CN106075562A - 一种负压伤口治疗用护创液的制备方法 - Google Patents

一种负压伤口治疗用护创液的制备方法 Download PDF

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CN106075562A
CN106075562A CN201610622665.5A CN201610622665A CN106075562A CN 106075562 A CN106075562 A CN 106075562A CN 201610622665 A CN201610622665 A CN 201610622665A CN 106075562 A CN106075562 A CN 106075562A
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章祥庆
唐海健
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Jiangsu Lanwan Biotechnology Co Ltd
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Abstract

本发明提供了一种负压伤口治疗用护创液的制备方法，先将聚乙烯醇、胶原蛋白、氯化钙、磷酸二氢铵加至去离子水中，分散，得到混合液A；再将聚丙烯酸钠、丙烯酰胺、维生素C、山梨醇、甘露糖加至去离子水中，分散，得到混合液B；然后将混合液A和混合液B混合，在搅拌条件下加入鳄梨油、微晶纤维素、乳糖、酒石酸、过氧化氢，超声，4～10℃静置30～60min，即得。本发明的护创液能渗透到创面深层组织，将深层部位的细菌和内毒素杀灭，并将坏死组织、脓块、血块松动化解排出体外，有助于缩短创面愈合时间；制备工艺简单，能适应量产化要求。

Description

一种负压伤口治疗用护创液的制备方法
技术领域
本发明属于外科用医药技术领域，具体涉及一种负压伤口治疗用护创液的制备方法。
背景技术
对于烧烫伤、手术伤口感染、植皮及植皮区保护、火器冲击伤；爆炸伤等患者难以愈合的各种急、慢性伤口，目前主要的治疗方法包括常规外科换药和负压伤口治疗，目前临床上各种常规治疗方法存在治疗效果不确切，病程较长的缺陷。每次换药对于患者来说是一次非常痛苦的过程，也占用医生大量的时间，有些创面经久难愈，不仅要花大量医药费用，而且在精神和身体带来巨大的损害。这些问题被负压伤口治疗的出现很好地解决。
负压伤口治疗(negative-pressure wound therapy，NPWT)是近三十多年开展的一种创面治疗的方法，其包括两项关键技术封闭负压引流技术(VSD)和负压辅助闭合(VAC)。负压伤口治疗可以在创面形成持续性的引流效果，并可为创面保持湿润的环境，为创面愈合和后期行手术治疗创造一个良好的生长愈合环境，透明的半透膜形成的创面相对密闭环境，可以保护创面被感染机率，抗生素可以相应减少使用，创面在透明膜下医护人员可以及时地观察与处理，与传统换药相比新型的负压伤口治疗敷料可以减少更换创面敷料的次数，减少医护人员的劳动量。目前，适用于微动力负压伤口治疗的护创液比较少，效果也不明显。
发明内容
本发明的目的是克服现有技术的不足而提供一种负压伤口治疗用护创液的制备方法，所得护创液能渗透到创面深层组织，将深层部位的细菌和内毒素杀灭，并将坏死组织、脓块、血块松动化解排出体外，有助于缩短创面愈合时间。
一种负压伤口治疗用护创液的制备方法，包括以下步骤：
步骤1，以重量份计，将聚乙烯醇8～12份、胶原蛋白2～5份、氯化钙1～4份、磷酸二氢铵1.5～3.5份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠5～10份、丙烯酰胺1～4份、维生素C 2～6份、山梨醇0.5～1.2份、甘露糖0.1～0.4份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油0.5～1份、微晶纤维素0.3～0.9份、乳糖0.1～0.4份、酒石酸0.5～1.5份、过氧化氢0.7～3.5份，超声，4～10℃静置30～60min，即得。
进一步地，步骤1中分散条件为15～25℃、400～600rpm、10～15min。
进一步地，步骤2中分散条件为10～15℃、400～600rpm、10～15min。
进一步地，步骤3中超声条件为70～120w、10～15min。
进一步地，步骤3中超声结束后需调节pH至7.0～8.0。
进一步地，采用5～10wt％氢氧化钠溶液调节pH。
本发明的护创液能渗透到创面深层组织，将深层部位的细菌和内毒素杀灭，并将坏死组织、脓块、血块松动化解排出体外，有助于缩短创面愈合时间；制备工艺简单，能适应量产化要求。
具体实施方式
实施例1
一种负压伤口治疗用护创液的制备方法，包括以下步骤：
步骤1，以重量份计，将聚乙烯醇8份、胶原蛋白2份、氯化钙1份、磷酸二氢铵1.5份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠5份、丙烯酰胺1份、维生素C 2份、山梨醇0.5份、甘露糖0.1份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油0.5份、微晶纤维素0.3份、乳糖0.1份、酒石酸0.5份、过氧化氢0.7份，超声，4℃静置60min，即得。
其中，步骤1中分散条件为15℃、400rpm、15min；步骤2中分散条件为10℃、400rpm、15min；步骤3中超声条件为70w、15min，超声结束后需采用5wt％氢氧化钠溶液调节pH至7.0～8.0。
实施例2
一种负压伤口治疗用护创液的制备方法，包括以下步骤：
步骤1，以重量份计，将聚乙烯醇9份、胶原蛋白4份、氯化钙3份、磷酸二氢铵1.8份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠6份、丙烯酰胺3份、维生素C 5份、山梨醇0.8份、甘露糖0.4份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油0.7份、微晶纤维素0.5份、乳糖0.2份、酒石酸0.9份、过氧化氢1.2份，超声，7℃静置40min，即得。
其中，步骤1中分散条件为20℃、500rpm、12min；步骤2中分散条件为12℃、500rpm、15min；步骤3中超声条件为100w、10min，超声结束后需采用8wt％氢氧化钠溶液调节pH至7.0～8.0。
实施例3
一种负压伤口治疗用护创液的制备方法，包括以下步骤：
步骤1，以重量份计，将聚乙烯醇11份、胶原蛋白4份、氯化钙3份、磷酸二氢铵2.5份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠8份、丙烯酰胺3份、维生素C 4份、山梨醇0.9份、甘露糖0.4份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油0.7份、微晶纤维素0.8份、乳糖0.3份、酒石酸1.2份、过氧化氢2.4份，超声，10℃静置30min，即得。
其中，步骤1中分散条件为25℃、600rpm、10min；步骤2中分散条件为15℃、600rpm、10min；步骤3中超声条件为120w、10min，超声结束后需采用5wt％氢氧化钠溶液调节pH至7.0～8.0。
实施例4
一种负压伤口治疗用护创液的制备方法，包括以下步骤：
步骤1，以重量份计，将聚乙烯醇12份、胶原蛋白5份、氯化钙4份、磷酸二氢铵3.5份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠10份、丙烯酰胺4份、维生素C 6份、山梨醇1.2份、甘露糖0.4份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油1份、微晶纤维素0.9份、乳糖0.4份、酒石酸1.5份、过氧化氢3.5份，超声，4℃静置60min，即得。
其中，步骤1中分散条件为15℃、400rpm、15min；步骤2中分散条件为10℃、400rpm、15min；步骤3中超声条件为70w、15min，超声结束后需采用5wt％氢氧化钠溶液调节pH至7.0～8.0。
选用健康成年的新西兰大耳兔(质量2.5±0.5kg)作实验动物，建立动物模型，在兔背部制成4个3.5cm*3.5cmⅡ度烧伤创面(经病理切片证实)。实验采用左右自身对照，以兔头为上部，兔尾巴为下部，兔左部为治疗组，兔右部为对照组。治疗组创面涂抹实施例2所得护创液，纱布覆盖；对照组凡士林纱布覆盖。兔进入特制单笼，常规饲养，自由进食。治疗组护创液和对照组无菌凡士林纱布均每日更换一次，直至创面愈合。
伤后第1d，兔烧伤后烫伤创面与正常皮肤分界明显，烫伤时间增加，背部创面表皮坏死，部分表皮脱落，创面周围组织充血明显，也有明显的水肿。伤后第18～21d后，实验组创面基本全部上皮化，达到创面愈合，对照组创面上皮化时间一般在伤后21～25d左右。
创面组织含水量(％)变化如下表：
烫伤后即刻 1d 3d 5d 7d
对照组 72.51±0.48 75.32±1.21 74.75±1.20 73.32±1.35 72.05±1.14
治疗组 72.51±0.23 72.54±0.83 71.54±0.75 70.54±0.87 67.32±0.65
应用本发明护创液的创面在烫伤后第1d、第3d、第5d和第7d创面组织含水量明显低于对照组，两组比较差异均有统计学意义。
创面组织微循坏血流量(Pu)的变化如下表：
烫伤后即刻 1d 3d 5d 7d
对照组 160.0±5.7 45.2±3.0 53.4±6.5 61.4±7.2 64.7±9.5
治疗组 157.6±4.8 46.5±2.8 75.6±13.5 104.3±16.9 157.2±34.2
烫伤后即刻，两组创面微循环血流量比较差异无统计学意义；应用本发明护创液的创面在烫伤后第3d、第5和第7d创面微循环血流量明显高于对照组，两组比较差异有统计学意义。
烫伤后第14d，应用本发明护创液的治疗组和对照组的创面愈合率分别为(83.34±10.36)％和(51.39±9.13)％，伤后第20d，应用本发明护创液的治疗组和对照组的创面愈合率分别为(96.61±3.84)％和(87.61±8.17)％。伤后14d和20d，对照组的创面愈合率均显著低于治疗组，两组比较差异有统计学意义。

Claims (6)

1.一种负压伤口治疗用护创液的制备方法，其特征在于：包括以下步骤：
步骤1，以重量份计，将聚乙烯醇8～12份、胶原蛋白2～5份、氯化钙1～4份、磷酸二氢铵1.5～3.5份加至去离子水15份中，分散，得到混合液A；
步骤2，以重量份计，将聚丙烯酸钠5～10份、丙烯酰胺1～4份、维生素C 2～6份、山梨醇0.5～1.2份、甘露糖0.1～0.4份加至去离子水10份中，分散，得到混合液B；
步骤3，以重量份计，将混合液A和混合液B混合，在搅拌条件下加入鳄梨油0.5～1份、微晶纤维素0.3～0.9份、乳糖0.1～0.4份、酒石酸0.5～1.5份、过氧化氢0.7～3.5份，超声，4～10℃静置30～60min，即得。
2.根据权利要求1所述的负压伤口治疗用护创液的制备方法，其特征在于：步骤1中分散条件为15～25℃、400～600rpm、10～15min。
3.根据权利要求1所述的负压伤口治疗用护创液的制备方法，其特征在于：步骤2中分散条件为10～15℃、400～600rpm、10～15min。
4.根据权利要求1所述的负压伤口治疗用护创液的制备方法，其特征在于：步骤3中超声条件为70～120w、10～15min。
5.根据权利要求1所述的负压伤口治疗用护创液的制备方法，其特征在于：步骤3中超声结束后需调节pH至7.0～8.0。
6.根据权利要求5所述的负压伤口治疗用护创液的制备方法，其特征在于：采用5～10wt%氢氧化钠溶液调节pH。
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