子4~8%和茶多酚0.5~1%,余量为溶剂。
在本发明的一些实施例中,上述祛除扁平疣精华液,所述溶剂包括水、甘油和丁二醇,所述水、甘油和丁二醇的质量比为1:(3~4):0.5。
在本发明的一些实施例中,上述祛除扁平疣精华液,包括如下重量百分数的原料,PHPV融合因子6%和茶多酚0.8%,余量为溶剂。
在本发明的一些实施例中,上述祛除扁平疣精华液,还包括消炎剂0.5~1.3wt%、促渗透剂1.2~2.5wt%、美白剂1~2wt%和/或保湿剂3~4wt%。
在本发明的一些实施例中,上述祛除扁平疣精华液,所述消炎剂包括败酱草提取物、花椒提取物和丹参提取物。
在本发明的一些实施例中,上述祛除扁平疣精华液,所述促渗透剂包括乙醇提取物、氮酮提取物和菠菜提取物中的一种或多种。
在本发明的一些实施例中,上述祛除扁平疣精华液,所述美白剂包括艾叶提取物、茴香提取物、白豆蔻提取物和巴婆树提取物中的一种或多种。
在本发明的一些实施例中,上述祛除扁平疣精华液,所述保湿剂为白蜡树提取物和白蔹提取物。
另一方面,本申请实施例提供一种前述祛除扁平疣精华液的制备方法,包括如下步骤:(1)将PHPV融合因子、茶多酚、消炎剂、美白剂和/或保湿剂分别溶于溶剂,制备成工作液;(2)将各工作液混合,并向其中加入促渗透剂,搅拌混匀,得到祛除扁平疣精华液。
在本发明的一些实施例中,上述制备方法,所述搅拌混匀的转速为220~260r/min,所述搅拌温度为4℃。
以下结合实施例对本发明的特征和性能作进一步的详细描述。
实施例1
本实施例的目的在于提供一种祛除扁平疣精华液,具体包括如下步骤:
(1)准确称量PHPV融合因子、茶多酚和溶剂,备用;
(2)将PHPV融合因子和茶多酚分别溶于水,制成PHPV融合因子工作液和茶多酚工作液;
(3)将PHPV融合因子工作液和茶多酚工作液混合,并向其中加入甘油和丁二醇,搅拌混匀,搅拌转速为220~260r/min,搅拌温度为4℃,搅拌完成后得到祛除扁平疣精华液,最终得到的祛除扁平疣精华液中含有PHPV融合因子4wt%、茶多酚0.5wt%,余量为水、甘油和丁二醇,水、甘油和丁二醇的质量比为1:3:0.5。
实施例2
本实施例的目的在于提供一种祛除扁平疣精华液,具体包括如下步骤:
(1)准确称量PHPV融合因子、茶多酚和溶剂,备用;
(2)将PHPV融合因子和茶多酚分别溶于水,制成PHPV融合因子工作液和茶多酚工作液;
(3)将PHPV融合因子工作液和茶多酚工作液混合,并向其中加入甘油和丁二醇,搅拌混匀,搅拌转速为220~260r/min,搅拌温度为4℃,搅拌完成后得到祛除扁平疣精华液,最终得到的祛除扁平疣精华液中含有PHPV融合因子6wt%、茶多酚0.8wt%,余量为水、甘油和丁二醇,水、甘油和丁二醇的质量比为1:3.5:0.5。
实施例3
本实施例的目的在于提供一种祛除扁平疣精华液,具体包括如下步骤:
(1)准确称量PHPV融合因子、茶多酚和溶剂,备用;
(2)将PHPV融合因子和茶多酚分别溶于水,制成PHPV融合因子工作液和茶多酚工作液;
(3)将PHPV融合因子工作液和茶多酚工作液混合,并向其中加入甘油和丁二醇,搅拌混匀,搅拌转速为220~260r/min,搅拌温度为4℃,搅拌完成后得到祛除扁平疣精华液,最终得到的祛除扁平疣精华液中含有PHPV融合因子8wt%、茶多酚1wt%,余量为水、甘油和丁二醇,水、甘油和丁二醇的质量比为1:4:0.5。
实施例4
本实施例的目的在于提供一种祛除扁平疣精华液,具体包括如下步骤:
(1)制备消炎剂:将败酱草洗净,去除杂质,反复蒸煮两次,合并滤液,并对滤液进行浓缩,浓缩至相对密度为1.15~1.2,得到败酱草提取物;将花椒洗净,去除杂质,利用超临界CO2在压力12MPa、温度35~50℃条件下萃取3h,得到花椒提取物;将丹参饮片用90vol%乙醇提取2次,合并提取液,去除溶剂后得到丹参提取物;
(2)制备美白剂:将艾叶去除杂质,利用超临界CO2在压力20MPa、温度40~60℃条件下萃取1h,得到艾叶提取物;将茴香去除杂质,利用超临界CO2在压力18MPa、温度30~40℃条件下萃取2h,得到茴香提取物;将白豆蔻粉碎,再加入6倍的水,蒸煮2次合并滤液,得到白豆蔻滤液,再浓缩后加入乙醇,使含醇量为30%,静置12-24小时,滤过,滤液浓缩后得到白豆蔻提取物;将巴婆树粉碎,再加入8倍的水,蒸煮2次合并滤液,得到巴婆树滤液,再浓缩后加入乙醇,使含醇量为30%,静置12-24小时,滤过,滤液浓缩后得到巴婆树提取物;
(3)制备保湿剂:将白蜡树粉碎成20目左右颗粒,再加入水中煎煮3次,合并滤液,浓缩至相对密度为1.15~1.18,得到含有白蜡树提取物;将白蔹去除杂质后于90vol%乙醇中浸泡3~5天,去除杂质,然后蒸发乙醇至乙醇含量低于20vol%,得到白蔹提取物;
(4)准确称量PHPV融合因子、茶多酚、溶剂、败酱草提取物、花椒提取物、丹参提取物、艾叶提取物、茴香提取物、白豆蔻提取物、巴婆树提取物、白蜡树提取物和白蔹提取物,备用;
(5)将PHPV融合因子和茶多酚分别溶于水,制成PHPV融合因子工作液和茶多酚工作液;
(6)将败酱草提取物、白蜡树提取物、白豆蔻提取物和巴婆树提取物混合,得到混合物一;
(7)将花椒提取物、艾叶提取物和茴香提取物混合,加入丁二醇混合,得到混合物二;
(8)将丹参提取物于搅拌状态下加入混合物二,再将混合物一加入其中,搅拌混匀,得到混合物三;
(9)将PHPV融合因子工作液和茶多酚工作液混合,并向其中加入甘油,搅拌混匀,搅拌转速为220~260r/min,搅拌温度为4℃,搅拌完成后得到混合液四;
(10)将混合液三和混合液四搅拌混匀,同时加入促渗透剂乙醇,得到祛除扁平疣精华液。
本实施例中所用原料比例如下表所示,溶剂中水、甘油和丁二醇的质量比为1:3.5:0.5。
表1
原料 | 重量百分数(%) |
PHPV融合因子 | 4 |
茶多酚 | 0.5 |
败酱草提取物 | 0.5 |
花椒提取物 | 0.5 |
丹参提取物 | 0.15 |
艾叶提取物 | 0.3 |
茴香提取物 | 0.4 |
白豆蔻提取物 | 0.3 |
巴婆树提取物 | 0.2 |
白蜡树提取物 | 1.5 |
白蔹提取物 | 1.5 |
菠菜提取物 | 1.5 |
溶剂 | 88.65 |
合计 | 100 |
实施例5
本实施例的目的在于提供一种祛除扁平疣精华液。
本实施例提供的祛除扁平疣精华液的制备方法与实施例4相同,区别在于原料比不同,本实施例中所用原料比例如下表所示,水、甘油和丁二醇的质量比为1:3.5:0.5。
表2
原料 | 重量百分数(%) |
PHPV融合因子 | 6 |
茶多酚 | 0.8 |
败酱草提取物 | 0.4 |
花椒提取物 | 0.2 |
丹参提取物 | 0.2 |
艾叶提取物 | 0.5 |
茴香提取物 | 0.6 |
白豆蔻提取物 | 0.4 |
巴婆树提取物 | 0.3 |
白蜡树提取物 | 3 |
白蔹提取物 | 0.5 |
菠菜提取物 | 2 |
溶剂 | 85.1 |
合计 | 100 |
实施例6
本实施例的目的在于提供一种祛除扁平疣精华液。
本实施例提供的祛除扁平疣精华液的制备方法与实施例4相同,区别在于原料比不同,本实施例中所用原料比例如下表所示,水、甘油和丁二醇的质量比为1:3.5:0.5。
表3
实施例7
本实施例的目的在于提供一种祛除扁平疣精华液。
本实施例提供的祛除扁平疣精华液的制备方法与实施例4相同,溶剂中,区别在于原料比不同,本实施例中所用原料比例如下表所示,水、甘油和丁二醇的质量比为1:3.5:0.5。
表4
原料 | 重量百分数(%) |
PHPV融合因子 | 6 |
茶多酚 | 0.8 |
败酱草提取物 | 0.3 |
花椒提取物 | 0.2 |
艾叶提取物 | 0.3 |
茴香提取物 | 0.3 |
巴婆树提取物 | 0.4 |
白蜡树提取物 | 2 |
白蔹提取物 | 1 |
乙醇 | 1.2 |
溶剂 | 87.5 |
合计 | 100 |
实施例8
本实施例的目的在于提供一种祛除扁平疣精华液。
本实施例提供的祛除扁平疣精华液的制备方法与实施例4相同,区别在于原料比不同,本实施例中所用原料比例如下表所示,水、甘油和丁二醇的质量比为1:3.5:0.5。
表5
原料 | 重量百分数(%) |
PHPV融合因子 | 6 |
茶多酚 | 0.8 |
丹参提取物 | 1.3 |
白豆蔻提取物 | 2 |
白蜡树提取物 | 1 |
白蔹提取物 | 3 |
氮酮 | 2.5 |
溶剂 | 83.4 |
合计 | 100 |
效果例
本效果例的目的在于验证前述实施例提供的祛除扁平疣精华液的效果。
1、实验材料和方法
患者的选择入选标准:40岁>年龄>18岁,HPV抗体经酶联免疫法(EUSA)和Westernblot法确认为阳性,自愿参加本试验并签署书面知情同意书。
患者征集结果:其中男性110例,女性130例,共计,均分为8组,编号为1~8,分别对应使用本发明实施例1~8提供的祛除扁平疣精华液,平均每组30人,平均年龄23±4岁。所有患者都曾经过西医、中医或自购药膏治疗,均反复。
供试药物为本发明实施例1~8提供的祛除扁平疣精华液,每天清洁患处后开始涂覆前述祛除扁平疣精华液,每天使用两次,使用量以涂覆满患处为准。
2、刺激性试验
每位患者均选择相同面积大小的扁平疣皮损区和皮肤健康区进行刺激性试验,扁平疣皮损区和皮肤健康区都涂抹相同量的祛除扁平疣精华液,连续使用7天后,统计每天的情况,包括扁平疣皮损区和皮肤健康区是否有瘙痒、刺痛和发炎情况。
连续监测7天后发现,使用本发明实施例1~8提供的祛除扁平疣精华液的患者无论扁平疣皮损区还是皮肤健康区均未出现瘙痒、刺痛和发炎情况,表明本发明提供的祛除扁平疣精华液温和无刺激,适用于皮肤疣的治疗。
3、治疗效果试验
各组患者使用本发明实施例1~8提供的祛除扁平疣精华液的方式和频率如前所述。统计各患者不同阶段的使用效果,包括皮损面积减少情况(某天皮损面积占刚治疗时皮损面积的比率,同组人员取平均值)、皮肤瘙痒情况(皮肤不瘙痒人数占每组总人数的比例)、结痂脱落后的皮肤状况等,具体如下表所示:
表6
由上表可知,本发明实施例能在3天内明显抑制皮肤瘙痒,抑制率高达97.9%,在实际使用中,绝大多数患者在一天内即可明显抑制皮肤瘙痒,个别较为严重的患者会在5天内抑制瘙痒。在治疗过程中,患者7天内基本能明显减少皮损面积,14天皮损面积减少可达到85.5%,到21天时,基本能达到90以上的皮损减少率,其中以实施例6提供的祛除扁平疣精华液效果最佳,以实施例4~8提供的祛除扁平疣精华液的治疗效果为优,在最后结痂痊愈后,各组人员的皮损区均无黑色素沉积,与原有皮肤肤色基本一致。
综上所述,本发明提供的祛除扁平疣精华液具有如下优点:
(1)PHPV融合因子是由穿膜肽与人寡肽-1(EGF)经高新层析技术修饰交联融合而成,PHPV融合因子表面构象中的正电荷(阳离子)C端与人乳头瘤病毒HPV颗粒上的N端负电荷(阴离子)相互络合,通过其表面所带负电荷的N端与中间疏水区含有肽酶的识别区位点的C端正电荷相结合,将膜转位信号ELP与核定位信号肽NLS偶联,通过正负电荷相亲和的物理作用,来阻断人乳头瘤病毒侵入宿主细胞内,通过穿膜肽的穿透作用达到快速破坏病毒胞膜外壳来灭活病毒;PHPV融合因子能对HPV病毒达到靶向治疗的目的,但在复杂的生物体内环境下,过多使用PHPV融合因子的靶向治疗容易引起生物体内的内分泌紊乱,加剧HPV的复制,进而加重病情。因此,本发明中采用PHPV融合因子和茶多酚联用,在PHPV融合因子精准治疗的基础上,以茶多酚调节免疫球蛋白的活性,提高人体免疫力,同时阻断各种病菌的进攻,阻断抗体、肾上腺素等的过敏反应,保证机体内环境的稳定,进而达到标本兼治的目的,并且无反复,不会像其他治疗方式或药物出现反复的情况。
(2)在PHPV融合因子和茶多酚的基础上,本发明还增添了消炎剂,包括败酱草提取物、花椒提取物和丹参提取物,以败酱草和花椒清热解毒,消痈排脓,祛瘀止痛,缓解扁平疣消除过程中的疼痛,达到无痛不刺激的目的,同时以花椒抗炎杀菌,减少外部细菌感染和内部细菌滋生,再以丹参祛瘀、生新和活血,在败酱草和花椒的基础上,提升皮肤免疫力,从根本上改善皮肤水平和局部微环境,减少感染,此外,本发明实施例中通过特定的提取方式,充分提取败酱草、花椒和丹参中对于去除扁平疣的有效成分,这是保证其消炎抗菌,从根本上改善皮损区微环境的基础;
(3)在前述原料作用的基础上,本发明实施例通过特定方式提取艾叶提取物、茴香提取物、白豆蔻提取物和巴婆树,以艾叶、茴香、白豆蔻和巴婆树抗氧化,清除细胞内自由基,减少结痂后的色素沉积,使皮损区的肤色与原有肤色达到一致,解决现有产品结痂后色素沉积的问题;
(4)通过添加白蜡树提取物和白蔹提取物,为肌肤提供一定的保湿力度,减少水分过多损失,避免了皮肤干燥加重患者的扁平疣皮损;
(5)通过添加促渗透剂,以乙醇、氮酮或者菠菜提取物为促渗透剂,提升祛除扁平疣精华液中有益成分迅速进入细胞,快速治愈扁平疣,同时由于祛除扁平疣精华液中各有益成分均进入细胞,渗透率高,表皮残留率低,故在皮损区可减少祛除扁平疣精华液的残留,也能在一定程度上减少发炎、白斑的发生,提升治愈率并减少治疗时间;
(6)通过以大量甘油为溶剂,辅以一定量的丁二醇,即能充分稳定祛除扁平疣精华液中的各种成分,又能减少溶剂对于皮损区的危害,降低因为溶剂加重扁平疣的风险。
整体而言,本发明提供的祛除扁平疣精华液,采用PHPV融合因子和茶多酚联用,在PHPV融合因子精准治疗的基础上,以茶多酚调节免疫球蛋白的活性,提高人体免疫力,同时阻断各种病菌的进攻,阻断抗体、肾上腺素等的过敏反应,保证机体内环境的稳定,进而达到标本兼治的目的,并且无反复,不会像其他治疗方式或药物出现反复的情况。此外,本发明的另一目的在于提供一种前述祛除扁平疣精华液的制备方法,通过将各成分制备为工作液,再将工作液制备搅拌混合即得,先制备工作液再混合,使得PHPV融合因子等成分,可以较好的溶解并稳定存在于溶剂中,使得后续搅拌混匀难度降低,利于祛除扁平疣精华液中各成分的稳定。
以上所描述的实施例是本发明一部分实施例,而不是全部的实施例。本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
Claims (10)
1.一种祛除扁平疣精华液,其特征在于,包括如下重量百分数的原料,PHPV融合因子4~8%和茶多酚0.5~1%,余量为溶剂。
2.根据权利要求1所述的祛除扁平疣精华液,其特征在于,所述溶剂包括水、甘油和丁二醇,所述水、甘油和丁二醇的质量比为1:(3~4):0.5。
3.根据权利要求1所述的祛除扁平疣精华液,其特征在于,包括如下重量百分数的原料,PHPV融合因子6%和茶多酚0.8%,余量为溶剂。
4.根据权利要求2所述的祛除扁平疣精华液,其特征在于,还包括消炎剂0.5~1.3wt%、促渗透剂1.2~2.5wt%、美白剂1~2wt%和/或保湿剂3~4wt%。
5.根据权利要求4所述的祛除扁平疣精华液,其特征在于,所述消炎剂包括败酱草提取物、花椒提取物和丹参提取物中的一种或多种。
6.根据权利要求5所述的祛除扁平疣精华液,其特征在于,所述促渗透剂包括乙醇、氮酮和菠菜提取物中的一种或多种。
7.根据权利要求4-6任意一项所述的祛除扁平疣精华液,其特征在于,所述美白剂包括艾叶提取物、茴香提取物、白豆蔻提取物和巴婆树提取物中的一种或多种。
8.根据权利要求7所述的祛除扁平疣精华液,其特征在于,所述保湿剂为白蜡树提取物和白蔹提取物。
9.一种权利要求4-8任意一项所述的祛除扁平疣精华液的制备方法,其特征在于,包括如下步骤:
(1)将PHPV融合因子、茶多酚、消炎剂、美白剂和/或保湿剂分别溶于溶剂,制备成工作液;
(2)将各工作液混合,并向其中加入促渗透剂,搅拌混匀,得到祛除扁平疣精华液。
10.根据权利要求9所述的制备方法,其特征在于,所述搅拌混匀的转速为220~260r/min,所述搅拌温度为4℃。
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