CN104524372A - 一种治疗宫颈癌的中药制剂 - Google Patents
一种治疗宫颈癌的中药制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗宫颈癌的中药制剂,其是由下述按重量配比的原料制成的颗粒剂:制苍术、秦艽、防风、当归、防己、茵陈蒿、白鲜皮、黄柏、白头翁、地榆、宣木瓜、双花炭、枳实、大黄炭、皂角子、甘草梢、三七粉、茜草炭、羌活、五灵脂、藁木、荞穗炭、乌贼骨、火麻仁、炙槐米、郁李仁、土茯苓、泽泻、木通、车前子、生地炭、栀子、蒲黄炭、条苓、猪苓;本发明药物具有凉血止血、消肿定痛、固精止带、散寒解表、泻火解毒、利尿通淋、燥湿杀虫、增强肌体免疫力和抗癌之功效,对宫颈癌有治愈和康复的功效,对人体无毒无害、稳定性好、标本兼治、价格低廉,治愈率95%。
Description
技术领域 本发明属于中药药物技术领域,具体涉及一种治疗宫颈癌的中药制剂。
背景技术 宫颈癌是女性常见恶性肿瘤之一,发病原因目前尚不清楚,早婚、早育、多产及性生活紊乱的妇女均有较高的患病率;其次,高危型HPV持续感染是宫颈癌的主要危险因素,90%以上的宫颈癌都伴有高危型HPV感染;另外,不良的生活习惯、卫生条件差以及吸烟都可引起疾病的发生。宫颈癌初期没有明显症状,后期可出现异常阴道流血,阴道排液,根据癌灶累及范围出现不同的继发性症状,如尿频、尿急、便秘、下肢肿痛等;癌肿压迫或累及输尿管时,可引起输尿管梗阻、肾盂积水及尿毒症;晚期可有贫血、恶病质等全身衰竭症状。不但在女性生殖器官癌瘤中占首位,而且是女性各种恶性肿瘤中最多见的癌瘤,但其发病率有明显的地区差异。宫颈癌患者的平均发病年龄,各国、各地报道也有差异,我国发病年龄以40~50岁为最多,60~70岁又有一高峰出现,20岁以前少见。由于年轻妇女处于性活跃期,雌激素水平和性交频率均较高,故更易以性交出血为首发症状。此外,白带增多也为宫颈癌常见症状,约80%的宫颈癌患者有此症状。目前,主要采用以手术切除和放疗为主、化疗为辅的综合治疗方案,但是,这种治疗方式不可避免的会对患者的身心造成一定的伤害。
发明内容 本发明的目的是提供一种提高机体免疫力、标本兼治、无副作用、价格低廉、治愈率高的治疗宫颈癌的中药制剂,以弥补现有技术的不足。
本发明的解决方案是基于祖国医学对宫颈癌的发病机理和提高机体免疫力的认识及治疗原则,参考古、今药理研究成就,对治疗宫颈癌有治愈和康复的作用。
本发明是由下述重量配比的原料制备而成:
制苍术9、秦艽12、防风9、当归9、防己9、茵陈蒿15、白鲜皮12、黄柏6、白头翁9、地榆9、宣木瓜9、双花炭15、枳实9、大黄炭3、皂角子6、甘草梢6、三七粉3、茜草炭9、羌活9、五灵脂9、藁木9、荞穗炭9、乌贼骨12、火麻仁12、炙槐米9、郁李仁9、土茯苓12、泽泻9、木通6、车前子9、生地炭30、栀子9、蒲黄炭9、条苓6、猪苓6。
其制备方法为:1)首先,将黄柏、皂角子和五灵脂分别用武火炒制表面发黑,备用;将栀子用武火炒制表面黄褐色,备用;将乌贼骨在170℃的高温中烘焙3分钟至表面黄褐色,备用;
2)将步骤1)炒制好的黄柏、皂角子、五灵脂、栀子和乌贼骨与其余原料药均匀混合在一起,加入2-4倍量水煎煮1-2个小时,待自然冷却至50℃,滤过,剩余药渣加水重复煎煮2-3次后,合并滤液;
3)将步骤2)滤得的药液放入真空减压浓缩罐中,在压力0.5Mpa下进行减压浓缩成膏状;
4)将步骤3)制得的膏状原料药放入真空干燥箱内,在压力0.05Mpa下进行减压干燥,制成细粉;
5)将步骤4)制得的细粉加入60%乙醇制成颗粒,在温度30℃下干燥,包装既得本发明的颗粒剂。
服用方法:每袋15g,每日分三次口服,每次一袋,温水送服。
本发明中的制苍术:为苍术的炮制加工品,可购买成品,别称赤术、枪头菜、马蓟,为菊科植物茅苍术或北苍术的干燥根茎。味辛、苦,性温。归脾、胃、肝经。具有燥湿健脾,祛风散寒,明目的功效。用于湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿蹙,风湿痹痛,风寒感冒,夜盲,眼目昏涩。
秦艽:别名大叶龙胆、大叶秦艽、西秦艽。辛、苦,平。归胃、肝、胆经,多年生草本植物,有极高的药用价值,是治疗风湿关节痛、结核病、潮热、黄疸等症的主药之一,祛风湿,清湿热,止痹痛。常用于筋脉拘挛,骨节酸痛,日晡潮热,小儿疳积发热。
防风:别名铜芸、回云、回草、百枝、百种,多年生草本植物,其根可生用,味辛、甘,性微温;有祛风解表,胜湿止痛,止痉的功效。
当归:也称干归、金当归、土当归,味甘、温,归肝、心、脾经,其根可入药,具有补血和血,调经止痛,润燥滑肠之功效。
防己:为防己科植物粉防己的干燥根,别称木防己,味辛、苦,性寒。归膀胱、肺经,用于风湿痹痛,水肿脚气,小便不利,湿疹疮毒。
茵陈蒿:为菊科、蒿属植物,别称因尘,味苦、辛,凉。清热利湿,利胆退黄。用于黄疸,胆囊炎,膀胱湿热,风痒疮疥。具有促进白细胞分裂,增加白细胞数目,提高T细胞的免疫活性,参与机体的免疫调节和诱生干扰素等作用,因而从多方面提高机体的免疫功能。
白鲜皮:别名白藓皮、八股牛、山牡丹、羊鲜草,为芸香科多年生草本植物白鲜和狭叶白鲜的根皮,味苦、寒,归脾、胃、膀胱经,具有清热燥湿,祛风解毒之功效。现代研究,白鲜皮的挥发油在体外有抗癌作用。
黄柏:为芸香科植物黄皮树或黄檗的干燥树皮,也称黄檗、檗木、元柏,味苦,性寒。归肾、膀胱、大肠经,主治清热。燥湿,泻火,解毒。治热痢,泄泻,消渴,黄疸,痿躄,梦遗,淋浊,痔疮,便血,赤白带下,骨蒸劳热,目赤肿痛,口舌生疮,疮疡肿毒。
白头翁:为毛茛科植物,多年生草本,别名奈何草、粉乳草、白头草、老姑草、菊菊苗、老翁花等;味苦,性寒;归胃经、大肠经;具有清热解毒,凉血止痢,燥湿杀虫的功效。主治热毒痢疾,鼻衄,血痔,带下,阴痒,痈疮,瘰疬。
地榆:是蔷薇科地榆属的植物,别名黄爪香、玉札、玉豉、酸赭等,性寒,味苦酸,无毒;归肝、肺、肾和大肠经。有凉血止血,清热解毒,培清养阴,消肿敛疮等功效。
宣木瓜:为蔷薇科植物贴梗海棠的成熟果实,性温,味酸涩,可舒筋活络、祛风湿痹;具有护肝降酶、促免疫、抗炎、降血脂血糖等作用。
双花炭:为金银花的炮制加工品,可购买成品,金银花又称忍冬、二花、双花,金银花自古被誉为清热解毒的良药,它性甘寒气芳香,甘寒清热而不伤胃,芳香透达又可祛邪;金银花既能宣散风热,还善清解血毒,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等症,均效果显著。
枳实:属芸香科植物酸橙及栽培变种或甜橙的干燥幼果,别称酸橙,味苦、辛,寒。归脾、胃、肝、心经,主治积滞内停,痞满胀痛,大便秘结,泻痢后重,子宫脱垂,脱肛。
大黄炭:为中药材大黄的炮制加工品,可购买成品,常用于凉血止血。味苦、性寒,归脾、胃、大肠、肝、心包经,具有攻积滞、清湿热、泻火、凉血、祛瘀、解毒等功效。
皂角子:皂角的种子,含有丰富的半乳甘露聚糖胶和蛋白质成分,入药可治癣和通便秘,味辛,温,有小毒;可搜风,祛痰,开窍,用于中风口噤,痰鸣喘咳,喉痹,疮癣肿毒。
甘草梢:为豆科植物甘草以根和根状茎入药,根的末梢部分或细小根称为甘草梢,归心、肝、脾经,具有泻火解毒,利尿通淋的功效。
三七粉:是植物三七的根茎制品,是用三七主根打成的粉,是云南白药的主要成分,人参补气第一,三七补血第一;性温,味甘微苦,入肝、胃、大肠经,三七粉的成分和三七主根一样,富含三七皂苷、三七多糖、三七素、黄酮有效成分,具有止血、活血化瘀、消肿定痛、滋补强壮、抗疲劳、耐缺氧、抗衰老、降血脂、降血糖、提高机体免疫功能等作用,可用于治疗外伤出血、瘀血、胃出血、尿血等各种内、外出血症。
茜草炭:为茜草科多年生攀缘草本植物茜草的炮制加工品,可购买成品,可凉血活血,祛瘀,通经。用于吐血、衄血、崩漏下血、外伤出血、经闭瘀阻、关节痹痛、跌扑肿痛。本品止血而不留瘀,用于热证出血、经闭腹痛、跌打损伤。配乌贼骨止血力更强。
羌活:别名羌青、护羌使者、胡王使者、羌滑、退风使者、黑药等,伞形科、羌活属植物,多年生草本;其性温,解表散寒、祛寒湿,用于外感风寒、头痛无汗、寒湿痹、上肢风湿疼痛。味辛、苦,性温,入膀胱、肾经。
五灵脂:又名药本、寒号虫粪,为复齿鼯鼠的干燥粪便,可用于瘀血内阻、血不归经之出血,如妇女崩漏经多,色紫多块,少腹刺痛;既可单味炒研末,温酒送服,又可与其他药物配合使用,五灵脂为活血化瘀中药。
藁木:多年生草本,伞形科藁本属的植物,有药用价值;辛温,入膀胱经;可散寒解表,祛风湿,止痛;用于感冒风寒、巅顶头痛,风寒湿痹、肢节疼痛,寒疝腹痛,疥癣等症。
荞穗炭:为一年生草本植物荞麦果实的炮制加工品,可购买成品,性甘味凉,有开胃宽肠,下气消积。治绞肠痧,肠胃积滞,慢性泄泻的功效。
乌贼骨:为乌鲗科动物无针乌鲗或金乌鲗的内壳,中医用做止血药,具有制酸止痛、止血、接骨、骨缺损修复、抗辐射、抗肿瘤、抗溃疡等作用。功能主治:收敛止血,固精止带,制酸止痛,收湿敛疮。主治吐血,呕血,崩漏,便血,衄血,创伤出血;肾气不固之遗精滑精,赤白带下;胃痛嘈杂,嗳气泛酸,湿疹溃疡;配茜草止血力更强。
火麻仁:为桑科植物大麻的干燥成熟种子,别名又叫大麻仁、火麻、线麻子;味甘,性平,归脾、胃、大肠经,功效润肠通便、润燥杀虫,能益脾补虚,养阴润燥,通便,用于血虚津亏。
炙槐米:为槐米的炮制加工品,可购买成品,性微寒、味苦,凉血止血,清肝泻火。用于便血、痔血、血痢、崩漏、吐血、衄血、肝热目赤、头痛眩晕。
郁李仁:别名山梅子、小李仁,性平,味辛、苦、甘;可润燥滑肠,下气,利水。用于津枯肠燥、食积气滞、腹胀便秘、水肿、脚气、小便不利。具有润燥滑肠,下气行滞,利水消肿的功效。
土茯苓:为百合科植物光叶菝葜的干燥根茎,入药部分只选择其干燥后的根茎。味甘、淡,性平。有解毒,除湿,通利关节之功效,主要用于梅毒及汞中毒所致的肢体拘挛,筋骨疼痛;湿热淋浊,带下,痈肿,瘰疬,疥癣。
泽泻:别称水泽、如意花等,多年生水生或沼生草本,味甘、寒,入肾、膀胱经,具有利水,渗湿,泄热的功效。治小便不利,水肿胀满,呕吐,泻痢,痰饮,脚气,淋病,尿血。
木通:别称通草、附支等,为木通科植物木通、三叶木通或白木通的干燥藤茎,味苦、寒;归心、小肠、膀胱经;有利尿通淋,清心除烦,通经下乳的功效。用于淋证,水肿,心烦尿赤,口舌生疮,经闭乳少,湿热痹痛。
车前子:别称车前实、虾蟆衣子,为车前科植物车前或平车前的干燥成熟种子,味甘、性寒,归肝、肾、肺、小肠经,具有清热利尿通淋,渗湿止泻,明目,祛痰的功效。用于热淋涩痛,水肿胀满,暑湿泄泻,目赤肿痛,痰热咳嗽。与木通同用,可用于湿热下注于膀胱而致小便淋沥涩痛者。
生地炭:为生地的炮制加工品,可购买成品,味甘、性寒。归心,肝,肾经。既有止血作用,又有抗凝血和抗真菌作用。
栀子:别名黄栀子、山栀、白蟾,是茜草科植物栀子的果实,具有护肝、利胆、降压、镇静、止血、消肿等作用。治热病虚烦不眠,黄疸,淋病,消渴,目赤,咽痛,吐血,衄血,血痢,尿血,热毒疮疡,扭伤肿痛。
蒲黄炭:为蒲黄的炮制加工品,可购买成品,味甘、性平。归肝、心包经。具有止血,化瘀,通淋的功效。用于吐血,衄血,咯血,崩漏,外伤出血,经闭痛经,脘腹刺痛,跌扑肿痛,血淋涩痛。
条苓:别称黄苓、子苓等,是一种常用的大宗药材。具有抗炎、抗变态反应、保肝利胆的作用;可降压、利尿、镇静、解热。
猪苓,别名猪茯苓、地乌桃,非褶菌目多孔菌科树花属药用真菌。其地下菌核黑色、形状多样,是著名中药,有利尿治水肿、提高免疫力、抗肿瘤之功效。
本发明药物临床使用结果表明,具有凉血止血、消肿定痛、固精止带、散寒解表、泻火解毒、利尿通淋、燥湿杀虫、增强肌体免疫力和抗癌之功效,对宫颈癌有治愈和康复的功效,对人体无毒无害、稳定性好、标本兼治、价格低廉,治愈率95%。
具体实施方式
实施例一
一种治疗宫颈癌的中药制剂,是由中药材制苍术9、秦艽12、防风9、当归9、防己9、茵陈蒿15、白鲜皮12、黄柏6、白头翁9、地榆9、宣木瓜9、双花炭、枳实9、大黄炭3、皂角子6、甘草梢6、三七粉3、茜草炭9、羌活9、五灵脂9、藁木9、荞穗炭9、乌贼骨12、火麻仁12、炙槐米9、郁李仁9、土茯苓12、泽泻9、木通6、车前子9、生地炭30、栀子9、蒲黄炭9、条苓6、猪苓6配伍;首先,将黄柏、皂角子和五灵脂分别用武火炒制表面发黑,备用;将栀子用武火炒制表面黄褐色,备用;其次,将炒制好的黄柏、皂角子、五灵脂和栀子与其余原料药均匀混合在一起,加入2-4倍量水煎煮1-2个小时,待自然冷却至50℃,滤过,剩余药渣加水重复煎煮2-3次后,合并滤液;第三,滤得的药液放入本医药技术领域常用的真空减压浓缩罐(如:临朐誉金机械设备有限公司生产的真空减压浓缩罐)中,在压力0.5Mpa下进行减压浓缩成膏状;第四,制得的膏状原料药放入本医药技术领域常用的真空干燥箱(如:南京神威制药设备有限公司生产的真空干燥箱)内,在压力0.05Mpa下进行减压干燥,制成细粉;第五,用本领域的常规方法将制得的细粉加入60%乙醇制成颗粒,在温度30℃下进行干燥,过15目筛后包装,既得本发明的颗粒剂。服用方法:每日分三次口服,每次一袋,每袋15g,温水送服。
临床试验:
病例选择
患者年龄在35-60岁,并签署进入临床研究知情同意书,符合宫颈癌诊断标准及中医证候诊断标准并适合放疗者,体力状况尚好,非妊娠或哺乳期妇女,非过敏体质,即可纳入备选病例。
排除病例标准:1.有心、肝、肾等严重疾病及其功能严重障碍者,糖尿病、高血压、精神病患者以及造血系统严重疾病患者;2.行手术切除、放射治疗的宫颈癌患者,正在进行放疗或化疗结束不足2个月者;3.过敏体质或对多种药物过敏者;4.近期曾采用同类药物治疗,如服用过相关或相拮抗作用的药物,致药效难以判断者。
本发明共纳入200例患者,其年龄在20-60周岁之间,其中治疗组100例,对照组100例。治疗组平均年龄为39.8岁,对照组平均年龄为40.7岁,患者病程1-5年,两组资料经统计学处理,两组间在年龄、吸烟、喝酒、体重、文化程度等方面无差异,无统计学异议,具有可比性。
给药情况
治疗组:治疗组患者服用本发明实施例一制备的颗粒剂,每次15g温水送服,每日分3次服用,服用时间为三个月。
对照组:服用抗宫炎片(江西济民可信药业有限公司制),一次3片,每片重0.55g(含干浸膏0.5克),一日3次,服用时间为三个月。
两组患者用药剂量和时间均一致,且在治疗期间患者不得服用其他药物,同时嘱咐患者注意休息,注意个人卫生,保持心情开朗,保持良好生活习惯,合理膳食,少食腌制、油炸等易治癌食物。
观察指标:
综合疗效:参照《妇产科学》(全国高等医药院校教材第五版)的判定标准。
(1)痊愈 治疗后下腹疼痛等症状消失,妇科检查及理化检测正常。证候、体征积分和减少≥95%。停药1月内未复发。
(2)显效 治疗后下腹疼痛等症状消失或明显减轻,妇科检查及理化检查明显改善。证候、体征积分和减少≥70%,<95%。
(3)有效 治疗后下腹疼痛等症状减轻,妇科检查及理化检查有所改善。证候、体征积分和减少≥30%,<70%。
(4)无效 治疗后下腹疼痛等症状无减轻或加重,妇科检查及理化检查较治疗前无改善或有加重。证候、体征积分和减少<30%。
有效率=(痊愈+显效)/治疗组例数×100%
统计学处理
所有数据的统计分析均采用 SPSS19.0 统计分析软件进行计算。所有的统计检验均采用双侧检测,P<0.05 将被认为所检验的判别有统计学意义,P <0.01 将被认为有显著性统计学意义。计量资料采用均数±标准差(x±S)进行统计描述。
试验结果 两组患者综合疗效的对比
表1
组别 | 痊愈 | 显效 | 有效 | 无效 |
治疗组 | 65 | 30 | 5 | 0 |
对照组 | 40 | 36 | 23 | 1 |
通过表1治疗组和对照组比较计算后可知,患者通过服用本发明的药物进行治疗,其痊愈和显效的总人数明显高于对照组,有效和无效的总人数也显效明显低于对照组,治疗组的治愈率在95%,对照组的治愈率在76%,由此可见,本中药制剂对治疗宫颈癌在短时间内达到了较好的治疗效果。
实施例二
本中药制剂进行了大量的动物急性毒性试验、动物长期毒性试验以及治疗疾病的大量临床试验,对该药投入治疗疾病的使用环节提供了科学而客观的依据。
动物急性毒性试验:
药物:本发明中药颗粒,实验前用蒸馏水进行10倍稀释,现用现配。
毒性:选30~35克雌性小鼠20只(购自上海斯莱克动物中心),按1.5ml/次剂量灌胃给药,早、中、晚各一次,连续给药观察10天动物无一例死亡;本实验还做了亚急性毒性试验。结果表明:本发明中药颗粒通过上述剂量给药后,各项检查指标及病理组织切片均未见任何明显异常。
实施例三
典型病例如下:
1.刘某,女,45岁,居住在农村,个人卫生状况差,患者自述腹痛多年,尿频、尿急,阴道常有白色或血性液体排出、有腥臭味,取本中药颗粒剂治疗,每日温水送服三次,1个月后腹痛感消失,阴道排液量减少,继续服用5个月后,不再出现尿频、尿急,叮嘱日后注意个人卫生。
2.苏某某,女,63岁,农村妇女,有6个子女,个人卫生状况差,患者自述独居多年,行动不便且少人照料,平日饮食不规律且营养跟不上,年轻时生育多且间隔短,就诊时低烧1周、腹痛,阴道有血性液体排出、腥臭味,且尿频、漏尿,取本中药颗粒剂治疗,每日温水送服三次,并叮嘱注意饮食规律增加营养,保持清洁的个人卫生,2个月后腹痛感消失,继续服用5个月后小便规律,不再出现尿频、漏尿的现象,回访时精神状态 ,体重正常。
3.刘某某,女,30岁,患者自述工作压力大,育有2女,第二次生产后便有隐隐的腹痛感,一年后症状加深,经期延长、经量多,阴道常有腥臭味的白色液体排出,取本中药颗粒剂治疗,每日温水送服三次,用药期间叮嘱不宜同房并注意个人卫生,1个月后腹痛感消失,经量减少,继续服用3个月后,经期正常,无阴道排液,身体恢复健康。
4.赵某某,女,35岁,农村妇女,患者自述生活作息和饮食不规律,经常吃腌制的咸菜,个人卫生状况差,经期长、经量多且伴有腹痛,阴道排液呈血红色带腥臭味,症状加深后前来就诊,取本中药治疗,每日温水送服三次,1个月后经期正常、经量减少,继续服用3个月后不见阴道排液,身体恢复,叮嘱日后少吃或不吃腌制类食物。
患者在服用本发明中药颗粒剂治疗期间,叮嘱应注意个人清洁卫生,适量锻炼,不得进食腌制、熏制等致癌物质或刺激性食物,用药期间夫妻双方不宜同房,同时让患者正确、理性的认识疾病本身,在宫颈癌的最开始的一期阶段治愈率可达到80%-90%,二期是60%-70%,进入三期时也会有40%-50%的治愈率,但到了四期只有10%的治愈率,使患者清楚自身的身体状况,保持积极乐观的心态,且定期进行体检,保持良好的生活作息。
本发明采用的上述各中药互作配伍,能发挥其协同治病的作用,所用中药原料各成分之间具有药效相互促进的效能;本发明人在临床上及时随访患者治疗效果,发明了此中药药物,治愈率达百分之九十五以上。
Claims (1)
1.一种治疗宫颈癌的中药制剂,其特征在于,所述中药制剂由下述按重量配比的原料制备而成:
制苍术9、秦艽12、防风9、当归9、防己9、茵陈蒿15、白鲜皮12、黄柏6、白头翁9、地榆9、宣木瓜9、双花炭15、枳实9、大黄炭3、皂角子6、甘草梢6、三七粉3、茜草炭9、羌活9、五灵脂9、藁木9、荞穗炭9、乌贼骨12、火麻仁12、炙槐米9、郁李仁9、土茯苓12、泽泻9、木通6、车前子9、生地炭30、栀子9、蒲黄炭9、条苓6、猪苓6;
所述中药制剂制备方法包括如下步骤:
1)首先,将黄柏、皂角子和五灵脂分别用武火炒制表面发黑,备用;将栀子用武火炒制表面黄褐色,备用;将乌贼骨在170℃的高温中烘焙3分钟至表面黄褐色,备用;2)将步骤1)炒制好的黄柏、皂角子、五灵脂、栀子和乌贼骨与其余原料药均匀混合在一起,加入2-4倍量水煎煮1-2个小时,待自然冷却至50℃,滤过,剩余药渣加水重复煎煮2-3次后,合并滤液;3)将步骤2)滤得的药液放入真空减压浓缩罐中,在压力0.5Mpa下进行减压浓缩成膏状;4)将步骤3)制得的膏状原料药放入真空干燥箱内,在压力0.05Mpa下进行减压干燥,制成细粉;5)将步骤4)制得的细粉加入60%乙醇制成颗粒,在温度30℃下干燥,包装既得本发明的颗粒剂。
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