CN105854072A - 一种医用凝胶及其用于制备医疗外用凝胶贴的方法 - Google Patents
一种医用凝胶及其用于制备医疗外用凝胶贴的方法 Download PDFInfo
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Abstract
本发明公开了一种医用凝胶,其由以下组分组成及其各自的总量份数比构成:10‑50硫酸镁、0.01‑10植物提取物、0.5‑15甘油、0.1‑5乙醇、3‑20亲水性高分子材料、0.1‑15增溶剂、余量纯化水。本发明还公开了利用上述医用凝胶制备的医疗外用凝胶贴及其制备方法。本发明的医用凝胶贴结合硫酸镁与亲水性高分子材料,有效避免了硫酸镁溶液湿敷沾湿病人衣物和床单的问题;在使用过程中,本发明的凝胶贴粘附稳定不易滑脱,不影响病人活动;使用方便,可反复揭贴;本发明精选植物提取物,并添加抑菌、护肤成分,对人体无刺激性,使用安全,起效快,疗效好。
Description
技术领域
本发明涉及一种医用凝胶,具体涉及一种利用上述凝胶制备的医疗外用凝胶贴及其制备方法,上述凝胶贴具备消除水肿,防治静脉炎及软组织损伤等功能。
背景技术
静脉给药是目前临床治疗常用的给药途径,药物作用和医护人员的不当操作等因素可引起静脉炎。药液外渗静脉炎的发生使患者静脉皮肤红肿,产生灼痛。50硫酸镁溶液对组织液而言为高渗溶液,局部湿敷可产生高渗透压,使肿胀部位组织水肿液在短时间内吸出、消肿。同时,镁离子能拮抗钙离子,抑制血管平滑肌的收缩,改善水肿部位的微循环,组织间液回流血管,从而减轻局部渗出。由于血液循环得到了改善,加强了新陈代谢和白细胞的吞噬功能,达到抗感染和消炎的目的。随着水肿和炎症的消退,病人疼痛感减轻。50硫酸镁溶液湿敷起到局部治疗作用,临床观察无副作用及不良反应。
临床常用30-50硫酸镁溶液浸湿纱布或毛巾敷于患处,此方法虽简单易行,但随着水分蒸发,纱布硬结,析出白色硫酸镁晶体,需要每隔一段时间添加硫酸镁溶液,且在使用过程中常出现硫酸镁溶液沾湿床单或病人衣物的状况,给患者和医护人员带来不便。
现有的硫酸镁湿敷贴多采用无纺布浸湿硫酸镁湿敷液封装于包装袋内,使用时,将湿敷贴敷于患处,用保鲜膜包裹,防止水分蒸发或液体流出沾湿床单或衣物。病人患处皮肤在密不透气的情况下,较长时间接触高浓度盐溶液,致使皮肤免疫功能下降,易受感染或引起水泡红疹等。
专利(CN 101485680 A)公开了一种复方硫酸镁巴布剂及其制备方法。该方案中,主要药用成分硫酸镁含量远低于临床常用浓度,且制成巴布剂为固态,对药物起缓释作用,虽加入薄荷脑作为促渗透剂,但不及50硫酸镁湿敷液见效快。盐酸利多卡因临床主要用于局部麻醉剂,具有止痛作用。参考盐酸利多卡因与硫酸镁的含量及该专利的临床资料,可知复方硫酸镁巴布剂具有较好的止痛作用,而其治疗水肿及静脉炎的作用相对较弱。
专利(CN 104107190 A)公开了一种一次性湿敷贴及其制备方法,其湿敷液存在以下不足:一、甘露醇经静脉注射给药,通过渗透性利尿达到脱水作用,而外敷不能达到脱水作用。二、***为糖皮质激素类药物,主要用于皮炎、湿疹,长期使用对人体有较大副作用。
另外,临床也用由高分子凝胶构成的冷敷贴、降温贴治疗局部水肿、静脉炎,但因为其中不含高渗硫酸镁,影响治疗效果。
发明内容
有鉴于现有技术的上述缺陷,本发明所要解决的技术问题是提供一种医疗外用凝胶贴,其具有去水肿、消炎、止痛、抑菌、护肤等作用且对人体无刺激性,使用安全,起效快,疗效好。
为实现上述目的,本发明提供了一种医疗外用凝胶贴,包括背衬层、凝胶层和防粘层,所述的背衬层为无纺布、脱脂棉、纱布、海绵、吸水纸其中的一种或其任意组合。所述的防粘层采用聚丙烯类、聚乙烯类、聚氨酯类其中一种或其任意组合的材料;所述的凝胶层位于背衬层和防粘层之间且采用医用凝胶制成。
上述凝胶层采用的医用凝胶,由以下组分及其重量份数比构成:10-50硫酸镁、0.01-10植物提取物、0.5-15甘油、0.1-5乙醇、3-20亲水性高分子材料、0-5交联剂,0.1-15增溶剂,余量纯化水。
所述的植物提取物为具有促透、抑菌、消炎、止痛作用的植物提取物,可以是具有透皮促进剂作用的物质,如薄荷油、冰片等,也可以是具有抑菌、消炎、止痛或去水肿作用的植物提取物,如丹皮、姜黄、桉叶、茶树、百里香、金盏菊、甘草、大黄、川芎、马齿苋、芦荟、金缕梅、野菊花、金银花、蒲公英、荆芥、薰衣草、丁香、迷迭香无患子、两面针、颠茄、百部、茯苓、洋甘菊、黄岑、黄连、芦丁、鼠尾草、虎杖、肉豆蔻、锯叶棕提取物等。在本医用凝胶中填加的植物提取物,具有以下功能:
1.促进透皮吸收,使药物起效更快;
2.轻微局麻作用,减轻患者疼痛;
3.辅助消肿、消炎;
4.抗菌作用,使凝胶具有内在抗菌性,并可抑制皮肤表面微生物滋生;
5.抗过敏作用,降低药物毒性;
6.护肤作用;
7. 添加植物精油,起辅助治疗作用并添加了促透、抑菌、镇痛、护肤功效,且具有怡人芳香。
所述的亲水性高分子材料为羧甲基纤维素钠、壳聚糖、明胶、琼脂、羧丙基纤维素、黄原胶、卡拉胶、槐豆胶、瓜尔胶、海藻酸钠、果胶、***胶和淀粉及其衍生物、羟乙基纤维素、聚乙烯醇、聚丙烯酸、聚乙烯吡咯烷酮等其中的一种或其任意组合。
在本医用凝胶中填加的亲水性高分子材料,具有以下功能:
1.使凝胶贴与皮肤的粘附性好,不易滑脱且可反复揭贴;
2.保水效果好,不易干结,使硫酸镁发挥持久、稳定的疗效,硫酸镁不易析出;
3.具有很好的透气性;
4. 以水凝胶为载体,对硫酸镁起一定的缓释作用,作用时间持久且硫酸镁在凝胶中分布均匀稳定,具有缓释作用,疗效持久;
5.不污染皮肤和床单衣物。
所述的交联剂为氯化钙或戊二醛,也可不添加交联剂,通过反复冷冻解冻的物理方法进行交联,或在添加一定量交联剂的基础上结合物理方法可有效缩短凝胶制备时间并减少交联剂用量,且不影响凝胶性质。本发明的高分子凝胶交联方式并不局限于此,还可通过其他化学试剂,如含Al3+、Gu2+、Ga2+、Zn2+、Fe3+等金属离子化合物或醇、醛、酯类有机物,或物理方式,如辐照交联。
所述的增溶剂为聚乙二醇氢化蓖麻油、聚氧乙烯脂肪酸酯类、聚氧乙烯脂肪醇醚类、聚氧乙烯脱水山梨醇脂肪酸酯类其中的一种或其任意组合。
本发明还提供了上述凝胶贴的制备方法。
本发明医疗凝胶贴的制备方法有两种,第一种方法包括以下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)取30g-80g聚乙烯醇,加入剩余硫酸镁溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,置冰箱中冷冻4小时后解冻,反复数次直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
第二种方法包括以下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)在剩余硫酸镁溶液中加入5g-50g氯化钙并使其溶解,另取30g-80g聚乙烯醇,加入硫酸镁、氯化钙混合溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,静置2-24小时,直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
本发明的有益效果是:
本发明的医用凝胶贴结合硫酸镁与亲水性高分子材料,有效避免了硫酸镁溶液湿敷沾湿病人衣物和床单的问题;在使用过程中,本发明的凝胶贴粘附稳定不易滑脱,不影响病人活动;使用方便,可反复揭贴;本发明精选植物提取物,并添加抑菌 、护肤成分 ,对人体无刺激性,使用安全,起效快,疗效好。
具体实施方式
下面结合实施例对本发明作进一步说明:
实施例一:
一种医用凝胶,由以下组分及其重量份数比构成:50硫酸镁、0.3植物提取物、1甘油、3乙醇、14亲水性高分子材料、1增溶剂、2交联剂、余量为纯化水;
实施例二:
一种医用凝胶,由以下组分及其重量份数比构成:30硫酸镁、0.5植物提取物、10甘油、0.5乙醇、7亲水性高分子材料、1.5增溶剂、1交联剂、余量为纯化水;
实施例三:
一种医用凝胶,由以下组分及其重量份数比构成:12.5-60硫酸镁,0.01-2薄荷油,0.1-1丹皮酚,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.5-15甘油,0.1-3乙醇,0.1-5氯化钙,0.5-2的PEG40-氢化蓖麻油,余量纯化水。
实施例四:
一种医用凝胶,由以下组分及其重量份数比构成:12.5-60硫酸镁,0.01-3冰片,0.1-5芦荟油,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.5-15甘油,0.1-3乙醇,0.1-1.5戊二醛,1-10 的PEG40-氢化蓖麻油,余量纯化水。
实施例五:
一种医用凝胶,由以下组分及其重量份数比构成:12.5-60硫酸镁,0.01-2薄荷油,0.1-5丁香油,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.5-15甘油,0.1-3乙醇,1-10的PEG40-氢化蓖麻油,余量纯化水。
实施例六:
一种医用凝胶,由以下组分及其重量份数比构成:10-60硫酸镁、0.01-5植物提取物、0.5-15甘油、0.1-5乙醇、3-10羧甲基纤维素钠、3-10聚乙烯醇、0.1-5氯化钙,1-10的PEG40-氢化蓖麻油,余量为纯化水。
实施例七:
一种医疗外用凝胶贴的制备方法,包括以下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)取30g-80g聚乙烯醇,加入剩余硫酸镁溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,置冰箱中冷冻4小时后解冻,反复数次直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
实施例八:
一种医疗外用凝胶贴的制备方法,包括以下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)取30g-80g聚乙烯醇,加入剩余硫酸镁溶液,继续加入5ml-15ml1戊二醛,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,静置2-24小时,直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
实施例九:
一种医疗外用凝胶贴的制备方法,包括以下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)在剩余硫酸镁溶液中加入5ml-10ml氯化钙并使其溶解,另取30g-80g聚乙烯醇,加入硫酸镁、氯化钙混合溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,静置2-24小时,直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
效果验证
将30只同龄,相近体重雄性大鼠腹部剃毛,静脉推注15甘露醇,每天三次,连续三天,建立药液外渗损伤模型。
将建模成功的实验大鼠随机分3组,每组10只。对照组一:生理盐水涂敷;对照组二:不含硫酸镁冷敷贴常温敷于患处;实验组:实施例五常温敷于患处。上述三组的涂敷要求为:每日3次,每次45min。共15天。
每3天,切取损伤部位皮肤及皮下组织,切片包埋染色后于光学显微镜下观察,观察项目为:表皮损伤程度、溃疡程度、炎细胞浸润程度、水肿程度,对观察项目设立程度指标,程度越高,得分越高:以( - )为 0 分 ,( + ) 为 1 分 , ( ++ )为 2 分 , ( +++ )为3 分。
对试验数据统计后进行方差分析,发现实验组各项指标均与对照组一、对照组二存在显著性差异(P1<0.05;P2<0.05),表明:实验组大鼠药液外渗损伤程度较对照组明显减轻,实验组采用的凝胶贴片对治疗药液外渗性皮肤损伤具有较好的治疗效果。
以上详细描述了本发明的较佳具体实施例。应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。
Claims (10)
1.一种医用凝胶,其特征在于,由以下组分组成及其各自的总量份数比构成:10-50硫酸镁、0.01-10植物提取物、0.5-15甘油、0.1-5乙醇、3-20亲水性高分子材料、0.1-15增溶剂、余量纯化水。
2.如权利要求1所述的一种医用凝胶,其特征在于,还包括交联剂,所述的交联剂与各组分按照重量份数比的添加量为0-5。
3.如权利要求2所述的一种医用凝胶,其特征在于,所述的植物提取物为薄荷、冰片、丹皮、姜黄、桉叶、茶树、百里香、金盏菊、甘草、大黄、川芎、马齿苋、芦荟、金缕梅、野菊花、金银花、蒲公英、荆芥、芦丁、鼠尾草、虎杖、肉豆蔻、锯叶棕、薰衣草、丁香、无患子、两面针、颠茄、百部、茯苓、洋甘菊、黄岑、黄连、迷迭香、桂皮、胡椒、大蒜提取物其中的一种或其任意组合;
所述的亲水性高分子材料为羧甲基纤维素钠、壳聚糖、明胶、琼脂、羧丙基纤维素、黄原胶、卡拉胶、槐豆胶、瓜尔胶、海藻酸钠、果胶、***胶和淀粉及其衍生物、羟乙基纤维素、聚乙烯醇、聚丙烯酸、聚乙烯吡咯烷酮其中的一种或其任意组合;
所述的增溶剂为聚乙二醇氢化蓖麻油、聚氧乙烯脂肪酸酯类、聚氧乙烯脂肪醇醚类、聚氧乙烯脱水山梨醇脂肪酸酯类其中的一种或其任意组合;
所述的交联剂为氯化钙或戊二醛。
4.如权利要求1-3任一所述的一种医用凝胶,其特征在于,由以下组分及其重量份数比组成:10-50硫酸镁,0.01-2薄荷油,0.1-1丹皮酚,3-10羧甲基纤维素钠,3-10聚乙烯醇,0-1.5戊二醛,0.5-5的PEG40-氢化蓖麻油,0.5-15甘油,0.1-5乙醇,余量纯化水。
5.如权利要求1-3任一所述的一种医用凝胶,其特征在于,由以下组分组成:10-50硫酸镁,0.1-3冰片,0.01-5芦荟油,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.1-1.5戊二醛,0.5-5的PEG40-氢化蓖麻油,0.5-15甘油,0.1-5乙醇,余量纯化水。
6.如权利要求1-3任一所述的一种医用凝胶,其特征在于,由以下组分组成:10-50硫酸镁,0.01-2薄荷油,0.01-5丁香油,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.1-5氯化钙,0.5-5的PEG40-氢化蓖麻油,0.5-15甘油,0.1-5乙醇,余量纯化水。
7.如权利要求1-3任一所述的一种医疗外用凝胶贴,其特征在于,由以下组分组成:10-50硫酸镁,0.01-2丁香油,0.01-5芦荟油,3-10羧甲基纤维素钠,3-10聚乙烯醇,0.5-5的PEG40-氢化蓖麻油,0.5-15甘油,0.1-5乙醇,余量纯化水。
8.一种医疗外用凝胶贴,其特征在于,由背衬层、凝胶层和防粘层组成,所述的凝胶层位于背衬层和防粘层之间且其由权利要求1-7任意所述的医用凝胶构成;
所述的背衬层采用无纺布、脱脂棉、纱布、海绵、吸水纸其中的一种或其任意组合制作;
所述的防粘层采用聚丙烯类、聚乙烯类、聚氨酯类其中一种或其任意组合的材料制作。
9.一种制备权利要求8所述的医疗外用凝胶贴的方法,其特征在于,包括如下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)取30g-80g聚乙烯醇,加入剩余硫酸镁溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,置冰箱中冷冻4小时后解冻,反复数次直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
10.一种制备权利要求8所述的医疗外用凝胶贴的方法,其特征在于,包括如下步骤:
(1)量取1000ml纯化水,煮沸3-10分钟,冷却至50℃,加入250g-400g硫酸镁,充分溶解;
(2)将30ml-50ml70乙醇、5ml-20ml的PEG40-氢化蓖麻油及5ml-150ml甘油混合,加入1ml-5ml植物精油溶解;
(3)取30g-80g羧甲基纤维素钠,加入200ml-300ml硫酸镁溶液,混匀;
(4)在剩余硫酸镁溶液中加入5g-50g氯化钙并使其溶解,另取30g-80g聚乙烯醇,加入硫酸镁、氯化钙混合溶液,混匀;
(5)将(2)、(3)、(4)混匀,充分搅拌,静置2-24小时,直至形成具有一定粘附性和弹性的水凝胶;
(6)用上述制备的凝胶均匀涂布于背衬层,用防粘层覆盖。
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