CN108721689A - 生物护创流体膜及其制备方法 - Google Patents
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Abstract
本发明公开了生物护创流体膜,由以下组分以及质量分数组成:黄原胶0.1~2.0%;葡萄柚种子提取物0.01~1.0%;明矾0.01~1.0%;氯化钠0.8~2.0%;加注射用水或纯化水至足量。该发明对人体无毒性、无刺激性、无致敏,具有良好的生物降解性,具有良好的杀灭作用。达到清除坏死组织和分泌物,促进新鲜肉芽组织再生和新生血管再见改善供血为改善氧平衡创造环境。
Description
技术领域
本发明涉及生物护创流体膜及其制备方法,属于医用敷料或药品领域。
背景技术
溃疡一般是由外伤、微生物感染、肿瘤、循环障碍和神经功能障碍、免疫功能异常或先天皮肤缺损等引起的局限性皮肤组织缺损。一般为外伤性溃疡往往是由物理和化学因素直接作用于组织引起。微生物感染性疾病多由细菌、真菌、螺旋体、病毒等引起组织破坏。结节或肿瘤破溃。免疫异常引起的血管炎性溃疡系因动脉或小动脉炎使组织发生坏死而形成。循环或神经功能障碍属营养障碍引起组织坏死,如静脉曲张、麻风溃疡等。
溃疡发病原因很复杂,目前由于环境破坏和糖尿病及肿瘤发病率上升引起慢性溃疡并发症增多尤其久治不愈溃疡面和伤口及瘘道,造成截肢和危及生命。开发用于治疗应用于创面清创处理,去除坏死组织和分泌物。 适应于久治不愈的慢性伤口、糖尿病及肿瘤溃疡创面、静脉溃疡、二度烧伤、表皮移植供皮区、压疮等创面清创及愈合修复。尤其必要,前景很好。
治疗慢性溃疡及感染性创面一般要进行清创、营造平衡环境(酸碱、菌群平衡、供氧)、杀菌消炎、促进创面愈合,改善病人体制(营养改善增强患者免疫力);因此开发生物护创流体膜用于进行清创、营造平衡环境(酸碱、菌群平衡、供氧)、杀菌消炎、促进创面愈合有很好临床意义。
发明内容
为了克服现有技术的不足,本发明提供了通过调节菌群平衡和环境平衡作用进而改善供血、改善氧平衡创造组织修复环境,促进新鲜肉芽组织再生和新生血管再生,具体涉及生物护创流体膜及其制备方法。
本发明是通过如下技术方案实现的,生物护创流体膜,由以下组分以及质量分数组成:
黄原胶 0.1~2.0%
葡萄柚种子提取物 0.01~1.0%
明矾 0.01~1.0%
氯化钠 0.8~2.0%
加注射用水或纯化水 至足量。
所述的生物护创流体膜的制备方法,包括如下步骤:
A)将黄原胶溶解于注射用水或纯化水中,得到溶液①;
B)将葡萄柚种子提取物溶解于注射用水或纯化水中,得溶液②备用;
C)将溶液①和溶液②混合后,通过均质机进行均质后,得溶液③;
D)将明矾溶液制得溶液④备用;
E)将制备溶液③和溶液④混合搅拌,制备得到溶液⑤;
F)将氯化钠溶解于注射用水或纯化水,得到溶液⑥;
G)将制备溶液⑥与溶液⑤混合充分搅拌均匀,加入足量注射用水或纯化水;然后滴加磷酸二氢钠或磷酸氢二钠调节PH为4.5-7.5;
H)将步骤G)所得的溶液经抽滤、精滤、无菌灌装于115℃、30分钟消毒灭菌后得成品。
其作用机理如下:
1、清创:利用流体膜盐的高渗透性;清洗及吸附去除溃疡面及创面坏死组织及分泌物;生物护创流体膜具有盐的高渗透性和成膜性;流体膜覆盖在溃疡及创面迅速成膜、通过对坏死组织高渗透快速将坏死组织与新鲜组织分离,进而形成新鲜创面。
2、隔离保护作用:坏死组织高渗透快速将坏死组织与新鲜组织分离后形成新鲜创面;流体膜是一种呼吸性生物膜,能够改进新鲜创面组织供养,和将外界与新鲜创面隔离保护预防感染营造环境。
3、促进膜溃疡面及创面愈合作用:流体膜具有直接表面性的作用;这些作用对伤口愈合都有积极地意义;促进上皮细胞和血管内皮细胞的生长;选在不影响组织正常愈合的情况下,有效地促进创面愈合。
所得产品的理化指标为:
外观为浅黄色透明液体;
透光率≥95%;
PH值4.5—7.5;
动力粘度≥3mpas;
重金属含量≤0.001%。
上述生物性能指标,均通过国家指定检验机构检测,符合标准的相关规定。
具体实施方式
下面结合实例进一步详述本发明。
实施例1
生物护创流体膜,由以下组分以及质量分数组成:
黄原胶 0.1%
葡萄柚种子提取物 0.1%
明矾 0.01%
氯化钠 0.9%
加注射用水或纯化水 至足量。
所述的生物护创流体膜的制备方法,包括如下步骤:
A)将黄原胶溶解于注射用水或纯化水中,得到溶液①;
B)将葡萄柚种子提取物溶解于注射用水或纯化水中,得溶液②备用;
C)将溶液①和溶液②混合后,通过均质机进行均质后,得溶液③;
D)将明矾溶液制得溶液④备用;
E)将制备溶液③和溶液④混合搅拌,制备得到溶液⑤;
F)将氯化钠溶解于注射用水或纯化水,得到溶液⑥;
G)将制备溶液⑥与溶液⑤混合充分搅拌均匀,加入足量注射用水或纯化水;然后滴加磷酸二氢钠或磷酸氢二钠调节PH为4.5-7.5;
H)将步骤G)所得的溶液经抽滤、精滤、无菌灌装于115℃、30分钟消毒灭菌后得成品。
实施例2
生物护创流体膜,由以下组分以及质量分数组成:
黄原胶 0.2%
葡萄柚种子提取物 0.15%
明矾 0.02%
氯化钠 0.15%
加注射用水或纯化水 至足量。
所述的生物护创流体膜的制备方法,包括如下步骤:
A)将黄原胶溶解于注射用水或纯化水中,得到溶液①;
B)将葡萄柚种子提取物溶解于注射用水或纯化水中,得溶液②备用;
C)将溶液①和溶液②混合后,通过均质机进行均质后,得溶液③;
D)将明矾溶液制得溶液④备用;
E)将制备溶液③和溶液④混合搅拌,制备得到溶液⑤;
F)将氯化钠溶解于注射用水或纯化水,得到溶液⑥;
G)将制备溶液⑥与溶液⑤混合充分搅拌均匀,加入足量注射用水或纯化水;然后滴加磷酸二氢钠或磷酸氢二钠调节PH为4.5-7.5;
H)将步骤G)所得的溶液经抽滤、精滤、无菌灌装于115℃、30分钟消毒灭菌后得成品。
实施例3
生物护创流体膜,由以下组分以及质量分数组成:
黄原胶 1.5%
葡萄柚种子提取物 0.9%
明矾 0.01%
氯化钠 2.0%
加注射用水或纯化水 至足量。
所述的生物护创流体膜的制备方法,包括如下步骤:
A)将黄原胶溶解于注射用水或纯化水中,得到溶液①;
B)将葡萄柚种子提取物溶解于注射用水或纯化水中,得溶液②备用;
C)将溶液①和溶液②混合后,通过均质机进行均质后,得溶液③;
D)将明矾溶液制得溶液④备用;
E)将制备溶液③和溶液④混合搅拌,制备得到溶液⑤;
F)将氯化钠溶解于注射用水或纯化水,得到溶液⑥;
G)将制备溶液⑥与溶液⑤混合充分搅拌均匀,加入足量注射用水或纯化水;然后滴加磷酸二氢钠或磷酸氢二钠调节PH为4.5-7.5;
H)将步骤G)所得的溶液经抽滤、精滤、无菌灌装于115℃、30分钟消毒灭菌后得成品。
Claims (2)
1.生物护创流体膜,其特征在于:由以下组分以及质量分数组成:
黄原胶 0.1~2.0%
葡萄柚种子提取物 0.01~1.0%
明矾 0.01~1.0%
氯化钠 0.8~2.0%
加注射用水或纯化水 至足量。
2.一种如权利要求1所述的生物护创流体膜的制备方法,其特征在于:包括如下步骤:
A)将黄原胶溶解于注射用水或纯化水中,得到溶液①备用;
B)将葡萄柚种子提取物溶解于注射用水或纯化水中,得溶液②备用;
C)将溶液①和溶液②混合后,通过均质机进行均质后,得溶液③备用;
D)将明矾溶液制得溶液④备用;
E)将制备溶液③和溶液④混合搅拌,制备得到溶液⑤备用;
F)将氯化钠溶解于注射用水或纯化水,得到溶液⑥备用;
G)将制备溶液⑥与溶液⑤混合充分搅拌均匀,加入足量注射用水或纯化水;然后滴加磷酸二氢钠或磷酸氢二钠调节PH为4.5-7.5;
H)将步骤G)所得的溶液经抽滤、精滤、无菌灌装于115℃、30分钟消毒灭菌后得成品。
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