CN109481429B - 一种鼻腔护理喷雾剂 - Google Patents
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Abstract
本发明提供一种鼻腔护理喷雾剂，并提供该喷雾剂的使用方法。所述喷雾剂中，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％防腐剂、0.1％Gemini表面活性剂，余量为生理性海水。本发明提供的鼻腔护理喷雾剂能有效溶解鼻腔粘液、缓解鼻涕鼻塞症状，并具有较强的抗菌能力，用于急慢性鼻炎、过敏性鼻炎、鼻息肉、鼻窦炎等鼻腔疾病患者的鼻腔清洗，也可用于鼻腔日常护理，鼻炎手术后及化疗后的鼻腔清洗。
Description
技术领域
本发明属于清洗剂领域，具体涉及一种清洗鼻腔的护理喷雾剂。
背景技术
鼻炎即鼻腔炎性疾病，是病毒、细菌、变应原、各种理化因子以及某些全身性疾病引起的鼻腔黏膜的炎症。鼻炎的主要病理改变是鼻腔黏膜充血、肿胀、渗出、增生、萎缩或坏死等。临床症状包括鼻塞、多涕、嗅觉下降、头痛、头晕等，人们可采用口服药物或药物喷剂来治疗鼻炎，同时，也会采用鼻腔喷雾剂来清洗鼻腔，用以缓解部分症状。
CN2012100521550公开了一种丙酮酸钠鼻喷剂，其组分包括丙酮酸钠、丙酮酸、等渗调节剂、防腐剂和水，用于清洗去除鼻腔通道、鼻窦、黏膜纤毛中的有害污染物，但该鼻喷剂中起清洗作用的是水，对鼻腔粘液的清洗作用非常有限。
表面活性剂，是指加入少量能使其溶液体系的界面状态发生明显变化的物质。具有固定的亲水亲油基团，在溶液的表面能定向排列。表面活性剂的分子结构具有两亲性：一端为亲水基团，另一端为疏水基团；亲水基团常为极性基团，如羧酸、磺酸、硫酸、氨基或胺基及其盐，羟基、酰胺基、醚键等也可作为极性亲水基团；而疏水基团常为非极性烃链，如8个碳原子以上烃链。表面活性剂分为离子型表面活性剂(包括阳离子表面活性剂与阴离子表面活性剂)、非离子型表面活性剂、两性表面活性剂、复配表面活性剂、其他表面活性剂等。
有多个现有技术在鼻腔喷雾剂中添加了表面活性剂。CN201410022393公开了一种鼻腔清洁护理溶液及其制配方法，该护理溶液包含吐温80，其作增溶剂和稳定剂、保持溶液的质量稳定。CN201510445083公开了一种鼻喷舒喷剂，其含有苯扎氯铵，苯扎氯铵是一种阳离子表面活性剂，属非氧化性杀菌剂，具有广谱、高效的杀菌能力，能有效地控制呼吸道中菌类的繁殖和生长，并具有良好的分散、渗透作用。上述两类表面活性剂均无溶解鼻腔粘液的作用。CN200880110989公开了一种盐鼻擦及其制造方法和用途，在一种实施方案中，提供承载着清洁水溶液的吸收基体，该溶液依次可以包括相组合的无机盐、润肤剂、防腐剂和表面活性剂，所述表面活性剂，例如可可咪唑啉双乙酸二钠，来帮助除去粘液，污垢和其他物质，可选择的，或者另外，该清洁溶液可以利用二乙基己基磺化琥珀酸钠，椰油肌氨酸铵，椰油异硫代硫酸铵，或者许多其他的温和阴离子表面活性剂中的一种。由此可见，选择合适的表面活性剂，可以实现溶解鼻腔粘液、缓解鼻涕鼻塞症状的作用。但发明人在实验过程中发现，CN200880110989所选择的表面活性剂的溶解鼻腔粘液的性能有限，溶解之后也仅能短时间维持，不能实现较长时间的症状缓解。因此，急需寻找对鼻腔粘液溶解性能好的表面活性剂。
发明内容
本发明的目的在于提供一种能有效溶解鼻腔粘液、缓解鼻涕鼻塞症状的护理喷雾剂，并提供该喷雾剂的使用方法。
为了实现上述发明目的，本发明提供了以下技术方案：
一种鼻腔护理喷雾剂，包括以下组分：丙酮酸钠、丙酮酸、防腐剂、Gemini表面活性剂、生理性海水。
进一步的，上述喷雾剂中，按照重量百分比包括如下组分：0.01-0.5％丙酮酸钠、0.01-0.5％丙酮酸、0.0001-0.5％防腐剂、0.01-0.5％Gemini表面活性剂，余量为生理性海水。
进一步的，上述喷雾剂中，按照重量百分比包括如下组分：0.088-0.22％丙酮酸钠、0.02-0.11％丙酮酸、0.0001-0.25％防腐剂、0.05-0.3％Gemini表面活性剂，余量为生理性海水。
进一步的，上述喷雾剂中，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％防腐剂、0.1％Gemini表面活性剂，余量为生理性海水。
进一步的，上述Gemini表面活性剂为季铵盐类阳离子表面活性剂，结构式如下：
进一步的，上述Gemini表面活性剂按照专利CN 201410819950所公开的方法制备得到。
进一步的，防腐剂选自聚六亚甲基双胍、对羟基苯甲酸酯、苯甲酸、山梨酸、苯扎氯胺中的一种。
进一步的，上述丙酮酸由酒石酸和焦硫酸钾反应合成得到。
本发明的另一目的是一种上述护理喷雾剂的使用方法，具体为：使用时打开防尘罩，头微微抬起，将喷头伸入一侧鼻孔内喷2-3次，喷时鼻腔同时吸气将护理液吸入体内，可咽下。换另一侧鼻孔，重复进行前面使用方法即可。使用后清洁喷嘴，盖上防尘罩。推荐每次每侧鼻孔2-3喷，每日4-5次，也可遵医嘱或依据个人症状确定使用量和次数。
本发明的有益效果是：本发明提供的鼻腔护理喷雾剂能有效溶解鼻腔粘液、缓解鼻涕鼻塞症状，并具有较强的抗菌能力，用于急慢性鼻炎、过敏性鼻炎、鼻息肉、鼻窦炎等鼻腔疾病患者的鼻腔清洗，也可用于鼻腔日常护理，鼻炎手术后及化疗后的鼻腔清洗。护理液pH值接近鼻腔粘液中糖蛋白的等电点，且与鼻腔粘膜内层等渗，为纤毛提供适宜的运动环境，能帮助纤毛和粘液正常运动，恢复功能。其中，生理学海水具有明显的清洗鼻腔和修复粘膜的作用。Gemini表面活性剂至少有两个疏水碳氢链、两个极性头基和一个联接基团，对鼻腔粘液具有非常好的持续溶解能力，阳离子季铵盐Gemini表面活性剂具有良好的杀菌抑菌性能。酒石酸和焦硫酸钾反应合成得到的丙酮酸，因为经过高温反应以及纯化步骤，相比市售的丙酮酸具有无菌和高纯度的优点。
具体实施方式
实施例1
一种鼻腔护理喷雾剂，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％聚六亚甲基双胍、0.1％Gemini表面活性剂，余量为生理性海水。
上述Gemini表面活性剂为季铵盐类阳离子表面活性剂，结构式如下：
本品外观为物色透明液体，体外无细胞毒性，无皮内刺激反应，无迟发型超敏反应；理化指标：pH：6.0-8.0，重金属(以Pb计)应≤20mg/ml；卫生学指标：细菌菌落总数应≤100cfu/ml，真菌菌落总数≤10cfu/ml，未检出大肠菌群、绿脓杆菌和金黄色葡萄球菌。
实施例2
一种鼻腔护理喷雾剂，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％聚六亚甲基双胍，余量为生理性海水。
实施例3
一种鼻腔护理喷雾剂，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％聚六亚甲基双胍、0.1％吐温80，余量为生理性海水。
实施例4
一种鼻腔护理喷雾剂，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％聚六亚甲基双胍、0.1％可可咪唑啉双乙酸二钠，余量为生理性海水。
实施例4
将上述护理喷雾剂应用于50个过敏性鼻炎患者，在同一天内，每隔4小时依次应用实施例1-4的护理喷雾剂，期间不服用任何药物制剂。
使用方法：打开防尘罩，头微微抬起，将喷头伸入一侧鼻孔内喷2次，喷时鼻腔同时吸气将护理液吸入体内，可咽下。换另一侧鼻孔，重复进行前面使用方法即可。
实验结果如下表：
本次研究结果显示：添加有表面活性剂的护理喷雾剂，比没有添加的见效更快、通讯持续时间更长；相比于吐温80和可可咪唑啉双乙酸二钠，季铵盐类阳离子Gemini表面活性剂的效果更为明显。
以上所述仅为本发明的优选实施例，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的相关技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替换，其中所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (4)
1.一种鼻腔护理喷雾剂，其特征在于，按照重量百分比包括如下组分：
0.088-0.22％丙酮酸钠、0.02-0.11％丙酮酸、0.0001-0.25％防腐剂、0.05-0.3％Gemini表面活性剂，余量为生理性海水；上述Gemini表面活性剂为季铵盐类阳离子表面活性剂，结构式如下：
2.根据权利要求1所述的鼻腔护理喷雾剂，其特征在于，上述喷雾剂中，按照重量百分比包括如下组分：0.22％丙酮酸钠、0.05％丙酮酸、0.05％防腐剂、0.1％Gemini表面活性剂，余量为生理性海水。
3.根据权利要求1或2所述的鼻腔护理喷雾剂，其特征在于，防腐剂选自聚六亚甲基双胍、对羟基苯甲酸酯、苯甲酸、山梨酸、苯扎氯胺中的一种。
4.根据权利要求1或2所述的鼻腔护理喷雾剂，其特征在于，上述丙酮酸由酒石酸和焦硫酸钾反应合成得到。
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