CN108310220B - 一种治疗褥疮的药物组合物及其制备方法和用途 - Google Patents

一种治疗褥疮的药物组合物及其制备方法和用途 Download PDF

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CN108310220B
CN108310220B CN201810342210.7A CN201810342210A CN108310220B CN 108310220 B CN108310220 B CN 108310220B CN 201810342210 A CN201810342210 A CN 201810342210A CN 108310220 B CN108310220 B CN 108310220B
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何淑玲
任秀英
孙国娟
刘志丹
郝佳丽
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Abstract

本发明涉及一种治疗褥疮的药物组合物及其制备方法和用途,本发明药物组合物以黄芪多糖5‑10份、白芨3‑5份、炒川贝3‑5份和薄荷醇1‑3份为活性成分,具有活血通络、排脓敛疮、去腐生肌、镇痛止痒的作用。药物组合物还具有优异的抑菌效果,具有协同的促进褥疮愈合的作用,可明显减轻褥疮患者的痛苦。

Description

一种治疗褥疮的药物组合物及其制备方法和用途
技术领域
本发明属于药物领域,具体的涉及一种治疗褥疮的药物组合物及其制备方法和用途。
背景技术
褥疮,又称压疮、压力性溃疡,是由于运动能力受损,导致局部软组织持续受压,血液动力学改变,发生持续性的缺血、缺氧,营养代谢障碍,进而导致组织溃烂坏死。常发于年老体弱、半身不遂、下肢瘫痪或长期卧床者,发病部位多发于背部、尾骶、足跟等骨突出部位。受压组织开始呈现苍白或灰白色,继而形成暗红色斑,继续发展,红斑上可见水泡,未及时处理则会发展为组织坏死、溃疡,创面可深至骨骼,且不易收口,患者痛苦不堪,严重影响了患者的生活。多数褥疮患者会合并细菌感染,严重者可危及患者生命。
对于褥疮的治疗,西医多采用手术清理患部,切除溃烂组织,采用抑菌消炎药促进患处愈合的对症治疗方法。但由于患者往往体质较弱,创面的愈合很慢,疗程长,且易反复,治疗效果不佳。中医认为褥疮是由于久病气血亏损,气血运行失常,经络受阻而无以荣肤。对于褥疮,中医多采用去腐生肌、活血化瘀、清热解毒、抑菌抗炎的药物,如甘石疮愈散、生肌散等,取得了较好的治疗效果。
医用敷料是指用于对各类创口表面进行临时性覆盖的医用材料,对伤口起到遮挡、保护作用,用于加速伤口的止血,防止伤口的细菌感染,从而可以促进伤口的愈合,在伤口护理领域发挥了越来越大的作用。
虽然中医在褥疮治疗上取得了一定的效果,但也存在成分复杂、起效慢、药效不确定的缺点,本发明致力于提供一种对于褥疮具有更好的治疗效果的药物组合物。
发明内容
本发明提供了一种治疗褥疮的药物组合物及其制备方法和用途。
一方面,本发明提供了一种治疗褥疮的药物组合物,其特征在于由黄芪多糖5-10份、白芨3-5份、炒川贝3-5份和薄荷醇1-3份制成。
优选的,由黄芪多糖8份、白芨4份、炒川贝4份和薄荷醇1份制成。
优选的,所述药物组合物为敷料。
更优选的,所述敷料选自:海藻酸盐敷料、水胶体敷料、纳米银敷料或壳聚糖敷料。
进一步的,本发明所述治疗褥疮的药物组合物还包括局部麻醉剂、抗菌剂。
优选的,所述局部麻醉剂选自:普鲁卡因、可卡因、利多卡因等;所述抗菌剂选自:β-内酰胺类、氨基糖苷类、氯霉素类、大环内酯类。
优选的,所述抗菌剂选自青霉素、头孢菌素、庆大霉素、妥布霉素。
再一方面,本发明提供了黄芪多糖、白芨、炒贝母和薄荷醇在制备治疗褥疮的药物组合物中的用途,其中黄芪多糖5-10份、白芨3-5份、炒贝母3-5份和薄荷醇1-3份。
优选的,所述药物组合物为局部制剂,所述局部制剂为敷料。
更优选的,所述敷料选自:海藻酸盐敷料、水胶体敷料、纳米银敷料或壳聚糖敷料。
进一步的,所述治疗褥疮的药物组合物还包括局部麻醉剂、抗菌剂。
优选的,所述局部麻醉剂选自:普鲁卡因、可卡因、利多卡因等;所述抗菌剂选自:β-内酰胺类、氨基糖苷类、氯霉素类、大环内酯类。
优选的,所述抗菌剂选自青霉素、头孢菌素、庆大霉素、妥布霉素。
另一个方面,本发明提供一种治疗褥疮的药物组合物的制备方法,包括以下步骤:
(1)备料:按配方称取各原料药;
(2)破碎:将白芨、炒川贝干燥后粉碎,过50-200目筛,得粉料,备用;
(3)混料:将黄芪多糖、薄荷醇与步骤(2)所得粉料及任选的局部麻醉剂、抗菌剂混
合,得混合料;
(4)制剂:将步骤(3)所得混合料添加药学上可接受的辅料后制备局部制剂。
本发明中,黄芪多糖为黄芪的活性成分之一,具有生肌、补气血,脱毒、排脓敛疮的功效;
白芨,味苦、涩,性微寒,归肺、肝、胃经,具有止血、敛疮、消肿生肌的作用;
川贝,味甘,性凉,入肺、胃经,具有润肺止咳化痰平喘的作用;
薄荷醇,为薄荷中的主要成分,具有薄荷香气和清凉止痒、止痛、抗炎的作用。
本发明的有益效果:
本发明提供了一种组成简单、疗效确切的治疗褥疮的药物组合物,具有活血通络、排脓敛疮、去腐生肌、镇痛止痒的作用。药物组合物具有优异的抑菌效果,具有协同的促进褥疮愈合的作用,可明显减轻褥疮患者的痛苦。
具体实施方式
以下实施例旨在说明本发明而不是本发明进一步的限定,本发明可以按发明内容所述的任一方式实施。
实施例1:一种治疗褥疮的药物组合物
由黄芪多糖8份、白芨4份、炒川贝4份和薄荷醇1份制成。
(1)备料:按配方称取各原料药;
(2)破碎:将白芨、炒川贝干燥后粉碎,过100目筛,得粉料,备用;
(3)混料:将黄芪多糖、薄荷醇与步骤(2)所得粉料混合,得混合料;
(4)制剂:将步骤(3)所得混合料添加药学上可接受的辅料后制备局部制剂。
实施例2:一种治疗褥疮的海藻酸盐敷料
由黄芪多糖8份、白芨4份、炒川贝4份、薄荷醇1份、普鲁卡因0.5份、头孢菌素1份制成。
按照实施例1的制备方法,制备成海藻酸盐敷料。
对比例1:一种黄芪多糖、白芨与薄荷醇的复合物
由黄芪多糖8份、白芨4份和薄荷醇1份制成,按照实施例1的方法步骤(1)-(3)制备得混合料。
对比例2:一种黄芪多糖、炒川贝与薄荷醇的复合物
由黄芪多糖8份、炒川贝4份和薄荷醇1份制成,按照实施例1的方法步骤(1)-(3)制备得混合料。
对比例3:一种白芨、炒川贝与薄荷醇的复合物
由白芨4份、炒川贝4份和薄荷醇1份制成,按照实施例1的方法步骤(1)-(3)制备得混合料。
效果例1:本发明药物组合物的抑菌效果
1.1试验药物
实施例1、对比例1-3中混合料添加蒸馏水配置为1g生药/mL的混悬液,灭菌后保存备用;
1.2试验方法
将金黄色葡萄球菌使用取菌环致密接种于普通琼脂培养基表面,在无菌台将浸有实施例1、对比例1-3的混悬液的直径为4mm的滤纸片贴至培养基表面,每组平行5组,于37℃培养箱,培养24小时,测量各组抑菌圈直径(mm),并计算其平均值,具体实验结果见表1。
1.3实验结果
表1本发明药物组合物对金黄色葡萄球菌的抑制作用
Figure BDA0001630970460000041
表1实验结果显示了本发明实施例1的药物组合物对于金黄色葡萄球菌均有明显的抑制效果,且抑制效果均优于对比例1-3组。
效果例2:本发明药物组合物对褥疮的治疗效果
2.1试验药物
实施例1、对比例1-3中混合料添加蒸馏水配置为1g生药/mL的混悬液,保存备用;生肌膏:当归60g、甘草30g、白芷15g、紫草9g、血竭12g、轻粉12g。
1.2试验方法
豚鼠40只,分别麻醉,对皮肤消毒,俯卧位固定后,于背部脊柱左侧切开3cm长的口子,植入灭菌后的不锈钢板:4.0cm×2.5cm×0.05cm,缝合并包扎伤口,单笼喂养。24h后用4.0cm×2.25cm×1.0cm磁铁压迫创面,每天压迫6h,总压迫时间为18h。压迫结束后肉眼观患处可见水肿严重,皮肤呈现青紫色,并有溃破渗出,符合Ⅲ~Ⅳ度褥疮标准,表明豚鼠褥疮模型已造模成功。
选取豚鼠褥疮造模成功的豚鼠30只,随机分为6组,每组5只,具体为模型组、实施例1组、对比例1组、对比例2组、对比例3组、生肌膏组。
将各组对应药物涂抹于患处,每天1次,连续涂抹3周,并记录伤口愈合的时间,记录各组治愈、好转、无效的豚鼠只数,计算治愈率、有效率和无效率,其中治愈为褥疮消失,皮肤完全愈合,治愈率为治愈的比例;好转:褥疮伤口相对于模型组缩小至少50%,渗液少,水肿消退,可见新鲜肉芽,其中有效率为治愈+好转的比例;无效:褥疮伤口相对于模型组缩小少于50%,存在脓性渗液,肉芽生长不良,无效率为无效的比例(具体实验结果见表2)。
表2本发明药物组合物对豚鼠褥疮的治疗作用
Figure BDA0001630970460000051
与模型组比较,**P<0.01。
表3本发明药物组合物对豚鼠褥疮的治愈率、好转率和无效率
Figure BDA0001630970460000052
表2-3实验结果显示了,本发明实施例1药物组合物对于豚鼠褥疮模型具有明显的治疗效果,治愈率达80%,有效率达100%,且豚鼠的愈合天数也明显短于对比例1-3组和生肌膏组,显示了优异的治疗作用。
以上实施例仅为本发明的例举,以本发明中药组合物预防和/或治疗多囊卵巢综合征及其相关疾病的技术方案均落入本发明的保护范围内。

Claims (3)

1.一种治疗褥疮的药物组合物,其特征在于由黄芪多糖8份、白芨4份、炒川贝4份和薄荷醇1份、普鲁卡因、头孢菌素制成,所述药物组合物为敷料,按照以下步骤制备:
(1)备料:按配方称取各原料药;
(2)破碎:将白芨、炒川贝干燥后粉碎,过50-200目筛,得粉料,备用;
(3)混料:将黄芪多糖、薄荷醇与步骤(2)所得粉料及普鲁卡因、头孢菌素混合,得混合料;
(4)制剂:将步骤(3)所得混合料添加药学上可接受的辅料后制备敷料。
2.根据权利要求1所述的治疗褥疮的药物组合物,其特征在于所述敷料选自:海藻酸盐敷料、水胶体敷料、纳米银敷料或壳聚糖敷料。
3.黄芪多糖、白芨、炒贝母和薄荷醇在制备治疗褥疮的药物组合物中的用途,其特征在于黄芪多糖8份、白芨4份、炒川贝4份和薄荷醇1份。
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