CN116785396A - 用于缓解痛经的卫生巾热感制剂 - Google Patents
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Abstract
本申请涉及中药制剂技术领域，具体为一种用于缓解痛经的卫生巾热感制剂，包括缓释剂、植物提取物、表面活性剂和溶剂，该制剂发热体感更为明显，发热起效时间快，热感可以维持3小时以上，使用卫生巾的过程全程都有温暖的呵护。
Description
技术领域
本申请涉及中药制剂技术领域，具体为一种用于缓解痛经的卫生巾热感制剂。
背景技术
痛经是指行经前后或月经期疼痛，呈下腹疼痛、坠胀、腰酸，其他症状包括头痛、乏力、头晕、恶心等，其盆腔、生殖道无器质性病变。我国妇女中有33.1%的人会发生痛经，其中痛经严重者占了13.55%。女性痛经是由于经期子宫肌肉痉挛性收缩，导致子宫缺血而引发。当前对于痛经的治疗，现代医学主要采用口服前列腺素合成酶抑制剂、非甾体激素类药物、解痉镇痛类药物和钙镁制剂等止痛药物进行治疗，然而止痛药虽可以缓解症状，但不能根治，且长期依赖止痛药物会产生恶心、胃肠黏膜溃疡、腹痛、粒细胞减少等副反应，并且疗效不能持久，不适合长期使用。
依据中医理论，痛经归属于中医“经行腹痛”范畴，祖国医学有关痛经的记载最早见于汉代张仲景《金匮要略·妇人杂病脉症并治》：“带下，经水不利，少腹满痛……”，认为原发性痛经的发生发展是阴阳失衡、气血失调、脏腑功能失常导致冲任瘀阻，胞官经血流通受阻所致“不通则痛”，“不荣而痛”。或因经期冒雨、涉水、游泳或经期贪食生冷，内伤于寒，或生活于湿地，风冷寒湿客于冲任、胞中，以致经血凝滞不畅；或素禀阳虚，阴寒内盛，冲任虚寒，致使经水运行迟滞，血滞不行，留聚而痛。
公开号为CN101927031的发明专利公开了“一种卫生巾热感剂”，采用了生姜油、洋甘菊或胡椒精油为主要成分敷贴于阴部，工作人员召集了100名有痛经情况的女性志愿者在经期使用喷涂该热感剂的卫生巾，65%的女性认为热感剂热效果起效时间超过3分钟，热效果起效较慢，不足以及时缓解经期所带来的不适，因此亟需对该款产品进行改进，以提升其缓解痛经的效果。
发明内容
针对现有的卫生巾热感剂起效慢的问题，本发明提出一种新的用于缓解痛经的卫生巾热感制剂。
本发明的用于缓解痛经的卫生巾热感制剂，其特征在于包括缓释剂、植物提取物、表面活性剂和溶剂，其中：
所述的缓释剂采用脂肪醇聚氧乙烯醚硫酸钠AES、吐温-80或卵磷脂；
植物提取物由生姜精油、洋甘菊精油、胡椒精油以及肉桂精油组成；
表面活性剂采用N-酰基肌氨酸；
溶剂采用去离子水；
按重量比记，所述缓释剂、植物提取物、表面活性剂和溶剂的添加比例为3~4：6~8：0.5~1：84~90.5。
进一步的，所述热感制剂中还填加有护肤剂，所述 护肤剂采用丙三醇、烷基糖苷APG或聚乙二醇PEG-200，所述护肤剂的添加比例为1~3。
所述植物提取物中生姜精油、洋甘菊精油、胡椒精油以及肉桂精油的添加比例为2：2：1：1~3。
与现有技术公开的卫生巾热感剂相比，本发明改进点在于：
一、植物提取物中添加了肉桂精油。在已经公开的植物提取物组合物，选择了具有抗炎、促进血液循环、抗过敏、舒缓神经功效的生姜精油、黑胡椒精油、洋甘菊油等草本植物提取物。而肉桂精油是一种黄色至红褐色的澄清液体，主要存在于肉桂的桂枝、桂皮、果实等部位，其有效成分主要有肉桂醛、蒎烯、邻甲氧基肉桂醛和杜松烯等。肉桂精油还具有良好的抑菌能力，对细菌及真菌均具有良好的抑制或杀灭作用。目前肉桂精油的应用主要集中在食品和制药行业作为抗菌、抗氧化剂使用，用于皮肤、特别是用于阴部的研究鲜见报道。
在植物提取物中有文献记载的具备抑菌效果的组分为洋甘菊精油和肉桂精油，洋甘菊精油对大肠杆菌和金黄色葡萄球菌的MIC值分别为0.125g/L和0.5g/L，肉桂精油对大肠杆菌和金黄色葡萄球菌的MIC值分别为0.25和0.5g/L，而肉桂精油与洋甘菊精油复配时对大肠杆菌和金黄色葡萄球菌的MIC值分别为0.5g/L和1g/L,其抑菌效果显著增加。
另一方面，在中药理论出发，肉桂有温通经脉的作用，与生姜、胡椒配伍有助于改善阳虚体质，具备散寒止痛的辅助效果，符合中医辨证施治原则。
二、制剂中添加了表面活性剂。外界化学物质经皮渗透吸收必须通过表皮或附属物如汗腺和毛囊，由于外阴汗腺和毛囊较少分布，分子量大于300的植物提取物不易通过无损的皮肤。表面活性剂分子具有双亲结构特性，可以增强植物提取物对皮肤的作用。外阴皮肤与常规身体皮肤不尽相同，主要由富含皮下脂肪的结缔组织组成，选用表面活性剂需同时考虑对皮肤的刺激性和与药剂的相容性问题，表面活性剂选用、刺激性较小且偏酸性的的N-酰基肌氨酸，促进皮肤对植物提取物的吸收；同时N-酰基肌氨酸以使植物提取物能与溶剂均匀混合，有利于药效长效释放。值得注意的是，由于阴道皮肤分布有大量皮脂腺，表面活性剂分子对细胞间脂质的溶解和提取，导致细胞脂质的减少或组成比例发生变化。表面活性剂-角质层脂质的相互作用比较复杂，都有可能会导致皮肤屏障功能恶化，皮肤的储水保湿功能降低，甚至出现刺激和干燥等症状，因此需严格控制N-酰基肌氨酸的用量，另外增大溶剂的比例，能显著缓解表面活性剂带来的刺激和干燥的不适效果。
三、增加了溶剂的比例，但阴部菌群较为复杂，湿度大容易滋生真菌和细菌，因此需依赖于肉桂精油与洋甘菊精油复配的抑菌效果实现长效抑菌作用。
四，相对于原制剂而言，其发热体感更为明显，发热起效时间快，热感可以维持3小时以上，使用卫生巾的过程全程都有温暖的呵护。通过这样的处理工艺，能够赋予卫生巾发热功效，缓解女性在经期的不适，给女性更好呵护。制剂pH值为4.3，其酸碱度位于健康女性阴道pH值3.8-4.4的范围内，有利于维持阴道益生菌群的平衡状态，对阴道粘膜的刺激符合国家标准。
具体实施方式
实施例：本发明的最佳实施方式，按以下方式实施：
（一）实验准备：
1、实验器材
①烧杯；
②电子秤（精确到0.1g）；
③喷涂瓶；
④反应釜；
⑤滴管；
2、原料准备
① AES；
②去离子水；
③洋甘菊精油；
④生姜精油；
⑤胡椒精油；
⑥肉桂精油；
⑦N-酰基肌氨酸
（二）实验过程：
A、按重量比记，将3gAES用10g纯水溶解；
B、将0.5gN-酰基肌氨酸放入纯水溶解，然后再放入2g生姜精油、2g胡椒精油、1g洋甘菊精油和1g肉桂精油在反应釜中搅拌溶解；
Ｃ、将A项加入到反应釜中与B项均匀搅拌，搅拌的速度为400r/min。搅拌30分钟后，形成澄清透明的溶液。
（三）发热性能测试方法：
测试1，人体感官测试
召集100名有痛经情况的女性志愿者在经期使用喷涂该热感剂的卫生巾，其中93%的女性认为在使用喷涂了缓释热感剂的卫生巾之后对经期疼痛确有缓解效果，剩下2%的女性认为护理液热效果过慢，不足以缓解经期所带来的不适，3%的女性感觉并未有发热或发热效果过慢，2%的女性认为热感过高，综合以上结果，该可缓解女性经期疼痛的护理液却对女性经期疼痛有缓解作用。
测试2，小鼠皮肤发热测试
选取SPF级昆明种小鼠40只，雌性，体重20g，饲养环境温度2℃，相对湿度60%左右，光照时间12h/d，自由饮食饮水喂养，采取随机分组法将小鼠分为对照组、发热剂干预组。将小鼠在室温为20℃~25℃的实验室适应3d，每天上午10：00用体温枪测量小鼠腹部皮肤3次（每次间隔20s）取平均值。实验前一天上午10：00测量小鼠体温，每隔0.5h测量一次，连续4次，取4次体温的平均值作为基础体温，剔除体温波动超过0.3℃的小鼠。实验前24h禁食不禁水。小鼠随机分为正常组、对照组、发热剂干预组。对照组不做任何处理，发热剂干预组使用几种不同浓度精油进行配比，均匀涂抹至小鼠腹部，并在0、15min、30min、1h、2h、3h、3.5h时间段进行涂抹精油部位温度测量，结果显示，使用实例1、实例2、实例3配方的小鼠涂抹部位温度较对照组小鼠有较为平稳的上升，温差为10℃，并能保持3h以上。
测试3，多次阴道粘膜刺激试验
选取普通级新西兰兔9只，雌性，体重2.0~2.5kg，饲养环境温度20℃~26℃，相对湿度40%~70%，自由饮食饮水喂养。其中实例1、实例2、实例3配方样品作为受实物1、2、3.试验时将动物仰面固定，暴露出会阴和阴道口。用注射器连接钝头软管，抽取2mL受实物，湿润软管，插入阴道口约cm，缓慢注入受试物，漏出的液体用纱布擦拭。对照组用入生理盐水做同样处理。染毒后24h，采用CO2安乐死处理动物，剖腹取出完整的阴道，纵向切开，肉眼观察是否有充血、水肿等表现。将阴道放入10%福尔马林溶液中固定24h，选取阴道的两端和中央3个部位的组织制片，HE染色后，进行组织病理学检查。
组织病理学检查结果，按阴道粘膜刺激反应评分标准对阴道粘膜的刺激反应进行评分。结果为受试物对新西兰兔阴道粘膜刺激反应强度为极轻度刺激性。
Claims (3)
1.用于缓解痛经的卫生巾热感制剂，其特征在于包括缓释剂、植物提取物、表面活性剂和溶剂，其中：
所述的缓释剂采用脂肪醇聚氧乙烯醚硫酸钠AES、吐温-80或卵磷脂；
植物提取物由生姜精油、洋甘菊精油、胡椒精油以及肉桂精油组成；
表面活性剂采用N-酰基肌氨酸；
溶剂采用去离子水；
按重量比记，所述缓释剂、植物提取物、表面活性剂和溶剂的添加比例为3~4：6~8：0.5~1：84~90.5。
2.如权利要求1所述的用于缓解痛经的卫生巾热感制剂，其特征在于热感制剂中还填加有护肤剂，所述护肤剂采用丙三醇、烷基糖苷APG或聚乙二醇PEG-200，所述护肤剂的添加比例为1~3。
3.如权利要求1所述的用于缓解痛经的卫生巾热感制剂，其特征在于植物提取物中生姜精油、洋甘菊精油、胡椒精油以及肉桂精油的添加比例为2：2：1：1~3。
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| CN101927031A (zh) * | 2010-09-03 | 2010-12-29 | 云南清逸堂实业有限公司 | 一种卫生巾热感剂 |
| CN102090950A (zh) * | 2011-02-28 | 2011-06-15 | 河南省宛西制药股份有限公司 | 一种能够缓解痛经的妇女卫生用品 |
| CN102813956A (zh) * | 2012-08-17 | 2012-12-12 | 天津市中科健新材料技术有限公司 | 一次性卫生用品用的温热暖肤剂组合物及其制备方法 |
| CN107929791A (zh) * | 2017-12-01 | 2018-04-20 | 东莞爱依纯生物科技有限公司 | 尿不湿及其制备方法 |
| CN112353874A (zh) * | 2020-11-24 | 2021-02-12 | 北京汉后中医研究院 | 一种阳虚体质复方油 |
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| CN101927031A (zh) * | 2010-09-03 | 2010-12-29 | 云南清逸堂实业有限公司 | 一种卫生巾热感剂 |
| CN102090950A (zh) * | 2011-02-28 | 2011-06-15 | 河南省宛西制药股份有限公司 | 一种能够缓解痛经的妇女卫生用品 |
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