CN110090197A - 一种可成膜的麻醉面膜膏 - Google Patents
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Abstract
本发明公开了一种可成膜的麻醉面膜膏，包括基质、麻药、成膜剂、缓凝剂；所述成膜剂为海藻酸盐、壳聚糖及其衍生物中的至少一种。本发明所述面膜膏采用成膜材料的成型技术，可以根据使用者需要，涂抹在指定治疗区域上，能快速在需要麻醉部位成膜，并可以快速分离，方便临床工作者操作应用，省去敷药、铺保湿膜、去除、清洗的过程，无需利用无菌纱布或其他器械清除麻膏。
Description
技术领域
本发明涉及一种麻醉膏，尤其是一种可成膜的麻醉面膜膏。
背景技术
目前临床常用的表面麻醉用剂型，多为利多卡因或复方利多卡因软膏，用于局部或全面部麻醉使用，临床工作者为减少水分蒸发，并增加麻醉成分的吸收，往往涂抹后，铺上保鲜膜，保证一定的治疗效果，表面麻醉后，施术前需要撕开保鲜膜，并用无菌纱布或其他无菌器械，去除附在局部施术区的麻膏，同时也需要用无菌用水或酒精清洗干净，方可进行手术操作。
然而，该去除麻膏，清洗操作过程相对较长，约5-10分钟，加上利多卡因或及同类衍生物，麻醉作用时间较短，往往待清理操作结束后，麻醉效果便逐渐消失，无法最大达到麻醉效果。而且，采用膏状物的利多卡因或其同类衍生物，若发生过敏反应，术者在去除诱因过程中，往往也因去除过程十分繁琐，而无法及时去除表面麻膏。
此外，尽管注射利多卡因，可以实现快速麻醉，但该技术具有一定创伤性，同时浅表皮的注射往往十分疼痛，无法接受，虽然通过表皮敷麻醉软膏，可以提高用户感受度，但在敷药，或清洗过程中，操作相对不便，但也被临床工作者勉强接受。
发明内容
基于此，本发明的目的在于克服上述现有技术的不足之处而提供一种可成膜的麻醉面膜膏。
为实现上述目的，本发明所采取的技术方案为：一种可成膜的麻醉面膜膏，包括基质、麻药、成膜剂、缓凝剂；所述成膜剂为海藻酸盐、壳聚糖及其衍生物中的至少一种。
本发明所述麻醉膏采用成膜材料、缓凝剂、麻药混合而成，可以根据使用者需要，涂抹在指定治疗区域上，能快速在需要麻醉部位成膜，并可以快速分离，无需利用无菌纱布或其他器械清除麻膏。
优选地，所述缓凝剂为钙盐。本申请所述缓凝剂可以很好的与所述成膜材料结合，使所述成膜材料快速在需要麻醉部位成膜，并可以快速分离。两者合用具有起效快、持续时间短、麻醉效能高、术中可控性强、术毕苏醒快等优点。
更优选地，所述缓凝剂为无水硫酸盐、磷酸二氢盐、磷酸氢盐、焦磷酸盐中的至少一种。上述缓凝剂可以更好的与所述成膜材料结合，使所述成膜材料快速在需要麻醉部位成膜，并可以快速分离。
优选地，所述麻药的重量份为10～25份，所述成膜剂的重量份为5～15份，所述缓凝剂的重量份为5～15份。
发明人经过大量探索发现，上述各成分的含量比例，更有利于快速成膜、易剥离，方便临床工作者操作应用，省去敷药、铺保湿膜、去除、清洗的过程，成膜技术能快速剥离，简单清洗后即可施术。
更优选地，所述成膜剂的重量份为5～10份，所述缓凝剂的重量份为10～15份。在上述成膜剂及缓凝剂的含量比例范围内，所述麻醉面膜膏可以更快的成膜，并易剥离。
更优选地，所述成膜剂与所述缓凝剂的重量比为：成膜剂：缓凝剂＝2：3。发明人经过大量探索发现，当成膜剂与缓凝剂的重量比为2：3时，成膜效果及剥离效果均最好，用户的感受度也最好。
优选地，所述麻药为利多卡因及其衍生物中的至少一种。
优选地，所述基质含有羟基丙基纤维素、甲基纤维素中的至少一种。
优选地，所述的可成膜的麻醉面膜膏，还包含保湿剂或/和促进剂。本发明的麻药膏，内含有保湿剂和促进剂，可以湿润皮肤表皮层，增加水分，促进麻醉成分进入，临床工作者无需再用保鲜膜进行保湿操作，减少术前繁琐工作。
更优选地，所述保湿剂的重量份为10～20份。
更优选地，所述保湿剂为聚乙烯醇、聚乙二醇、丙二醇、甘油中的至少一种。
优选地，所述的可成膜的麻醉面膜膏，还包含抗氧剂，所述抗氧剂为维生素C、谷胱甘肽中的至少一种。抗氧剂主要是为了进一步保护肌肤。本发明中的抗氧剂和促进剂的含量，本领域技术人员可根据实际情况进行选择。
此外，本申请所述麻醉膏的制备方法，本领域技术人员可根据常规方法进行制备。
相对于现有技术，本发明的有益效果为：
本发明所述麻醉膏采用成膜材料、缓凝剂、麻药混合而成，采用成膜材料的成型技术，可以根据使用者需要，涂抹在指定治疗区域上，能快速在需要麻醉部位成膜，并可以快速分离，无需利用无菌纱布或其他器械清除麻膏。
同时，本发明的麻药膏，内含有保湿剂和促进剂，可以湿润皮肤表皮层，增加水分，促进麻醉成分进入，临床工作者无需再用保鲜膜进行保湿操作，减少术前繁琐工作。
具体实施方式
为更好的说明本发明的目的、技术方案和优点，下面将结合具体实施例对本发明作进一步说明。
实施例1
本发明可成膜麻醉面膜膏的一种实施例，本实施例所述麻醉面膜膏包含以下重量份的成分：
基质(含有羟基丙基纤维素)100份、麻药(利多卡因)10份、成膜剂(海藻酸盐)5份、缓凝剂(无水硫酸盐)5份、保湿剂(聚乙烯醇)10份、抗氧剂(维生素C)3份。
将上述成分按照常规方法制成膏状，即为所述可成膜麻醉面膜膏。
实施例2
本发明可成膜麻醉面膜膏的一种实施例，本实施例所述麻醉面膜膏包含以下重量份的成分：
基质(含有甲基纤维素)100份、麻药(利多卡因衍生物)25份、成膜剂(壳聚糖)15份、缓凝剂(磷酸二氢盐)15份、保湿剂(聚乙二醇)20份、促进剂5份、抗氧剂(谷胱甘肽)5份。
将上述成分按照常规方法制成膏状，即为本发明所述可成膜麻醉面膜膏。
实施例3
本发明可成膜麻醉面膜膏的一种实施例，本实施例所述麻醉面膜膏包含以下重量份的成分：
基质(含有羟基丙基纤维素)100份、麻药(利多卡因)25份、成膜剂(海藻酸盐)10份、缓凝剂(磷酸氢盐)15份、保湿剂(聚乙烯醇)10份、抗氧剂(维生素C)3份。
将上述成分按照常规方法制成膏状，即为本发明所述可成膜麻醉面膜膏。
实施例4
本发明可成膜麻醉面膜膏的一种实施例，本实施例所述麻醉面膜膏包含以下重量份的成分：
基质(含有羟基丙基纤维素)100份、麻药(利多卡因)10份、成膜剂(海藻酸盐)5份、缓凝剂(焦磷酸盐)10份、保湿剂(甘油)20份、促进剂5份、抗氧剂(维生素C)5份。
将上述成分按照常规方法制成膏状，即为本发明所述可成膜麻醉面膜膏。
实施例5
根据临床观察疗效总结：经临床100例使用的结果来看，手术麻醉有效率达98.2％(局部皮肤无痛，手术无痛感，术后体验感较好)，无效率仅为1.8％(局部皮肤麻痹，无疼痛，在手术过程中有轻微的疼痛感)。下面举三个具体的临床应用病例如下：
病例1，患者，女，26岁，面部微整容。用小棉签蘸本药膏，反复涂擦在面部约10分钟，行整容手术，处理完很容易将膜剥离。患者反映并无其他感觉，手术处无痛感。
病例2，患者，女，45岁，外伤，脸部烫伤，使用本药膏反复涂抹面部患处10分钟，行手术。患者反映并无其他感觉，手术处无痛感。
病例3，患者，男，32岁，外伤，脸部划伤需缝合。初步止血、清理伤口后，使用本药膏反复涂抹患处8分钟，行缝合处理，处理完很容易将膜剥离。患者并无痛感，也无其他不良反应。
实施例6
麻醉效果具体实验验证
设置5组实验，分别为实验组1～4和对照组，实验组1～4为分别使用本申请实施例1～4中的麻醉面膜膏，对照组为使用现有市面上常用的复方利多卡因软膏。准备75只蟾蜍，分为5组，每组15只。
参考《小组合作学习与脊蛙反射实验》(王小军.小组合作学习与脊蛙反射实验[J].课堂内外：教师版,2011(9):72-72.)和《蟾乌表面麻醉剂的药效学初步实验研究》(张艳,代佳音,张敏,等.蟾乌表面麻醉剂的药效学初步实验研究[J].中外健康文摘,2011,08(7):50-52.)预选合格脊蟾蜍，然后参考《利多卡因对蛙坐骨神经干动作电位传导速度的影响》进行坐骨神经的分离。
将实验组1～4及对照组中的麻醉膏均匀的涂于分离出的左下肢坐骨神经，然后参考《蟾乌表面麻醉剂的药效学初步实验研究》(张艳,代佳音,张敏,等.蟾乌表面麻醉剂的药效学初步实验研究[J].中外健康文摘,2011,08(7):50-52.)，检测药物起效时间和药物作用持续时间。所得实验结果如表1所示。
表1
从表1可以看出，与对照组相比，本申请可成膜面膜膏具有麻醉起效快、麻醉维持时间长以及药物分离快的特点，而且，实验组3、4的效果要明显优于实验组1、2，且实验组3的效果最好。
最后所应当说明的是，以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种可成膜的麻醉面膜膏，其特征在于，包括基质、麻药、成膜剂、缓凝剂；所述成膜剂为海藻酸盐、壳聚糖及其衍生物中的至少一种。
2.如权利要求1所述的可成膜的麻醉面膜膏，其特征在于，所述缓凝剂为钙盐。
3.如权利要求2所述的可成膜的麻醉面膜膏，其特征在于，所述缓凝剂为无水硫酸盐、磷酸二氢盐、磷酸氢盐、焦磷酸盐中的至少一种。
4.如权利要求1所述的可成膜的麻醉面膜膏，其特征在于，所述麻药的重量份为10～25份，所述成膜剂的重量份为5～15份，所述缓凝剂的重量份为5～15份。
5.如权利要求4所述的可成膜的麻醉面膜膏，其特征在于，所述成膜剂的重量份为5～10份，所述缓凝剂的重量份为10～15份。
6.如权利要求1～5任一项所述的可成膜的麻醉面膜膏，其特征在于，所述麻药为利多卡因及其衍生物中的至少一种。
7.如权利要求1～5任一项所述的可成膜的麻醉面膜膏，其特征在于，所述基质含有羟基丙基纤维素、甲基纤维素中的至少一种。
8.如权利要求1～5任一项所述的可成膜的麻醉面膜膏，其特征在于，还包含保湿剂或/和促进剂。
9.如权利要求8所述的可成膜的麻醉面膜膏，其特征在于，所述保湿剂为聚乙烯醇、聚乙二醇、甘油中的至少一种。
10.如权利要求1～5任一项所述的可成膜的麻醉面膜膏，其特征在于，还包含抗氧剂，所述抗氧剂为维生素C、谷胱甘肽中的至少一种。
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| CN1093897A (zh) * | 1993-04-22 | 1994-10-26 | 孟丽君 | 表面麻醉涂膜剂的制备方法 |
| CA2268535A1 (en) * | 1996-10-14 | 1998-04-23 | Kowa Company, Ltd. | Local anesthetic for external use |
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