CN101365513A - 用于皮肤病学用途的粘弹性凝胶 - Google Patents

用于皮肤病学用途的粘弹性凝胶 Download PDF

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CN101365513A
CN101365513A CNA2007800020380A CN200780002038A CN101365513A CN 101365513 A CN101365513 A CN 101365513A CN A2007800020380 A CNA2007800020380 A CN A2007800020380A CN 200780002038 A CN200780002038 A CN 200780002038A CN 101365513 A CN101365513 A CN 101365513A
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吉尔斯·波斯
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Abstract

本发明涉及用于皮肤病学用途的天然来源的多糖凝胶，其包含0.1到5％重量/体积的多糖例如透明质酸的水溶液，和0.5－5％重量/体积的粘性和强亲水性的生物相容醇例如甘油，和任选的通常用于皮肤病学的助剂。该凝胶通过将多糖溶液和粘性和强亲水性的醇在灭菌之前混合、然后将全部混合物通过例如湿热灭菌法灭菌而制备。

Description

用于皮肤病学用途的粘弹性凝胶
本发明涉及用于皮肤病学用途的粘弹性凝胶。
天然来源的多种聚合物，诸如胶原蛋白、透明质酸或纤维素衍生物，通常被用于美容医学和皮肤病学中，用于填平皱纹、面部重塑，丰满唇体积，和面部皮肤回春；最后一种类型的治疗直接来自中胚层疗法(mesotherapy)。
对于皮肤回春，从业者经常使用透明质酸，有时结合维生素、氨基酸、无机盐和核酸的复合物。
本发明的目的是天然来源的多糖特别是玻尿糖苷(hyaluronan)和粘性醇的组合，从而提供可注射的既用型(ready-to-use)组合物，该组合物优化了面部回春治疗，该组合物特别地包括在皮肤病学中可用作注射剂的天然来源的多糖凝胶，所述组合包括0.1-5％重量/体积的多糖水溶液，和0.5-5％重量/体积的粘性和强亲水性的生物相容醇，其通过制备多糖和醇的水溶液、然后对该溶液和任选的通常用于皮肤病学的助剂进行灭菌获得，在将具有可显著增加所得凝胶的粘度的作用的各组合混合之后进行灭菌。
事实上，已经发现多糖或其盐，特别是玻尿糖苷或透明质酸钠，和少量的粘性的生物相容醇的组合提供了一种组合物，该组合物的粘度大大地增加，并且当粘性的生物相容醇也具有亲水性时，其显著增加当组合物被注射到待治疗皮肤下方时的保水性。
亲水性化合物被定义为是任何具有强水亲合性的化合物。在醇中，OH基的密度越高，则其亲水性越高。例如，甘油，作为含有三个OH基的低分子量(92.09g/mol)的醇，具有极高的亲水性。
已经发现添加少量(约0.5到5％重量/体积)的粘性的生物相容醇可显著增加在0.1-5％重量/体积浓度下的天然来源的多糖溶液的粘度，使得该溶液在灭菌期间保持稳定，并且保持了用于皮肤组织回春的特别有利的粘度性质。粘性醇可参与皮肤重构和该组织细胞的成熟以及确保混合物的等张性。
优选使用具有防腐性的生物相容醇，其降低皮肤感染的风险。事实上，考虑到在面部内的大量注射，这种风险显著存在于回春治疗期间。这种醇的例子特别是甘油和聚乙二醇十二烷基硫酸酯。
市售的透明质酸，根据制造商的不同而具有不同的分子量(MW)和不同的浓度。例如，可能使用浓度为1.8％重量/体积的低分子量到中等分子量(0.5到1.8MDa)的透明质酸，和浓度为1.5％重量/体积的高分子量(2.0到3.0MDa)的透明质酸。
本发明还提供了制备用于皮肤病学用途的天然来源的多糖凝胶的方法，其包括以下步骤：
a)制备以所需比例存在的多糖以及粘性和强亲水性的生物相容醇的水溶液，
b)将得到的溶液灭菌，特别是通过湿热灭菌法灭菌，和
c)任选地将凝胶制成既用型形式。
图1-3是表示本发明的实施例1和2以及实施例3(用于比较)的组合物的粘度图。
实施例1：透明质酸的浓度和甘油的存在对用于面部回春的溶液的粘度的影响
制备了基于相同透明质酸的三种溶液，透明质酸的特征在于具有1.6MDa的平均分子量。
第一种溶液是1％的透明质酸溶液。
第二种溶液是相同透明质酸的溶液，但是浓度为2％。
第三中溶液仅仅包含1.8％的前述的透明质酸，向其中添加浓度在2％重量/体积的甘油。
将三种制剂进行湿热杀菌，然后使用流变仪，通过基于施加于产品的剪切速率测量粘度，分析三种制剂的流变性质。
显然，根据图1的图表，对于低的剪切速率(相当于这样的剪切速率，将该制剂暴露于该剪切速率下用于在注射后的皮肤组织回春)，向透明质酸溶液中添加甘油比依靠增加透明质酸的浓度来获得高粘性制剂具有更大的效果。
实施例2：甘油对高分子量透明质酸溶液的粘度的影响
制备了特征在于极高的平均分子量(2.6MDa)的两种基于透明质酸的溶液。
第一制剂是1.5％的透明质酸溶液。
第二制剂也包含1.5％的高分子量透明质酸，对其添加了2％重量/体积的甘油。
将二种制剂进行湿热杀菌，然后使用流变仪，通过基于施加于产品的剪切速率测量粘度，分析它们的流变性质。
图2的图表显示了，即使当制剂由高分子量的透明质酸组成时—因此最初的特征在于高粘度—甘油仍然倾向于增加该产品的粘度。
实施例3：在灭菌期间，甘油对制剂的稳定性(用于比较)
制备了特征在于极高平均分子量(2.6MDa)的1.5％透明质酸的溶液。然后通过湿热灭菌法对该溶液进行杀菌(制剂1)。
向该经杀菌的溶液中添加几毫升的甘油(制剂2)。
在这两种制剂之间没有观察到流变性差异；图3的图表和上面提供的实施例表明甘油在灭菌期间具有稳定作用。
因此，为了增加粘度，在灭菌之前将粘性醇与透明质酸溶液混合是必要的。
灭菌之后，将组合物制成既用型形式，例如装入安瓿或烧瓶内，其包含可借助于注射器被注射的剂量。
该组合物可包括通常用于皮肤病学的助剂，其在灭菌之前被加入到混合物中。这种助剂是维生素、无机酸、无机盐和核酸。

Claims (6)

1.用于皮肤病学用途的注射用的天然来源的多糖凝胶，特征在于其包含0.1-5％重量/体积的多糖水溶液和0.5-5％重量/体积的粘性和强亲水性的生物相容醇，其通过制备多糖和醇的水溶液、然后对该溶液和任选的通常用于皮肤病学的助剂进行灭菌获得，在将具有可显著增加所得凝胶的粘度的作用的各组合混合之后进行灭菌。
2.权利要求1的凝胶，其中多糖是透明质酸。
3.权利要求1或2的凝胶，其中生物相容醇是甘油。
4.权利要求1到3中任一项的凝胶，其中水溶液包含1.8％重量/体积的平均分子量为0.5到1.8MDa的透明质酸和2％重量/体积的甘油。
5.权利要求1到3中任一项的凝胶，其中水溶液包含1.5％重量/体积的分子量为2.0到3.0MDa的高分子量透明质酸和2％重量/体积的甘油。
6.制备权利要求1-3中任一项的用于皮肤病学用途的天然来源的多糖凝胶的方法，其包括以下步骤：
a)制备以所需比例存在的多糖以及粘性和强亲水性的生物相容醇的水溶液，
b)将得到的溶液灭菌，特别是通过湿热灭菌法灭菌，和
c)任选地将凝胶制成既用型的形式。
CNA2007800020380A 2006-01-06 2007-01-05 用于皮肤病学用途的粘弹性凝胶 Pending CN101365513A (zh)

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FR0600138A FR2895907B1 (fr) 2006-01-06 2006-01-06 Gel viscoelastique a usage dermatologique

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CN102905677A (zh) * 2010-03-12 2013-01-30 阿勒根工业有限公司 用于改善皮肤状况的包含透明质烷聚合物和甘露糖醇的流体组合物
CN114712530A (zh) * 2022-04-18 2022-07-08 哈尔滨敷尔佳科技股份有限公司 提高重组胶原蛋白填充剂稳定性的湿热灭菌方法

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BRPI0706221B1 (pt) 2016-03-15
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KR20080083654A (ko) 2008-09-18
CA2636203C (fr) 2013-10-01
US8685944B2 (en) 2014-04-01
WO2007077399A2 (fr) 2007-07-12
RU2008128401A (ru) 2010-01-20
US9468779B2 (en) 2016-10-18
RU2419415C2 (ru) 2011-05-27
EP1968711A2 (fr) 2008-09-17
PL1968711T3 (pl) 2013-08-30
FR2895907B1 (fr) 2012-06-01
JP2009522342A (ja) 2009-06-11
EP1968711B1 (fr) 2013-04-10
CA2636203A1 (fr) 2007-07-12
BRPI0706221A2 (pt) 2011-03-22
KR101357693B1 (ko) 2014-02-03
US20140162975A1 (en) 2014-06-12
US20110230438A1 (en) 2011-09-22

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