CN110124095A - 一种抗菌液体创可贴及其制备方法 - Google Patents
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Abstract
本发明涉及一种抗菌液体创可贴及其制备方法。抗菌液体创可贴包括如下组分：多西环素、硝基纤维素、白芨提取物、增塑剂、液体溶剂、防腐剂。以硝酸纤维素为成膜材料制备而得。处方材料中加入多西环素作为抗菌物质，扩大了其临床和生活应用范围，尤其是皮肤创口较小但可能有病原微生物感染时，效果更好。抗菌液体创可贴在皮肤创伤部位迅速形成一层薄膜，该薄膜具有较好的机械性能，适用于机体任何部位的损伤的保护，且保证病人使用的舒适性；具有一定的亲水性，可以承载一定量的水分，保证创面的湿润性并避免组织液残留，有利于细胞的生长和迁移以促进伤口愈合。
Description
技术领域
本发明涉及一种抗菌液体创可贴及其制备方法。
背景技术
皮肤是机体防御外部侵袭的第一层屏障，也是机体面积最大的组织。皮肤组织的损伤，不仅会引起皮下组织的破坏，还会影响机体的内平衡日常生活中，可引起皮肤损伤的原因有很多，如摩擦、利器割伤、烧伤等，当皮肤组织受到损伤后，机体会启动创伤愈合过程，如果急性皮肤损伤得不到正常的修复，便会形成慢性、不愈性的伤口或者形成增生性的疤痕组织。在创伤愈合过程中，创伤敷料的使用应该有利于保护组织免受外界的物理性损害，避免细菌等造成创面的二次感染，促进创面的正常修复。
传统创可贴具有一定的压迫止血、保护创面、预防感染、促进愈合作用，具有体积小、使用简单、携带方便等优点。但其所用的胶布透气性差，人体局部所正常分泌的水汽和汗液不能穿透这层胶布，于是对局部皮肤产生浸泡作用，甚至会引起再次感染。对于爱美的人来讲影响美观，而且创可贴都是与伤口粘连的，在撕掉创可贴的时候，会造成不必要伤害，有的伤口会留疤。现代社会，生活水平逐渐升高，人们的形象意识增强；生活节奏加快，简捷适用显得尤为重要。液体创可贴优点在于可快速干燥并形成透气、防水且有弹性的保护膜，避免因伤口形状的不规则而导致胶布创可贴很难贴好、贴牢的缺点。
因此，设计出一种无细胞毒性、无致敏性、具有较强的抗感染性能、较好的物理特性、有利于气体的交换液体创可贴为当前所需，在医疗领域具有广阔的应用前景。
发明内容
本发明研制的液体创可贴，以硝酸纤维素为成膜材料制备而得。处方材料中加入多西环素作为抗菌物质，扩大了其临床和生活应用范围，尤其是皮肤创口较小但可能有病原微生物感染时，效果更好。抗菌液体创可贴在皮肤创伤部位迅速形成一层薄膜，该薄膜具有较好的机械性能，适用于机体任何部位的损伤的保护，且保证病人使用的舒适性；具有一定的亲水性，可以承载一定量的水分，保证创面的湿润性并避免组织液残留，有利于细胞的生长和迁移以促进伤口愈合。
本发明的第一个目的是提供了：
一种抗菌液体创可贴，包括如下组分：多西环素、硝基纤维素、白芨提取物、增塑剂、液体溶剂、防腐剂。
优选地，所述的增塑剂选自蜂蜡、蓖麻油、乙酰柠檬酸三丁酯的混合。
优选地，所述的组分的用量是按照重量份计的：多西环素0.005-0.02份、硝基纤维素1-3份、白芨提取物0.05-0.2份、蜂蜡0.5-2份、蓖麻油0.5-4份、液体溶剂20-40份、乙酰柠檬酸三丁酯0.5-10份、防腐剂1-5份。
优选地，所述的液体溶剂是乙酸乙酯。
优选地，所述的防腐剂是苯甲醇。
本发明的第二个目的是提供了：
一种抗菌液体创可贴的制备方法，包括如下步骤：
将多西环素加入到液体溶剂，充分溶解，得到含有多西环素的溶液；
再加入硝基纤维素、白芨提取物、增塑剂、液体溶剂、防腐剂，混合均匀后，使硝酸纤维素溶解，得到液体创可贴。
本发明的第三个目的是提供了：
多西环素在制备抗菌液体创可贴中的应用
处方作用分析：
①多西环素：广谱抗生素，对金色葡萄球菌、肺炎链球菌、化脓性链球菌、破伤风杆菌具有较强的抑制和杀灭作用，临床上常用于皮肤伤口感染的处理；
②硝基纤维素：成膜材料；
③白芨提取物：凝血剂，可缩短出血和凝血时间，促进伤口愈合；
④蜂蜡，增塑剂；
⑤蓖麻油：增塑剂；
⑥乙酸乙酯：液体溶剂；
⑦乙酰柠檬酸三丁酯：增塑剂；
⑧苯甲醇：止痛药，防腐剂。
有益效果
抗菌液体创可贴的发明为当下创伤敷料的应用提供了一个更加便捷、有效的方法。本发明旨在筛选出液体创可贴最佳配方的基础上，对其在创伤愈合过程中的作用进行研究，为今后液体创可贴在临床及日常生活中的应用推广提供了技术支持。
附图说明
图1 家兔称重；
图2 家兔剪毛；
图3 家兔皮肤涂药（抗菌液体创可贴）；
图4 家兔给药24h观察。
具体实施方式
将0.01 g多西环素加入到5mL乙酸乙酯中，充分溶解，得到含有多西环素的溶液。于干燥洁净的装量瓶中，按照表1中1、2、3、4、5和6所给定的剂量，依次加入硝化纤维素和各类试剂；密封，过夜，使硝酸纤维素充分的溶解。
表1
液体创可贴所成膜的厚度的测定
用具有相同长、宽，不同高度的模具，制备不同厚度的液体创可贴所成膜，待溶剂完全挥发，对所得薄膜的厚度进行测定，每张膜在不同部位分别进行测定（5个点），取平均值；重复测定相同配方得到的5张薄膜的厚度，得到标准差（SD值），结果见表2。
液体创可贴机械性能测定
取充分溶解的液体创可贴适量，倒入模具槽中，静置10分钟，使之形成均匀无气泡，厚度不同的薄膜，横切面积分别为20mm×（0.025mm±0.003 mm）为膜的横截面积A（mm2）。轻轻地取下薄膜，使之边缘光滑无缺口，两端夹于拉伸试验仪中，测定此时位于两个夹子中间的薄膜的长度，记为膜测试前的长度（L1）。以2.5mm/min的拉伸速度，500N的载荷量进行实验，当薄膜从中央断裂时，记下此时的断裂力量C（n）和两端夹子的距离L2（mm）。采用下列公式计算抗张强度和断点伸长率：
抗张强度（N/mm2）= C/L2 断点伸长率（%）= L2/L1
表2 不同处方所成膜的厚度、抗张强度、 断点伸长率（数据使用平均值和SD值）
由表2可知，样品1和2的抗张强度较小，所成膜的断点伸长百分率较小，所成膜较粘稠。样品3和 4所成膜的抗张强度介于样品5与6之间，样品5、6与样品1、2、3和4相比，具有较好的机械性能和断点伸长百分率。最后选择以样品5的处方进行接下来的皮肤刺激性性实验。
皮肤刺激性实验（参照《中国药典》2015版）
试验前24h，将3只家兔背部脊柱两侧毛剪掉，去毛范围左、右各约15cm×8cm；取抗菌液体创可贴约1.0mL直接涂在家兔皮肤上，另一侧皮肤作为对照。采用封闭试验，敷用时间为48h。于清除受试物后的1、12、24和48h观察涂抹部位皮肤反应（图1、图2、图3、图4）。按表3进行皮肤反应评分，以受试动物积分的平均值进行综合评价，根据1、12、24和48h各观察时点最高积分均值，按表4判定皮肤刺激强度。
皮肤反应记分系统
参加表3项下内容和表4项下内容。
表3 皮肤刺激反应评分
表4 皮肤刺激强度分级
表5 实验动物红斑和水肿积分（数据使用平均值和SD值）
从表5红斑和水肿积分结果可知，实验用样品 1 h 后，此时抗菌液体创可贴组极轻微的刺激反应，同时，抗菌液体创可贴组出现极轻微的水肿，摘除实验用样品24 h、48 h样品组显示无刺激反应。从抗菌液体创可贴皮肤刺激性统计结果表明：抗菌液体创可贴对家兔的刺激反应为无刺激性反应类型，符合创伤敷料的要求。
Claims (8)
1.一种抗菌液体创可贴，其特征在于，包括如下组分：多西环素、硝基纤维素、白芨提取物、增塑剂、液体溶剂、防腐剂。
2.权利要求1所述的抗菌液体创可贴，其特征在于，所述的增塑剂选自蜂蜡、蓖麻油、乙酰柠檬酸三丁酯的混合。
3.权利要求2所述的抗菌液体创可贴，其特征在于，所述的组分的用量是按照重量份计的：多西环素0.005-0.02份、硝基纤维素1-3份、白芨提取物0.05-0.2份、蜂蜡0.5-2份、蓖麻油0.5-4份、液体溶剂20-40份、乙酰柠檬酸三丁酯0.5-10份、防腐剂1-5份。
4.权利要求1所述的抗菌液体创可贴，其特征在于，所述的液体溶剂是乙酸乙酯。
5.权利要求1所述的抗菌液体创可贴，其特征在于，所述的防腐剂是苯甲醇。
6.权利要求1所述的抗菌液体创可贴的制备方法，其特征在于，包括如下步骤：
将多西环素加入到液体溶剂，充分溶解，得到含有多西环素的溶液；
再加入硝基纤维素、白芨提取物、增塑剂、防腐剂，混合均匀后，使硝酸纤维素溶解，得到液体创可贴。
7.根据权利要求6所述的制备方法，其特征在于，制备步骤是：将0.01 g多西环素加入到5mL乙酸乙酯中，充分溶解，得到含有多西环素的溶液；于干燥洁净的装量瓶中，依次加入硝化纤维素2g，白芨提取物0.1g、蜂蜡1g，蓖麻油1.0g，乙酸乙酯25g，乙酰柠檬酸三丁酯5g和苯甲醇3g，密封，过夜，使硝酸纤维素充分的溶解，得到液体创可贴。
8.多西环素在制备抗菌液体创可贴中的应用。
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110859989A (zh) * | 2019-10-25 | 2020-03-06 | 天津冠勤医药科技有限公司 | 一种液体创可贴及其制备方法 |
| CN110898092A (zh) * | 2019-11-25 | 2020-03-24 | 上海强德食品科技有限公司 | 一种液体止血消肿贴组合物及其制备方法 |
| CN112245652A (zh) * | 2020-10-16 | 2021-01-22 | 合肥贝壳派创新科技有限公司 | 可快速成膜的抑菌液体创可贴及其制备方法 |
| CN112402687A (zh) * | 2020-11-26 | 2021-02-26 | 嘉应学院 | 一种广东紫珠液体创可贴及其制备方法 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110859989A (zh) * | 2019-10-25 | 2020-03-06 | 天津冠勤医药科技有限公司 | 一种液体创可贴及其制备方法 |
| CN110898092A (zh) * | 2019-11-25 | 2020-03-24 | 上海强德食品科技有限公司 | 一种液体止血消肿贴组合物及其制备方法 |
| CN112245652A (zh) * | 2020-10-16 | 2021-01-22 | 合肥贝壳派创新科技有限公司 | 可快速成膜的抑菌液体创可贴及其制备方法 |
| CN112402687A (zh) * | 2020-11-26 | 2021-02-26 | 嘉应学院 | 一种广东紫珠液体创可贴及其制备方法 |
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