CN109316628B - 一种凝胶及其制备方法和应用 - Google Patents
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Abstract
本发明涉及一种凝胶及其制备方法和应用，属于医药领域。本发明的凝胶，包括以下重量份的组分：聚己内酯3～30份、透明质酸4～35份、聚乙二醇2～25份。本发明采用特定组分的聚己内酯、透明质酸和聚乙二醇，稳定性高，对皮肤无刺激作用，在局部存留时间长、可塑性好，消除皱纹效果明显。
Description
技术领域
本发明涉及一种凝胶及其制备方法和应用，属于医药领域。
背景技术
近年来医美发展迅速，其中人工化学合成的高分子材料与动物来源的材料相比，由于减少了感染疾病的风险，使用安全，使其使用范围逐渐变大，为了满足现阶段医学美容行业的发展需求，急需发明一种短期内具有良好形态及效果，并可中长期留存或刺激皮下胶原增生，最重要的是可以完全被人体降解并且无毒副作用的产品。
申请号为200810009190.8的专利公开了一种含大分子水凝胶的透明质酸或其盐的混悬液及其制备方法，但是其大分子为单一组分的交联多糖化合物或聚合物，治疗效果不明显，并且透明质酸容易在体内扩散和被肌体组织中的酶降解，存留时间短，不能起到长期美容的效果。申请号为200810009193.1的专利公开了一种混合凝胶及其制备方法，制备过程工艺繁琐，在体内存留时间短，不能起到长期美容的效果。
发明内容
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稳定性高，对皮肤无刺激作用，在局部存留时间长、可塑性好，消除皱纹效果明显的凝胶及其制备方法和应用。
为实现上述目的，本发明采取的技术方案为：一种凝胶，包括以下重量份的组分：聚己内酯3～30份、透明质酸4～35份、聚乙二醇2～25份。
聚己内酯具有良好的生物相容性、良好的有机高聚物相容性，以及良好的生物降解性，可用作细胞生长支持材料，降解后可参与体内的新城代谢，无体内积聚的问题，此外，聚己内酯还具有良好的形状记忆温控性质，被广泛应用于药物载体、医学美容领域。透明质酸具有特殊的保水作用，是目前发现的自然界中保湿性最好的物质，被称为理想的天然保湿因子(Natural moisturizing factor，NMF，例如：2％的纯透明质酸水溶液能牢固地保持98％水分)，人类皮肤成熟和老化过程也随着透明质酸的含量和新陈代谢而变化，它可以改善皮肤营养代谢，使皮肤柔嫩、光滑、去皱、增加弹性、防止衰老，在保湿的同时又是良好的透皮吸收促进剂，与其他营养成分配合使用，可以起到促进营养吸收的更理想效果。聚乙二醇在化妆品工业和制药工业中的应用很广泛，具有很多优良的性质：水溶性、不挥发性、生理惰性、温和性、润滑性和使皮肤润湿、柔软、有愉快用后感等。本发明采用特定组分的聚己内酯、透明质酸和聚乙二醇，稳定性高，对皮肤无刺激作用，在局部存留时间长、可塑性好，消除皱纹效果明显。
作为本发明所述凝胶的优选实施方式，所述凝胶包括以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份。
作为本发明所述凝胶的优选实施方式，所述凝胶还包括以下重量份的组分：羧甲基纤维素1～10份、植物提取物1～5份、抗氧化剂1～10份、利多卡因1～5份。
作为本发明所述凝胶的优选实施方式，所述凝胶还包括以下重量份的组分：羧甲基纤维素5份、植物提取物3份、抗氧化剂5份、利多卡因3份。
作为本发明所述凝胶的优选实施方式，所述抗氧化剂为熊果苷、维生素C、维生素E、超氧化物歧化酶中的至少一种。
作为本发明所述凝胶的优选实施方式，所述植物提取物为藏红花提取物、当归提取物、茯苓提取物、洋甘菊提取物、白术提取物中的至少一种。
第二方面，本发明提供了上述凝胶的制备方法，包括以下步骤：
(1)将透明质酸制成透明质酸水凝胶；
(2)将除透明质酸外的其他组分按配比混合并溶于步骤(1)制得的透明质酸水凝胶中，得到凝胶。
作为本发明所述凝胶的制备方法的优选实施方式，所述步骤(1)中，透明质酸水凝胶为将透明质酸溶于水后，加入交联剂，待其溶胀而成。
作为本发明所述凝胶的制备方法的优选实施方式，所述步骤(1)中，水的用量为透明质酸重量的10倍，交联剂的用量为透明质酸重量的0.05倍，所述交联剂为1,4-丁二醇缩水甘油醚、己二酸二酰肼中的至少一种。
第三方面，本发明提供了上述凝胶在制备用于美容或医疗用途的凝胶中的应用。
与现有技术相比，本发明的有益效果为：本发明采用特定组分的聚己内酯、透明质酸和聚乙二醇，制得的凝胶，稳定性高，对皮肤无刺激作用，在局部存留时间长、可塑性好，消除皱纹效果明显。
具体实施方式
为更好地说明本发明的目的、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。
本发明所述植物提取物的制备方法为：将植物加入10倍的水对它进行提取，提取的温度90～95℃、提取次数为4次，浓缩干燥后得到水提取物；在提取后的植物中加入乙醇，使含醇量达到90wt％以上进行提取，浓缩干燥后得到乙醇提取物，将水提取物和乙醇提取物合并，即得植物提取物。
实施例1
一种凝胶，包含以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份、羧甲基纤维素5份、藏红花提取物3份、熊果苷5份、利多卡因3份。
本实施例所述凝胶的制备方法为：
(1)将透明质酸溶于水后，加入1,4-丁二醇缩水甘油醚作为交联剂，待其溶胀而成透明质酸水凝胶，水的用量为透明质酸重量的10倍，交联剂的用量为透明质酸重量的0.05倍；
(2)将聚己内酯、聚乙二醇、羧甲基纤维素、藏红花提取物、熊果苷、利多卡因按配比混合并溶于步骤(1)制得的透明质酸水凝胶中，得到凝胶。
实施例2
一种凝胶，包含以下重量份的组分：聚己内酯3份、透明质酸35份、聚乙二醇2份、羧甲基纤维素1份、藏红花提取物1份、熊果苷1份、利多卡因1份。
本实施例所述凝胶的制备方法同实施例1。
实施例3
一种凝胶，包含以下重量份的组分：聚己内酯30份、透明质酸4份、聚乙二醇25份、羧甲基纤维素10份、藏红花提取物5份、熊果苷10份、利多卡因5份。
本实施例所述凝胶的制备方法同实施例1。
实施例4
一种凝胶，包含以下重量份的组分：聚己内酯10份、透明质酸20份、聚乙二醇15份、羧甲基纤维素7份、藏红花提取物2份、熊果苷4份、利多卡因2份。
本实施例所述凝胶的制备方法同实施例1。
实施例5
一种凝胶，包含以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份、羧甲基纤维素5份、当归提取物3份、维生素C 5份、利多卡因3份。
本实施例所述凝胶的制备方法同实施例1。
实施例6
一种凝胶，包含以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份、羧甲基纤维素5份、茯苓提取物3份、维生素E 5份、利多卡因3份。
本实施例所述凝胶的制备方法同实施例1。
实施例7
一种凝胶，包含以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份、羧甲基纤维素5份、洋甘菊提取物3份、超氧化物歧化酶5份、利多卡因3份。
本实施例所述凝胶的制备方法同实施例1。
对比例1
一种凝胶，包含以下重量份的组分：透明质酸25份、聚乙二醇20份、羧甲基纤维素5份、藏红花提取物3份、熊果苷5份、利多卡因3份。
本实施例所述的凝胶的制备方法为：
(1)将透明质酸溶于水后，加入1,4-丁二醇缩水甘油醚作为交联剂，待其溶胀而成透明质酸水凝胶，水的用量为透明质酸重量的10倍，交联剂的用量为透明质酸重量的0.05倍；
(2)将聚乙二醇、羧甲基纤维素、藏红花提取物、熊果苷、利多卡因按配比混合并溶于步骤(1)制得的透明质酸水凝胶中，得到凝胶。
对比例2
一种凝胶，包含以下重量份的组分：聚己内酯20份、透明质酸25份、羧甲基纤维素5份、藏红花提取物3份、熊果苷5份、利多卡因3份。
本实施例所述凝胶的制备方法为：
(1)将透明质酸溶于水后，加入1,4-丁二醇缩水甘油醚作为交联剂，待其溶胀而成透明质酸水凝胶，水的用量为透明质酸重量的10倍，交联剂的用量为透明质酸重量的0.05倍；
(2)将聚己内酯、羧甲基纤维素、藏红花提取物、熊果苷、利多卡因按配比混合并溶于步骤(1)制得的透明质酸水凝胶中，得到凝胶。
对比例3
一种凝胶，包含以下重量份的组分：聚己内酯35份、透明质酸1份、聚乙二醇20份、羧甲基纤维素5份、藏红花提取物3份、熊果苷5份、利多卡因3份。
本实施例所述凝胶的制备方法同实施例1。
对比例4
一种凝胶，包含以下重量份的组分：聚己内酯15份、透明质酸40份、聚乙二醇30份、羧甲基纤维素5份、藏红花提取物3份、熊果苷5份、利多卡因3份。
本实施例所述凝胶的制备方法同实施例1。
效果例1
本发明实施例1～7和对比例1～4的推力试验
在15～50N的压力下，实施例1～7所得凝胶可以比较容易推出，对比例1～2用27G针头不易推出，而对比例3～4用27G针头不推即流出。可见，本发明制备的凝胶既可用于涂抹，也适用于注射。
效果例2
本发明实施例1～7和对比例1～4的稳定性试验
将实施例1～7和对比例1～4所得的凝胶置于冰箱4℃保存一周后，取出同置35℃～40℃保温10min，实施例1～7所得凝胶均为均匀的混悬状态，对比例1～2中发生显著沉降，有明显的固液分离现象，对比例3～4有少量絮状物生成，粘度下降。可见，本发明制备的凝胶具有良好的稳定性。
效果例3
本发明实施例1～7和对比例1～4的临床应用试验
选用220只健康大鼠作为试验对象，在每只大鼠的背部以125mg/kg.d的量涂抹D-半乳糖溶液，连续涂抹40天，得到大鼠衰老模型，然后将其平均分为11组，每组20只，分别涂抹实施例1～7和对比例1～4所得的凝胶，涂抹剂量均为1ml/kg，涂抹60天和180天后每组分别处死10只，解剖观察涂抹部位，结果如表1所示。
表1
| 60天真皮厚度(μm) | 180天真皮厚度(μm) | |
| 实施例1 | 710.2±30.5 | 806.6±25.6 |
| 实施例2 | 689.3±32.4 | 786.4±27.6 |
| 实施例3 | 684.4±28.6 | 784.5±26.7 |
| 实施例4 | 685.6±29.5 | 782.9±30.1 |
| 实施例5 | 696.9±27.4 | 792.6±28.7 |
| 实施例6 | 695.4±31.5 | 786.4±26.8 |
| 实施例7 | 684.9±31.7 | 790.6±24.6 |
| 对比例1 | 615.3±31.5 | 580.2±30.6 |
| 对比例2 | 613.8±30.4 | 578.6±28.7 |
| 对比例3 | 606.8±27.6 | 568.5±30.1 |
| 对比例4 | 604.5±24.6 | 577.6±28.6 |
从表1中可看出，60天后解剖大鼠，经过组织学观察，实施例1～7的涂抹部位被较多的胶原纤维包覆，起到了较好的填充效果，对比例1～4的涂抹部位填充剂被少量的胶原纤维包覆，填充效果较差；180天后解剖大鼠，经过组织学观察，实施例1～7的涂抹部位的真皮层厚度明显增加，并且涂抹部位被大量的胶原纤维包覆，起到了长久的填充效果，对比例1～4的涂抹部位的皮肤填充剂效果消失，未起到长久的填充效果；且对小鼠涂抹实施例1～7和对比例1～4所得的凝胶后，涂抹部位均未发现红、肿、青紫等反应。
结果表明，本发明的凝胶性质稳定，涂抹后，对皮肤无刺激作用，在局部存留时间长，可塑性好，消除皱纹效果明显，适用于美容和医疗用途。
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 (9)
1.一种凝胶，其特征在于，包括以下重量份的组分：聚己内酯3～30份、透明质酸4～35份、聚乙二醇2～25份、羧甲基纤维素1～10份、植物提取物1～5份、抗氧化剂1～10份、利多卡因1～5份。
2.如权利要求1所述的凝胶，其特征在于，包括以下重量份的组分：聚己内酯20份、透明质酸25份、聚乙二醇20份。
3.如权利要求1所述的凝胶，其特征在于，还包括以下重量份的组分：羧甲基纤维素5份、植物提取物3份、抗氧化剂5份、利多卡因3份。
4.如权利要求3所述的凝胶，其特征在于，所述抗氧化剂为熊果苷、维生素C、维生素E、超氧化物歧化酶中的至少一种。
5.如权利要求3所述的凝胶，其特征在于，所述植物提取物为藏红花提取物、当归提取物、茯苓提取物、洋甘菊提取物、白术提取物中的至少一种。
6.如权利要求1～5任一项所述的凝胶的制备方法，其特征在于，包括以下步骤：
(1)将透明质酸制成透明质酸水凝胶；
(2)将除透明质酸外的其他组分按配比混合并溶于步骤(1)制得的透明质酸水凝胶中，得到凝胶。
7.如权利要求6所述的凝胶的制备方法，其特征在于，所述步骤(1)中，透明质酸水凝胶为将透明质酸溶于水后，加入交联剂，待其溶胀而成。
8.如权利要求7所述的凝胶的制备方法，其特征在于，所述步骤(1)中，水的用量为透明质酸重量的10倍，交联剂的用量为透明质酸重量的0.05倍，所述交联剂为1,4-丁二醇缩水甘油醚、己二酸二酰肼中的至少一种。
9.如权利要求1～5中任一项所述的凝胶在制备用于美容或医疗用途的凝胶中的应用。
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