CN104586962A - 一种生肌长皮烧伤药膏及其制备方法 - Google Patents

一种生肌长皮烧伤药膏及其制备方法 Download PDF

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CN104586962A
CN104586962A CN201510029293.0A CN201510029293A CN104586962A CN 104586962 A CN104586962 A CN 104586962A CN 201510029293 A CN201510029293 A CN 201510029293A CN 104586962 A CN104586962 A CN 104586962A
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张金安
张壮一
张闻一
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Abstract

本发明公开了一种生肌长皮烧伤药膏及其制备方法，该药膏其包括如下重量份的组分：头孢菌素5-15份，庆大霉素5-15份、人参5-20份、蜂胶10-20份、紫草5-20份、黄芩10-20份、蒙脱石10-20份、大黄6-20份、人胎盘组织液10-20份、冰片0.5-5份、维生素B6 5-15份、维生素C 8-15份、软膏基质200份。本发明能够快速修复局部被损组织，加速创面的愈合，明显缩短了Ⅲ度烧伤的愈合天数。

Description

一种生肌长皮烧伤药膏及其制备方法
技术领域
本发明涉及一种生肌长皮烧伤药膏及其制备方法。
技术背景
烧伤是一种危害人类健康和容貌的常见病。烧伤本身造成的皮肤损伤或者治疗过程中导致的新的皮肤损伤，很容易造成色素沉着、疤痕残留等容貌问题，最后多需植皮整容，不仅加重病人痛苦，且费用昂贵。
烧伤后次日，由于病人烧伤部位会出现水泡式皮损，重度肿胀，按照传统疗法，需撕皮包扎，肿胀加重需手术切开减胀，这会加重病人痛苦，给病人火上浇油。
国内外传统治疗烧伤是在进行一般的创面清洁处理后，然后剪掉视为腐皮及坏死组织的水泡组织，包扎保护、分期切痂植皮等保守疗法，并辅以静脉注射抗生素。数次切痂植皮，病人痛苦异常，并且费用昂贵，最后多需整形美容，治疗期延长，容易造成伤口感染。目前通用的暴露疗法在抑制大量细菌繁殖的同时，也导致人体正常细胞的分裂增生受阻，因而不利于烧伤创面的修复和再生，容易造成疤痕残留，病程变长，需过“三关”，死里逃生。
专利号为ZL95118978.6的中国专利是本发明人的早期研究成果，其公开了一种消炎止痛烧伤药膏，采用抗生素和中药中西结合，抗感染作用强，镇痛效果好，可缩短创面愈期，能有效降低疤痕发生率。其对于深Ⅱ度创面愈合天数一般为4-13天，较使用“美宝”湿润烧伤膏药的对照组愈合天数明显缩短，但其对于Ⅲ度烧伤的愈合天数仍较长，为21-30天。
发明内容
针对以上技术问题，本发明的目的是提供一种能有效缩短Ⅲ度烧伤愈合天数、无瘢痕残留且有效减轻病人痛苦的生肌长皮烧伤药膏，并提供其制备方法，该药膏能解决“Ⅱ度烧伤不留疤，Ⅲ度烧伤不植皮”的世界难题，用涂药生肌长皮代替手术植皮。
为实现以上目的，本发明采用如下技术方案：
一种生肌长皮烧伤药膏，其包括如下重量份的组分：头孢菌素5-15份，庆大霉素5-15份、人参5-20份、蜂胶10-20份、紫草 5-20份、黄芩10-20份、蒙脱石10-20份、大黄6-20份、人胎盘组织液10-20份、冰片0.5-5份、维生素B6 5-15份、维生素C 8-15份、软膏基质200份。
优选地，所述头孢菌素为头孢哌酮钠。对特殊病人，可根据其细菌培养药敏实验结果选用其它抗生素。
优选地，所述软膏基质为凡士林或W/O型基质。
人胎盘组织液选用市售产品均可，如邯郸康业制药有限公司生产的批准文号为“国药准字S13020002”的人胎盘组织液。
本发明还提供了所述生肌长皮烧伤药膏的制备方法，其步骤如下：
（1）按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75%酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
（2）按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
（3）按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤（1）和（2）所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
本发明药膏在治疗时，采用暴露疗法，对烧伤创面进行一般的清洁处理后，将有水泡处穿泡放水，不撕掉传统疗法中误认为的腐皮及坏死组织，将该烧伤药膏均匀地涂在创面上，次日，在原创面上再补涂该药膏（原药膏不必清除），如此反复涂抹，直至结药痂，待到痂脱伤愈，恢复原貌。
本发明通过各药物组分的合理配伍，在有效杀灭被损皮肤组织中残留或繁殖的细菌、消除急性感染病因的同时，还具有良好的生肌长皮作用，药物透皮吸收度强，明显减少创面渗出液，能够快速修复局部被损组织，加速创面的愈合，明显缩短了Ⅲ度烧伤的愈合天数，并有效地避免了肉芽组织的再生，抑制了大纤维母细胞生长，防止了疤痕的形成。此外本发明药膏还具有良好的镇痛效果，大大减轻了烧伤引起的疼痛给患者带来的痛苦，同时也有效地避免了烧伤疼痛给病人带来的生理、病理方面的负效应。
本发明药物所产生的积极效果从下述临床验证资料中得以证实。
一、烧伤病例的选择：
符合黄家驷所著《外科学》Ⅲ度烧伤者，按双盲随机法分为两组，实验组使用本发明药物，对照组使用“美宝”湿润烧伤膏。
二、疗效评定标准
1、创面感染的评定标准
按Pruitt（1979）所述创面感染
2、创面愈合的评定标准
按黄家驷所著《外科学》所定标准
3、瘢痕愈合评定标准
按黄家驷所著《外科学》所定标准
4、创面疼痛的评定标准
以15分钟后仍感到疼痛难耐，病人要求使用镇痛药为阳性统计对象。
三、临床观察结果
表1  创面感染发生率对比情况
组  别 总例数 感染数 感染率 P
实验组 180 0 0  
对照组 120 3 2.50% <0.01
  表2  烧伤瘢痕发生率对比情况
组  别 总例数 疤痕数 疤痕率 P
实验组 240 0 0  
对照组 240 128 53 <0.05
    表3  创面植皮率对比情况
组  别 总例数 植皮数 植皮率 P
实验组 180 0 0  
对照组 120 2 1.57% <0.05
    表4  创面疼痛发生率对比情况
组  别 总例数 疼痛数 疼痛率 P
实验组 180 0 0  
对照组 120 38 31.6 <0.01
本发明与专利号为ZL95118978.6的中国专利对于Ⅲ度烧伤创面愈合天数的比较见表5（其中实验组为使用本发明药膏，对照组为使用ZL95118978.6的药膏）。
表5  Ⅲ度创面愈合天数对比情况
   。
典型病例
1、张安生，男，38岁，山东省曹县桃园乡闫村人。
2014年11月26日下午15：30 
主诉：面部烫伤半天
缘于当日11点，在家做饭时，高压锅爆炸，烫伤面部，当即到河北医大一院烧伤科喷药水、疼痛难忍、慕名求医。
查：面部潮红、存在水泡、Ⅲ度烫伤，坐立不宁，涂本发明药膏后片刻鼾声入睡。 
处理：常规消毒、外涂本发明烧伤药膏，第5天患者洗光，面如常人。
2、谭剑，男，28岁，中国人民解放军军械工程学院保卫处，现役军人。
2007年5月25日
主诉面部烧伤6天
缘于6天前燃放火药烧伤面部及左上臂，当时被送解放军和平医院烧伤科住院，面貌全非，全面部焦痂，面肿如斗，为Ⅲ度烧伤，第六天烧伤科主任准备植皮，告知本人准备毁容破相，故慕求名医。经涂本发明药膏后，未植皮，10天治愈，面部无疤痕，色素无沉着，面如常人。
3、张日升，男，58岁。2014年12月1日在维修煤气管道时不慎失火，将面、颈部及双手深Ⅲ度烧伤，立即外涂湿润伤灵膏，次日面部及双手重度肿胀，面部皮肤大部脱落，疼痛难忍。外涂本发明药膏，未输液，未住院，六天治愈，未留疤痕，面貌如常。
具体实施方式
实施例1：
本实施例包括如下重量的组分：头孢哌酮钠15千克、庆大霉素15千克、维生素C 15千克、维生素B6 15千克、人参20千克、黄芩20千克、蜂胶20千克、紫草20千克、大黄6千克、蒙脱石20千克、人胎盘组织液10千克、冰片5千克、软膏基质200千克。
本实施例的制备方法为：
（1）按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75%酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
（2）按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
（3）按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤（1）和（2）所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
将蒙脱石研磨粉碎，过120目筛后，加入冰片，研均，待用；
将头孢哌酮、庆大霉素、复合维生素C，细粉混合后加入中草药粉、冰片粉混匀，最后加入熔溶后的麻油，充匀研匀。
以下6个实施例药膏的制备方法同实施例1相同，只是药物组分配比有所不同，但疗效基本相同。
。

Claims (4)

1.一种生肌长皮烧伤药膏，其特征在于：其包括如下重量份的组分：头孢菌素5-15份，庆大霉素5-15份、人参5-20份、蜂胶10-20份、紫草 5-20份、黄芩10-20份、蒙脱石10-20份、大黄6-20份、人胎盘组织液10-20份、冰片0.5-5份、维生素B6 5-15份、维生素C 8-15份、软膏基质200份。
2.根据权利要求1所述的一种生肌长皮烧伤药膏，其特征在于：所述头孢菌素为头孢哌酮钠。
3.根据权利要求1所述的一种生肌长皮烧伤药膏，其特征在于：所述软膏基质为凡士林或W/O型基质。
4.权利要求1-3任一项所述的生肌长皮烧伤药膏的制备方法，其特征在于步骤如下：
（1）按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75%酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
（2）按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
（3）按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤（1）和（2）所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
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