CN111658765A - 一种宫颈修复凝胶及其制备方法 - Google Patents
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Abstract
本发明公开了一种宫颈修复凝胶及其制备方法，解决了目前宫颈疾病由于细菌或病毒刺激，或者通过激光或微波等治疗对宫颈造成累积性损伤的问题，本发明包括以下质量浓度的各组分：聚六亚甲基双胍盐酸盐：0.01‑1％；益母草碱：0.01％‑1％；铁皮石斛：0.5％‑5％；燕麦葡聚糖：1％‑10％；灵芝糖肽：0.05％‑5％；胶原蛋白：0.1％‑5％；甘油：5‑10％；羟乙基纤维素：1‑2％；其余余量为纯化水。本技术方案能有效修复宫颈组织损伤，制备方法极大地保留了各组分的生物活性，各组分复配性能良好。
Description
技术领域
本发明涉及生物医药领域，尤其涉及一种宫颈修复凝胶及其制备方法。
背景技术
宫颈炎、宫颈纳囊、宫颈息肉、宫颈糜烂和HPV病毒感染等宫颈疾病是成年女性常见妇科病，发病率高达60％-80％。由于宫颈处于阴道深处，宫颈病变较轻时不易察觉，检查发现后由于位置较深不方便治疗或用药，无明显不适时也是等待自愈。情况比较严重，有疼痛或出血等症状时多采用物理治疗，例如激光、微波和利普刀等。宫颈部位基本为结缔组织，周围神经不丰富，对疼痛感觉比较迟钝，但不代表宫颈组织没有损伤。无论细菌或病毒刺激，还是激光或微波等治疗，都会对宫颈造成累积性损伤。
为预防细菌或病毒感染对组织的刺激，减轻宫颈炎症状，同时修复前期宫颈疾病遗留的组织损伤，开发本技术方案的宫颈修复凝胶，填补相关领域空白。本宫颈修复凝胶能有效抵御病原菌或病毒感染，同时具有一定的组织修复能力，对宫颈疾病的主动预防、积极治疗和保障妇女健康具有重要意义。
发明内容
本发明为了解决上述不足，提供了一种宫颈修复凝胶及其制备方法，该产品能积极、主动地预防宫颈炎症和HPV感染，有效治疗宫颈炎症，同时修复已有的宫颈损伤。
本发明的上述目的通过以下的技术方案来实现：一种宫颈修复凝胶，其特征在于，包括以下质量浓度的各组分：
聚六亚甲基双胍盐酸盐：0.01-1％；
益母草碱：0.01％-1％；
铁皮石斛：0.5％-5％；
燕麦葡聚糖：1％-10％；
灵芝糖肽：0.05％-5％；
胶原蛋白：0.1％-5％；
甘油：5-10％；
羟乙基纤维素：1-2％；
其余余量为纯化水。
宫颈炎是妇科常见病，细菌或真菌感染宫颈组织，改变宫颈微生态，炎性环境长期刺激局部组织会引发宫颈纳囊或宫颈息肉。产品配方中的聚六亚甲基双胍盐酸盐能有效抑制细菌生长，对白色念珠菌等致病菌的抑制率可达99％，而且性能温和不刺激机体组织。同时，益母草碱有较强而普遍的抑菌活性，对多种细菌、霉菌和酵母菌都有很强的抑制作用，可有效预防妇科炎症；益母草碱强力清除自由基，可促进成纤维细胞增殖以及胶原合成，修复已经受损的组织。
女性一生中接触到HPV病毒的几率高达90％，但只有部分人感染HPV病毒，一小部分人发展成宫颈癌，这其中的差异主要是由免疫力高低决定。增强免疫力可有效预防病毒感染，或促进HPV感染阳转阴。铁皮石斛提取物富含小分子石斛多糖，石斛多糖进入人体后与人体内蛋白质结合，形成糖蛋白，糖蛋白具有抗病毒、抗癌、增强免疫力、延缓衰老等生物性功效。李时珍在《本草纲目》中提到石斛“强阴益精，厚肠胃，补内绝不足，轻身延年”。燕麦葡聚糖与皮下朗格罕氏细胞膜受体结合激活巨噬细胞，生产白介素类、表皮细胞生长因子和血管生成因子等细胞因子。部分细胞因子可诱导免疫级联反应，增强机体的特异性和非特异性免疫力，增强宿主对各种由细菌、真菌、病毒和寄生虫引起的感染性疾病的抵抗能力。另外，燕麦葡聚糖诱导巨噬细胞产生的表皮细胞生长因子能提高胶原蛋白合成，血管生成因子能促进新的血管形成，从而有效修复损伤组织。灵芝糖肽是通过生物技术将灵芝中的灵芝多糖和灵芝酸提取出来，灵芝多糖生物活性强，分支度高，特有的灵芝三萜类成分在免疫系统修复上表现优异，促进单核巨噬细胞系统的吞噬功能，促进细胞免疫功能，调节体液免疫功能，抗免疫抑制。
配方中的胶原蛋白选取分子量在3kDa左右的小分子，利于组织吸收。宫颈基本是结缔组织，胶原是结缔组织的重要组成，补充胶原蛋白可以快速修复损伤的组织。配方中的甘油、羟乙基纤维素和纯化水作为辅料成分提供赋形、润滑和保湿作用。
作为优选，各组分及其配方质量百分比如下：
聚六亚甲基双胍盐酸盐：0.02％；
益母草碱：0.05％；
铁皮石斛：1％；
燕麦葡聚糖：10％；
灵芝糖肽：0.5％；
胶原蛋白：1％；
甘油：10％；
羟乙基纤维素：1.5％；
纯化水：75.93％。
一种宫颈修复凝胶的制备方法，首先将胶原蛋白和聚六亚甲基双胍盐酸盐用纯化水溶解形成水溶液，另将羟乙基纤维素用10％甘油分散，将前述水溶液和分散了羟乙基纤维素的甘油加入水相内，加热搅拌，升温至80℃搅拌15分钟，提前混合好低温相物质益母草碱、铁皮石斛、燕麦葡聚糖和灵芝糖肽，待温度降至45℃加入上述低温相混合物质搅拌均匀后制作完成。
进一步的，将上述制作完成后的凝胶剂分装于妇科用凝胶推注器内，使用时，打开凝胶推注器前段塞子或保护盖，将凝胶推注器的推管深入阴道内，推管口到达宫颈时推动推杆挤出凝胶覆盖于宫颈。
一种宫颈修复凝胶及其制备方法，产品配方重点加强了提升免疫力的功效物质，添加了高效抗菌和抗病毒的成分，同时能有效修复宫颈组织损伤，制备方法极大地保留了各组分的生物活性，各组分复配性能良好。
具体实施方式
下面结合实施例对本发明进一步详述。
实施例1
一种宫颈修复凝胶及其制备方法，首先将胶原蛋白和聚六亚甲基双胍盐酸盐用纯化水溶解，羟乙基纤维素用10％甘油分散，将前述水溶液和分散了羟乙基纤维素的甘油加入水相内，加热搅拌，升温至80℃搅拌15分钟。提前混合好低温相物质益母草碱、铁皮石斛、燕麦葡聚糖、灵芝糖肽，待温度降至45℃加入低温相搅拌均匀后制作完成。凝胶剂分装于妇科用凝胶推注器内，使用时，打开前段塞子或保护盖，将推管深入阴道内，推管口到达宫颈时推动推杆挤出凝胶覆盖于宫颈。
上述制备的各组分质量百分比为：
1.聚六亚甲基双胍盐酸盐：0.01-1％；
2.益母草碱：0.01％-1％；
3.铁皮石斛：0.5％-5％；
4.燕麦葡聚糖：1％-10％；；
5.灵芝糖肽：0.05％-5％；
6.胶原蛋白：0.1％-5％；
7.甘油：5-10％；
8.羟乙基纤维素：1-2％；
其余余量为纯化水。
本技术方案的成分选取和重量比的选择均可以按照权利要求中所述的范围进行自由配比，不在此一一举例。
为了验证本产品的治疗效果，取其中一个配方进行对照试验。
试验所用凝胶剂的各组分配比为：
1.聚六亚甲基双胍盐酸盐：0.02％
2.益母草碱：0.05％
3.铁皮石斛：1％
4.燕麦葡聚糖：10％
5.灵芝糖肽：0.5％
6.胶原蛋白：1％
7.甘油：10％
8.羟乙基纤维素：1.5％
9.纯化水：75.93％
宫颈修复凝胶对宫颈损伤修复效果评价
1、实验目的：
宫颈修复凝胶对大鼠宫颈人造损伤面治疗效果观察。
2、实验内容：
取洁净级实验大白鼠60只，雌性未孕，体重180±20克，饲养于温度20-24℃、湿度40％-70％实验室环境。
将动物随机分成4组，每组15只：1)正常对照组；2)造模空白组；3)造模宫颈修复凝胶组；4)造模保妇康栓组。
实验造模：除正常对照组外其余三组的大鼠宫颈给药造模，25％苯酚胶浆灌装入1ml注射器，将注射器推入大鼠阴道深部注入25％苯酚胶浆，每只大鼠每次0.5ml，3天一次，共给药三次。
给药：正常对照组和造模空白组动物不用给药，宫颈修复凝胶组动物给予上述配制的凝胶剂，1ml注射器深入阴道给药，每次0.5ml，每天一次，连续给药14天；保妇康栓组动物给予保妇康栓药物，将保妇康栓制成0.1g-0.2g/粒，放入大鼠阴道深处，每次一粒，每天一次，连续给药14天。然后4组动物同时处死，解剖子宫取宫颈组织，用4％多聚甲醛固定24h，组织从中线纵向切开，进行常规石蜡切片和HE染色，显微镜下观察组织形态、细胞状态和炎性情况。
评价标准：宫颈上皮正常为2-3层,复层鳞状细胞形态，有刺激时鳞状上皮可能增厚，正常记录为0级，局部略有增厚记录为I级，明显增厚记录为II级，广泛增厚使黏膜凹凸不平记录为III级；宫颈口正常为鳞状上皮，发生宫颈糜烂时柱状上皮外移替代鳞状上皮，正常记录为0级，极少区域鳞状上皮被邻近柱状上皮替代记录为I级，柱状上皮明显替代鳞状上皮记录为II级，柱状上皮大面积替代鳞状上皮记录为III级；正常组织无炎细胞浸润记录为0级，组织内少量炎细胞浸润记录为I级，中等量炎细胞浸润记录为II级，大量广泛炎细胞浸润记录为III级。
试验结果：通过HE染色镜检评价宫颈鳞状上皮是否增厚、宫颈糜烂程度和炎细胞浸润情况，具体如下表1所示：
表1.四组动物宫颈组织情况列表
结论：HE染色镜检结果显示，造模后动物宫颈组织鳞状上皮层普遍增厚，均出现明显或大面积糜烂面，且全部有炎性细胞浸润。在使用修复凝胶2周后，有三分之一动物宫颈鳞状上皮厚度恢复正常，剩余三分之二也多处于局部略有增厚；有近一半动物宫颈糜烂完全修复，剩余一半基本只有极少区域存在糜烂；有三分之一动物炎性细胞消退，6例少量炎细胞浸润，3例中度炎细胞浸润，1例仍呈中度炎性浸润。妇保康栓组动物，鳞状上皮增厚有2例修复至正常，多数为轻度和中度增厚，还有1例呈重度；宫颈糜烂修复后基本正常或轻度，有2例中度；修复后的炎性情况正常、轻度和重度各3例，中度有6例。妇保康栓组对鳞状上皮增厚、宫颈糜烂和炎细胞浸润有明显修复作用，但修复率和修复程度比凝胶组差些。可见本发明凝胶剂对宫颈损伤修复效果显著。
以上所述仅为本发明的实施例，并非因此限制本发明的专利范围，凡是利用本发明说明书及实施例内容所作的等效结构或等效流程变换，或直接或间接运用在其他相关的技术领域，均同理包括在本发明的专利保护范围内。
Claims (4)
1.一种宫颈修复凝胶，其特征在于，包括以下质量浓度的各组分：
聚六亚甲基双胍盐酸盐：0.01-1％；
益母草碱：0.01％-1％；
铁皮石斛：0.5％-5％；
燕麦葡聚糖：1％-10％；
灵芝糖肽：0.05％-5％；
胶原蛋白：0.1％-5％；
甘油：5-10％；
羟乙基纤维素：1-2％；
其余余量为纯化水。
2.根据权利要求1所述的一种宫颈修复凝胶，其特征在于，各组分及其配方质量百分比如下：
聚六亚甲基双胍盐酸盐：0.02％；
益母草碱：0.05％；
铁皮石斛：1％；
燕麦葡聚糖：10％；
灵芝糖肽：0.5％；
胶原蛋白：1％；
甘油：10％；
羟乙基纤维素：1.5％；
纯化水：75.93％。
3.根据权利要求1所述的一种宫颈修复凝胶的制备方法，其特征在于：首先将胶原蛋白和聚六亚甲基双胍盐酸盐用纯化水溶解形成水溶液，另将羟乙基纤维素用10％甘油分散，将前述水溶液和分散了羟乙基纤维素的甘油加入水相内，加热搅拌，升温至80℃搅拌15分钟，提前混合好低温相物质益母草碱、铁皮石斛、燕麦葡聚糖和灵芝糖肽，待温度降至45℃加入上述低温相混合物质搅拌均匀后制作完成。
4.根据权利要求3所述的一种宫颈修复凝胶的制备方法，其特征在于：将上述制作完成后的凝胶剂分装于妇科用凝胶推注器内，使用时，打开凝胶推注器前段塞子或保护盖，将凝胶推注器的推管深入阴道内，推管口到达宫颈时推动推杆挤出凝胶覆盖于宫颈。
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