CN108606994A - 一种洁阴液及其制备方法 - Google Patents
一种洁阴液及其制备方法 Download PDFInfo
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- CN108606994A CN108606994A CN201810446306.8A CN201810446306A CN108606994A CN 108606994 A CN108606994 A CN 108606994A CN 201810446306 A CN201810446306 A CN 201810446306A CN 108606994 A CN108606994 A CN 108606994A
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Abstract
本发明公开了一种洁阴液，其包括70％‑90％的A相组合物、1％‑10％的B相组合物、1％‑10％的C相组合物和1％‑10％的D相组合物；本发明还公开了洁阴液的制备方法；本发明采用现代中药精华萃取技术，提取蛇床子、地肤子、迷迭香、龙胆、积雪草、人参等中药材的活性精华成分，以植物原液的形式、复配薄荷脑、蕲艾叶油等调配制成，该洁阴液安全无毒，使用可靠，无刺激且不会破坏阴道的酸碱度；具有多种功能，多效合一：抗菌消炎去异味；暖宫；滋养紧肤；修复损伤；且配方精良，使用方便。
Description
技术领域
本发明涉及中药组合物技术领域，尤其涉及一种洁阴液。
背景技术
阴道炎即阴道炎症。正常健康妇女阴道由于解剖组织的特点，对病原体的侵入有自然防御功能，如阴道口的闭合，阴道前后壁紧贴，阴道上皮细胞在雌激素的影响下的增生和表层细胞角化，阴道酸碱度保持平衡。当阴道的自然防御功能受到破坏时，病原体易于侵入，导致阴道炎症。临床上以白带的性状发生改变以及外阴瘙痒灼痛为主要临床特点，性交痛也较常见，感染累及尿道时，伴有尿痛、尿急等症状。正常情况下阴道内有需氧菌及厌氧菌寄居其内，形成正常的阴道菌群，任何原因将阴道菌群之间的生态平衡打破，便可形成条件致病菌。临床上常见的有：细菌性阴道炎、念珠菌性阴道炎、滴虫性阴道炎、老年性阴道炎和幼女性阴道炎。
目前市场上有许多中药洗液，但大多以清热燥湿、祛湿止痒为主，组方中多以苦寒药物为主，因而只会出现即时效果，其作用不长久，效果不显著，容易复发。过多的苦寒药物还会使下焦变得更加虚寒，犯虚虚实实之戒，抵抗力更加下降，不能暖宫护巢，调节内分泌失调，促进雌激素分泌；也不能促进阴道内受损的上皮细胞组织、病灶创面和溃疡面修复，因而治标不治本，效果不显著，适用人群不广，容易复发。而化学药物的洗液，以化学杀菌剂为主，对阴道菌群无选择性，且易产生耐药性。
发明内容
本发明的目的在于克服现有技术之缺陷，提供了一种洁阴液，能抑制阴道常见有害菌(如金黄色葡萄球菌(ATCC6538)、铜绿假单胞菌(ATCC15442)、大肠杆菌(8099)、白色念珠菌(ATCC10231))生长、消炎、去异味，且能暖宫，调节内分泌，促进雌激素分泌；能迅速激活细胞活力，促进阴道内受损的上皮细胞组织、病灶创面和溃疡面修复；能滋养紧肤，增强阴道弹性；且配方合理，安全可靠，没有添加任何化学抗生素、杀菌剂、激素、防腐剂。
本发明是这样实现的：
本发明的目的之一在于提供一种洁阴液，其包括70％-90％的A相组合物、1％-10％的B相组合物、1％-10％的C相组合物和1％-10％的D相组合物；其中，
所述A相组合物包括1％-15％的泊洛沙姆、9％-35％的多味壳聚糖溶液、0％-10％的甜菜碱和40％-60％的溶剂水；所述泊洛沙姆为F407和F188中的至少一种；所述甜菜碱为C60和CAB35中的至少一种；
所述B相组合物包括1％-9％的地龙浸膏和1％-9％的溶剂水；
所述C相组合物包括0.02％-5％的积雪草总苷、0.02％-5％的人参总皂苷、0.01％-5％的苦参碱和1％-9.9％的溶剂水；
所述D相组合物包括0.1％-5％的蛇床子浸膏、0.2％-9％的迷迭香醇浸膏、0.4％-9％的乙醇、0.01％-1％的薄荷脑、0.4％-9％的表面活性剂和0.05％-2％的蕲艾叶油；所述表面活性剂为RH40和TW80中的至少一种；
以所述洁阴液总原料重量为100％计，所述百分比均为各组分占总原料的重量百分比，
其中，所述多味壳聚糖溶液的原料包括有机酸和糖组分，所述糖组分为壳聚糖和壳寡糖中的至少一种；
所述地龙浸膏的原料包括地肤子和龙胆；
所述蛇床子浸膏的原料包括蛇床子和乙醇；
所述迷迭香醇浸膏的原料包括迷迭香和乙醇。
本发明的目的之二在于提供一种所述的洁阴液的制备方法，其特征在于，包括如下步骤：
步骤1、制备A相组合物：取有机酸酸加入到溶剂水中搅拌均匀后，加入壳聚糖和壳寡糖搅拌溶解均匀即得多味壳聚糖溶液；取溶剂水，加入所述泊洛沙姆搅拌溶解完全后，依次加入多味壳聚糖溶液和所述甜菜碱，搅拌溶解均匀，即得A相组合物；
步骤2、制备B相组合物：取龙胆和地肤子均打成粗粉，加水浸泡后，煎煮提取得到煎液，滤过后滤液浓缩，加入乙醇混匀，冷藏静置过夜，取上清液，回收乙醇，即得地龙浸膏；向所述地龙浸膏中加入溶剂水，即得B相组合物；
步骤3、制备C相组合物：将积雪草总苷、人参总皂苷、苦参碱按权利要求1的比例分别加入水中，搅拌溶解完全后，即得C相组合物；
步骤4、制备D相组合物：取迷迭香，加乙醇提取，提取液浓缩，即得迷迭香醇浸膏；取蛇床子，加乙醇提取，提取液浓缩，即得蛇床子浸膏；取乙醇溶解所述迷迭香醇浸膏，滤过取滤液，再加入薄荷脑、蕲艾叶油、所述表面活性剂和蛇床子流浸膏，搅拌均匀，即得D相组合物；
步骤5、总配：将所述B、C相组合物加入到A相组合物中搅拌均匀后，加入D相组合物搅拌均匀，滤过出料，密封储存，即得洁阴液；所述步骤1-5中各组分的配比按所述的配比。
本发明中各主要原料药的功效活性如下：
1、人参：人参活性成分可被皮肤吸收，对皮肤没有不良刺激，可以提高免疫力、抗衰老。
2、迷迭香：具有缩阴、抗氧化性和杀菌作用。
3、积雪草：清热利湿，解毒消肿。可促进皮肤生长，修复皮肤损伤。
4、地肤子：清热利湿，祛风止痒。用于小便涩痛、阴痒带下、风疹、湿疹、皮肤瘙痒。
5、龙胆：有清热燥湿，泻肝胆实火、抗菌抗炎、紧致肌肤的作用。
6、蛇床子：增强免疫功能，暖宫护巢，用于宫冷、不孕、寒湿带下，具有广谱抗菌性，能治疗多种妇科炎症。
7、苦参：清热燥湿，治疗赤白带下，阴肿阴痒，尤其对滴虫性阴道炎有效。
8、薄荷脑：能选择性地刺激人体皮肤或黏膜，引起皮肤黏膜血管收缩，对深部组织的血管也可引起收缩而起到止痒的作用。
9、壳聚糖、壳寡糖：现代医学研究指出，该成分是自然界中唯一的阳离子生物多糖，有较好的抗菌活性，能抑制真菌、细菌、和病毒的生长繁殖，起到天然抗生素的作用，以及抗炎作用，快速修复基底热损伤，快速愈合伤口，修复表皮屏障。
与现有技术相比，本发明具有如下优点和效果：
1、安全无毒，使用可靠，无刺激且不会破坏阴道的酸碱度：主要原料来源于天然药用动植物，无添加任何化学抗生素、杀菌剂、激素、防腐剂；按2002年版《消毒技术规范》规定进行毒理试验鉴定，对白色大耳家兔阴道黏膜刺激试验和白色豚鼠皮肤变态反应试验表明，本品应用于皮肤黏膜安全无刺激；pH值4.0-4.5仿真酸碱度，不会破坏阴道的酸碱度。
2、本发明的洁阴液具有多种功能，多效合一，具体地：
(1)抗菌消炎去异味：本发明的洁阴液对大肠杆菌、金黄色葡萄球菌、铜绿假单孢菌、绿脓杆菌和白色念珠菌等多种致病菌具有广泛的抑制作用，且对大肠杆菌的抑制率达到75％以上；对金黄色葡萄球菌的抑制率达到73％以上；对铜绿假单胞菌的抑制率达到59％以上；对白色念珠菌的抑制率达到79％以上。
(2)暖宫护巢：调节内分泌失调，促进雌激素分泌，有效延缓卵巢萎缩和生殖细胞的衰老，推迟更年期，延缓女性衰老；
(3)滋养紧肤：含人参总皂苷，能增强细胞活力，增加皮肤弹性，同时还具有抑制黑色素的合成性能，使肌肤美白光滑。女性私处的肌肤比较脆弱，容易松弛老化，故配合龙胆和迷迭香紧致肌肤的作用，让私处肌肤年轻化；
(4)修复损伤：能迅速激活细胞活力，促进细胞再生，促进阴道内受损的上皮细胞组织、病灶创面和溃疡面修复，提高生殖腔道的自洁自愈功能。
3、配方精良：此款配方组合多种中草药有效成分，根据寒、凉、温、热搭配的原则，按照组份的属性对草本植物进行了相对充分和平衡的搭配，能让每种植物发挥均衡的调理作用，综合具有清洁、去污、排毒、滋养、紧肤、暖宫等作用。
4、使用方便：免稀释原液配方，只需轻轻按压阀门，抑菌洗液即成泡沫状喷涌而出，瞬间充满需要清洁抑菌的部位，作用数分钟后，泡沫即自行破灭，携带污物流出，使用非常方便。
具体实施方式
实施例1洁阴液的制备
一种洁阴液，其包括70％的A相组合物、10％的B相组合物、10％的C相组合物和10％的D相组合物；其中，所述A相组合物、B相组合物、C相组合物和D相组合物包括如下含量的组分，如表1：
其中，所述多味壳聚糖溶液、地龙浸膏、蛇床子浸膏和迷迭香醇浸膏包括如下含量的组分如表2，以下份数均为重量份：
表1
表2
所述的一种洁阴液的制备方法，包括如下步骤：
步骤1、制备A相组合物：取有机酸酸加入到溶剂水中搅拌均匀后，加入壳寡糖搅拌溶解均匀即得多味壳聚糖溶液；取溶剂水，加入F407搅拌溶解完全后，依次加入多味壳聚糖溶液和C60，搅拌溶解均匀，即得A相组合物；
步骤2、制备B相组合物：取龙胆和地肤子均打成粗粉，加水浸泡后，煎煮提取得到煎液，滤过后滤液浓缩，加入乙醇混匀，冷藏静置过夜，取上清液，回收乙醇，即得地龙浸膏；向所述地龙浸膏中加入溶剂水，搅拌，静置，滤过取滤液，即得B相组合物；
步骤3、制备C相组合物：将积雪草总苷、人参总皂苷、苦参碱按权利要求1的比例分别加入水中，搅拌溶解完全后，即得C相组合物；
步骤4、制备D相组合物：取迷迭香，加乙醇提取，提取液浓缩，即得迷迭香醇浸膏；取蛇床子，加乙醇提取，提取液浓缩，即得蛇床子浸膏；取乙醇溶解迷迭香醇浸膏，滤过取滤液，再加入薄荷脑、蕲艾叶油、RH40和蛇床子流浸膏，搅拌均匀，即得D相组合物；
步骤5、总配：将所述B、C相组合物加入到A相组合物中搅拌，90-100℃水浴保温搅拌10分钟，降温至50-60℃，搅拌下加入D相组合物搅拌均匀，搅拌下降温至常温；取样检查外观和pH值，溶液应澄清透明，pH值(25℃)应在4.0-4.5。100目滤过出料至干燥干净的容器中密封储存待灌装。配制完成的洁阴液充填于气雾罐中，封装抛射剂(氢氟烷烃、二甲醚、烷烃、二氧化碳、氮气等液化气体)，抛射剂的质量分数在5％-50％，完成定量包装和装箱。得洁阴液成品。
实施例2洁阴液的制备
一种洁阴液，其中，A相组合物、B相组合物、C相组合物和D相组合物包括如下含量的组分，如表3；所述多味壳聚糖溶液、地龙浸膏、蛇床子浸膏和迷迭香醇浸膏包括如下含量的组分如表4，以下份数均为重量份：
表3
表4
所述的一种洁阴液的制备方法，具体步骤同实施例1。
实施例3洁阴液的制备
一种洁阴液，其中，A相组合物、B相组合物、C相组合物和D相组合物包括如下含量的组分，如表5；所述多味壳聚糖溶液、地龙浸膏、蛇床子浸膏和迷迭香醇浸膏包括如下含量的组分如表6，以下份数均为重量份：
表5
表6
所述的一种洁阴液的制备方法，具体步骤同实施例1。
实施例4洁阴液的制备
一种洁阴液，其中，A相组合物、B相组合物、C相组合物和D相组合物包括如下含量的组分，如表7；所述多味壳聚糖溶液、地龙浸膏、蛇床子浸膏和迷迭香醇浸膏包括如下含量的组分如表8，以下份数均为重量份：
表7
表8
所述的一种洁阴液的制备方法，具体步骤同实施例1。
实验例1体外抑菌试验
1、试验样品的制备
(1)实施例1-4的洁阴液。
(2)对照样品：市场上购买的一般的洁阴液。
2、试验器材
(1)金黄色葡萄球菌(ATCC6538)、铜绿假单胞菌(ATCC15442)、大肠杆菌(8099)、白色念珠菌(ATCC10231)菌悬液。
(2)抑菌剂载体(5mm直径园形新华一号定性滤纸片,经压力蒸汽灭菌处理后，置120℃烤干2h,保存备用)。
(3)活菌培养计数所需器材(见《消毒技术规范》2002年版2.1.1.3)。
(4)微量移液器(5μl～50μl,可调式)。
(5)游标卡尺。
(6)营养琼脂培养基、胰蛋白胨大豆琼脂培养基与沙堡琼脂培养基
3、操作程序
(1)抑菌片的制备：对液体抑菌剂，取无菌并干燥的滤纸片。每片滴加原液20μl，然后将滤纸片平放于清洁的无菌平皿内,开盖置温箱(37℃)中烤干，或置室温下自然干燥后备用。
(2)阴性对照样片的制备：取无菌干燥滤纸片,每片滴加无菌蒸馏水20μl，干燥后备用。
(3)试验菌的接种:用无菌棉拭子蘸取浓度为5×105cfu/ml～5×106cfu/ml试验菌悬液，在营养琼脂培养基平板表面均匀涂抹3次。每涂抹1次，平板应转动60°，最后将棉拭子绕平板边缘涂抹一周。盖好平皿，置室温干燥5min。
(4)抑菌剂样片贴放:每次试验贴放1个染菌平板,每个平板贴放4片试验样片,1片阴性对照样片,共5片。用无菌镊子取样片贴放于平板表面。各样片中心之间相距25mm以上，与平板的周缘相距15mm以上。贴放好后，用无菌镊子轻压样片，使其紧贴于平板表面。盖好平皿，置37℃温箱，培养16h～18h观察结果。用游标卡尺测量抑菌环的直径(包括贴片)并记录。试验重复3次。
测量抑菌环时，应选均匀而完全无菌生长的抑菌环进行。测量其直径应以抑菌环外沿为界。
4、试验结果
表9：洁阴液体外抑菌试验杀灭率结果
表明本发明的洁阴液对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌和白色念珠菌等多种菌具有显著的抑制作用，且对大肠杆菌的抑制率达到75％以上；对金黄色葡萄球菌的抑制率达到73％以上；对铜绿假单胞菌的抑制率达到59％以上；对白色念珠菌的抑制率达到79％以上。
实验例2洁阴液对试验动物皮肤变态反应试验及阴道黏膜刺激试验
1、样品：实施例1-4的洁阴液。
2、试验动物：SD大鼠，雌性，普通级，42只，体重230克-250克，随机分7组，实施例1-4、赋形剂组、空白对照组和阳性对照组，每组6只。
3、试验方法：参照2002年版《消毒技术规范》。将纱布在洁阴液中充分浸透后，取出置动物阴道内，与阴道黏膜接触4小时。赋形剂组用棉条0.01克浸以灭菌生理盐水作同样的试验。空白对照组不做任何处理。阳性对照组即已知的会引起皮肤刺激的药物；于24小时处死动物，取出局部阴道组织，观察有无充血、水肿现象。参照2002年版《消毒技术规范》中皮肤刺激反应强度的评分标准评分及皮肤刺激强度分级，进行对阴道黏膜刺激强度的评定。
4、试验结果：
表10：洁阴液对试验动物皮肤变态反应试验
表11：洁阴液对试验动物阴道黏膜刺激试验
洁阴液对大鼠阴道黏膜刺激反应最高总积分均值为0，属无刺激性。
应用例：临床应用
黄冈市人民医院于2016年8月至2016年12月用本制剂对100名女性进行了临床观察，结果报告如下：
一、对象：选择30-55岁的女性，检测其雌激素水平下降，将有症状积分在10分以上者纳入观察范围。
二、方法：80名女性均外用本制剂，每日1次，40岁以下者每次3～6g；40～45岁，每次3～8g；50岁以上或绝经者，每次5～8g，均睡前使用，连续使用1个月，月经期间停用，性生活不禁。
三、观察指标
观察雌激素不足所表现出的症状和体征，同时观察使用前后血中雌激素水平。100例女性表现出的症状和体征及使用本制剂后症状和体征改善情况见下表：
表12
从表中可看出，服用本制剂对女性雌激素分泌不足所表现出来的各种症状和体征有明显疗效。
临床应用表明，本发明的洁阴洗液能暖宫护巢：调节内分泌失调，促进雌激素分泌，有效延缓卵巢萎缩和生殖道细胞的衰老，推迟更年期。
典型病例：
1、谭某，女，35岁，外阴瘙痒且有轻微的灼痛，但无皮损，白带有腥臭异味，阴道分泌物呈白色豆腐渣状，同时伴有性交痛；使用本发明的外用药物组合物2周痊愈，随访3个月未复发。
2、王某，女，40岁，外阴瘙痒，内裤黄染，下体有臭鸡蛋样异味，分泌物呈豆渣样，并伴有尿黄，尿少尿频，尿痛等尿路感染症状，舌苔黄腻；使用本发明的外用药物组合物1周症状明显改善，继续使用1个疗程症后痊愈，随访半年未复发。
3、赵某，女，28岁，外阴轻微瘙痒，白带色白质稠且有异味，舌苔白腻；使用本发明的外用药物组合物1个疗程痊愈，随访1年未复发。
所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包括在本发明的保护范围之内。
Claims (11)
1.一种洁阴液，其特征在于，其包括70％-90％的A相组合物、1％-10％的B相组合物、1％-10％的C相组合物和1％-10％的D相组合物；其中，
所述A相组合物包括1％-15％的泊洛沙姆、9％-35％的多味壳聚糖溶液、0％-10％的甜菜碱和40％-60％的溶剂水；所述泊洛沙姆为F407和F188中的至少一种；所述甜菜碱为C60和CAB35中的至少一种；
所述B相组合物包括1％-9％的地龙浸膏和1％-9％的溶剂水；
所述C相组合物包括0.02％-5％的积雪草总苷、0.02％-5％的人参总皂苷、0.01％-5％的苦参碱和1％-9.9％的溶剂水；
所述D相组合物包括0.1％-5％的蛇床子浸膏、0.2％-9％的迷迭香醇浸膏、0.4％-9％的乙醇、0.01％-1％的薄荷脑、0.4％-9％的表面活性剂和0.05％-2％的蕲艾叶油；所述表面活性剂为RH40和TW80中的至少一种；
以所述洁阴液总原料重量为100％计，所述百分比均为各组分占总原料的重量百分比，
其中，所述多味壳聚糖溶液的原料包括有机酸和糖组分，所述糖组分为壳聚糖和壳寡糖中的至少一种；
所述地龙浸膏的原料包括地肤子和龙胆；
所述蛇床子浸膏的原料包括蛇床子和乙醇；
所述迷迭香醇浸膏的原料包括迷迭香和乙醇。
2.如权利要求1所述的洁阴液，其特征在于，所述多味壳聚糖溶液的配方组分为0％-50％的壳寡糖、0％-50％的壳寡糖和10％-70％的有机酸。
3.如权利要求1或2所述的洁阴液，其特征在于，所述多味壳聚糖溶液中的有机酸为乳酸、醋酸、盐酸、柠檬酸、磷酸和酒石酸中的一种。
4.如权利要求1所述的洁阴液，其特征在于，所述地龙浸膏的配方组分为30％-70％的地肤子和30％-70％的龙胆。
5.如权利要求1所述的洁阴液，其特征在于，所述蛇床子浸膏的配方组分为1％-50％的蛇床子和50％-99％的乙醇。
6.如权利要求1所述的洁阴液，其特征在于，所述迷迭香醇浸膏的配方组分为1％-50％的迷迭香和50％-99％的乙醇。
7.一种如权利要求1-6任一所述的洁阴液的制备方法，其特征在于，包括如下步骤：
步骤1、制备A相组合物：取有机酸酸加入到溶剂水中搅拌均匀后，加入壳聚糖和壳寡糖搅拌溶解均匀即得多味壳聚糖溶液；取溶剂水，加入所述泊洛沙姆搅拌溶解完全后，依次加入多味壳聚糖溶液和所述甜菜碱，搅拌溶解均匀，即得A相组合物；
步骤2、制备B相组合物：取龙胆和地肤子均打成粗粉，加水浸泡后，煎煮提取得到煎液，滤过后滤液浓缩，加入乙醇混匀，冷藏静置过夜，取上清液，回收乙醇，即得地龙浸膏；向所述地龙浸膏中加入溶剂水，即得B相组合物；
步骤3、制备C相组合物：将积雪草总苷、人参总皂苷、苦参碱按权利要求1的比例分别加入水中，搅拌溶解完全后，即得C相组合物；
步骤4、制备D相组合物：取迷迭香，加乙醇提取，提取液浓缩，即得迷迭香醇浸膏；取蛇床子，加乙醇提取，提取液浓缩，即得蛇床子浸膏；取乙醇溶解所述迷迭香醇浸膏，滤过取滤液，再加入薄荷脑、蕲艾叶油、所述表面活性剂和蛇床子流浸膏，搅拌均匀，即得D相组合物；
步骤5、总配：将所述B、C相组合物加入到A相组合物中搅拌均匀后，加入D相组合物搅拌均匀，滤过出料，密封储存，即得洁阴液；所述步骤1-5中各组分的配比按权利要求1-6任一所述的配比。
8.一种如权利要求7所述的洁阴液的制备方法，其特征在于，所述步骤2中地龙浸膏的具体制备方法为：龙胆、地肤子，分别打成粗粉，加水浸泡1h，煎煮提取两次，第一次8倍量水、提取2h，第二次6倍量水、提取1h，合并煎液，滤过，滤液浓缩至药液：药材比为1：2，冷却至40～50℃，搅拌下加入2倍重量乙醇，混匀，冷藏，静置过夜，取上清液，回收乙醇，得地龙浸膏，密封冷藏，备用。
9.一种如权利要求7所述的洁阴液的制备方法，其特征在于，所述步骤4中蛇床子浸膏的具体制备方法为：蛇床子打碎成粗粉，加90％乙醇量润透浸渍过夜，至漉液基本无色止，收集漉液，减压回收乙醇，继续浓缩至稠膏，即得蛇床子浸膏。
10.一种如权利要求7所述的洁阴液的制备方法，其特征在于，所述步骤4中迷迭香醇浸膏的具体制备方法为：取迷迭香加8倍量80％的乙醇，浸渍30分钟后，回流提取1小时，滤过，收集提取液，备用；第二次加6倍量80％的乙醇，回流提取1小时，滤过，收集提取液，合并两次提取液，减压回收乙醇至无醇味，冷藏保存。
11.一种如权利要求7所述的洁阴液的制备方法，其特征在于，所述步骤5中，配制完成的洁阴液充填于气雾罐中，封装抛射剂，所述抛射剂包括氢氟烷烃、二甲醚、烷烃、二氧化碳、氮气的液化气体，且所述抛射剂的质量分数在5％-50％。
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