CN116617136A - 一种控油祛痘沐浴露及其制备方法 - Google Patents
一种控油祛痘沐浴露及其制备方法 Download PDFInfo
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- CN116617136A CN116617136A CN202310728677.6A CN202310728677A CN116617136A CN 116617136 A CN116617136 A CN 116617136A CN 202310728677 A CN202310728677 A CN 202310728677A CN 116617136 A CN116617136 A CN 116617136A
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Abstract
一种控油祛痘沐浴露,按重量百分比计,包括以下原料成分:10‑18%表面活性剂、0.3‑1%增稠剂、0.5‑2%氯化钠、0.05‑0.2%pH调节剂、0.1‑0.6%壬二酸、0.1‑0.5%辛酰甘氨酸、0.1‑0.6%植物除螨剂、0.2‑2%苦参提取物、0.01‑0.1%弗来歇氏柳叶菜提取物、0.1‑0.5%糖类同分异构体混合物、0.1‑0.5%抗坏血酸磷酸酯钠、0.5‑1.5%银耳提取物、0.01‑0.2%龙胆提取物、0.3‑0.7%防腐剂以及余量水。
Description
技术领域
本发明涉及日用化妆品领域,尤其涉及一种控油祛痘沐浴露及其制备方法。
背景技术
沐浴露已逐渐成为人们日常生活中最常用、消耗量最大的一类日用品,随着人们生活水平的提高,人们对于沐浴露的要求也越来越高,目前,市面上常见的沐浴露,大多数含有较多化学成分,频繁使用,会破坏皮肤水分和油脂的平衡,容易引起皮肤干燥、出油、起痘的问题,长期使用,不利于人们的皮肤健康。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此,本发明提出一种控油祛痘沐浴露及其制备方法。
本发明的一种实施例解决其技术问题所采用的技术方案是:
一种控油祛痘沐浴露,按重量百分比计,包括以下原料成分:10-18%表面活性剂、0.3-1%增稠剂、0.5-2%氯化钠、0.05-0.2%pH调节剂、0.1-0.6%壬二酸、0.1-0.5%辛酰甘氨酸、0.1-0.6%植物除螨剂、0.2-2%苦参提取物、0.01-0.1%弗来歇氏柳叶菜提取物、0.1-0.5%糖类同分异构体混合物、0.1-0.5%抗坏血酸磷酸酯钠、0.5-1.5%银耳提取物、0.01-0.2%龙胆提取物、0.6%防腐剂以及余量水。
优选的,所述表面活性剂由月桂醇聚醚硫酸酯钠、甲基椰油酰基牛磺酸钠、椰油酰胺丙基甜菜碱、月桂酰两性基乙酸钠、椰油酰胺甲基MEA组成。
优选的,所述植物除螨剂由百里香提取物、迷迭香水、1,3-丙二醇、二氯苯甲醇、苯氧乙醇组成。
优选的,所述增稠剂由生育酚和PEG-120甲基葡糖二油酸酯组成。
优选的,所述糖类同分异构体混合物包括有糖类同分异构体、水、柠檬酸以及柠檬酸钠。
优选的,所述pH调节剂为氢氧化钾。
制备上述一种控油祛痘沐浴露,制备方法包括如下步骤:
S1:将水分成两部分,将第一部分水投入生产锅中,升温至80-85℃,加入表面活性剂搅拌至溶解均匀;
S2:在生产锅中继续加入增稠剂、壬二酸、辛酰甘氨酸搅拌至溶解均匀;
S3:降温至45℃,加入植物除螨剂、苦参提取物、pH调节剂、糖类同分异构体混合物、抗坏血酸磷酸酯钠、银耳提取物、龙胆提取物、弗来歇氏柳叶菜提取物搅拌溶解均匀;
S4:氯化钠先用第二部分水溶解完全后投入生产锅中搅拌均匀,调节PH以及粘度、出料。
本发明的有益效果:
1、针对雄激素对皮脂腺调控异常和皮脂腺导管角质化异常引起的痤疮/痘痘,本申请利用壬二酸和弗来歇氏柳叶菜提取物的协同作用达到祛痘控油的效果。壬二酸别名杜鹃花酸,目前其主要用于治疗黑色素瘤、黄褐斑、酒糟鼻、色素过度沉着、痤疮等方面。壬二酸作用机制:抑制皮肤油脂分泌。雄性激素特别是二氢睾酮诱发皮脂腺的活性是痤疮的成因之一。皮脂腺中5a-还原酶能增加睾酮生物转化为二氢睾酮,而壬二酸对此还原酶能产生竞争性浓度抑制作用,从而使皮肤减少油脂分泌;对正常皮肤和痤疮感染的皮肤有抗角质化作用,减少丝状角蛋白的合成,防止毛囊角化过度,疏通毛孔。同时配方中添加的弗来歇氏柳叶菜提取物对5a-还原酶也具有很强的抑制作用。通过将歇氏柳叶菜提取物与壬二酸进行复配,减少壬二酸的使用量和皮肤刺激,同时达到显著的祛痘控油效果。
2、针对痤疮丙酸杆菌过度繁殖引起的痤疮/痘痘,辛酰甘氨酸具有良好的皮肤亲和性,对皮肤温和,同时它对痤疮丙酸杆菌、金黄色葡萄球菌在较短时间内(2min-5min)即可达到很好的抑制作用,对粉刺、痘痘的预防和治疗具有显著的效果。因此,本配方选择以辛酰甘氨酸作为抑制痤疮丙酸杆菌的活性物,一方面充分考虑了其作用时间短,作用效率高的特点,同时也考虑了其对皮肤的温和性。
3、针对炎症免疫反应引发的痤疮/痘痘,主要通过苦参提取物来实现。苦参提取物具有广谱抗菌性,不仅能抑制菌体的生物合成,又能影响菌体的生物氧化过程。苦参提取物的抗炎机理是通过对红细胞膜的稳定作用所致,而且具有较强的免疫调节作用,可通过对免疫细胞的变化、细胞因子及其他炎性调节因子的影响发挥其抗炎作用,对湿疹、皮炎具有很好的疗效,能够缓解炎症引起的皮肤瘙痒,加速痘痘皮肤的修复。
4、针对受皮肤螨虫的影响引起的痤疮/痘痘,配方中添加了植物除螨剂,该除螨剂的主要活性成分是:百里香提取物、迷迭香、水和二氯苯甲醇。其对各类螨虫具有很强的杀灭和驱避效果。能够有效预防或缓解皮肤因螨虫引起的痘痘情况。
综上所述,本配方祛痘控油成分的配伍机理涵盖了痤疮/痘痘的各种发病机理,可以达到更加显著的祛痘控油效果,同时还考虑了整体配方的温和性和安全性,适用群体更加广泛,不仅可以作为痘痘肌肤的祛痘用途,也可以作为日常清洁的预防痘痘用途。
附图说明
本发明的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解,其中:
图1为受试者1使用的效果示意图;
图2为受试者2使用的效果示意图;
图3为不同时间点ISGA评分比较(x±s,n=30);
图4为痤疮平均体积变化(mm3,x±s,n=30);
图5为皮肤油脂含量变化(μg/cm3,x±s,n=30)。
具体实施方式
具体实施方式对于充分公开、理解和再现发明创造,支持和解释权利要求是十分重要的。实施方式的描述应当与解决技术问题所采用的技术方案相一致,对于简单的技术方案,可以只给出一个实施例,对于保护范围较宽的技术方案,应当给出一个以上的实施例,以支持要求保护的范围。
实施例的配方示例
制备方法如下:
1.准确称量配方成分中的各组分物料,同时将生产设备清洁干净;
2.搅拌锅中加入1号原料(预留5%水),升温至80885℃,加入2、3号原料,搅拌至完全溶解;
3.依次加入4、5、6号原料,搅拌20分钟至溶解均匀;
4.依次加入7、8、9号原料,搅拌至完全溶解后降温;
5.降温至45℃,加入10、11、12、13、14、15、16、17、18号原料,每加一个原料必须搅拌均匀后再加下一个物料;
6.加入剩余水溶解的19号原料,调好pH、粘度后抽样检验;
7.经检验合格后,半成品出料、储存;
8.灌装、包装、喷码;
9.抽检合格后入库。
本申请用的植物除螨剂由广东迪美新材料科技有限公司生产并提供。
皮肤封闭型斑贴试验皮肤反应测试
一、材料和方法
1.受试物:化妆品终产品原物(稀释为l%的水溶液).
2.对照:空白滤纸对照。
3.受试者:共30人,男l人,女29人,年龄21至59岁,平均年龄39.77±12.14岁,符合受试者志愿入选标准。
4.试验方法:选用合格的斑试器材,以封闭性斑贴试验方法.将稀释后的受试物约0.020mL-0.025mL(液体)置于斑试器内,外用低致敏胶带贴敷于受试者背部,24小时后去除受试物,分别于去除后0.5、24、48小时观察皮肤反应,按《化妆品安全技术规范》(2015年版)中皮肤反应分级标准记录其结果。
皮肤封闭型斑贴试验皮肤反应分级标准
二、试验结果
化妆品人体皮肤斑贴试验结果汇总
结果显示:人体皮肤斑贴试验结果显示,30人中出现6例1级皮肤不良反应。
祛痘和控油效果实验
一、材料和方法
1.受试物:化妆品终产品原物
2.对照:自身前后对照
3.受试者:共30人(33例受试者入组,3例脱落),其中女性14人,男性16人,年龄18至40岁,平均年龄29.50±6.31岁,符合受试者入选标准。
4.仪器测量参数及相关设备:
5.试验环境:温度:20℃822℃,湿度:40%~60%,并且进行实时动态监测。
6.试验方法:
6.1试验目的及原理
招募至少30名受试者连续使用测试样品28天,通过主观评价及医生评价痤疮皮损改善等级,利用Antera 3D采集及分析受试者背部痤疮相应参数,并通过测试探头SM815进行皮肤表面油脂含量测量,比较使用前后各指标变化,判断产品的祛痘、控油效果。
6.2试验设计原则
双盲,随机,自身前后对照
6.3受试者筛选
6.3.1受试者人数:最低有效例数30例
6.3.2受试者条件:
6.3.2.1入选标准:
(1)年龄为18845岁,健康男性或女性。
(2)全身健康状况良好、无重要的全身系统性疾病。
(3)背部有2颗以上痤疮。
(4)能严格按照研究方案的要求和时间安排,并签署知情同意书和保密协议。
6.3.2.2排除标准:
(1)目前处于孕期、哺乳期或者在接下来的两个月计划怀孕的女性。
(2)背部有急性炎症或其他皮肤疾病(如湿疹、红斑狼疮、脂溢性皮炎、银屑病、严重的表皮脱落等)。
(3)有高度敏感体质或化妆品过敏。
(4)背部具有明显晒伤、瘢痕及多毛或其他可能影响试验测量结果者。
(5)近一个月内服或外用任何可能会影响皮肤状态或反应的药物,如抗组胺药、抗生素、胰岛素、抗炎药物、维生素A、类固醇类药物、阿司匹林、甲状腺药物等。
(6)近一月内曾使用激素类药物及免疫抑制剂者。
(7)现在或近一个月受试部位参加其他临床实验者。
(8)三个月内背部进行过化学剥脱(果酸治疗)、微晶焕肤术、激光磨皮等美容治疗。
(9)参照国际改良痤疮分级法及Pillsbury分类法属于IV级的痤疮。
6.3.2.3剔除标准:试验过程中出现严重不良反应以及不遵守研发方案(如测试期间使用其它化妆品、药物以及其它原因要求退出者)
表1国际改良痤疮分级法
6.4试验前的准备
受试部位试验当天不能使用任何产品。试验前,受试者需要在人体功效评价室(温度:20℃822℃,
湿度:40%~60%)静坐30min,期间不能喝水和饮料。受试者保持放松,背部避免触碰。
试验前对受试者进行试验说明,并签署知情同意书。
测试区域为背部。
6.5产品使用方法
洗澡时,取适量试验产品替代惯用的沐浴产品使用,轻揉全身后洗净。每天1次,连续使用28天。在试验期间,受试者禁止使用祛痘、控油、抗炎抑菌的制剂;受试者禁止点滴、注射、口服或其他形式摄入影响祛痘、控油测试的制剂;受试者以室内活动为主,避免长期暴露在室外光照下。
6.6受试者主观评价
受试者在使用产品后28天(D28)回访时在人体功效实验室填写问卷评价背部情况,并记录评分。使用7分评分法,分别从产品的肤感、使用效果、温和度及使用满意度这4个方面对产品进行评分,然后进行判断,每次回访进行一次记录。
6.7半定量评价(医生评估)
皮肤科医生在受试者使用产品前(D0)及使用产品后28天(D28)回访时就照片中受试者背部痤疮皮损情况进行评价。通过ISGA 量表(表2)对受试者使用前后皮损症状改善进行评分,并计算皮损减少百分率。
表2ISGA量表
6.8客观定量评价
在人体功效评价室休息30min后,使用Antera 3D皮肤图像分析仪进行背部痤疮位置拍摄,通过软件分析得到待测区域内痤疮平均体积,并SM815于试验部位检测皮肤油脂值,其测量值作为基线值(D0),然后进行产品发放并指导使用方法。受试者使用产品后28天(D28)需回访并进行同样的指标检测。
同一个受试者的测试使用同一仪器、同一测试人员完成。两个测试时间点之间应保持测试部位前后一致。
6.9统计分析
对各测试区域的测量值进行统计,包括数量、均值、标准差、标准误、最小值、中位数、最大值等。如测试数据为正态分布,则采用配对t检验方法进行统计分析;如测试数据为非正态分布,则采用秩和检验方法进行统计分析。统计方法均采用双尾检验,检验水准α=0.05。数据统计采用SPSS 25.0软件进行统计分析。当结果出现显著性差异时,分别用*p<0.05和**p<0.01进行标注。*p<0.05表示呈显著性差异,**p<0.01表示呈极显著性差异。测试区域各项指标数值若有显著性差异,表示该产品具有祛痘、控油效果。
二、试验结果
试验过程中,33例受试者入组,3例脱落(因个人原因自动退出),最终30例受试者符合方案,为有效案例。其中,女性14人,男性16人,平均年龄29.50±6.31岁;本研究以此人群做统计分析
1.安全性和不良反应评价
试验过程中,由专业皮肤科医生询问受试者在使用被测试产品过程中是否出现干燥、油腻、脱屑、发红、刺痛等症状,并观察记录背部是否有皮疹、红肿及脱屑的现象。而后根据表3的评分标准进行评分,得分记入事件报告表,并根据表4所列的标准进行关联性评估。在试验期间,没有受试者出现不良反应。
表3不良反应的评分标准
表4被测试产品的评估
2.受试者主观评价
使用7级评分法(表5),对调查问卷中的关于产品的使用效果、温和度及使用满意度评分,受试者在试用产品后4周(D28)填写问卷。由此分析受试者对产品使用感受及功效的评价和满意度。
表5自评分值标准(7级评分法)
以下是根据受试者填写的问卷调查进行统计的图表,由表格和图中的数据得出结论。
2.1产品肤感评价
表6产品肤感评价结果(n=30)
从产品肤感上来看,评分均值在6.1分以上,统计学上超过50%的受试者对产品肤感评分给予积极评价。其中在D28时,“使用后感觉背部皮肤不紧绷”均值为6.17分,有96.67%受试者认同;在D28时,“温和无刺激”均值为6.30分,有100.00%受试者认同。
2.2产品的使用效果评价
在使用4周(D28)时,受试者分别对产品的祛痘和控油效果进行评价。
问卷数据统计如下所示:
2.2.1祛痘效果
表7产品祛痘效果评价结果(n=30)
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从祛痘方面来看,使用28天(D28)后所有评分均值均在5.8分以上,统计学上超过50%的受试者对产品的祛痘效果评分给予积极评价。其中“使用后对痘痘区域红肿有舒缓的作用”和“使用后感觉皮肤变平滑了”在D28时均有93.33%受试者认同;“使用后感觉背部突起痘痘体积变小了”在D28时有96.67%受试者认同;“使用后感觉易长痘肤质有改善,痘痘数量减少了”在D28时有90.00%受试者认同。
2.2.2控油效果
表8产品控油效果评价结果(n=30)
从控油方面来看,使用28天(D28)后所有评分均值均在5.9分以上,统计学上超过50%的受试者对产品控油效果评分给予积极评价。其中“使用后感觉背部肌肤出油减少了”在D28时有100.00%受试者认同;“使用感觉后背部皮肤清爽”在D28时有90.00%受试者认同。
2.3产品满意度评价
表9产品满意度评价结果(n=30)
从产品的整体满意度上来看,使用28天(D28)后统计学上超过50%的受试者对产品满意度调查结果给予积极评价。在D28时有93.33%受试者对产品表示满意。
3.半定量评价(医生评估)
皮肤科医生在受试者使用产品前后对受试者背部痤疮皮损情况进行评价。通过ISGA 量表对受试者使用前后皮损症状改善进行评分,并计算皮损减少百分率。皮损减少百分率以公式1计算。通过比较使用前后的ISGA 评分,可反映产品的祛痘功效。
皮损减少百分率=(使用产品前ISGA评分-使用产品后ISGA评分)/使用产品前ISGA评分×100%
表10使用前后ISGA评分值比较(x±s,n=30)
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评估结果如表10,图3所示(利用秩和检验分析对ISGA评分的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):
与使用前基线值(D0)相比,ISGA皮损评分在使用产品后呈现下降趋势,在使用28天(D28)后皮损减少百分率为36.51%,两者具有极显著性差异(p<0.01)。
4.痤疮平均体积分析
Antera3D拍摄的痤疮区域图像经软件分析,可衡量不同时间点AOI选区中的痤疮平均体积变化。通过比较使用前后的痤疮平均体积变化,可反映产品的祛痘功效。
痤疮平均体积在不同回访时间点的数值与使用前基线值(D0)相比下降越多,痤疮皮损的改善效果越好,提示产品的祛痘效果越好。
痤疮平均体积下降率=(使用产品前痤疮平均体积-使用产品后痤疮平均体积)/使用产品前痤疮平均体积×100%
表11痤疮平均体积描述性统计(mm3,n=30)
表12痤疮平均体积差异性分析(mm3,x±s,n=30)
试验结果如表12,图4所示(利用配对t检验分析对痤疮平均体积的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):
与使用前基线值(D0)相比,痤疮平均体积在使用产品后呈现下降趋势,在使用28天(D28)后下降了74.17%,与基线值相比具有极显著性差异(p<0.01),使用产品后痤疮平均体积低于基线值。
5.皮肤表面油脂含量分析
由Sebumeter SM815测得的皮肤表面皮脂含量数值越大,代表皮肤表面油脂含量越高。通过比较使用前后皮肤特定区域内的油脂含量变化,可反映产品的控油效果。皮脂量在不同回访时间点的数值与使用前基线值(D0)相比下降越多,测试区域内表面油脂含量的改善效果越好,提示产品的减少皮肤表面油脂含量的效果越好。
皮肤油脂含量下降率=(使用产品前油脂含量-使用产品后油脂含量)/使用产品前油脂含量×100%
表13皮肤油脂含量描述性统计(μg/cm3,n=30)
表14皮肤油脂含量差异性分析(μg/cm,x±s,n=30)
试验结果如表14,图5所示(利用秩和检验分析对皮肤油脂含量的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):
与使用前基线值(DO)相比,皮肤表面油脂含量在使用产品后呈现下降趋势,在使用28天(D28)后下降了45.39%,与基线值相比具有极显著性差异(p<0.01),使用产品后皮肤表面油脂含量低于基线值。
三、试验结论
通过30例受试者多次使用由中山市长兴实业有限公司提供的柏缇控油祛痘沐浴露,进行化妆品祛痘、控油功效评价,结果表明:
1、本试验未发生不良反应案例,试验产品具有较高安全性。
2、受试者主观评价显示,使用28天(D28)后,评分均值均在5分以上,统计学上超过50%的受试者对产品肤感、祛痘、控油效果、温和度和满意度给予积极评价。在D28时,100%的受试者对“使用后感觉背部肌肤出油减少了”和“产品温和无刺激”表示认同;90%以上的受试者对“使用后对痘痘区域红肿有舒缓的作用”、“使用后感觉背部突起痘痘体积变小了”、“使用后感觉皮肤变平滑了”、“使用后感觉易长痘肤质有改善,痘痘数量减少了”、“使用感觉后背部皮肤清爽”和“使用后感觉背部皮肤不紧绷”表示认同。以及90%以上的受试者对产品满意度给予积极评价。
3、半定量评价(医生评价)显示,受试者使用产品后,ISGA评分在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。
4、痤疮平均体积分析显示,受试者使用产品后,痤疮平均体积在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。
5、皮肤表面油脂含量分析显示,受试者使用产品后,皮肤表面油脂含量在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。
综上所述,使用柏缇控油祛痘沐浴露28天后,能降低ISGA评分,改善背部整体痤疮皮损情况,降低背部痤疮平均体积,减少背部油脂含量,达到祛痘、控油的作用,并且在主观评价中统计学上超过50%的受试者对产品肤感、祛痘、控油效果、温和度和满意度给予积极评价,说明产品具有祛痘、控油功效。
尽管参照上面实施例详细说明了本发明,但是通过本公开对于本领域技术人员显而易见的是,而在不脱离所述的权利要求限定的本发明的原理及精神范围的情况下,可对本发明做出各种变化或修改。因此,本公开实施例的详细描述仅用来解释,而不是用来限制本发明,而是由权利要求的内容限定保护的范围。
Claims (7)
1.一种控油祛痘沐浴露,其特征在于,按重量百分比计,包括以下原料成分:10-18%表面活性剂、0.3-1%增稠剂、0.5-2%氯化钠、0.05-0.2%pH调节剂、0.1-0.6%壬二酸、0.1-0.5%辛酰甘氨酸、0.1-0.6%植物除螨剂、0.2-2%苦参提取物、0.01-0.1%弗来歇氏柳叶菜提取物、0.1-0.5%糖类同分异构体混合物、0.1-0.5%抗坏血酸磷酸酯钠、0.5-1.5%银耳提取物、0.01-0.2%龙胆提取物、0.3-0.7%防腐剂以及余量水。
2.根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述表面活性剂由月桂醇聚醚硫酸酯钠、甲基椰油酰基牛磺酸钠、椰油酰胺丙基甜菜碱、月桂酰两性基乙酸钠、椰油酰胺甲基MEA组成。
3.根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述植物除螨剂由百里香提取物、迷迭香水、1,3-丙二醇、二氯苯甲醇、苯氧乙醇组成。
4.根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述增稠剂由生育酚和PEG-120甲基葡糖二油酸酯组成。
5.根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述糖类同分异构体混合物包括有糖类同分异构体、水、柠檬酸以及柠檬酸钠。
6.根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述pH调节剂为氢氧化钾。
7.制备如权利要求1所述的一种控油祛痘沐浴露,其特征在于,制备方法包括如下步骤:
S1:将水分成两部分,将第一部分水投入生产锅中,升温至80-85℃,加入表面活性剂搅拌至溶解均匀;
S2:在生产锅中继续加入增稠剂、壬二酸、辛酰甘氨酸搅拌至溶解均匀;
S3:降温至45℃,加入植物除螨剂、苦参提取物、pH调节剂、糖类同分异构体混合物、抗坏血酸磷酸酯钠、银耳提取物、龙胆提取物、弗来歇氏柳叶菜提取物搅拌溶解均匀;
S4:氯化钠先用第二部分水溶解完全后投入生产锅中搅拌均匀,调节PH以及粘度、出料。
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