CN109512802A - 一种退热贴及其制备方法 - Google Patents
一种退热贴及其制备方法 Download PDFInfo
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- CN109512802A CN109512802A CN201811528337.4A CN201811528337A CN109512802A CN 109512802 A CN109512802 A CN 109512802A CN 201811528337 A CN201811528337 A CN 201811528337A CN 109512802 A CN109512802 A CN 109512802A
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- plaster used
- defervescence plaster
- menthol
- gel
- preservative
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- 239000011505 plaster Substances 0.000 title claims abstract description 76
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 54
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims abstract description 34
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 34
- 229940041616 menthol Drugs 0.000 claims abstract description 34
- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 0.000 claims abstract description 26
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- 239000000463 material Substances 0.000 claims abstract description 22
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims abstract description 17
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- UTUUIUQHGDRVPU-UHFFFAOYSA-K aluminum;2-aminoacetate;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Al+3].NCC([O-])=O UTUUIUQHGDRVPU-UHFFFAOYSA-K 0.000 claims abstract description 16
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- NNMHYFLPFNGQFZ-UHFFFAOYSA-M sodium polyacrylate Chemical compound [Na+].[O-]C(=O)C=C NNMHYFLPFNGQFZ-UHFFFAOYSA-M 0.000 claims description 15
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- 238000001704 evaporation Methods 0.000 abstract description 4
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- ABBQHOQBGMUPJH-UHFFFAOYSA-N sodium;2-hydroxybenzoic acid Chemical compound [Na+].OC(=O)C1=CC=CC=C1O ABBQHOQBGMUPJH-UHFFFAOYSA-N 0.000 abstract 1
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- 238000005260 corrosion Methods 0.000 description 3
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
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- ZWVHTXAYIKBMEE-UHFFFAOYSA-N 2-hydroxyacetophenone Chemical compound OCC(=O)C1=CC=CC=C1 ZWVHTXAYIKBMEE-UHFFFAOYSA-N 0.000 description 1
- 206010063659 Aversion Diseases 0.000 description 1
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical compound [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 description 1
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- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 1
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- 241000700605 Viruses Species 0.000 description 1
- 125000003158 alcohol group Chemical group 0.000 description 1
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical compound [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 description 1
- 239000005030 aluminium foil Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
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Abstract
本发明涉及医药技术领域,具体涉及一种退热贴及其制备方法。本发明提供的退热贴包括背衬材料、凝胶基质层和盖衬材料,凝胶基质层包括薄荷醇、酒石酸、硅烷二醇水杨酸酯、聚丙烯酸钠、甘油、甘羟铝、乙二胺四乙酸二钠、防腐剂和水。本发明提供的退热贴刚贴上时薄荷醇挥发、水分汽化达到快速降温效果,因硅烷二醇水杨酸酯吸附一定量薄荷醇,部分薄荷醇缓慢挥发,可延长退热时间,解决了现有退热贴作用时间短,适应性差的缺点。并且,防腐剂中含有甘油辛酸酯,辛酰羟肟酸和对羟基苯乙酮增加甘油的保湿效果,起到维持贴剂中水凝胶基质的稳定性的作用,使凝胶基质不易受温度影响、水分蒸发过快而凝固,维持贴剂水凝胶基质稳定性,延长降温时间。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种退热贴及其制备方法。
背景技术
发热是最常见的临床症状之一,通常为病毒、细菌感染或其他疾病引起的。发热是人体的一种保护性反应,通过发热可刺激网状内皮系统的吞噬功能,形成抗体,增加白细胞活力以及肝脏解毒作用等,但发热会人食欲减退、乏力,影响身体各个器官和组织的功能。为快速降温,人们普遍会服用解热镇痛药,以及杀菌消炎的抗生素,而服用药物会给人体带来不良反应,尤其是孕妇、婴儿等特殊人群更不宜服用抗菌素。
退热贴也叫退热贴片、降温贴、冷敷贴、一贴凉,是以凝胶为载体,通过凝胶内水分的汽化带走人体局部大量热量,起到降温、退热的作用。退热贴基本构造由料膜、非织造布以及凝胶层组成,凝胶层包括医用高分子凝胶、薄荷、冰片和水,因此,凝胶层为其主要功效部分。退热贴属于物理降温用品,其无需口服,不良反应少或几乎没有,被广泛运用于小儿发热发烧、消夏及高温作业等情况。
专利文献CN201410534070.5公开了一种高分子水凝胶儿童退热贴及其制备方法,该退热贴和水凝胶层中含有高分子物质10%~20%、保湿因子5%~15%、薄荷醇0.08%~1%、冰片0.01%~0.5%、蒸馏水73%~90%、乙醇0.2%~2.0%,制备得到的退热贴通过水的蒸发吸热,带走人体发烧时产生的热量,从而达到降温退热的效果,具有物理降温与天然清凉剂降温的双重功效,但该退热贴在使用时随薄荷醇和冰片的快速挥发,使后续降温效果显著下降甚至为零,多次使用才能达到长效降温效果,反复黏贴使儿童对其适用性下降。
因此,有必要提供一种降温快速并且可持续降温的退热贴,增加儿童对退热贴的适应性。
发明内容
本发明旨在提供一种既可快速降温又可延长降温时间的退热贴,该退热贴降温效果好,稳定性好,适合儿童使用,为此,本发明采用以下技术方案:
本发明提供的一种退热贴,包括背衬材料、凝胶基质层和盖衬材料,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.5%-1%、酒石酸0.2%-0.6%、硅烷二醇水杨酸酯0.5%-5%、聚丙烯酸钠4%-8%、甘油20%-30%、甘羟铝0.15%-0.45%、乙二胺四乙酸二钠0.2%-0.3%、防腐剂0.2%-0.4%和水54%-75%。
优选地,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.6%-0.8%、酒石酸0.3%-0.4%、硅烷二醇水杨酸酯1%-2%、聚丙烯酸钠5%-7%、甘油22%-26%、甘羟铝0.2%-0.3%、乙二胺四乙酸二钠0.24%-0.26%、防腐剂0.25%-0.35%和水62%-71%。
优选地,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.75%、酒石酸0.36%、硅烷二醇水杨酸酯1.5%、聚丙烯酸钠6%、甘油24%、甘羟铝0.27%、乙二胺四乙酸二钠0.25%、防腐剂0.3%和水66.57%。
优选地,所述聚丙烯酸钠为NP 700聚丙烯酸钠。
优选地,所述防腐剂为GC-04。
优选地,所述背衬材料为无纺布背衬层。
优选地,所述盖衬材料为聚羧乙烯薄膜。
另外,本发明还提供了一种退热贴的制备方法,包括以下步骤:
S1.将聚丙烯酸钠、甘油、甘羟铝和乙二胺四乙酸二钠加入水中,混合均匀,静置8-12h,得混合溶液A;
S2.将薄荷醇、酒石酸、硅烷二醇水杨酸酯和防腐剂加入水中,混合均匀,得混合溶液B,将混合溶液B加入至步骤S1中制得的混合溶液A中,搅拌10-15min,冷却至室温,得混合凝胶基质;
S3.将步骤S2的混合凝胶基质基质涂抹在盖衬层聚羧乙烯薄膜上,压上背衬层无纺布,灭菌,即得。
本发明中表面活性剂硅烷二醇水杨酸酯具有分散、吸附作用,因薄荷醇微溶于水,溶解度低于0.1%(w/v),硅烷二醇水杨酸酯与薄荷醇混合后吸附薄荷醇,使其在水中分布均匀,随后,甘羟铝和酒石酸混合后发生中和反应,使凝胶基质进一步固化,反应后的甘羟铝中Al3+上链接的O原子和硅烷二醇水杨酸酯上Si上连接的H原子通过氢键结合形成多孔状结构排列,具有强吸附作用,更好地吸附薄荷醇,现有退热贴使用时,因薄荷醇具有清凉感和挥发性,刚贴上时薄荷醇挥发、水分汽化达到快速降温效果,本发明因硅烷二醇水杨酸酯吸附一定量薄荷醇,使薄荷醇缓慢挥发,延长退热时间。
防腐剂GC-04含有甘油辛酸酯,辛酰羟肟酸,对羟基苯乙酮,和甘油一起协同作用,增加甘油的保湿效果,起到维持贴剂中水凝胶基质的稳定性的作用,使凝胶基质不易受温度影响、水分蒸发过快而凝固,维持贴剂水凝胶基质稳定性,延长降温时间。
与现有技术相比,本发明的退热贴具有以下优点:
(1)本发明提供的退热贴中含有硅烷二醇水杨酸酯、甘羟铝和酒石酸,使制备得到的退热贴在刚贴上时,未被硅烷二醇水杨酸酯吸附的薄荷醇挥发、水分汽化达到快速降温效果,被硅烷二醇水杨酸酯吸附的部分薄荷醇缓慢挥发,延长退热时间,解决了现有退热贴作用时间短、适应性差的问题。
(2)本发明提供的退热贴中的防腐剂GC-04含有甘油辛酸酯,辛酰羟肟酸,对羟基苯乙酮,实验发现,防腐剂GC-04可增加甘油的保湿效果,起到维持贴剂中水凝胶基质的稳定性的作用,使凝胶基质不易受温度影响以及因水分蒸发过快而凝固,维持贴剂水凝胶基质稳定性,延长降温时间。
具体实施方式
以下通过实施例形式的具体实施方式,对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下实施例。
实施例1、一种退热贴
所述退热贴由背衬材料无纺布、凝胶基质层和盖衬材料聚羧乙烯薄膜组成,所述凝胶基质层由下列成分及其质量百分数组成:
薄荷醇0.5%、酒石酸0.2%、硅烷二醇水杨酸酯0.5%、NP 700聚丙烯酸钠4%、甘油20%、甘羟铝0.15%、乙二胺四乙酸二钠0.2%、防腐剂GC-040.2%和水74.25%。
制备方法如下:
S1.将聚丙烯酸钠、甘油、甘羟铝和乙二胺四乙酸二钠加入水中,混合均匀,静置8-12h,得混合溶液A;
S2.将薄荷醇、酒石酸、硅烷二醇水杨酸酯和防腐剂加入水中,混合均匀,得混合溶液B,将混合溶液B加入至步骤S1中制得的混合溶液A中,搅拌10-15min,冷却至室温,得混合凝胶基质;
S3.将步骤S2的混合凝胶基质基质涂抹在盖衬层聚羧乙烯薄膜上,压上背衬层无纺布,灭菌,即得。
实施例2、一种退热贴
所述退热贴由背衬材料无纺布、凝胶基质层和盖衬材料聚羧乙烯薄膜组成,所述凝胶基质层由下列成分及其质量百分数组成:
薄荷醇1%、酒石酸0.4%、硅烷二醇水杨酸酯1%、NP 700聚丙烯酸钠7%、甘油24%、甘羟铝0.3%、乙二胺四乙酸二钠0.26%、防腐剂GC-040.35%和水65.89%。
制备方法与实施例1类似。
实施例3、一种退热贴
所述退热贴由背衬材料无纺布、凝胶基质层和盖衬材料聚羧乙烯薄膜组成,所述凝胶基质层由下列成分及其质量百分数组成:
薄荷醇0.75%、酒石酸0.36%、硅烷二醇水杨酸酯1.5%、聚丙烯酸钠6%、甘油24%、甘羟铝0.27%、乙二胺四乙酸二钠0.25%、防腐剂GC-040.3%和水66.57%。
制备方法与实施例1类似。
对比例1、一种退热贴
所述退热贴由背衬材料无纺布、凝胶基质层和盖衬材料聚羧乙烯薄膜组成,所述凝胶基质层由下列成分及其质量百分数组成:
薄荷醇0.75%、酒石酸0.36%、聚丙烯酸钠6%、甘油24%、甘羟铝0.27%、乙二胺四乙酸二钠0.25%、防腐剂GC-040.3%和水68.07%。
制备方法与实施例1类似。
与实施例3的区别在于无硅烷二醇水杨酸酯。
对比例2、一种退热贴
所述退热贴由背衬材料无纺布、凝胶基质层和盖衬材料聚羧乙烯薄膜组成,所述凝胶基质层由下列成分及其质量百分数组成:
薄荷醇0.75%、酒石酸0.36%、硅烷二醇水杨酸酯1.5%、聚丙烯酸钠6%、甘油24%、甘羟铝0.27%、乙二胺四乙酸二钠0.25%、防腐剂0.3%和水66.57%。
制备方法与实施例1类似。
与实施例3的区别在于防腐剂用对羟基苯甲酸乙酯代替GC-04。
试验例一、降温效果试验
1.实验对象:市售普通退热贴(购于岳阳今华医疗器械有限公司,批号:湘岳械备20140001号)、实施例1-3制得的退热贴、对比例1制得的退热贴。
2.实验方法:
取家兔使用电推剔除家兔的被毛,并在(22±2)℃实验室中饲养7天,每天上午8点和下午4点测肛温2次,连续4天。开始实验前禁食12h,自由饮水,次日上午测肛温2次,间隔1h,取平均值为正常体温。选取两次温差不超过0.3℃,平均体温在36.6~38.3℃的家兔70只,将家兔随机分为正常对照组和造模组,对照组10只,造模组60只,对造模组的家兔背部皮下注射20%干酵母悬液10mL/kg,正常对照组注射等量0.9%氯化钠注射液。
致热6h后,取体温升高0.8℃以上的家兔,60只,随机分为6组,每组10只,依次设为:阳性对照组、市售退热贴组、对比例1制得的退热贴、实施例1制得的退热贴、实施例2-3制得的退热贴。正常对照组生理盐水灌胃;造模组在家兔背部分组别贴敷退热贴。药后1、2、3、5h各测肛温1次,以正常体温为基数,计算各时间点家兔体温的变化值(△℃)。
3.实验结果:
实验结果见表1。
表1.退热贴对干酵母所致发热家兔体温的影响(n=10)
与阳性对照组相比:**P<0.01;*P<0.05。
如表1所示:
(1)正常对照组和阳性对照组数据表明,本试验造模成功,测定数值稳定,数据可靠。1h时,市售的退热贴、实施例1-3制备得到的退热贴和对比例1制备得到的退热贴与阳性对照组相比有明显降温作用,但无显著性差异;其中实施例1-3制备得到的退热贴与市售的退热贴退热效果相当,比对比例1组退热效果好。
(2)给药后2h后,市售的退热贴、实施例1-3制备得到的退热贴和对比例1制备得到的退热贴的退热效果基本达到最大值,与对照组相比,实施例1-3制备得到的退热贴有显著性差异,差异明显(P<0.01),市售的退热贴和对比例1制备得到的退热贴差异不明显(P<0.05)。
(3)给药5、6、8h后,实施例1-3制备得到的退热贴的退热效果与对照组相比仍然有显著性差异,而市售的退热贴和对比例1制备得到的退热贴的退热效果与对照组相比无差异。
(4)综上结果说明,本发明实施例1-3制备得到的退热贴的退热效果好,对比例1中因未添加硅烷二醇水杨酸酯无延长退热时间的效果,是说明硅烷二醇水杨酸酯具有延长退热贴退热时间的作用。说明在本发明提供的配方比例中,薄荷醇部分被硅烷二醇水杨酸酯吸附,因薄荷醇具有清凉感和挥发性,刚贴上时薄荷醇挥发、水分汽化达到快速降温效果,之后因硅烷二醇水杨酸酯吸附一定量薄荷醇,使薄荷醇缓慢挥发,而可延长退热时间,增加使用的适应性。
试验例二、稳定性试验
1、试验材料:实施例3和对比例2制备得到的退热贴。
2、试验方法:实施例3和对比例2制备得到的退热贴采用铝箔袋+纸盒包装,在温度为40±2℃,相对湿度为60%±10%,进行6个月温室留样试验,对样品的外观和微生物限度进行考察测定,外观评价主要观察退热贴是否柔软或变硬,凝胶层是否有结块变现象。
3、试验结果:
试验结果如表3-5所示。
表3.外观(温度40±2℃,相对湿度60%±10%)
表4.实施例3制备得到的退热贴的稳定性试验
0月 | 1月 | 2月 | 3月 | 6月 | |
总细菌数 | 无 | 10个/5cm<sup>2</sup> | 15个/5cm<sup>2</sup> | 15个/5cm<sup>2</sup> | 20个/5cm<sup>2</sup> |
霉菌、酵母菌数 | 无 | 1个/5cm<sup>2</sup> | 1个/5cm<sup>2</sup> | 2个/5cm<sup>2</sup> | 2个/5cm<sup>2</sup> |
金黄色葡萄球菌 | 未检出 | 未检出 | 未检出 | 未检出 | 未检出 |
铜绿假单胞菌 | 未检出 | 未检出 | 未检出 | 未检出 | 未检出 |
大肠杆菌 | 未检出 | 未检出 | 未检出 | 未检出 | 未检出 |
表5.对比例2制备得到的退热贴的稳定性试验
如表3-5所示,
(1)在6个月后,对比例2的退热贴大部分变硬和结块,而本发明实施例2的退热贴只出现部分变硬和些许结块,说明防腐剂GC-04具有提高退热贴稳定性的效果,且效果显著。
(2)对比例2的退热贴在6个月后检测出金黄色葡萄球菌、铜绿假单胞菌和大肠杆菌,且3个月后总细菌数量开始上升,6个月后超标。对比例2与实施例4的退热贴区别仅在于用防腐剂对羟基苯甲酸乙酯替代防腐剂GC-04,说明本发明的防腐剂GC-04的防腐效果好。
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。
Claims (8)
1.一种退热贴,包括背衬材料、凝胶基质层和盖衬材料,其特征在于,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.5%-1%、酒石酸0.2%-0.6%、硅烷二醇水杨酸酯0.5%-5%、聚丙烯酸钠4%-8%、甘油20%-30%、甘羟铝0.15%-0.45%、乙二胺四乙酸二钠0.2%-0.3%、防腐剂0.2%-0.4%和水54%-75%。
2.根据权利要求1所述的一种退热贴,其特征在于,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.6%-0.8%、酒石酸0.3%-0.4%、硅烷二醇水杨酸酯1%-2%、聚丙烯酸钠5%-7%、甘油22%-26%、甘羟铝0.2%-0.3%、乙二胺四乙酸二钠0.24%-0.26%、防腐剂0.25%-0.35%和水62%-71%。
3.根据权利要求2所述的一种退热贴,其特征在于,所述凝胶基质层包括下列成分及其质量百分数:
薄荷醇0.75%、酒石酸0.36%、硅烷二醇水杨酸酯1.5%、聚丙烯酸钠6%、甘油24%、甘羟铝0.27%、乙二胺四乙酸二钠0.25%、防腐剂0.3%和水66.57%。
4.根据权利要求1-3任一所述的一种退热贴,其特征在于,所述聚丙烯酸钠为NP 700聚丙烯酸钠。
5.根据权利要求1-3任一所述的一种退热贴,其特征在于,所述防腐剂为GC-04。
6.根据权利要求1-3任一所述的一种退热贴,其特征在于,所述背衬材料为无纺布背衬层。
7.根据权利要求1-3任一所述的一种退热贴,其特征在于,所述盖衬材料为聚羧乙烯薄膜。
8.根据权利要求1-7任一所述的退热贴的制备方法,其特征在于,包括以下步骤:
S1.将聚丙烯酸钠、甘油、甘羟铝和乙二胺四乙酸二钠加入水中,混合均匀,静置8-12h,得混合溶液A;
S2.将薄荷醇、酒石酸、硅烷二醇水杨酸酯和防腐剂加入水中,混合均匀,得混合溶液B,将混合溶液B加入至步骤S1中制得的混合溶液A中,搅拌10-15min,得混合凝胶基质;
S3.将步骤S2的混合凝胶基质基质涂抹在盖衬层聚羧乙烯薄膜上,压上背衬层无纺布,灭菌,即得。
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