CN107929234A - 一种应用于烧伤创面修复的新型外用制剂膏体 - Google Patents
一种应用于烧伤创面修复的新型外用制剂膏体 Download PDFInfo
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Abstract
本发明公开了一种应用于烧伤创面修复的新型外用制剂膏体,包括下述重量份组成:敷料制剂1‑2份、混合基料1000份;敷料制剂包括下述重量份组成:非甾体类消炎镇痛药物:200‑600份、α2肾上腺素能受体激动剂:1‑2份、皮质类固醇药:3‑10份;联合制剂的镇痛通过利用创面血供丰富、吸收较快的特点,将上述联合制剂制作为外用敷料,既有利于发挥三种药物的优点,又可避免单独应用时作用较弱的缺陷,同时不需要通过静脉注射,提高了安全性和临床的应用便捷程度,同时可以缩短药物的起效时间并延长药物的作用时间,增加安全性能,降低副作用。
Description
技术领域
本发明涉及医药领域,更具体的说是涉及一种应用于烧伤创面修复的新型外用制剂膏体。
背景技术
烧伤造成严重创面感染、剧烈疼痛、休克,影响围术期炎症反应发生,并导致预后不良。烧伤后免疫紊乱仍然是临床烧伤死亡的重要原因。烧伤后的机体发生一系列复杂的病理生理学变化,烧伤引起的组织液丢失、疼痛、创面组织坏死以及随后发生的感染、休克等因素,可促进体内炎症细胞大量活化。活化的炎症细胞释放多种细胞因子,如:TNF-α、INF-γ、CRP(C-reaction protein)、IL-1,2,6,8,10等,对烧伤病人的免疫系统改变有着重要的影响。
烧伤患者常伴随较大的受损创面,疼痛剧烈,围术期的镇痛药物应用是必然的选择。目前应用最广泛的是吗啡、芬太尼等阿片类镇痛药物,给药方式主要为静脉注射或静脉泵。缺点在于阿片类药物的长期应用会导致出现药物依赖,并伴随瘙痒、嗜睡、呼吸抑制等副作用。同时烧伤病人静脉注射困难,并非最好的给药途径。
如何有效的解决围术期镇痛,并对烧伤患者的免疫系统进行保护,是本发明亟待解决的问题。
氟比洛芬酯脂微球制剂是一种非甾体类抗炎镇痛药,同时兼具镇痛和抗炎的双重功效,由脂微球释放氟比洛芬酯,抑制PG合成,通过消炎作用改善拔管期患者的免疫功能;通过镇痛作用改善患者的外周刺激,减少拔管期躁动的发生。但烧伤患者创面较大,且需要清创、植皮等多次手术操作,单一消炎镇痛药物的使用效果尚不够完善。
右美托咪啶是一种新型的高选择性α2肾上腺素能受体激动剂,对α2受体的特异性是可乐定的8倍,可以产生剂量依赖性的镇静、镇痛和抗交感活性作用,且有稳定血流动力学,无呼吸抑制的优势。
地塞米松是一种人工合成的皮质类固醇,列名于世界卫生组织基本药物标准清单之中,为基础公卫体系必备药物之一。具有抗炎、抗内毒素、抑制免疫、抗休克及增强应激反应等药理作用,故广泛应用于各科治疗多种疾病,对烧伤创面的抗炎及修复有利。
目前三种药物会单独临床应用于需要镇痛消炎的病人上,其在单独应用时效果甚微,在目前临床医学中对上述三种药物的联合配比应用在烧伤感染病人围术期免疫功能及镇痛效应的临床研究没深入研究,另一方面,上述三种药物在应用时往往都采用静脉注射的方式,同时由于一些烧伤患者创面较大,其静脉建立比较困难,现有的镇痛药物给药方式不方便。
发明内容
针对现有技术存在的不足,本发明的目的在于提供一种应用于烧伤创面修复的新型外用制剂膏体,发明通过合理的创面应用药物,提高了安全性和临床的应用便捷程度,同时可以缩短药物的起效时间并延长药物的作用时间,增加安全性能,降低副作用。
为实现上述目的,本发明提供了如下技术方案:一种应用于烧伤创面修复的新型外用制剂膏体,包括下述重量份组成:
敷料制剂1-2份
混合基料1000份;
所述敷料制剂包括下述重量份组成:
非甾体类消炎镇痛药物:200-600份
α2肾上腺素能受体激动剂:1-2份
皮质类固醇药:3-10份。
作为本发明的进一步改进,非甾体类消炎镇痛药物为氟比洛芬酯,α2肾上腺素能受体激动剂为盐酸右美托咪定,皮质类固醇药为地塞米松。
作为本发明的进一步改进,混合基料包括有白凡士林和液体石蜡中至少一种。
作为本发明的进一步改进,混合基料包括水溶性壳聚糖或者其衍生物。
本发明还提供一种应用于烧伤创面修复的新型外用制剂敷料,其包括上述外用制剂膏体和敷料载体,敷料载体由纤维纺织形成,敷料制剂和混合基料混合涂覆在敷料载体上。
作为本发明的进一步改进,敷料制剂和混合基料形成的涂覆层的厚度为0.1-0.3mm。
作为本发明的进一步改进,敷料载体设置有抗菌层,该抗菌层负载有银离子。
作为本发明的进一步改进,敷料载体为聚乳酸防黏连膜。
本发明的有益效果为:非甾体类消炎镇痛药物与α2肾上腺素能受体激动剂及皮质类固醇药联合制剂有效改善了烧伤患者围术期疼痛及免疫功能。联合制药的镇痛通过利用创面血供丰富、吸收较快的特点,将上述联合制剂制作为外用敷料,既有利于发挥三种药物的优点,又可避免单独应用时作用较弱的缺陷,同时不需要通过静脉注射,提高了安全性和临床的应用便捷程度,同时可以缩短药物的起效时间并延长药物的作用时间,增加安全性能,降低副作用。
附图说明
图1为本发明各个观察组和对照组的Ki67/GAPDH比值;
图2为本发明各个观察组和对照组用药前、用药半小时后、用药24小时后血液中的IL-6因子含量;
图3为本发明各个观察组和对照组用药前、用药半小时后、用药24小时后血液中的IFNα因子含量;
图4为本发明各个观察组和对照组小鼠的镇痛百分率。
具体实施方式
下面将结合实施例对本发明做进一步的详述。
一种应用于烧伤创面修复的新型外用制剂膏体,包括下述重量份组成:
敷料制剂1-2份
混合基料1000份;
所述敷料制剂包括下述重量份组成:
非甾体类消炎镇痛药物:200-600份
α2肾上腺素能受体激动剂:1-2份
皮质类固醇药:3-10份。
非甾体类消炎镇痛药物可以选择为:阿司匹林、吲哚美辛、水杨酸胆碱镁等;α2肾上腺素能受体激动剂可以选择为:可乐定或者盐酸右美托咪定;皮质类固醇药可以选择为:糖皮质类固醇、盐皮质类固醇和性激素等。
非甾体类消炎镇痛药物优选为氟比洛芬酯,α2肾上腺素能受体激动剂优选为盐酸右美托咪定,皮质类固醇药优选为地塞米松。
混合基料包括有白凡士林和液体石蜡或者包括水溶性壳聚糖或者其衍生物。
本发明的药物比份根据烧伤患者的烧伤程度和体重进行配比给药。
下列实施对制剂膏体的各个组分配比做进一步阐述:
实施例一:氟比洛芬酯200mg、盐酸右美托咪定100ug、地塞米松10mg、白凡士林150mg、液体石蜡100mg;
实施例二:氟比洛芬酯150mg、盐酸右美托咪定200ug、地塞米松5mg、白凡士林150mg、液体石蜡100mg;
实施例三:氟比洛芬酯100mg、盐酸右美托咪定200ug、地塞米松10mg、白凡士林150mg、液体石蜡100mg;
实施例四:氟比洛芬酯100mg、盐酸右美托咪定200ug、地塞米松10mg、水溶性壳聚糖200mg、盐酸缓冲液50ml。
对比例一:以用白凡士林150mg和液状石蜡油100mg混合涂层;
对比例二:盐酸右美托咪定注射液200ug与白凡士林150mg和液状石蜡100mg混合涂层;
对比例三:地塞米松10mg与白凡士林150mg和液状石蜡100mg混合涂层;
对比例四:氟比洛芬酯100mg与白凡士林150mg与液状石蜡100mg混合涂层;
对比例五:氟比洛芬酯100mg+地塞米松10mg与白凡士林150mg和液状石蜡100mg混合涂层;
对比例六:盐酸右美托咪定200ug+地塞米松10mg与白凡士林150mg和液状石蜡100mg混合涂层;
对比例七:氟比洛芬酯100mg+盐酸右美托咪定200ug与白凡士林150mg和液状石蜡100mg混合涂层。
修复效果试验:
1.动物材料:C57/BL6小鼠,雄性,6周龄,20-25g。
2.建立切口痛动物模型:小鼠背部皮肤剃毛,以速眠新(0.03ml/只)麻醉后固定于操作台,以大镊子将浸满95%酒精的硬纸片2cm×1.5cm=3cm2(约占小鼠体表面积5%)固定于待烧伤区,点火20s,以湿纱布熄火,构建切口痛模型。
3.动物实验分组:将建立切口痛模型的小鼠进行分组,每组10只,依次涂覆实施例一、二、三、四以及对比例一、二、三、四、五、六、七的制剂膏体分为观察组a、b、c、d和对照组e、f、g、h、i、j、k。
4.1烧伤创面修复效果的检测方法:
各个实验组的小鼠在烧伤区涂覆以上观察组和对照组的药物2个小时后,通过手术剪取皮肤组织50~100mg加1ml裂解液,每样本以微量计取样器分成3份,即刻在4℃下,离心力12000G,2min,取上清液,再次用1%Triton X-100溶解匀浆,储存于-20℃的环境中。
(1)进行Bradford比色法测定总蛋白质浓度;
(2)Western-blotting分析增殖细胞核蛋白Ki67在皮肤不同表层表达量
取根据总蛋白浓度取5μg蛋白加入SDS聚丙酰胺凝胶每个点样孔中电泳,确定片段大小后,电印迹转染到酸纤维素膜,加叠氮化钠室温1h,继用β-catnin、phospho-GSK-3β、GSK-3β、c-myc、Bcl-2、Bax第一抗体4℃过夜孵育,TBST冲洗,再用结合辣根过氧化物酶的二抗孵育,最后用ECL发光液显现蛋白带,转移至Kodak X-Omat AR薄膜,照像,用SigmaGelsoftware对Ki67条带进行密度分析;
根据以上步骤以GAPDH蛋白为内参蛋白,用SigmaGel software对内参蛋白条带进行密度分析。
(3)结果
表一
增殖细胞核蛋白Ki67的表达量反应了烧伤创面的修复效果,如表1和图1所示,根据本发明设置的观察组c组的皮肤表层表达的增殖细胞核蛋白Ki67远远高于其他对照组,根据增殖细胞核蛋白Ki67的特性可以得知其表达量越高处于有丝分裂的细胞就越多,细胞分裂越活跃,其修复效果越好。
表二
如表2和图1所示,实施例1、实施例2、实施例3和实施例4的Ki67表达量均远远高于对照组,其所公开的药物组分均对创面修复有显著的效果。
4.2免疫因子活性的检测方法
通过分别通过小鼠IL-6ELISA试剂盒和小鼠IFNαELISA试剂盒检测检验各个观察组和对照组的IL-6和IFNα水平;
取样:抽取切口痛模型在用药前的静脉血,通过离心取上清液;抽取用各个实验组和对照组用药后半小时和用药后24小时的静脉血以及切口痛模型用药前的的静脉血,通过离心取上清液;
(1)加入稀释好后的标准品50ul于反应孔、加入上述步骤中的上清液50ul于反应孔内;立即加入50ul的生物素标记的抗体;盖上膜板,轻轻振荡混匀,37℃温育1小时。
(2)甩去孔内液体,每孔加满洗涤液,振荡30秒,甩去洗涤液,用吸水纸拍干。重复此操作3次。如果用洗板机洗涤,洗涤次数增加一次;每孔加入80ul的亲和链酶素-HRP,轻轻振荡混匀,37℃温育30分钟。
(3)甩去孔内液体,每孔加满洗涤液,振荡30秒,甩去洗涤液,用吸水纸拍干。重复此操作3次。如果用洗板机洗涤,洗涤次数增加一次;每孔加入底物A、B各50ul,轻轻振荡混匀,37℃温育10分钟。避免光照。
(4)取出酶标板,迅速加入50ul终止液,加入终止液后,在450nm波长处测定各孔的OD值。
其切口痛模型在用药前的IL因子的平均值为210pg/ml,其和IFNα因子的平均值为532pg/ml,各个实验组和对照组小鼠的IL-6和IFNα水平如下表3所示:
表3
IL-6和IFNα因子均能够刺激参与免疫反应的细胞增殖、分化并且提高免疫功能,其二者是反映免疫反应强度的重要指标,如表3和图2-3所示,根据本发明设置的观察组c组的血液中的IL-6和IFNα因子远远高于其他对照组,表明如观察组c所公开的制剂膏体在应用至烧伤创面修复治疗,对增强其免疫效果显著提高。
表4
如表4和图2-3所示,实施例1、实施例2、实施例3和实施例4的IL-6和IFNα因子表达量均远远高于对照组,其所公开的药物组分均对增强免疫有显著的效果,适应不同炎症程度的病患。
4.3镇痛百分率的测定方法
在给药30min后,各个实验组和对照组的小鼠分别腹腔注射1.1%醋酸溶液0.1ml/10g,记录20min内小鼠的扭体反应次数和首次扭体反应潜伏期,其扭体反应表现为腹部内凹、躯干与后腿伸张、臀部抬高。
镇痛百分率=(切口痛模型扭体反应次数-用药组反应次数)/切口痛模型扭体反应次数*100%。
表5
c组 | e组 | f组 | g组 | h组 | i组 | j组 | k组 | |
镇痛百分率 | 82.6 | 54.3 | 56.3 | 49.3 | 56.2 | 57.2 | 62.5 | 45.3 |
通过镇痛百分率反映各个观察组和实验组的镇痛效果,如表5和图4所示,根据本发明设置的观察组c组其小鼠的镇痛百分率远远高于其他小组的小鼠,表明如观察组c所公开的制剂膏体在应用至烧伤创面修复治疗时,对减缓疼痛显著提高。
表6
a组 | b组 | c组 | d组 | |
镇痛百分率 | 74.5 | 84.2 | 82.6 | 82.3 |
如表6和图4所示,实施例1、实施例2、实施例3和实施例4的镇痛百分率表达量均远远高于对照组,其所公开的药物组分均对减缓疼痛有显著的效果,以适应具有不同疼痛阈值的病患。
将混合基料设置为水溶性壳聚糖,采用水溶性的壳聚糖,其具有良好的促愈合效果,并且能够与敷料制剂协同作用可达到长效抑菌,同时可在创面形成一层柔和透明的保护层。
非甾体类消炎镇痛药物与α2肾上腺素能受体激动剂及皮质类固醇药联合制剂改善烧伤病人的围术期镇痛效果及免疫系统。联合制药的镇痛利用烧伤患者创面较大、对药物吸收较快的特殊性,将上述联合制剂制作为外用敷料,提高了安全性和临床的应用便捷程度,同时可以缩短药物的起效时间并延长药物的作用时间,增加安全性能,降低副作用。
本发明还提供一种应用于烧伤创面修复的新型外用制剂敷料,其包括上述外用制剂膏体和敷料载体,敷料载体由纤维纺织形成,敷料制剂和混合基料混合涂覆在敷料载体上,敷料制剂和混合基料形成的涂覆层的厚度为0.1-0.3mm,敷料载体设置有抗菌层,该抗菌层负载有银离子,敷料载体为聚乳酸防黏连膜。
将膏体涂覆在聚乳酸防黏连膜,使得药物在外敷时使用更加方便,其聚乳酸防黏连膜由于由乳酸聚合形成,其可参与人体代谢过程,被生物降解,对创伤表面不会进一步伤害,同时能够加快创面上皮进化过程,促进创面的修复,并且使形成的瘢痕平整光滑,更有利于预防粘连的形成,通过设置银离子层,进一步具有抗菌消炎的效果。
以上仅是本发明的优选实施方式,本发明的保护范围并不仅局限于上述实施例,凡属于本发明思路下的技术方案均属于本发明的保护范围。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理前提下的若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种应用于烧伤创面修复的新型外用制剂膏体,其特征在于:包括下述重量份组成:
敷料制剂1-2份
混合基料1000份;
所述敷料制剂包括下述重量份组成:
非甾体类消炎镇痛药物:200-600份
α2肾上腺素能受体激动剂:1-2份
皮质类固醇药:3-10份。
2.根据权利要求1所述的一种应用于烧伤创面修复的新型外用制剂膏体,所述非甾体类消炎镇痛药物为氟比洛芬酯,所述α2肾上腺素能受体激动剂为盐酸右美托咪定,所述皮质类固醇药为地塞米松。
3.根据权利要求1或2所述的一种应用于烧伤创面修复的新型外用制剂膏体,其特征在于:所述混合基料包括白凡士林和液体石蜡中至少一种。
4.根据权利要求1或2所述的一种应用于烧伤创面修复的新型外用制剂膏体,其特征在于:所述混合基料包括水溶性壳聚糖或者其衍生物。
5.根据权利要求1所述膏体制备的外用制剂敷料,其特征在于:包括膏体和辅料载体,所述敷料载体由纤维纺织形成,所述敷料制剂和混合基料混合涂覆在敷料载体上。
6.根据权利要求5所述膏体制备的外用制剂敷料,其特征在于:所述敷料制剂和混合基料形成的涂覆层的厚度为0.1-0.3mm。
7.根据权利要求5或6所述膏体制备的外用制剂敷料,其特征在于:所述敷料载体设置有抗菌层,该抗菌层负载有银离子。
8.根据权利要求7所述膏体制备的外用制剂敷料,其特征在于:所述敷料载体为聚乳酸防黏连膜。
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