CN107349243A - 一种适用于盆底康复的冷敷贴 - Google Patents
一种适用于盆底康复的冷敷贴 Download PDFInfo
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Abstract
本发明公布了一种适用于盆底康复的冷敷贴,同时公开了利用该冷敷贴能够缓解生物电刺激疗法进行盆底肌康复训练时产生的肌肉损伤。所述的冷敷贴主要包括膜液和膜纸,所述膜液包含以下质量百分数的成分:0.05%至0.5%的透明质酸,0.1%至0.5%的丙二醇,0.05%至0.5%的甘油,0.05%至0.5%的尿囊素,0.025%至0.5%的羟苯甲酯,0.1%至0.5%的卡波姆,0.1%至0.5%的pH调节剂,人参提取物3.5%至6.5%,当归提取物3.5%至6.5%,三七提取物3.5%至6.5%,冰片0.1%至0.5%及蓄冷剂。本发明能够降低局部组织温度,可以达到收缩局部血管,镇痛,减轻炎性肿胀等多种效果。
Description
技术领域
本发明涉及一种适用于盆底康复的冷敷贴。
背景技术
盆底功能障碍性疾病(pe1vic floor dysfunction , PFD) 是产后女性及更年期女性的多发病,严重影响女性身心健康和生活质量,现己成为威胁妇女健康的5 种常见慢性疾病之一。其临床症状主要表现为尿液储存及排泄障碍、盆腔脏器脱垂、慢性盆腔疼痛、大使储存及排泄障碍、性功能障碍等,流行病学调查研究发现,在成年女性中的发病率约为20%~ 40% ,随着人口的老龄化进展,发病率呈上升趋势,30年后其发病率将增加1 倍。盆底康复治疗是防治的关键环节,目前国内外盆底功能康复疗法是肌电生物反馈训练和神经肌肉电剌激疗法,其是治疗盆底功能障碍性疾病的一线治疗方法,就是将一个阴道电极放入患者阴道,治疗设备通过阴道电极采集患者盆底表面肌电信号或发出脉冲电剌激,进行盆底肌电生物反馈训练和神经肌肉电剌激治疗,唤醒被损伤的盆底肌肉,增加盆底肌肉肌力和弹性,使盆底功能恢复正常,并增强阴道紧缩度,提高性生活质量,同时有利于预防、治疗尿夫禁、子宫脱垂、阴道松弛等盆底障碍性疾病。但是这类治疗方法会对盆底肌产生一定的刺激,会对盆底肌肉造成一定损伤。因此,在进行生物电刺激疗法的同时,需要对盆底肌肉进行一定的修复与保护。
发明内容
针对上述问题,本发明提供一种适用于盆底康复的冷敷贴,将浸过护理液的冷敷贴置于阴部,即可进行阴部护理,有效的简化了女性外阴护理的过程,同时,可根据使用需要即时使用和更换护理膜。
具体技术方案如下:本发明一种女性护理膜,包括膜液和膜纸,其特征在于所述膜液包含以下质量百分数的成分: 0.05% 至0.5% 的透明质酸, 0.1% 至0.5% 的丙二醇,0.05% 至0.5% 的甘油, 0.05% 至0.5% 的尿囊素, 0.025% 至0.5% 的羟苯甲酯, 0.1% 至0.5% 的卡波姆, 0.1% 至0.5% 的pH调节剂,人参提取物3.5%至6.5%,当归提取物3.5%至6.5% ,三七提取物3.5%至6.5%,冰片0.1% 至0.5%及蓄冷剂。
作为优选,进一步的技术方案是所述膜液包含以下质量百分数的成分:0.1%的透明质酸,0.25%的丙二醇,0.25%的甘油,0.25%的尿囊素,0.2%的羟苯甲酯,0.20%的卡波姆,0.75% 的pH调节剂,人参提取物4.5%,当归提取物4.5%,三七提取物4.5%,冰片0.3%及蓄冷剂。
作为优选,进一步的技术方案是所述pH调节剂为氢氧化钾溶液或氢氧化钠溶液。
作为优选,进一步的技术方案是透明质酸由中分子量透明质酸及小分子量透明质酸构成。
作为优选,进一步的技术方案是中分子量透明质酸和小分子量透明质酸的质量比为1:1。
作为优选,进一步的技术方案是所用的蓄冷剂为聚乙烯醇-硼砂高效蓄冷剂。
作为优选,进一步的技术方案是透明质酸敷料涂覆或浸泡于无纺布上。
作为优选,进一步的技术方案是无纺布的形状为膜状。
本发明含有的人参提取物具有极强的抗氧化能力,并具有促进血液循环,加速新陈代谢等多重功效,可有效调理肌肤,恢复其健康年轻状态。当归提取物具有改善人体皮肤颜色,增加皮肤白皙、透明效果,透明质酸可瞬间深层保湿、增加皮肤弹性与张力,恢复肌肤正常油水平衡,冰片可以刺激盆底肌收缩,辅助盆底肌康复,蓄冷剂能够保持一定的较低温度,达到冷敷的目的。所以本发明的冷敷贴能有效安全的提高皮肤活力,促进皮肤新陈代谢能力与胶原蛋白的合成,缓解生物电刺激疗法进行盆底肌康复训练时产生的肌肉损伤。
与现有技术相比,本发明具有下列有益效果:(1)本发明同时采用人参提取物、当归提取物、三七提取物及冰片为冷敷贴的有效成分,所得冷敷贴能够达到收缩局部血管,镇痛,减轻炎性肿胀等多种效果。 (2) 从产品的安全性来看,上述均是天然中药,比其它化学制剂对皮肤的刺激性小。 (3)从产品的实用性来看,膜状女性专用护理产品比液体型护理产品方便卫生。
具体实施方式
为了更充分理解本发明的技术内容,下面结合具体实施例对本发明的技术方案进一步介绍和说明。
以下实施例中制备的护理液,各组分百分比为重量百分比,去离子水的含量为其他组分百分比和的余量。
实施例一
本次实验所采用的膜液成分如下,0.1%的透明质酸,0.25%的丙二醇,0.25%的甘油,0.25%的尿囊素,0.2%的羟苯甲酯,0.20%的卡波姆, 0.75% 的pH调节剂,白芷提取物4.5%,人参提取物4.5%,当归提取物4.5%,三七提取物4.5%,冰片0.3%及蓄冷剂。
在本实施例中,透明质酸补水性能可更好的提供水环境,同时促进胶原生长;草本提取成分提供更好微环境,补充营养成分。
实施例二
以上述的实施例为基础,本次实验所采用的透明质酸敷料成分如下(以质量百分比计):0.4%的透明质酸,0.2%的丙二醇,0.2%的甘油,0.3%的尿囊素,0.1%的羟苯甲酯,0.20%的卡波姆, 0.75% 的pH调节剂,白芷提取物5%,人参提取物5%,当归提取物5%,三七提取物5%,冰片0.3%及蓄冷剂。
在本实施例中,实验采用上述的配比配制而成的膜液基本实现与实施例一相类似的技术效果。
实施例三
在上述成分配比的基础上,发明人还认为可在透明质酸敷料中加入其它的辅助成分,因此在本实施例中,在上述成分中预留了可加入其它辅助成分的空间,具体为以质量百分比计: 0.4%的透明质酸,0.2%的丙二醇,0.2%的甘油,0.3%的尿囊素,0.1%的羟苯甲酯,0.20%的卡波姆, 0.75% 的pH调节剂,白芷提取物5%,人参提取物5%,当归提取物5%,三七提取物4.5%,冰片0.3%,6.25% 的其它辅助成分及蓄冷剂。
在本实施例中,实验采用上述配比配制而成的膜液基本延续了实施例一与实施例二中配比的辅助治疗效果,并且可根据添加的除上述成分之外的辅助成分进行治疗效果的叠加;但需要说明的是,上述6.25%的其它辅助成分应为化学性能温和的物质,混入透明质酸敷料中后不可与上述任意一种成分的化学性能相冲突。
实施例四
按照实施例三中透明质酸敷料的配比,发明人选用不同的成分质量百分比再次进行了实验,具体如下:以质量百分比计: 0.4%的透明质酸,0.2%的丙二醇,0.2%的甘油,0.3%的尿囊素,0.1%的羟苯甲酯,0.20%的卡波姆, 0.75% 的pH调节剂,白芷提取物5%,人参提取物5%,当归提取物5%,三七提取物4.5%,冰片0.3% ,4.25% 的其它辅助成分及蓄冷剂。
在不考虑在透明质酸敷料中加入的其它辅助成分与现有成分存在化学性能冲突的情况下,本次实验所获得技术效果基本与实施例三所类似。
至此,上述所给出的透明质酸敷料中各种成分范围中的任意一个值,经混合后均可用于生产女性专用护理膜的膜液,且获得上述至少一个技术效果。
临床疗效
选取2016年6月至2017年6月期间收治的112例产后6周归院复诊足月妊娠产妇,均经阴道分娩(或者70%以上经阴道分娩),分娩顺利且无严重疾病史,产妇年龄在22~36岁之间,按国际通用的会阴肌力测试法对其进行盆底肌力测定盆底肌力测定均低于3级。将产妇随机按康复治疗方式分为盆底肌训练组、盆底电刺激组、盆底肌训练联合护理冷敷贴治疗组、盆底电刺激联合护理冷敷贴治疗组,每组30例,进行产后盆底康复的临床效果观察。
一、纳入/排除标准:1.纳入标准单胎婴儿存活且为初次分娩产妇;对本组实验知情同意并自愿参加,配合康复治疗; 无泌尿系统感染及肾脏功能性病变患者。2.排除标准存在严重心脏疾病、糖尿病、高血压患者; 已置入心脏起搏器产妇; 晚期、恶性肿瘤患者;子宫肌瘤、卵巢肿瘤等妇科疾病手术病史。
二、评定方法:
1).对盆底深、浅层肌肉进行手法检测,用口令叫患者收缩阴道,以收缩持续的时间和次数来分级:0级表示毫无收缩;1级表示能感觉到肌肉轻微收缩,但不能持续;2级能感觉肌肉明显收缩,并持续2s;3级肌肉收缩能使手指向上向前运动;持续时间可达3s;4级表示肌肉收缩有力,能抵抗手指的压力,持续时间可达4s;5级表示肌肉收缩有力,能持续抵抗手指的压力达5s或以上。
2).对外阴部位颜色进行比照,根据颜色深浅变化记录:1外阴颜色显著加深;2外阴颜色加深,变化不明显;3外阴颜色无变化;4外阴颜色变浅,变化不明显;5外阴颜色显著变浅。
三、治疗方法:
1. 盆底肌训练组:首先Kegel运动治疗,嘱产妇放轻松,平卧位,双腿屈曲,张开双腿,随呼吸节奏调节肛门。吸气时收缩肛门6s,呼气时放松6s,休息6s再重复,训练30min。每天3次。其次采用阴道哑铃训练,置入前在尾端涂抹少量润滑液,平躺或站立姿态,分开双腿缓慢置入,受阻时可稍抬高臀部继续放置。首次置入时锻炼时间保持10min,逐渐增加到30min。应减少坐卧,以走猫步等形式增加阴道收缩。
2.盆底电刺激组:采用神经肌肉电刺激仪(使用法国PHENIX USB4低频神经肌肉高级智能型治疗仪)进行康复治疗,产妇取膀胱结石位,将电极消毒,缓慢置入产妇阴道,阴式探头设置电击频率为8~10Hz,脉冲宽度设置为20~750μs,电流大小控制以患者自感肌肉跳动且无疼痛为标准,随着电疗次数的增加可根据实际情况加大电流根据盆底肌力检测结果设置仪器参数。每次治疗时间20min,2次/周,5周为1个疗程。
3.盆底肌训练联合护理冷敷贴组:该组患者在运用训练组治疗方法(治疗方法、时间、疗程均与训练组相同)的同时,清洗患处后,双手洗净,将盆底护理医用冷敷贴敷于患处,约15~20分钟取下,每日1次,2周为1个疗程。
4.盆底电刺激联合护理冷敷贴组:该组患者在运用电刺激组治疗方法(治疗方法、时间、疗程均与训练组相同)的同时,清洗患处后,双手洗净,将盆底护理医用冷敷贴敷于患处,约15~20分钟取下,每日1次,2周为1个疗程。
四、疗效观察:肌力测定依据《会阴肌力测定法》中的相关标准进行执行,所有产妇盆底肌力检测均由同一名医师执行。
1. 显效:盆底肌力均提升到3级以上,阴道无膨出症状,前后壁紧贴。
2. 有效:盆底肌力较前提高但未达到3级以上,阴道前后壁紧贴但有膨出症状。
3.无效:盆底肌力无改善,阴道前后壁未紧贴,且伴有膨出。
五、指标观察:
1. 于产后2、6个月随访复查采集各组产妇产后并发症发生情况(子宫脱垂、膀胱脱垂、直肠脱垂、尿失禁等)进行评价。
2. 于产后2、6个月分别进行随访调查各组产妇阴道肌张力、阴道肌电压、夜尿次数、阴部色泽改变等情况,阴道张力评价采用法国会阴肌肉测试标准进行评价,将阴道张力器置入阴道约5 cm 深处,根据压力表显示压力指数评价阴道肌肉张力情况,数值越高表示阴道肌肉张力越好,可作为盆底肌肉收缩能力的间接表现。
3.于治疗前、治疗后对各组产妇盆底压力、Ⅰ~Ⅱ类肌纤维进行检测,包括静息压、盆底收缩压、持续收缩压、持续时间、快速收缩压、收缩个数等指标。
4. 于治疗前、治疗后对各组产妇外阴颜色进行肉眼观察记录,可根据需要进行照片留样进行比对。
5. 于每组治疗结束后对各组产妇进行咨询,对产妇每组使用情况的舒适度、感官进行比对。
经过比较盆底电刺激联合护理冷敷贴组疗效显著,明显优于单纯盆底电刺激组,盆底肌训练联合护理冷敷贴组疗效略优于单纯盆底肌训练组。
故冷敷贴能够有效缓解盆底电刺激疗法引起的盆底肌损伤,使其疗效明显增加,并且能够对盆底肌起到收缩局部血管,镇痛,减轻炎性肿胀等多种效果,适用于盆底康复。
在本说明书中所谈到的"一个实施例"、"另一个实施例"、"实施例"等,指的是结合该实施例描述的具体特征、结构或者特点包括在本申请概括性描述的至少一个实施例中。在说明书中多个地方出现同种表述不是一定指的是同一个实施例。进一步来说,结合任一实施例描述一个具体特征、结构或者特点时,所要主张的是结合其他实施例来实现这种特征、结构或者特点也落在本发明的范围内。
尽管这里参照本发明的多个解释性实施例对本发明进行了描述,但是,应该理解,本领域技术人员可以设计出很多其他的修改和实施方式,这些修改和实施方式将落在本申请公开的原则范围和精神之内。更具体地说,在本说明书和权利要求的范围内,可以对主题组合布局的组成部件和/或布局进行多种变型和改进。除了对组成部件和/或布局进行的变型和改进外,对于本领域技术人员来说,其他的用途也将是明显的。
Claims (8)
1.一种冷敷贴膜,包括膜液和膜纸,所述膜液包含以下质量百分数的成分: 0.05% 至0.5% 的透明质酸, 0.1% 至0.5% 的丙二醇, 0.05% 至0.5% 的甘油, 0.05% 至0.5% 的尿囊素, 0.025% 至0.5% 的羟苯甲酯, 0.1% 至0.5% 的卡波姆, 0.1% 至0.5% 的pH调节剂,人参提取物3.5%至6.5%,当归提取物3.5%至6.5% ,三七提取物3.5%至6.5%,冰片0.1% 至0.5%及蓄冷剂,其特征在于,可用于盆底康复,修复生物电刺激疗法导致的肌肉损伤。
2.根据权利要求1 所述的膜液,其特征在于,所述膜液包含以下质量百分数的成分:0.1%的透明质酸,0.25%的丙二醇,0.25%的甘油,0.25%的尿囊素,0.2%的羟苯甲酯,0.20%的卡波姆, 0.75% 的pH调节剂,人参提取物4.5%,当归提取物4.5%,三七提取物4.5%,冰片0.3%及蓄冷剂。
3.根据权利要求1所述的膜液,其特征在于:所述pH调节剂为氢氧化钾溶液或氢氧化钠溶液。
4.根据权利要求1所述的膜液,其特征在于: 透明质酸由中分子量透明质酸及小分子量透明质酸构成。
5.根据权利要求1所述的膜液,其特征在于:中分子量透明质酸和小分子量透明质酸的质量比为1:1。
6.根据权利要求1所述的冷敷贴,其特征在于所用的蓄冷剂为聚乙烯醇-硼砂高效蓄冷剂。
7.一种权利要求1 至5 任意一项所述膜液的应用方法,其特征在于:所述透明质酸敷料涂覆或浸泡于无纺布上。
8.根据权利要求7 所述的膜液的应用方法,其特征在于:所述无纺布的形状为膜状。
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