CN111437436A - 一种用于皮肤浅表损伤高效修复的膏体伤口敷料及其制备方法 - Google Patents
一种用于皮肤浅表损伤高效修复的膏体伤口敷料及其制备方法 Download PDFInfo
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- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
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Abstract
本发明提供一种用于皮肤浅表损伤高效修复的膏体伤口敷料及其制备方法,每千克膏体伤口敷料含有以下质量的原料:甘油65~95g、十六十八醇35~60g、丁二醇35~60g、白油85~100g、异十六烷58~84g、二甲硅油15~25g、海藻糖15~25g、戊二醇15~25g、鲸蜡硬脂醇聚醚‑25 7~16g、海藻酸钠0.3~0.8g、透明质酸钠1~4g、对羟基苯甲酸乙酯0.5~1.2g。本发明膏体伤口敷料给浅表损伤皮肤创造良好的修复环境,很好抑制创面细菌的生长,促进纤维细胞的生成,并刺激血管增生,对皮肤浅表损伤的有较好的修复效果。
Description
技术领域
本发明涉及伤口敷料技术领域,特别涉及一种用于皮肤浅表损伤高效修复的膏体伤口敷料及其制备方法。
背景技术
生活、工作中,比较多的人时常出现皮肤浅表损伤,任其自然愈合,很容易留下疤痕。皮肤伤口敷料通过在皮肤创面表面形成保护层,起物理屏障作用,用于擦伤、切割伤等浅表性创面及周围皮肤的护理。但伤口愈合后容易出现细微疤痕,中老年皮肤伤口愈合后相对更容易留下疤痕,影响皮肤外表美观。另外,人们尤其重视医美术后伤口的修复,对修复后的皮肤美观要求极高。故急需一种伤口敷料,能够解决上述问题。
发明内容
鉴于此,本发明提出一种用于皮肤浅表损伤高效修复的膏体伤口敷料及其制备方法,解决上述技术问题。
本发明的技术方案是这样实现的:一种用于皮肤浅表损伤高效修复的膏体伤口敷料,每千克膏体伤口敷料含有以下质量的原料:甘油65~95g、十六十八醇35~60g、丁二醇35~60g、白油85~100g、异十六烷58~84g、二甲硅油15~25g、海藻糖15~25g、戊二醇15~25g、鲸蜡硬脂醇聚醚-25 7~16g、海藻酸钠0.3~0.8g、透明质酸钠1~4g、对羟基苯甲酸乙酯0.5~1.2g。优选,每千克膏体伤口敷料含有以下质量的原料:甘油85g、十六十八醇48g、丁二醇53g、白油90g、异十六烷72g、二甲硅油23g、海藻糖20g、戊二醇20g、鲸蜡硬脂醇聚醚-25 13g、海藻酸钠0.5g、透明质酸钠2g、对羟基苯甲酸乙酯0.8g。
本发明还提供一种用于皮肤浅表损伤高效修复的膏体伤口敷料的制备方法,包括以下步骤:
(1)溶液A的制备:在配制罐中加入配制总量15-25%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇,搅拌加热至60~105℃,使其完全溶解,得溶液B;
(3)溶液C的制备:在真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25,加热至60~105℃,保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化1~14分钟;降温至23~52℃,加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
进一步的,每千克膏体伤口敷料还含有以下质量的原料:蟒蛇油0.5~0.8g和白花地胆草提取物0.1~0.3g。优选地,每千克膏体伤口敷料还含有以下质量的原料:蟒蛇油0.65g和白花地胆草提取物0.2g。
进一步的,所述白花地胆草提取物的制备方法包括以下步骤:取白花地胆草,洗净,先使用70v/v%乙醇溶液进行第一次醇提0.5-1h,再于80v/v%乙醇溶液进行第二次醇提1-2h,合并提取液,减压浓缩,纯化后干燥,制得白花地胆草提取物。
本发明还提供一种用于皮肤浅表损伤高效修复的膏体伤口敷料的制备方法,包括以下步骤:
(1)溶液A的制备:在配制罐中加入配制总量15-25%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇、蟒蛇油,搅拌加热至60~105℃,使其完全溶解,得溶液B;
(3)溶液C的制备:在真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25、白花地胆草提取物,加热至60~105℃,保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化1~14分钟;降温至23~52℃,加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
与现有技术相比,本发明的有益效果是:
本发明以海藻糖为基,搭配甘油、十六十八醇、丁二醇、白油、异十六烷、二甲硅油、戊二醇、鲸蜡硬脂醇聚醚-25、海藻酸钠、透明质酸钠、对羟基苯甲酸乙酯和纯化水,制得膏体伤口敷料,给浅表损伤皮肤创造良好的修复环境,很好抑制创面细菌的生长,促进纤维细胞的生成,并刺激血管增生,对皮肤浅表损伤的有较好的修复效果。在基础方上加入特定量的蟒蛇油和白花地胆草提取物,一方面增强抑菌修复润肤之功效,另一方面,有效促进海藻糖的渗透,提高海藻糖功效发挥,显著提高对创面的修复效果,提高修复效率,缩短愈合时间,改善肌肤,更好减少疤痕生成,修复后皮肤外表美观,而且适用性广,能满足不同年龄层的人对修复效果的需求,优化使用者的肤感和体验感,增加使用者的依从性。同时,在本发明配方基础上,采用本发明制备方法,获得膏体伤口敷料产品稳定性更好,更利于产品的存放。
具体实施方式
为了更好理解本发明技术内容,下面提供具体实施例,对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明,均为常规方法。
本发明实施例所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
实施例1-3膏体伤口敷料配方表
上述实施例1-3的膏体伤口敷料的制备方法,包括以下步骤:
(1)溶液A的制备:在洁净干燥的配制罐中加入配制约总量20%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在洁净干燥的真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇,搅拌加热至65~100℃(±5℃),使其完全溶解,得溶液B;
(3)溶液C的制备:在洁净干燥的真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25,加热至65~100℃(±5℃),保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化3~12分钟(±2分钟);降温至25~50(±2℃),加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
实施例4
本实施例与实施例3的区别在于,每千克膏体伤口敷料还含有以下质量的原料:蟒蛇油0.65g和白花地胆草提取物0.2g;所述蟒蛇油为市售蟒蛇油,其由人工养殖蟒蛇所制得,所述白花地胆草提取物的制备方法包括以下步骤:取白花地胆草,洗净,先使用70v/v%乙醇溶液进行第一次醇提1h,再于80v/v%乙醇溶液进行第二次醇提2h,合并提取液,减压浓缩,依次利用10v/v%乙醇溶液、60v/v%乙醇溶液经大孔吸附树脂洗脱纯化,收集洗脱液,浓缩干燥,制得白花地胆草提取物;
(1)溶液A的制备:在配制罐中加入配制约总量20%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇、蟒蛇油,搅拌加热至65~100℃(±5℃),使其完全溶解,得溶液B;
(3)溶液C的制备:在真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25、白花地胆草提取物,加热至65~100℃(±5℃),保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化3~12分钟(±2分钟);降温至25~50(±2℃),加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
实施例5-本实施例与实施例4的区别在于,蟒蛇油0.5g和白花地胆草提取物0.3g。
实施例6-本实施例与实施例4的区别在于,蟒蛇油0.8g和白花地胆草提取物0.1g。
对比例1-本对比例与实施例3的区别在于,
所述海藻糖替换为壳聚糖,
所述十六十八醇替换为十八醇,
所述异十六烷替换为异十二烷,
所述鲸蜡硬脂醇聚醚-25替换为鲸蜡硬脂醇聚醚-20。
对比例2-本对比例与实施例3的区别在于,所述膏体伤口敷料,每千克膏体伤口敷料含有以下质量的原料:甘油50g、十六十八醇70g、丁二醇20g、白油50g、异十六烷100g、二甲硅油30g、海藻糖30g、戊二醇10g、鲸蜡硬脂醇聚醚-25 20g、海藻酸钠1g、透明质酸钠5g、对羟基苯甲酸乙酯2g,加入适量三乙醇胺调节pH值至5~8,加纯化水至配制总质量为1000g。
对比例3-本对比例与实施例4的区别在于,所述蟒蛇油替换为市售眼镜蛇油,所述白花地胆草提取物替换为市售的鱼腥草乙醇提取物。
对比例4-本对比例与实施例4的区别在于,所述蟒蛇油添加量为0.35g,所述白花地胆草提取物的添加量为0.5g。
一、安全试验
将实施例1-6、对比例1-4的膏体伤口敷料分别进行动物皮肤刺激试验、皮肤致敏试验、体外细胞毒性试验,表明安全无毒。
二、功效试验
收集40-60岁发生皮肤浅表损伤的志愿者,创面面积2~5cm2、深度0.5cm以内。经处理,无活动性出血或仅有微量出血。
分组:共收集200人,随机分组,每组20人,试验组1-10分别对应使用实施例1-6、对比例1-4的膏体伤口敷料;各组平均年龄为49.3~51.7岁。
处理方法:使用时清洁伤口,干燥后,将伤口敷料涂抹伤口,连续使用5天,分别在第3、5、7天后观察修复情况,计算创面缩小率。
创面缩小率:(修复前创面面积-修复后创面面积)/修复前创面面积×100%。
良好修复的标准:修复后,创面闭合,未见疤痕,皮肤外表平整。
结果下表1:
上述结果表明,与对比例1-2相比,本发明实施例1-6膏体伤口敷料对皮肤浅表损伤的有较好的修复效果,修复速度较快。本发明膏体伤口敷料,给浅表损伤皮肤创造良好的修复环境,很好抑制创面细菌的生长,促进纤维细胞的生成,并刺激血管增生,对皮肤浅表损伤的有较好的修复效果。
实施例4与对比例3-4对比,加入特定量的蟒蛇油和白花地胆草提取物,不但提高修复效率,缩短愈合时间,而且改善肌肤,较好减少疤痕生成。在基础方上加入特定量的蟒蛇油和白花地胆草提取物,一方面增强抑菌润肤之功效,另一方面,有效促进海藻糖的渗透,提高海藻糖功效发挥,显著提高对创面的修复效果。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种用于皮肤浅表损伤高效修复的膏体伤口敷料,其特征在于,每千克膏体伤口敷料含有以下质量的原料:甘油65~95g、十六十八醇35~60g、丁二醇35~60g、白油85~100g、异十六烷58~84g、二甲硅油15~25g、海藻糖15~25g、戊二醇15~25g、鲸蜡硬脂醇聚醚-25 7~16g、海藻酸钠0.3~0.8g、透明质酸钠1~4g、对羟基苯甲酸乙酯0.5~1.2g。
2.根据权利要求1所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料,其特征在于,每千克膏体伤口敷料含有以下质量的原料:甘油85g、十六十八醇48g、丁二醇53g、白油90g、异十六烷72g、二甲硅油23g、海藻糖20g、戊二醇20g、鲸蜡硬脂醇聚醚-25 13g、海藻酸钠0.5g、透明质酸钠2g、对羟基苯甲酸乙酯0.8g。
3.根据权利要求1或2所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料,其特征在于,每千克膏体伤口敷料还含有以下质量的原料:蟒蛇油0.5~0.8g和白花地胆草提取物0.1~0.3g。
4.根据权利要求1或2所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料,其特征在于,每千克膏体伤口敷料还含有以下质量的原料:蟒蛇油0.65g和白花地胆草提取物0.2g。
5.根据权利要求3所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料,其特征在于,所述白花地胆草提取物的制备方法包括以下步骤:取白花地胆草,洗净,先使用70v/v%乙醇溶液进行第一次醇提0.5-1h,再于80v/v%乙醇溶液进行第二次醇提1-2h,合并提取液,减压浓缩,纯化后干燥,制得白花地胆草提取物。
6.根据权利要求1或2所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料的制备方法,其特征在于,包括以下步骤:
(1)溶液A的制备:在配制罐中加入配制总量15-25%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇,搅拌加热至60~105℃,使其完全溶解,得溶液B;
(3)溶液C的制备:在真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25,加热至60~105℃,保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化1~14分钟;降温至23~52℃,加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
7.根据权利要求3所述的一种用于皮肤浅表损伤高效修复的膏体伤口敷料的制备方法,其特征在于,包括以下步骤:
(1)溶液A的制备:在配制罐中加入配制总量15-25%水,依次缓慢加入称量好的透明质酸钠、海藻酸钠、海藻糖、对羟基苯甲酸乙酯,搅拌5~18分钟,静置,使其充分浸润吸水溶胀后,得溶液A;
(2)溶液B的制备:在真空均质乳化机油相锅中,依次加入称量好的白油、异十六烷、二甲硅油、十六十八醇、蟒蛇油,搅拌加热至60~105℃,使其完全溶解,得溶液B;
(3)溶液C的制备:在真空均质乳化机主锅中依次加入称量好的余量水、丁二醇、甘油、戊二醇、鲸蜡硬脂醇聚醚-25、白花地胆草提取物,加热至60~105℃,保温8~12分钟,得溶液C;
(4)成品的制备:开启真空,将溶液B打入溶液C中,搅拌3~8分钟后,均质乳化1~14分钟;降温至23~52℃,加入溶液A,搅拌均匀;用三乙醇胺调节溶液pH值至5~8,搅拌均匀,抽真空排气泡,制得膏体伤口敷料。
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