CN107115497A - 一种医用抗hpv敷料及其制备方法 - Google Patents

一种医用抗hpv敷料及其制备方法 Download PDF

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CN107115497A
CN107115497A CN201710318402.XA CN201710318402A CN107115497A CN 107115497 A CN107115497 A CN 107115497A CN 201710318402 A CN201710318402 A CN 201710318402A CN 107115497 A CN107115497 A CN 107115497A
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阮伟
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Abstract

本发明公开了一种医用抗HPV敷料及其制备方法，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物5‑6份、青黛粉2‑5份、黑三棱5‑10份、莪术3‑10份、茶树油2‑3份、五倍子1‑1.5份、薏苡仁8‑10份、夏枯草6‑8份、败酱草6‑8份、凤仙子6‑8份、牡丹皮8‑10份、山豆根1‑1.3份、苦参碱1‑1.2份、白芨1‑1.3份、沙棘籽油2‑3份、皂角刺2‑5份、杏仁6‑8份、虾青素2‑2.5份、狼毒花1‑1.3份、山慈姑1.2‑1.3份、蔗虫1‑1.3份，秦岭松萝酸3‑6份、壳寡糖2‑2.5份，该医用抗HPV敷料具有预防、清除、宫颈上皮细胞病毒，调理不同程度宫颈糜烂异常,清除异味，平衡生殖系统分泌，紧致缩阴，恢复其弹性。

Description

一种医用抗HPV敷料及其制备方法
技术领域
本发明涉及医药技术领域，尤其涉及一种医用抗HPV敷料及其制备方法。
背景技术
HPV是导致宫颈癌的病因。由于引发宫颈癌病变的高危型HPV病毒为弱病毒，如能及时发现感染，及时清除，可达到防治宫颈癌的目的。控制宫颈癌的发生，重在预防，关键在早期筛查，而难点是目前还没有理想的方法能有效的将HPV病毒清除。
HPV是一种嗜上皮性病毒，在人和动物中分布广泛，有高度的特异性。
目前妇科疾病的药物治疗主要通过阴道给药，目前常用阴道给药制剂的剂型主要有栓剂、凝胶剂、泡腾片、阴道片、洗剂、胶囊剂、膜剂等，但这些剂型或多或少存在一些缺陷，影响药物发挥作用。
如：洗液，作用时间短，不易深入腔道深处，难以充分到达病症部位，药物不易充分发挥作用，用于治疗宫颈糜烂的药物，不宜制成洗剂；阴道片剂，普通阴道片剂分布性差，与粘膜接触面小，不宜渗入皱襞；阴道泡腾片需要阴道黏液的配合，不适于干燥性阴道炎患者。同时泡腾片易吸潮崩解，影响储存。而且，片剂的辅料主要为一些不溶性成分，排除困难，引起病人的不适；栓剂，药物释放不好，与阴道粘膜接触面小，难以渗入粘膜皱襞。而且栓剂在温度较高时易变形，稳定性不好；胶囊剂，药物不易释放，涂布面较差，受胶囊崩解的影响；阴道膜剂，药物与粘膜接触面小、渗透性差，不适于阴道分泌物少的妇女。有时粘滞的高分子浆状物会使人产生不适；阴用凝胶剂，药物涂布面及渗透性较不够，稳定性不好。
发明内容
为了解决以上技术问题，本发明提供了一种在治疗和预防生殖器病毒感染，慢性宫颈炎、宫颈癌和阴茎癌有良好效果的医用抗HPV辅料，
为了实现本发明的技术效果，采用了以下技术方案予以实现：
一种医用抗HPV敷料，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物5-6份、青黛粉提取物2-5份、黑三棱提取物5-10份、莪术提取物3-10份、茶树油2-3份、五倍子提取物1-1.5份、薏苡仁提取物8-10份、夏枯草提取物6-8份、败酱草提取物6-8份、凤仙子提取物6-8份、牡丹皮提取物8-10份、山豆根提取物1-1.3份、苦参碱提取物1-1.2份、白芨提取物1-1.3份、沙棘籽油2-3份、皂角刺提取物2-5份、杏仁提取物6-8份、虾青素2-2.5份、狼毒花提取物1-1.3份、山慈姑提取物1.2-1.3份、蔗虫v1-1.3份，松萝酸v3-6份、壳寡糖2-2.5份。
所述桃儿七提取物、青黛粉提取物、黑三棱提取物、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、皂角刺提取物、杏仁提取物、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物为超临界二氧化碳萃取而成，是为了有效地防止了热敏性物质的氧化和逸散，在萃取物中保持着药用植物的全部成分，而且能把高沸点，低挥发度、易热解的物质在其沸点温度以下萃取出来。
所述莪术提取物制备方法为：把莪术放入醋中侵泡一个礼拜，然后取出晾干并制粉，再通过超临界二氧化碳萃取的方法取得莪术提取物。
所述茶树油以蒸馏的方式从港木桃金娘科白千层叶中提取的纯天然植物精油。
所述沙棘籽油以超临界二氧化碳萃取技术从沙棘中萃取所得。
作为进一步的改进，医用抗HPV辅料的各物质按照重量份数做如下配比：桃儿七提取物5.5份、青黛粉提取物3份、黑三棱提取物7份、莪术提取物6份、茶树油2份、五倍子提取物1.1份、薏苡仁提取物9份、夏枯草提取物9份、败酱草提取物9份、凤仙子提取物7份、牡丹皮提取物9份、山豆根提取物1.2份、苦参碱提取物1.1份、白芨提取物1.2份、沙棘籽油2.5份、皂角刺提取物3份、杏仁提取物7份、虾青素2.2份、狼毒花提取物1.2份、山慈姑提取物1.2份、蔗虫提取物1份，松萝酸提取物4.5份、壳寡糖2份。
本发明还提供了医用壳寡糖复合剂敷料修复宫颈糜烂中的应用其特征在于，将权医用抗HPV敷料涂抹于外阴处。
本发明还提供了医用壳寡糖复合剂敷料的制备方法，所述制备方法按照以下工艺步骤：按比例称取桃儿七提取物、青黛粉提取物、黑三棱提取物、莪术提取物、茶树油、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、沙棘籽油、皂角刺提取物、杏仁提取物、虾青素、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物和壳寡糖置于搅拌器中进行搅拌15～20min，混合均匀装瓶即可
本发明的有益效果如下：
1)预防、清除、宫颈上皮细胞病毒(HPV病毒及部分病毒)，有效增加宫颈抗病毒抵抗力，祛腐生肌-祛腐活血。
2)调理不同程度宫颈糜烂异常,清除异味；抗病毒,细菌，原虫，支原体，衣原体。
3)平衡生殖系统分泌,清热解毒,消除各种经常复发的久治不愈妇科炎症。
4)调节内分泌，保养卵巢-提高宫颈上皮组织免疫力。
5)紧致缩阴，恢复其弹性。解决阴道松弛，干涩，性生活冷淡。
6)集预防，保健，养护，调理为一体
7)男性生殖系统HPV感染，疱疹，由细菌病毒引起的无名瘙痒。
具体实施方式
实施例1
一种医用抗HPV敷料，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物5-6份、青黛粉提取物2份、黑三棱提取物5份、莪术提取物3份、茶树油2份、五倍子提取物1份、薏苡仁提取物8份、夏枯草提取物6份、败酱草提取物6份、凤仙子提取物6份、牡丹皮提取物8份、山豆根提取物1份、苦参碱提取物1份、白芨提取物1份、沙棘籽油2份、皂角刺提取物2份、杏仁提取物6份、虾青素2份、狼毒花提取物1份、山慈姑提取物1.2份、蔗虫1份，松萝酸3份、壳寡糖2份。
该组合物制备方法为:
首先：桃儿七提取物、青黛粉提取物、黑三棱提取物、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、皂角刺提取物、杏仁提取物、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物为超临界二氧化碳萃取而成，是为了有效地防止了热敏性物质的氧化和逸散，在萃取物中保持着药用植物的全部成分，而且能把高沸点，低挥发度、易热解的物质在其沸点温度以下萃取出来，其以上提取物可以从外部采购所得。
莪术提取物制备方法为：把莪术放入醋中侵泡一个礼拜，然后取出晾干并制粉，再通过超临界二氧化碳萃取的方法取得莪术提取物，此提取物可以通过购买取得。
沙棘籽油以超临界二氧化碳萃取技术从沙棘中萃取所得，可以从外部购买取得。
其次：茶树油以蒸馏的方式从港木桃金娘科白千层叶中提取的纯天然植物精油，可以从外部购买取得。
最后：在氮气环境下，按比例称取桃儿七提取物、青黛粉提取物、黑三棱提取物、莪术提取物、茶树油、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、沙棘籽油、皂角刺提取物、杏仁提取物、虾青素、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物和壳寡糖置于搅拌器中进行搅拌15～20min，混合均匀装瓶即可。
该抗HPV敷料的用方法为：将医用抗HPV敷料涂抹于外阴处即可。
实施例2
一种医用抗HPV敷料，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物6份、青黛粉提取物5份、黑三棱提取物10份、莪术提取物10份、茶树油3份、五倍子提取物1.5份、薏苡仁提取物10份、夏枯草提取物8份、败酱草提取物8份、凤仙子提取物8份、牡丹皮提取物10份、山豆根提取物1.3份、苦参碱提取物1.2份、白芨提取物1.3份、沙棘籽油3份、皂角刺提取物5份、杏仁提取物8份、虾青素2..5份、狼毒花提取物1.3份、山慈姑提取物1.3份、蔗虫1.3份，松萝酸6份、壳寡糖2.5份。
该组合物的制备方法和应用方法与实施例1相同。
实施例3
一种医用抗HPV敷料，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物5.5份、青黛粉提取物3份、黑三棱提取物7份、莪术提取物6份、茶树油2份、五倍子提取物1.1份、薏苡仁提取物9份、夏枯草提取物9份、败酱草提取物9份、凤仙子提取物7份、牡丹皮提取物9份、山豆根提取物1.2份、苦参碱提取物1.1份、白芨提取物1.2份、沙棘籽油2.5份、皂角刺提取物3份、杏仁提取物7份、虾青素2.2份、狼毒花提取物1.2份、山慈姑提取物1.2份、蔗虫提取物1份，松萝酸提取物4.5份、壳寡糖2份
该医用抗HPV敷料的制备方法和应用方法与实施例1相同。
其中，实施例3相比于实施例1和实施例2，效果更加。
试用效果
三种实施例中制备的抗HPV敷料的试用效果。
将实施例中的抗HPV敷料用于100个患有HPV感染的患者(含低危和高危HPV病毒)。
使用本发明抗HPV敷料三个月后，粘膜低微型病毒：转阴例数为34名患者，为转阴例数为66名，转阴率为33％；粘膜高危型病毒：转阴例数为8名患者，未转阴例数为92名患者，转阴率为8％。
使用本发明抗HPV敷料六个月后，粘膜低微型病毒：转阴例数为78名患者，为转阴例数为22名，转阴率为78％；粘膜高危型病毒：转阴例数48名患者，未转阴例数为52名患者，转阴率为48％。
使用本发明抗HPV敷料九个月后，粘膜低微型病毒：转阴例数为92名患者，为转阴例数为8名，转阴率为92％；粘膜高危型病毒：转阴例数81名患者，未转阴例数为19名患者，转阴率为81％。
使用本发明抗HPV敷料十二个月后，粘膜低微型病毒：转阴例数为97名患者，为转阴例数为3名，转阴率为97％；粘膜高危型病毒：转阴例数91名患者，未转阴例数为9名患者，转阴率为91％。
检测结果
检查结构可靠，检查灵敏度和特异性均在95％以上，在国内多家医院进行了1004例与FDA注册产品的检查结果进行了比较(表1、2)并对不同结果的37例样本进行了DNA序列分析。
表1.凯普荧光定量PCR检测和FDA注册产品检测的临床验证结果比较(浙江大学医学院附属妇科医院)
表1，阳性预示值：97.5％；阴性预示值：92.2％；敏感度：96.7％。
表2.凯普荧光定量PCR检测和FDA注册产品检测的临床验证结果比较(上海长征医院)
表2，阳性预示值：98.4％；阴性预示值：92.3％；敏感度：96.8％。
以上所述者，仅为本发明之较佳实施例而已，当不能以此限定本发明实施之范围，即大凡依本发明权利要求及发明说明书所记载的内容所作出简单的等效变化与修饰，皆仍属本发明权利要求所涵盖范围之内。此外，摘要部分和标题仅是用来辅助专利文件搜寻之用，并非用来限制本发明之权利范围。

Claims (8)

1.一种医用抗HPV敷料，其特征在于，该医用抗HPV敷料包括按重量份数计的下述物质：桃儿七提取物5-6份、青黛粉提取物2-5份、黑三棱提取物5-10份、莪术提取物3-10份、茶树油2-3份、五倍子提取物1-1.5份、薏苡仁提取物8-10份、夏枯草提取物6-8份、败酱草提取物6-8份、凤仙子提取物6-8份、牡丹皮提取物8-10份、山豆根提取物1-1.3份、苦参碱提取物1-1.2份、白芨提取物1-1.3份、沙棘籽油2-3份、皂角刺提取物2-5份、杏仁提取物6-8份、虾青素2-2.5份、狼毒花提取物1-1.3份、山慈姑提取物1.2-1.3份、蔗虫v1-1.3份，松萝酸v3-6份、壳寡糖2-2.5份。
2.如权利要求1所述的医用抗HPV敷料，其特征在于，敷料的各物质按照重量份数做如下配比：桃儿七提取物5.5份、青黛粉提取物3份、黑三棱提取物7份、莪术提取物6份、茶树油2份、五倍子提取物1.1份、薏苡仁提取物9份、夏枯草提取物9份、败酱草提取物9份、凤仙子提取物7份、牡丹皮提取物9份、山豆根提取物1.2份、苦参碱提取物1.1份、白芨提取物1.2份、沙棘籽油2.5份、皂角刺提取物3份、杏仁提取物7份、虾青素2.2份、狼毒花提取物1.2份、山慈姑提取物1.2份、蔗虫提取物1份，松萝酸提取物4.5份、壳寡糖2份。
3.如权利要求1所述的医用抗HPV敷料，其特征在于，所述桃儿七提取物、青黛粉提取物、黑三棱提取物、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、皂角刺提取物、杏仁提取物、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物为超临界二氧化碳萃取而成。
4.如权利要求1所述的医用抗HPV敷料，其特征在于，所述莪术提取物制备方法为：把莪术放入醋中侵泡一个礼拜，然后取出晾干并制粉，再通过超临界二氧化碳萃取的方法取得莪术提取物。
5.如权利要求1所述的医用抗HPV敷料，其特征在于，所述茶树油以蒸馏的方式从港木桃金娘科白千层叶中提取的纯天然植物精油。
6.如权利要求1所述的医用抗HPV敷料，其特征在于，所述沙棘籽油以超临界二氧化碳萃取技术从沙棘中萃取所得。
7.权利要求1-6任一项所述医用抗HPV敷料的应用，其特征在于，将医用抗HPV敷料涂抹于外阴处。
8.一种制备如权利要求1-6所述的医用抗HPV敷料的方法，其特征在于，所述敷料的制备按照以下工艺步骤：按比例称取桃儿七提取物、青黛粉提取物、黑三棱提取物、莪术提取物、茶树油、五倍子提取物、薏苡仁提取物、夏枯草提取物、败酱草提取物、凤仙子提取物、牡丹皮提取物、山豆根提取物、苦参碱提取物、白芨提取物、沙棘籽油、皂角刺提取物、杏仁提取物、虾青素、狼毒花提取物、山慈姑提取物、蔗虫提取物，松萝酸提取物和壳寡糖置于搅拌器中进行搅拌15～20min，混合均匀装瓶即可。
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