CN113116809A - 一种外用型分娩镇痛组合物及其应用 - Google Patents
一种外用型分娩镇痛组合物及其应用 Download PDFInfo
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Abstract
本发明提供了一种聚合物协效的外用型分娩镇痛组合物。其中协效物为聚乙二醇长链烷基胺,一方面,聚乙二醇片段可以通过其众多氧原子的配位作用有效地包裹中药活性成分(生半夏、生南星、生川乌和生草乌),而长链烷基片段则产生隔离作用,降低活性成分的降解速度,从而实现长效镇痛;另一方面,聚乙二醇长链烷基胺作为一种有效的表面活性剂,可以更加有效地促进活性成分的提取和在皮肤表面的分散和渗透,增强镇痛效果。
Description
技术领域
本发明涉及分娩镇痛领域,尤其是一种高分散性的分娩镇痛组合物。
背景技术
目前国内外公认的分娩镇痛效果最可靠、使用最广泛的方法是椎管内注药镇痛,镇痛有效率达95%以上。但是该方法技术含量高,需要由掌握麻醉专业技能的麻醉科医师来操作,给药不太简便;有技术风险,伴有3%的镇痛失败率;并且,药物剂量和浓度选择不当时,对运动阻滞、产程及母婴产生不良影响。椎管内注药的分娩镇痛法具有一定的操作和技术风险。
因此,寻求一种易于给药、起效快、作用可靠、无毒副作用、可满足整个产程镇痛需求的药物,是妇产科医务人员和产妇所迫切需要的。
发明内容
本发明提供一种外用型分娩镇痛组合物。该组合物主要包括聚乙二醇长链烷基胺及中药活性成分,如生半夏、生南星、生川乌和生草乌等。
其中聚乙二醇长链烷基胺具有以下结构特征:
以上结构中,Alkyl选自直链或者带有支链的含有6~30个碳的烷基;n指重复的乙氧基单元个数,即对应的不同分子量的聚乙二醇片段,一般情况下聚乙二醇片段选自分子量 200-1000的聚乙二醇中的一种或几种混合物,优选自分子量为200,300,400,500,600,800,1000中的一种或几种混合物。
聚乙二醇长链烷基胺由聚乙二醇和长链烷基通过胺基桥连而成。一方面,聚乙二醇片段可以通过其众多氧原子的配位作用有效地包裹中药活性成分,而长链烷基片段则产生隔离作用,降低活性成分的降解速度,从而实现长效镇痛;另一方面,聚乙二醇长链烷基胺作为一种有效的表面活性剂,可以更加有效地促进活性成分的提取和在皮肤表面的分散和渗透,增强镇痛效果。
本发明的目的可以通过以下技术方案来实现:
所述的一种外用型分娩镇痛组合物,其特征在于,按质量份数,它由以下组分制备而成:
进一步地,所述的一种外用型分娩镇痛组合物,其特征在于,其制备方法包括如下步骤:
(1)按比例称取聚乙二醇长链烷基胺、生半夏、生南星、生川乌、生草乌、甘油和纯水;
(2)将生半夏、生南星、生川乌和生草乌一起研磨成粉末状;
(3)将步骤(2)所得的粉末和聚乙二醇长链烷基胺、甘油、纯水一起煮沸1小时,乘热过滤掉固体药渣,收集滤液。
(4)将步骤(3)所得的滤液在50-60℃水浴加热浓缩至水浴前溶液总体积的1/4-1/5,冷却得膏状物,即为所述的外用型分娩镇痛组合物。
进一步地,所述的一种外用型分娩镇痛组合物,其特征在于,按上所述方法制得的膏状物,可作为表皮涂抹剂,应用于分娩时镇痛。
进一步地,所述的一种外用型分娩镇痛组合物,其特征在于,按上所述方法制得的膏状物,可制作成镇痛贴,应用于分娩时镇痛。该技术方案为,在贴敷胶布表面均匀涂布上述膏状组合物,涂布量为0.2-1g/cm2。
本发明的有益效果为:
本发明提供了一种聚合物协效的外用型分娩镇痛组合物。其中协效物为聚乙二醇长链烷基胺,一方面,聚乙二醇片段可以通过其众多氧原子的配位作用有效地包裹中药活性成分(生半夏、生南星、生川乌和生草乌),而长链烷基片段则产生隔离作用,降低活性成分的降解速度,从而实现长效镇痛;另一方面,聚乙二醇长链烷基胺作为一种有效的表面活性剂,可以更加有效地促进活性成分的提取和在皮肤表面的分散和渗透,增强镇痛效果。
具体实施方式
实施例1
聚乙二醇长链烷基胺(聚乙二醇1000十八烷基胺)的制备:
烷基链含有18个碳原子、聚乙二醇片段分子量为1000的聚乙二醇长链烷基胺制备方法:在500ml的高压反应釜中依次加入分子量1000的聚乙二醇单甲醚(mPEG1000) 100克(0.1mol)、二氧化硅3克(0.05mol),氧化铝10克(0.1mol),十八烷基胺27克(0.1mol),180摄氏度下反应36小时后,用水和乙酸乙酯萃取三次.除去水层,有机层用无水硫酸钠干燥。用旋转蒸发仪除去溶剂,再用二氯甲烷萃取出产品后蒸除溶剂,得到111克聚乙二醇十八烷基胺(1),收率89%
实施例2
聚乙二醇长链烷基胺(聚乙二醇500十六烷基胺)的制备:
烷基链含有16个碳原子、聚乙二醇片段分子量为500的聚乙二醇长链烷基胺制备方法:在500ml的高压反应釜中依次加入分子量500的聚乙二醇单甲醚(mPEG500)50 克(0.1mol)、二氧化硅3克(0.05mol),氧化铝10克(0.1mol),十六烷基胺26克(0.1mol), 180摄氏度下反应36小时后,用水和乙酸乙酯萃取三次.除去水层,有机层用无水硫酸钠干燥。用旋转蒸发仪除去溶剂,再用二氯甲烷萃取出产品后蒸除溶剂,得到65克聚乙二醇十六烷基胺(2),收率88%
实施例3(组合物1)
称取20克聚乙二醇1000十八烷基胺、15克生半夏、15克生南星、15克生川乌、15克生草乌、20克甘油和300克纯水;将生半夏、生南星、生川乌和生草乌一起研磨成粉末状;所得的粉末和聚乙二醇1000十八烷基胺、甘油、纯水一起煮沸1小时,乘热过滤掉固体药渣,收集滤液;将所得滤液在50-60℃水浴加热浓缩至水浴前溶液总体积的1/4,冷却得膏状物,即为所述的外用型分娩镇痛组合物。
实施例4(组合物2)
称取15克聚乙二醇500十六烷基胺、20克生半夏、20克生南星、20克生川乌、20克生草乌、40克甘油和500克纯水;将生半夏、生南星、生川乌和生草乌一起研磨成粉末状;所得的粉末和聚乙二醇500十六烷基胺、甘油、纯水一起煮沸1小时,乘热过滤掉固体药渣,收集滤液;将所得滤液在50-60℃水浴加热浓缩至水浴前溶液总体积的1/5,冷却得膏状物,即为所述的外用型分娩镇痛组合物。
实施例5(分娩镇痛效果测试)
本测试通过跟踪对比5组孕妇分娩时的疼痛感实现,其中:
第一组30人,自然分娩不使用任何辅助器具或药物,作为对照组;
第二组30人,使用实施例3所制备的组合物1作为膏剂直接涂抹在腹部(剂量20克);
第三组30人,使用实施例4所制备的组合物2作为膏剂直接涂抹在腹部(剂量20克);
第四组30人,在腹部贴敷镇痛贴,该镇痛贴是由20克实施例3所制备的组合物1在10cm ×10cm贴敷胶布表面均匀涂布而成;
第五组30人,在腹部贴敷镇痛贴,该镇痛贴是由20克实施例4所制备的组合物2在10cm ×10cm贴敷胶布表面均匀涂布而成。
分娩前告知孕妇疼痛等级的划分:0为无痛;0到3为轻度疼痛;达到4就会影响睡眠;4到 6为中度疼痛;达到7会无法入睡;7以上为重度疼痛;10为剧痛。并跟踪采访、记录孕妇生产时宫缩最厉害时的痛感,具体记录数据如下:
由上表可知,对照组(第一组)中大部分孕妇的痛感在7-8级,使用镇痛膏或者镇痛贴的组别,孕妇的痛感大部分都降到了5-6级,个别孕妇甚至降到了3-4级。说明本发明所提供的组合物有明显镇痛效果。
Claims (5)
3.根据权利要求1~2所述的一种外用型分娩镇痛组合物,其特征在于,其制备方法包括如下步骤:
(1)按比例称取聚乙二醇长链烷基胺、生半夏、生南星、生川乌、生草乌、甘油和纯水;
(2)将生半夏、生南星、生川乌和生草乌一起研磨成粉末状;
(3)将步骤(2)所得的粉末和聚乙二醇长链烷基胺、甘油、纯水一起煮沸1小时,乘热过滤掉固体药渣,收集滤液。
(4)将步骤(3)所得的滤液在50-60℃水浴加热浓缩至水浴前溶液总体积的1/4-1/5,冷却得膏状物,即为所述的外用型分娩镇痛组合物。
4.根据权利要求1~2所述的一种外用型分娩镇痛组合物,其特征在于,按上所述方法制得的膏状物,可作为表皮涂抹剂,应用于分娩时镇痛。
5.根据权利要求1~2所述的一种外用型分娩镇痛组合物,其特征在于,按上所述方法制得的膏状物,可制作成镇痛贴,应用于分娩时镇痛。
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