CN115054539B - 一种消炎祛疤凝胶的制备工艺 - Google Patents
一种消炎祛疤凝胶的制备工艺 Download PDFInfo
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- CN115054539B CN115054539B CN202110994185.2A CN202110994185A CN115054539B CN 115054539 B CN115054539 B CN 115054539B CN 202110994185 A CN202110994185 A CN 202110994185A CN 115054539 B CN115054539 B CN 115054539B
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Abstract
本发明涉及A61K8/81领域，尤其涉及一种消炎祛疤凝胶的制备工艺，包括将第一凝胶、第二凝胶、第三凝胶按比例混合均匀，所述第一凝胶的制备方法包括如下步骤：(1)在纯水中加入第一螯合剂进行溶解；(2)继续加入第一保湿剂，边搅拌边加入第一胶凝剂进行均质；(3)用第一pH调节剂调节pH值。本发明所述的修护凝胶中添加了特定的伊红染色剂，结合Lumiheal治疗仪或Kleresca治疗仪中特定波长的荧光，凝胶中的发色团将治疗仪发出的蓝光转换成荧光光能量，产生的多色荧光穿透皮肤的表皮层、真皮层，触发皮肤自身的愈合反应，并激活其愈合机制。
Description
技术领域
本发明涉及A61K8/81领域，尤其涉及一种消炎祛疤凝胶的制备工艺。
背景技术
当皮肤组织受到外力破坏，如烧烫伤、车祸、医美失败、医疗手术、严重痤疮后对皮肤造成伤害后，所带来的瘢痕和增生曾一度被业界认为是永久性的、难以消除的，多年来医药行业一直致力于研发出一款能有效消除瘢痕的特效药，现有技术中最为常见的是药膏或凝胶，可以分为纯植物型和激素型两种，植物型药膏更为天然健康，但祛疤效果甚微，激素型凝胶修复效果较为明显，但副作用高，对身体健康不利。随着科技的发展，近年来仪器和凝胶复配使用的方法越来越流行，通过激光的方式将表层坏死细胞切除，术后表层皮肤结痂再脱落，反复多次后皮肤宛如新生。这样的方式破坏了皮肤角质层，激光治疗后的皮肤极为敏感脆弱，且治疗周期长，费用高，治疗后有10天左右的结痂期，影响患者生活。
CN103495155A公开了用于增生性疤痕修复的贴膜及其制备方法，通过药物活性成分对皮肤增生处进行贴敷式治疗，但治疗对象仅限于愈合后的增生皮肤，对处于发炎阶段的伤口无法治疗。
CN102108211A公开了一种壳聚糖胶原蛋白凝胶及应用，通过添加壳聚糖解决吸收不彻底的问题，对于面部的痤疮、粉刺、酒糟鼻等激素型皮肤问题治疗效果甚微且难以根治。
发明内容
本发明提供了一种消炎祛疤凝胶的制备工艺，包括将第一凝胶、第二凝胶、第三凝胶按比例混合均匀，所述第一凝胶的制备方法包括如下步骤：(1)在纯水中加入第一螯合剂进行溶解；(2)继续加入第一保湿剂，边搅拌边加入第一胶凝剂进行均质；(3)用第一pH调节剂调节pH值。
优选的，按重量份计，所述第一凝胶的制备原料包括：第一螯合剂0.5-1份、第一保湿剂50-100份、第一pH调节剂0.5-1.5份、第一胶凝剂0.5-3份、纯水15-35份。
进一步优选的，按重量份计，所述第一凝胶的制备原料包括：第一螯合剂0.6份、第一保湿剂65份、第一pH调节剂0.7份、第一胶凝剂2.5份、纯水20份。
作为一种优选的实施方式，所述第二凝胶的制备方法包括如下步骤：(1)在第二保湿剂中缓缓加入第二螯合剂与纯水的预混溶液，继续加入抑菌剂、乳化剂与纯水的预混溶液，搅拌均匀；(2)加入第二胶凝剂进行均质，用第二pH调节剂调节pH值；(3)加入染色剂与纯水的预混溶液进行搅拌，继续用第二pH调节剂调节pH值。
作为一种优选的实施方式，所述pH值均为4.5-7.5。
优选的，所述pH值均为6.0。
作为一种优选的实施方式，所述第三凝胶的重量占第一凝胶重量的50-80wt％。
优选的，所述第三凝胶的重量占第一凝胶重量的66.7wt％。
作为一种优选的实施方式，所述第一凝胶、第二凝胶的重量比为(3-7)：(0.5-1)。
优选的，所述第一凝胶、第二凝胶的重量比为6：1。
优选的，按重量份计，所述第二凝胶的制备原料包括：抑菌剂0.07-0.5份、第二螯合剂0.5-1份、第二保湿剂35-65份、乳化剂20-25份、第二pH调节剂0.5-1.5份、第二胶凝剂0.5-3份、染色剂0.1-2份、纯水20-40份。
优选的，按重量份计，所述第二凝胶的制备原料包括：抑菌剂0.2份、第二螯合剂0.6份、第二保湿剂40份、乳化剂20份、第二pH调节剂0.5份、第一胶凝剂1.5份、染色剂0.9份、纯水25份。
作为一种优选的实施方式，按重量份计，所述第三凝胶的制备原料包括：过氧化物及其盐类1-15份。
优选的，所述过氧化物及其盐类包括过氧化脲、过氧化氢、过碳酸钠、过硼酸钠中的至少一种。
优选的，所述过氧化物及其盐类为过氧化脲或过氧化氢。
作为一种优选的实施方式，所述第一保湿剂包括甘油、丙二醇、透明质酸钠、聚谷氨酸、辛甘醇、1,2戊二醇、、尿素、水解蛋白、木糖醇、海藻糖中的至少一种。
优选的，所述第一保湿剂为甘油、丙二醇。
优选的，所述甘油、丙二醇的重量比为(4-7)：(1-3)。
优选的，所述甘油、丙二醇的重量比为5：2。
优选的，所述第二保湿剂为甘油。
作为一种优选的实施方式，所述第二保湿剂和乳化剂的重量比为(1-3)：1。
优选的，所述第二保湿剂和乳化剂的重量比为2：1。
优选的，所述乳化剂为丙二醇。
作为一种优选的实施方式，所述第一螯合剂、第二螯合剂包括EDTA盐、多磷酸钠、偏磷酸钠中的至少一种。
优选的，所述第一螯合剂、第二螯合剂为EDTA盐。
优选的，所述EDTA盐包括EDTA二钠、EDTA四纳中的至少一种。
优选的，所述第一螯合剂、第二螯合剂为EDTA二钠。
作为一种优选的实施方式，所述第一胶凝剂、第二胶凝剂包括卡波姆、黄原胶、刺槐豆胶、瓜尔豆胶、葡甘露聚糖、卡拉胶、海藻酸钠、β-环糊精、羧甲基纤维素钠、罗望子多糖胶中的至少一种。
作为一种优选的实施方式，所述第一胶凝剂、第二胶凝剂的粘度为40000-60000cps。
优选的，所述第一胶凝剂、第二胶凝剂为卡波姆。
进一步优选的，所述卡波姆的粘度(25℃，质量浓度为0.5％水溶液)为40000-60000cps，购买自上海舜水化工有限公司，型号为Carbopol 940。
作为一种优选的实施方式，所述抑菌剂包括羟苯甲酯、尼泊金丙酯、纳米银、苯扎氯铵、苯扎溴铵、聚六亚甲基单胍盐、聚六亚甲基双胍盐或氯己定、高良姜素、甘草黄酮和丁香酚、十一烯酸锌、十一烯酸单乙醇酰胺磺基琥珀酸酯二钠、甘宝素、二氯苯基咪唑二氧戊环、吡啶酮乙醇胺、羟乙磺酸六脒中的至少一种。
作为一种优选的实施方式，所述抑菌剂为羟苯甲酯、尼泊金丙酯。
优选的，所述羟苯甲酯、尼泊金丙酯的重量比为(0.5-3)：(0.2-2)。
优选的，所述羟苯甲酯、尼泊金丙酯的重量比为1.5：1。
作为一种优选的实施方式，所述染色剂为伊红。
本发明不对第一pH调节剂、第二pH调节剂做特殊限定，本领域常用的pH调节剂都可以，包括但不限于氢氧化钠、柠檬酸、柠檬酸钠。
与现有技术相比，本发明具有以下有益效果：
1.本发明所述的修护凝胶分别设置第一凝胶、第二凝胶、第三凝胶的复配使用，且现用现配，分别使用无效果。
2.本发明第一凝胶的制备工艺中，采用预先加入第一螯合剂、后加入第一胶凝剂进行均质的工艺，所制备的凝胶稳定性好，密度均匀，在配合Lumiheal治疗仪或Kleresca治疗仪使用时对荧光光能量生成的绿色、黄色、橙色、红色的光谱折射光路均匀稳定，有助于光路直达皮下组织加速皮肤自身的愈合反应。
3.本发明第二凝胶的制备工艺中，采用在第二保湿剂中加入第二螯合剂与纯水的预混溶液，进一步加入抑菌剂、乳化剂与纯水的预混溶液，并在均质后加入染色剂的制备工艺，所制备的凝胶与第一凝胶配合使用后，能够更多的簇成凝胶中发色团的生成，在荧光光能的作用下，能够在伤口的急性炎症期、细胞增生期、瘢痕形成期三个关键阶段对皮肤进行及时修复，以阻断疤痕的生成。
4.本发明独创性采用三种凝胶并现用现配的方式，无防腐剂的添加，解决了现有技术中凝胶不耐储存、防腐剂不健康的技术问题。
附图说明
图1-3为患者下肢静脉性溃疡，接受实施例1的凝胶配合Lumiheal治疗仪治疗前后的效果图，其中图1为治疗前，图2为治疗第15天，图3为治疗第26天，图4为治疗第70天。
图4-6为患者糖尿病足溃疡，接受实施例1的凝胶配合Lumiheal治疗仪治疗前后的效果图，其中图4为治疗前，图5为治疗第22天，图6为治疗第75天。
图7-9为重度痤疮患者接受实施例1的凝胶配合Kleresca治疗仪治疗前后的效果图，其中图7为治疗第1天，图8为治疗第21天，图9为治疗第42天。
图10-11为重度痤疮患者接受实施例1的凝胶配合Kleresca治疗仪治疗前后的效果图，其中图10为治疗第1天，图11为治疗第42天。
具体实施方式
实施例1
本实施例提供了一种消炎祛疤凝胶的制备工艺，包括将第一凝胶、第二凝胶、第三凝胶按比例混合均匀，所述第一凝胶、第二凝胶、第三凝胶的重量比为6：1：4。
所述第一凝胶的制备方法包括如下步骤：(1)在纯水20份加入EDTA二钠0.6份进行溶解；(2)继续加入第一保湿剂65份，边搅拌边加入卡波姆(粘度(25℃，质量浓度为0.5％水溶液)为40000-60000cps)2.5份进行均质；(3)用氢氧化钠的水溶液(质量浓度为20％)0.7份调节pH值至6.0。
所述第一保湿剂为甘油、丙二醇以重量比为5：2复配。
所述第二凝胶的制备方法包括如下步骤：(1)在甘油40份中缓缓加入EDTA二钠0.6份与纯水10份的预混溶液，继续加入抑菌剂0.2份、丙二醇20份与纯水10份的预混溶液，搅拌均匀；(2)加入卡波姆(粘度(25℃，质量浓度为0.5％水溶液)为40000-60000cps)1.5份进行均质，用氢氧化钠的水溶液(质量浓度为20％)0.25份调节pH值至6.0；(3)加入伊红0.9份与纯水15份的预混溶液进行搅拌，继续用氢氧化钠的水溶液(质量浓度为20％)0.25份调节pH值至6.0。
所述抑菌剂为羟苯甲酯、尼泊金丙酯以重量比为1.5：1复配。
所述第三凝胶的制备原料包括：过氧化氢3份。
对比例1
本对比例提供了一种消炎祛疤凝胶的制备工艺，具体实施方式同实施例1，不同之处在于，所述第一凝胶、第二凝胶、第三凝胶的重量比为1：12：3。
对比例2
本对比例提供了一种消炎祛疤凝胶的制备工艺，包括将第二凝胶、第三凝胶按比例混合均匀，所述第二凝胶、第三凝胶的重量比为1：4，第三凝胶制备方法同实施例1。
对比例3
本对比例提供了一种消炎祛疤凝胶的制备工艺，具体实施方式同实施例1，不同之处在于，卡波姆的粘度(25℃，质量浓度为0.5％水溶液)为30500-39400cps，购买自上海舜水化工有限公司，型号为Carbopol 934。
性能测试
将实施例的凝胶涂敷于创口表面，涂敷厚度约2mm，配合使用Lumiheal治疗仪，单次治疗时间为5min，将实施例的凝胶涂敷于痤疮表面，涂敷厚度约2mm，配合使用Kleresca治疗仪，单次治疗时间为9min，治疗前后的效果图见图1-11。
图1-3为患者下肢静脉性溃疡，接受实施例1的凝胶配合Lumiheal治疗仪治疗前后的效果图；图4-6为患者糖尿病足溃疡，接受实施例1的凝胶配合Lumiheal治疗仪治疗前后的效果图；图7-9为重度痤疮患者接受实施例1的凝胶配合Kleresca治疗仪治疗前后的效果图；图10-11为重度痤疮患者接受实施例1的凝胶配合Kleresca治疗仪治疗前后的效果图。
稳定性测试：将实施例和对比例的凝胶分别涂敷于塑料板材上，使用Lumiheal治疗仪分别进行照射，观察凝胶在照射后有无水分析出、起泡或固化等不良现象。
| 稳定性 | |
| 实施例1 | 无变化 |
| 对比例1 | 凝胶明显融化，大量水分析出 |
| 对比例2 | 凝胶明显融化，大量水分析出，表面有气泡 |
| 对比例3 | 凝胶明显融化，大量水分析出，表面有气泡 |
Claims (1)
1.一种消炎祛疤凝胶的制备工艺，其特征在于，包括将第一凝胶、第二凝胶、第三凝胶按比例混合均匀，所述第一凝胶、第二凝胶、第三凝胶的重量比为6：1：4；
所述第一凝胶的制备方法包括如下步骤：（1）在纯水20份加入EDTA二钠0.6份进行溶解；（2）继续加入第一保湿剂65份，边搅拌边加入卡波姆940 2.5份进行均质；（3）用质量浓度为20%的氢氧化钠的水溶液0.7份调节pH值至6.0；
所述第一保湿剂为甘油、丙二醇以重量比为5：2复配；
所述第二凝胶的制备方法包括如下步骤：（1）在甘油40份中缓缓加入EDTA二钠0.6份与纯水10份的预混溶液，继续加入抑菌剂0.2份、丙二醇20份与纯水10份的预混溶液，搅拌均匀；（2）加入卡波姆940 1.5份进行均质，用质量浓度为20%的氢氧化钠的水溶液0.25份调节pH值至6.0；（3）加入伊红0.9份与纯水15份的预混溶液进行搅拌，继续用质量浓度为20%的氢氧化钠的水溶液0.25份调节pH值至6.0；
所述抑菌剂为羟苯甲酯、尼泊金丙酯以重量比为1.5：1复配；
所述第三凝胶的制备原料为过氧化氢3份。
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