CN101977589A - 皮肤病学使用的壳聚糖凝胶、其制备方法及其用途 - Google Patents

皮肤病学使用的壳聚糖凝胶、其制备方法及其用途 Download PDF

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CN101977589A
CN101977589A CN2009801097247A CN200980109724A CN101977589A CN 101977589 A CN101977589 A CN 101977589A CN 2009801097247 A CN2009801097247 A CN 2009801097247A CN 200980109724 A CN200980109724 A CN 200980109724A CN 101977589 A CN101977589 A CN 101977589A
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阿里尔·沙乌尔哈森尼西斯
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Abstract

本发明涉及设计用于在皮肤上留下保护膜的药物组合物，其包含壳聚糖和在过敏性皮肤上提供治愈性质、镇定性质和吸水性质的药剂。凝胶的特征在于其包括2％至8％之间的壳聚糖和预定比例的对产品提供改善的治疗特性的其他成分，和向凝胶提供特定特性并向该凝胶提供在延长的一段时间内的合适稳定性的其他成分，所述对产品提供改善的治疗特性的其他成分诸如0.1％至90％之间的马齿苋和0.1％至45％之间的泛醇。所述凝胶在外表上应用，并且一般适合用于过敏性皮肤、浅度烧伤、皮肤磨削术、皮肤磨削术后、激光治疗后和腐蚀性皮肤。

Description

皮肤病学使用的壳聚糖凝胶、其制备方法及其用途
发明描述
壳聚糖(聚-β-1，4-D-葡糖胺)是已知命名为甲壳质(聚-β-1，4-D-乙酰葡糖胺)的天然多糖的衍生物，所述甲壳质主要发现于甲壳类的外骨骼中。
通过加入几种物质(壳聚糖、马齿苋、α羟基酸、泛醇和无害防腐剂)，可改良并增强可生物降解的聚合物的性质。通常，通过在烧伤和腐蚀及破损的皮肤中使用具有公知的生物降解性和治疗性质的成分，本发明支持的凝胶是完全地可生物降解的，并具有改善的特性，并且可以低成本获得。
通过将壳聚糖溶解于在水中具有良好溶解度的主要类型是α-羟基酸的有机酸溶液，获得壳聚糖凝胶，所述α羟基酸诸如：乙醇酸、乳酸、α羟基乙酸、α羟基辛酸(alpha hydroxyoctanoic acid)、α羟基羊脂酸(alpha hydroxycaprilic acid)、苹果酸、柠檬酸和酒石酸。通过使用具有25,000g/mol至1,250,000g/mol之间的不同分子量并具有高于80％的脱乙酰度的壳聚糖获得水凝胶。
通过加入泛醇和马齿苋或具有相似特性的另一天然物质，每种的比例在0.1％至45％之间变化，改善了水凝胶的性质。
出人意料地，pH 5.0至5.9的稳定制品已用0.2％至10％之间的百分比的壳聚糖作为唯一的增粘剂(viscosifier)来制备，并加入至少两种防腐剂，还包括马齿苋和泛醇或另一天然成分，所述另一天然成分提供治疗皮肤的烧伤型或腐蚀型损伤的相关特征，因此实现受损组织的快速再生和愈合。
在以下显示的一系列图片中，评价了水凝胶对受损皮肤的作用。
图1显示具有浅度烧伤的个体的腿，
Figure BPA00001228897900021
图2和3显示应用水凝胶后的腿部区域，其具有保护性和组织再生产品的涂层。
Figure BPA00001228897900022
图2
Figure BPA00001228897900031
图3
图4显示应用产品后第三天的腿部区域，观察到受损组织的明显恢复，因此允许确认水凝胶的治疗效益。
Figure BPA00001228897900032
水凝胶制备的方法
在具有蒸馏水的不锈钢容器中，加入稀释的有机酸，将其均化，并在制备水凝胶期间，使pH保持在4.0至4.5之间；之后，在制剂中出现的所有壳聚糖在连续搅拌下被缓慢加入直到完成溶解。
随后，加入防腐剂聚氨丙基双胍、葡萄糖酸内酯、苯甲酸钠和葡萄糖酸钙，或本专利中包括的其他防腐剂的混合物；随后，加入马齿苋或另一天然提取物，然后加入泛醇。
最后，通过使用稀释到1％和2％之间的有机酸溶液或2％氢氧化钠溶液，将pH调节至5.0和5.9之间。
随后，将制品储存在容器中，直到分装(fractioning)。
在本专利中，组合物被表示为实施例，并且它们不限制本发明的范围和保护。
实施例1
壳聚糖粉末          3.50g
聚氨丙基双胍        1.50g
马齿苋提取物        4.00g
泛醇                4.00g
柠檬酸1％w/v适量    pH 5.5
蒸馏水适量          100g
实施例2
壳聚糖粉末          4.0g
聚氨丙基双胍        1.5g
马齿苋提取物        6.0g
泛醇                4.0g
柠檬酸1％w/v适量    pH 5.5
蒸馏水适量          100g
实施例3
壳聚糖粉末        4.0g
聚氨丙基双胍      1.5g
马齿苋提取物      4.0g
泛醇              6.0g
乳酸1％w/v适量    pH 5.5
蒸馏水适量        100g
实施例4
壳聚糖粉末        8.0g
聚氨丙基双胍      1.5g
马齿苋提取物      4.0g
泛醇              6.0g
柠檬酸1％w/v适量  pH 5.5
蒸馏水适量        100g
实施例5
壳聚糖粉末                      3.50g
聚氨丙基双胍                    1.50g
葡萄糖酸内酯/苯甲酸钠/葡糖酸钙  1.50g
马齿苋提取物                    4.00g
泛醇                            4.00g
乳酸1％w/v适量                  pH 5.5
蒸馏水适量                      100g
实施例6
壳聚糖粉末                      4.0g
聚氨丙基双胍                    1.50g
葡萄糖酸内酯/苯甲酸钠/葡糖酸钙  1.50g
马齿苋提取物                    6.00g
泛醇                            4.00g
乳酸1％w/v适量                  pH 5.5
蒸馏水适量                      100g
实施例7
壳聚糖粉末                      4.0g
聚氨丙基双胍                    1.50g
葡萄糖酸内酯/苯甲酸钠/葡糖酸钙  1.50g
马齿苋提取物                    4.00g
泛醇                            6.00g
乳酸1％w/v适量                  pH 5.5
蒸馏水适量                      100g
实施例8
壳聚糖粉末                      8.0g
聚氨丙基双胍                    1.50g
葡萄糖酸内酯/苯甲酸钠/葡糖酸钙  1.50g
马齿苋提取物                    4.00g
泛醇                            6.00g
乳酸1％w/v适量                  pH 5.5
蒸馏水适量                      100g
表1
组合物的稳定性
  第1个月  第2个月   第3个月
  实施例   黏度   pH   微生物学   黏度   pH   微生物学   黏度   pH   微生物学
  1   10,000cps   5.5   低于100   100cps   5.4   高于1000   100cps   5.4   高于1000
  2   12,000cps   5.5   低于100   50cps   5.5   高于1000   50cps   5.5   高于1000
  3   12,000cps   5.5   低于100   200cps   5.4   高于1000   200cps   5.2   高于1000
  4   15,000cps   55   低于100   200cps   5.3   高于1000   200cps   5.3   高于1000
  5   11,000cps   5.5   低于100   11,500cps   5.5   低于100   11,900cps   5.5   低于100
  6   14,000cps   5.5   低于100   14,800cps   5.4   低于100   14,600cps   5.4   低于100
  7   15,000cps   5.5   低于100   15,300cps   5.4   低于100   15,100cps   5.5   低于100
  8   18,000cps   5.5   低于100   18,200cps   5.5   低于100   18,100cps   5.5   低于100
最终产物的说明：
外观，凝胶具有中等黏度、悬浮液中无奇怪的颗粒、淡黄色并且半透明。黏度值在5.000cps和20.000cps之间。
pH值在5.0至5.9之间
微生物学：无嗜温需氧菌且病原体≤100UFC/克，且真菌和酵母≤100UFC/g；
在表1中，可以观察到组合物中包含防腐剂混合物的水凝胶的重要性，在实施例1至4中，组合物具有较低的变化，但最重要的是仅包含一种防腐剂，在实施例5至8中，组合物具有较低的变化，但最重要的是包含防腐剂的混合物的成分。从表的结果中可以了解，在黏度显著变化的研究的第二个月，在制剂1至4中产生明显的降低以及明显的微生物污染，特别是被真菌污染。这并未在包括防腐剂混合物的实施例5至8的制剂中出现。
在温度和相对湿度(25℃±2℃和60±5％H)的正常室内条件下进行这一实验。
必须使用防腐剂的混合物以保持该条件这一事实是不寻常且出人意料的(产品的说明书)，因为已预期一种防腐剂的使用足以保持产品的稳定性。没有预见仅一种防腐剂的使用会产生观察到的黏度的变化。

Claims (12)

1.一种局部应用的基于稳定亲水的聚合物凝胶，其特征在于：
a)其包括壳聚糖，
b)所述壳聚糖通过加入溶剂溶解，
c)其包括增加组织恢复能力的一种或多种物质，
d)其包括对皮肤无害的防腐剂。
2.根据权利要求1所述的凝胶，其特征在于具有25,000g/mol至1,250,000g/mol之间的分子量的壳聚糖是水凝胶的主成分，并且以在2％至8％之间变化的比例存在。
3.根据权利要求1至2所述的凝胶，其特征在于所述溶剂是稀释的有机酸，来自α羟基酸族，诸如：乙醇酸、乳酸、α羟基乙酸、α羟基辛酸、α羟基羊脂酸、苹果酸、柠檬酸和酒石酸。
4.根据权利要求1至3所述的凝胶，其特征在于所述增强所述组织恢复能力的天然来源物质选自马齿苋提取物、乳香木提取物、繁缕提取物、大车前提取物、金盏花提取物、乳香树提取物、没药提取物、果香菊提取物、香叶天竺葵提取物、泛醇和亚油酸。
5.根据权利要求1至4所述的凝胶，其特征在于所述天然来源的物质以在0.1％至45％之间变化的百分比存在。
6.根据权利要求1至5所述的凝胶，其特征在于包括防腐剂的混合物，每种防腐剂的浓度在0.1％至30％之间变化。
7.根据权利要求6所述的凝胶，其特征在于优选的防腐剂是聚氨丙基双胍、葡萄糖酸内酯、苯甲酸钠和葡萄糖酸钙的混合物。
8.一种用于获得权利要求1至7所述的局部应用的凝胶的方法，其特征在于以下步骤：
a)由含有2％至8％w/w之间的壳聚糖的弱有机酸的1-2％w/v溶液制备壳聚糖溶液，
b)以在0.1％至30％之间变化的比例将防腐剂的混合物加入到在(a)中获得的溶液中，
c)然后，当所述混合物均匀后，在连续搅拌下以在0.1％至45％之间变化的比例加入天然来源的物质，
d)最后用2％氢氧化钠溶液或稀释到1％至2％之间的有机酸溶液将pH调节到5.0至5.9之间。
9.一种用于获得根据权利要求8所述的壳聚糖水凝胶的方法，其特征在于使用α羟基酸作为有机酸，诸如：乙醇酸、乳酸、α羟基乙酸、α羟基辛酸、α羟基羊脂酸、苹果酸、柠檬酸和酒石酸。
10.权利要求1至7所述的凝胶的用途，其特征在于其通过薄层的局部应用用于治疗溃疡皮肤和烧伤。
11.权利要求1至7所述的凝胶的用途，其特征在于其通过在受感染的皮肤上的薄层应用，用于皮肤擦伤的治疗、脱屑后以及激光后的治疗。
12.权利要求1至7所述的凝胶的用途，其特征在于其通过在治疗中的表面上的层应用，用于治疗腐蚀的皮肤。
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