CN116077567B - 一种金丝桃促创面愈合药物组合物及其制备方法与应用 - Google Patents
一种金丝桃促创面愈合药物组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明提供了一种金丝桃促创面愈合药物组合物及其制备方法与应用,涉及促创面愈合药物技术领域。本发明的金丝桃促创面愈合药物组合物由金丝桃、苦丁茶、花椒、水杨酸、小蓟和艾叶为原料制成,并以此制成了一种促创面愈合喷雾剂或气雾剂。本发明通过喷雾剂或气雾剂的形式对创面直接给药,能够促使皮肤创面愈合,同时还具有预防感染,消肿止痛、祛瘀生肌、通经活络、健康皮肤组织等多种功能。本发明的药物组合物具有使用安全、创面愈合效果高和稳定性好的特点。本发明的原料来源广泛,易于收集,制备方法简单,工艺流程较短,易于批量加工生产,具有良好的应用前景。
Description
技术领域
本发明涉及促创面愈合药物组合物技术领域,尤其涉及一种金丝桃促创面愈合药物组合物及其制备方法与应用。
背景技术
皮肤是人体最大的器官系统,是人体的第一道防线,不仅可以挡住外来侵入,保住水分,且有保暖、阻隔、感觉之用。健康皮肤的完整性在维持人体生理稳态方面起着至关重要的作用。创面是正常皮肤(组织)在外界致伤因子,如外科手术、外力、热、电流、化学物质、低温以及机体内在因素,如局部血液供应障碍等作用下所导致的损害,常伴有皮肤完整性的破坏以及一定量正常组织的丢失。皮肤的正常功能受损,也称为伤口或者创伤。创面愈合是一个重要的生理过程,可通过手术来保持创伤后皮肤的完整性。目前,如何促进皮肤创面快速愈合已成为当代外科研究领域的重点。而中药是我国的传统药物,其来源广泛,并且在治疗创伤中积累了丰富经验。金丝桃是一种中草药,根茎叶花果均可入药,金丝桃的化学成分有包括黄酮类、甾体类、三萜类、饱和脂肪酸酯类、氧杂蒽酮类、多环多异戊烯基取代间苯三酚衍生物等,具有抗抑郁、降血脂血糖、改善缺氧、镇静、抗菌消炎、创伤收敛等药理特性,其抗病毒作用突出,能抗DNA、RNA病毒,还可用于艾滋病的治疗。如何将传统中药与促进皮肤创面快速愈合相结合,得到一种促创面愈合药物组合物是本发明所要解决的技术问题。
发明内容
为解决上述问题,本发明提供了一种金丝桃促创面愈合药物组合物,包括以下重量份的原料:金丝桃2500份、苦丁茶1000份、花椒60份、水杨酸50份、小蓟50份和艾叶40份。
本发明还提供了所述金丝桃促创面愈合药物组合物的制备方法,具体包括以下步骤:
(1)按比例分别称取原料;
(2)将金丝桃、苦丁茶、花椒、水杨酸、小蓟和艾叶粗粉碎后加入10倍体积的蒸馏水浸泡12h,浸泡完成后在65℃水浴锅中加热30min,加热完成后在超声频率为25kHz、功率为300w、温度45℃的条件下进行超声处理30min,超声处理结束后抽滤分离,得到原料药液和药物残渣,将药物残渣重复提取两次,合并原料药液后备用;
(3)将原料药液蒸发浓缩,得到金丝桃促创面愈合药物组合物。
进一步地,所述金丝桃促创面愈合药物组合物的相对密度为1.0-1.5。
本发明的另一个目的是提供所述金丝桃促创面愈合药物组合物用于制备促创面愈合喷雾剂或促创面愈合气雾剂的应用。
所述促创面愈合喷雾剂或促创面愈合气雾剂的方法如下:将730重量份的辅料溶于40wt%-85wt%的乙醇溶液后,添加350-600重量份金丝桃促创面愈合药物组合物,并搅拌均匀,再加无水乙醇使溶液的含醇量为70wt%-95wt%,经抽滤,灌装,封口,灭菌后得到促创面愈合喷雾剂或促创面愈合气雾剂。
进一步地,所述辅料包括以下重量份的原料:增溶剂150份、助溶剂80份。
进一步地,所述增溶剂为十二烷基硫酸钠、所述助溶剂为卵磷脂。
进一步地,所述辅料中还包括450体积份稀释剂。
进一步地,所述稀释剂为丙二醇。
进一步地,所述辅料中还包括如下辅料中的一种或几种:矫味剂50重量份、防腐剂50重量份、稳定剂50重量份、抗氧化剂50重量份。
进一步地,所述防腐剂为山梨醇、稳定剂为甘油。
在本发明的配方中,苦丁茶具有清热解毒、消炎利便等功效;花椒具有温中止痛、杀虫止痒等功效;水杨酸具有助渗等功效,这三种其他药物配伍应用,可促进药物经皮吸收;小蓟具有凉血止血、祛瘀消肿等功效;艾叶具有温经止血、止痛散寒等功效;诸药合用可化瘀止血、活血止痛、解毒消肿。
与现有技术相比,本发明的有益技术效果:
(1)本发明通过将金丝桃促创面愈合药物组合物制成喷雾剂或气雾剂的方法,实现了从创面直接给药的目的,且喷雾剂或气雾剂的作用形式对人体安全性高并具有良好的促进创面愈合效果与稳定性;
(2)本发明的金丝桃促创面愈合药物组合物具有促皮肤创面愈合,预防感染,消肿止痛、祛瘀生肌、通经活络、健康皮肤组织等多种功能,且利用多种中药组份的协同作用,实现了促进黏膜吸收,快速高效发挥药物促进创面愈合的效果;
(3)本发明的原料来源广泛,易于收集,制备方法简单,工艺流程较短,易于批量加工生产。
附图说明
下面结合附图说明对本发明作进一步说明。
图1为兔子创面不同时间恢复情况;
图2为新西兰兔创面肉芽组织病理学变化(HE染色×100);
图3为各时间点各组创面天狼猩红染色图片(×100);
图4为各组不同时间点创面微血管计数的比较;
注:图4中与生理盐水组比较,极显著用“**”表示(P<0.01),显著用“*”表示(P<0.05),无统计学差异用“ns”表示(P>0.05)。
具体实施方式
以下结合实施例对本发明提供的技术方案进行进一步说明。
实施例1
1.材料
1.1实验对象
新西兰大白兔13只,体重1.5-3.0kg,购买后正常喂养两周,使其适应环境。
1.2主要试剂
10%水合氯醛、生理盐水(贵州科伦药业有限公司)、75%酒精(贵州鑫源生物科技有限公司)、云南白药(云南白药集团股份有限公司)、4%多聚甲醛固定液(武汉赛维尔生物科技有限公司)
1.3主要仪器
2.方法
2.1药物组合喷雾剂的制备
步骤一:分别称取金丝桃2500g、苦丁茶1000g、花椒60g、水杨酸50g、小蓟50g重量份和艾叶40g;
步骤二:将金丝桃、苦丁茶、花椒、水杨酸、小蓟和艾叶粉碎后加入10倍体积的蒸馏水浸泡12h,浸泡完成后在65℃水浴锅中加热30min,加热完成后在超声频率为25kHz、功率为300w、温度45℃的条件下进行超声处理30min,超声处理结束后抽滤分离,得到原料药液和药物残渣,将药物残渣重复提取两次,合并原料药液后备用;
步骤三:将原料药液用旋转蒸发仪在55℃下蒸发浓缩至相对密度为1.5的浓缩提取液,得到金丝桃促创面愈合药物组合物;
步骤四:将增溶剂、稀释剂、助溶剂、稳定剂和防腐剂用1600mL75%乙醇溶解后,添加500重量份金丝桃促创面愈合药物组合物,并搅拌均匀,再加400mL无水乙醇使含醇量达到93.75%,经抽滤,灌装,封口,灭菌,即得喷雾剂。
2.2动物创面构建及分组处理
(1)取13只重约1.5kg新西兰兔,10%水合氯醛耳缘静脉麻醉;
(2)剃去背部毛发,常规消毒铺巾;
(3)于脊柱中间及两旁距脊柱1cm处构建5个圆形全层皮肤缺损模型,创面压迫止血;
(4)五个创面分为生理盐水组、金丝桃组、中药组、金丝桃+中药组、云南白药组,术后第二天开始上药,1天/次,生理盐水组创面予生理盐水清洗创面,予棉纱布包扎;其他组创面予生理盐水清洗创面后敷药,再予棉纱布依次包扎创面;
(5)将13只兔子随机分成两组,观察组6只在给药的第0、4、8、12天,去除敷料,距离创面10cm的垂直上方予创面拍照,计算愈合率,切片组7只分别于第三天处死2只、第八天处死2只,第十二天处死3只新西兰兔,取创面组织及创周0.5cm正常组织,以创面纵轴均匀切开创面,放入中性缓冲福尔马林固定。
2.3观察指标
(1)创面大体观察
肉眼观察新西兰免在术后4、8、12天创面是否红肿、渗出、有无脓性分泌物、创面面积、创周皮肤组织的收缩及创缘新生等基本情况。
(2)创面愈合率
将6只新西兰兔分别于创面制备时0、4、8、12d固定,用透明薄膜覆盖创面并进行描记,用记号笔沿创缘画膜,再将透明膜敷贴在网格纸上进行网格计数,测量各组创面实际面积,计算出不同时间点各组创面愈合率。
计算创面愈合率:(原始创面面积-未愈合创面面积)/原始创面面积×100%。
(3)组织标本的采集和处理
将取的皮肤组织立即放入4%多聚甲醛固定,固定24h后放入组织自动脱水机中脱水,脱水后再石蜡包埋,每块组织标本需连续切取厚度为4μm的石蜡切片保存在4℃冰箱内备用。一部分切片作HE常规组织学染色和天狼猩红染色,光镜下观察表皮、真皮结构、组织坏死及炎症反应程度。剩余切片作SP法免疫组化染色,行CD34标记的微血管密度(MVD)计数。
2.4数据处理
采用统计软件Excel、GraphPadPrsim8及SPSS23.0分析,计量资料用均数±标准差(x±s)表示,通过使用单因素方差分析(one-wayANOVA)中的LSD-t检验方法分析组间差异显著性,以P<0.05和P<0.01为差异有统计学意义。
二.实验结果
1.创面大体观察
如图所示,术后4天,五组皮肤创面均结痂,无红肿、无渗液、无明显感染等情况发生,各组创面开始形成痂皮,收缩致周边皮肤皱褶。术后8天,各组创面均形成痂皮,颜色加深并褐色改变,给药四组痂皮与基底结合牢靠,边缘收缩明显,而生理盐水组仍存在不同程度的创缘反应,部分创面有些许红肿,创缘新生上皮生长较少,创面收缩较前明显,但不如其它四组;术后12天,金丝桃+中药组创面几乎完全被新生上皮覆盖,云南白药组只有部分结痂创面残留,金丝桃组、中药组较这两组恢复较差,还有部分创面组织存在,而生理盐水组创面明显缩小,部分创面组织被薄且易破的新生上皮所覆盖,但创面愈合明显较其它四组差(见图1)。
2.药物组合喷雾剂对兔创面愈合率的影响
五组创面经处理后面积随术后时间延长而逐渐缩小,实验研究结果显示术后4d、8d、12d(见表2),云南白药组、金丝桃组和金+中组的创面愈合率均高于生理盐水组,术后4d、8d,中药组与生理盐水组创面愈合率比较差异无统计学意义。术后12d,中药组的创面愈合率高于生理盐水组,差异有统计学意义。
组别 | 生理盐水 | 云南白药 | 金丝桃 | 中药 | 金+中 |
第4天 | 21.82±7.84 | 37.42±5.98** | 35.15±11.86* | 28.27±9.28 | 34.80±8.70* |
第8天 | 39.77±10.96 | 62.80±12.96** | 55.31±10.50* | 48.42±10.27 | 62.80±6.39** |
第12天 | 71.89±10.81 | 94.19±3.49** | 91.51±6.05** | 86.38±6.77* | 96.68±1.30** |
注:与生理盐水组比较,极显著用“**”表示(P<0.01),显著用“*”表示(P<0.05)。
3.各组新西兰兔创面肉芽组织病理学变化
五组创面取材标本在清创后4d、8d、12d显微镜下观察,结果如下:术后4天,各组镜下均可见大量炎性细胞浸润,部分胶原纤维裂,云南白药组可见少量上皮细胞生长;术后8天,云南白药、金丝桃、金+中三组炎性细胞明显减少,各组创面均有上皮细胞生长,上皮增生明显,胶原纤维增生明显,中药组炎性细胞也减少了,但不如其他三组。而生理盐水组还存在大量的炎性细胞;术后12天,给药四组创面组织结构完整,层次较为清晰,有些可见大量新生上皮细胞、腺体样结构,胶原纤维呈编织状排列,炎性细胞较少。而生理盐水组新生上皮较薄,胶原纤维排列无序,腺体样结构少,且有较多炎性细胞浸润(见图2)。
4.创面内胶原纤维比较
术后4天,云南白药、金丝桃和金+中三组均可见较多胶原纤维生成,而中药组创面组织胶原纤维稀少,部分断裂,排列无序,生理盐水组创面仅点状分布少许胶原纤维;术后8天,云南白药、金丝桃和金+中三组胶原纤维增多,排列较之前有序。中药组和生理盐水组胶原纤维略有增加;术后21天,给药四组创面中胶原纤维含量均逐渐增多,接近正常皮肤组织,排列更加规则、有序。而生理盐水组胶原纤维密度尚可,排列杂乱(见图3)。
5.创面微血管计数
各组创面微血管计数在清创后4d、8d、12d呈上升趋势。云南白药、金丝桃和金+中三组创面在各时间点微血管计数均显著高于生理盐水组(P均<0.01),而中药组和生理盐水组在各时间点创面微血管计数比较差异无统计学意义(P>0.05)(见图4)。
由此可见,本实施例以建立新西兰兔创面动物模型为基础,在此基础上进行清创和不同药物的治疗,通过大体观察、创面愈合率、愈合时间、病理学染色、免疫组化标记微血管计数等一系列指标对不同药物治疗效果进行评价,得出以下结论:一种含有金丝桃的促创面愈合的药物组合喷雾剂可消除炎症,促进慢性皮肤溃疡创面肉芽组织新生血管形成,改善溃疡创面病理学变化,最终促使创面愈合。
本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处。综上所述,本说明书内容不应理解为对本发明的限制。
Claims (10)
1.一种金丝桃促创面愈合药物组合物,其特征在于,所述药物组合物由以下重量份的原料组成:金丝桃2500份、苦丁茶1000份、花椒60份、水杨酸50份、小蓟50份和艾叶40份。
2.权利要求1所述的金丝桃促创面愈合药物组合物的制备方法,其特征在于,包括以下步骤:
(1)按比例分别称取原料;
(2)将金丝桃、苦丁茶、花椒、水杨酸、小蓟和艾叶粉碎后加入10倍体积的蒸馏水浸泡12h,浸泡完成后在65℃水浴锅中加热30 min,加热完成后在超声频率为25 kHz、功率为300w、温度45℃的条件下进行超声处理30 min,超声处理结束后抽滤分离,得到原料药液和药物残渣,将药物残渣重复提取两次,合并原料药液后备用;
(3)将原料药液蒸发浓缩,得到金丝桃促创面愈合药物组合物。
3.根据权利要求2所述的金丝桃促创面愈合药物组合物的制备方法,其特征在于,所述金丝桃促创面愈合药物组合物的相对密度为1.0-1.5。
4.根据权利要求2制备方法获得的金丝桃促创面愈合药物组合物,其特征在于,用于制备促创面愈合喷雾剂。
5.根据权利要求4所述的金丝桃促创面愈合药物组合物,其特征在于,所述促创面愈合喷雾剂的制备方法如下:将730重量份的辅料溶于40wt%-85wt%的乙醇溶液后,添加350-600重量份金丝桃促创面愈合药物组合物,并搅拌均匀,再加无水乙醇使溶液的含醇量为70wt%-95wt%,经抽滤,灌装,封口,灭菌后得到促创面愈合喷雾剂。
6.根据权利要求5所述的金丝桃促创面愈合药物组合物,其特征在于,所述辅料包括以下重量份的原料:增溶剂150份、助溶剂80份。
7.根据权利要求6所述的金丝桃促创面愈合药物组合物,其特征在于,所述增溶剂为十二烷基硫酸钠;所述助溶剂为卵磷脂。
8.根据权利要求5所述的金丝桃促创面愈合药物组合物,其特征在于,所述辅料中还包括450体积份稀释剂,所述稀释剂为丙二醇。
9.根据权利要求5所述的金丝桃促创面愈合药物组合物,其特征在于,所述辅料中还包括如下辅料中的一种或几种:矫味剂50重量份、防腐剂50重量份、稳定剂50重量份、抗氧化剂50重量份。
10.根据权利要求9所述的金丝桃促创面愈合药物组合物,其特征在于,所述防腐剂为山梨醇、稳定剂为甘油。
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CN108578586A (zh) * | 2018-06-22 | 2018-09-28 | 陕西杨凌陕特农业发展有限公司 | 一种外用消肿止痛药及其制备方法 |
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