CN112089827A - 一种用于调节女性阴道微生态平衡的含益生元的药物组合、制备和使用 - Google Patents
一种用于调节女性阴道微生态平衡的含益生元的药物组合、制备和使用 Download PDFInfo
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- CN112089827A CN112089827A CN202011192430.XA CN202011192430A CN112089827A CN 112089827 A CN112089827 A CN 112089827A CN 202011192430 A CN202011192430 A CN 202011192430A CN 112089827 A CN112089827 A CN 112089827A
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Abstract
本发明提供了一种用于调节女性阴道微生态平衡的含益生元的药物组合、制备和使用，由修复抑菌液a、养护抑菌液b以及抑菌喷剂c组成，且修复抑菌液a、养护抑菌液b以及抑菌喷剂c组合使用。本发明通过研发含益生元调节女性阴道微生态平衡的抑菌液，抑制、修复阴道微生态正常环境，有效地解决传统妇科洗液在杀灭致病菌的同时杀灭了益生菌，导致阴道内菌群失调、免疫力低，致使阴道炎反复发作的问题。
Description
技术领域
本发明属于妇科用药技术领域，具体涉及一种用于调节女性阴道微生态平衡的含益生元的药物组合、制备和使用。
背景技术
健康妇女阴道内存在着多种的正常微生物菌落，它与宿主、环境之间构成相互制约、相互协调、动态的微生态平衡，给妇女健康带来舒适和欢乐。
女性阴道是一个复杂是微生态体系，一旦阴道的微生态平衡被破坏，就会导致阴道内的菌群失调，引起多种疾病。细菌性阴道病(BV)是由阴道内微生态平衡失调，厌氧菌和阴道加德纳菌过盛生长，兼性厌氧性乳酸杆菌受抑制所引起的一种阴道粘膜炎症表现的综合征。是妇科常见的阴道感染性疾病，多见育龄妇女，绝大多数患者年龄在15～44岁，无论是否有临床症状，均可合并多种并发症，如影响妊娠，可导致不孕症、异位妊娠、流产或死胎，影响出生人口的质量，影响夫妻性生活等。且可增加HIV的易感性，其检查和治疗越来越引起临床医生的重视，并受到社会各方面的关注。
综上所述，改善阴道微环境，修复阴道微损伤，维持阴道微生态平衡、改善阴道清洁度、提高阴道粘膜免疫力，对于治疗女性阴道常见疾病具有重要意义，同时要考虑避免使用抗生素所引发的耐药性、二重感染、过敏反应以及对机体的毒副作用等弊端。目前市场上出现的阴道用洗液、凝胶多为中药成分，且主要是通过抑制有害病菌来达到治疗妇科病的目的，在杀灭致病菌的同时也杀灭了很多益生菌，导致阴道内菌群失调、阴道免疫力低下，从而致使阴道炎反复发作，无法根治。
因此，如何能够提供一种合理的辅助治疗手段，能够同时持久保健和维持女性阴道的微生态平衡，从而达到预防和治疗女性阴道微生态失衡的目的，是摆在广大科研和医务工作者面前的重要难题。
发明内容
本发明的目的在于提供一种用于调节女性阴道微生态平衡的含益生元的药物组合，从三种不同功效的产品组合来实现对女性阴道进行修复、养护从而达到女性阴道微生态的平衡。
为了解决上述技术问题，本发明所采用的技术方案如下：
一种用于调节女性阴道微生态平衡的含益生元的药物组合，由修复抑菌液a、养护抑菌液b以及抑菌喷剂c组成，且修复抑菌液a、养护抑菌液b以及抑菌喷剂c组合使用，其中，修复抑菌液a包括如下重量百分比的原料：
益生元10.0％，库拉索芦荟提取物(Aloe barbadensis extract)6％、β葡聚糖(Beta-glucan)5％、马齿苋提取物(Portulacaoleracea extract)3％、赤芝提取物(Ganoderma lucidum extract)3％、香菇菌丝体提取物(Lentinus edodes myceliumextract)2％、灰树花子实体提取物(Grifola frondosa fruiting body extract)2％、蛇床子提取液3％、透明质酸钠(Sodium hyaluronate)1％、乳酸(Lacticacid)0.2％-0.6％；
养护抑菌液b包括如下重量百分比的原料：
益生元(Prebiotics)10％、角豆提取物(Ceratoniasiliqua(carob)seedextract)5％、白芨根提取物(Bletilla striata root extract)5％、红三叶草提取物(Clover tops red extract)3％、东洋参提取物(Driental ginseng extract)3％、海藻糖(Trehalose)2％、霍霍巴油(Jojoba oil)2％、互生叶白千层提取物(Melaleucaalternifolia(teatree)extract)2％、乳酸(Lactic acid)0.2％-0.6％；
抑菌喷剂c包括如下重量百分比的原料：
益生元(Prebiotics)10％、母菊花提取物(Chamomilla recutita flowerextract)5％、龙舌兰茎提取物(Agave americana stem extract)5％、水解胶原(Hydrolyzed collagen)3％、赤藓醇(Erythrito)2％、羟脯氨酸(Hydroxyproline)1％、透明质酸钠(Sodium hyaluronate)0.5％、乳酸(Lactic acid)0.1％-0.3％；
该修复抑菌液a、养护抑菌液b以及抑菌喷剂c还包括水，所述的水为纯化水。
所述益生元包括65％菊粉与20％α-葡聚糖寡糖的生态营养液。
所述透明质酸，又名玻尿酸，是一种酸性粘多糖，也是肌肤水嫩的重要基础物质，具有特殊的保水作用，是目前发现的自然界中保湿性最好的物质，被称为理想的天然保湿因子，能保持皮肤表面湿润。
所述库拉索芦荟叶提取物有良好的保湿作用，因为芦荟的叶汁很多，而且渗透力很强，能使肌肤吸饱水分。库拉索芦荟具有一种平衡肌肤的成分，能够有效的去油，调理油性皮肤，还具有对人体皮肤有良好的营养、滋润、增白作用的多糖和多种维生素。
所述马齿苋提取物种含有植物多糖和维生素可以营养润滑皮肤和促进上皮细胞的生理功能趋于正常，含有的氨基酸可以收缩血管平滑肌，收缩作用兼有的中枢及末梢性，生物碱和黄酮可以抗菌和抑制常见致病性皮肤真菌。
所述赤芝提取物对于前发炎因子(PGE2)，具有抑制效果，故赤芝提取物对于发炎引起的红、肿、热、痛等情形具有舒缓效果。
香菇菌丝体提取物(Lentinus edodes mycelium extract)其能够提供抗氧化剂和对皮肤的抗炎性益处。
灰树花提取物具有：①促进皮肤细胞的新陈代谢，增强皮肤的免疫防御机能；促进骨胶原、弹性硬蛋白和蛋白多糖等皮肤大分子物质的合成，降低皮肤大分子物质的蛋白分解和糖化；②治疗因细菌或激素引起的皮肤过敏症，促进伤口愈合；③耐受性好，生物利用度高，且稳定性好等功效。
蛇床子的提取物主要成分是蛇床子素，中医外用可以治疗滴虫性阴道炎，但单味蛇床子的功效不佳，通常和其他成分合成复方制剂用于治疗。
乳酸由玉米淀粉糖在乳酸菌作用下发酵法生产，由于L-乳酸是皮肤固有天然保湿因子的一部分被广泛用作许多护肤品的滋润剂。它是最温和的羟基酸AHA，也是维持阴道弱酸性环境的主要成分，可用作pH值调节剂。
β-葡聚糖促进成纤维细胞合成胶原蛋白，促进伤口愈合，控制细菌感染，使感染面尽快恢复，修复受损肌肤。
角豆提取物为一种来源于角豆的天然降糖成分，它可以提高女性排卵、改善月经不调，用于阴道养护抑菌液组合物，配合其他药物增强养护效果，为创新性尝试，为妇科细菌、病毒感染治疗提供了新方法。
白芨根提取物含有多糖、联苄类和菲类及其衍生物，提取物中的联苯及双氢菲类化合物对枯草杆菌、金黄色葡萄球菌、白色念珠菌有抑制作用。
红三叶草提取物含有刺芒柄花素、鹰嘴豆芽素及相应的苷等8种主要异黄酮成分，这些成分具有抗肿瘤、解痉、降血脂、抗心律不齐、抗氧化、抗炎杀菌作用。
东洋参提取物具有提高肌体免疫力，调节内分泌等作用。
海藻糖具有极强的保湿作用。
霍霍巴油含丰富维生素D及蛋白质，是很好的滋润及保湿油，可以维护皮肤水分，预防皱纹以及软化皮肤。
互生叶白千层提取物属于植物提取物中的醇类物质，其具有强力的消炎杀菌功效。
母菊别名为洋甘菊或欧药菊，母菊花提取物含有胆碱、芹菜素-7-葡萄糖甙、万寿菊甙、木犀草素-7-葡萄糖甙、槲皮黄甙等多种黄酮类，花中的粘液质由半乳糖醛酸、半乳糖、木糖、阿拉伯糖、葡萄糖、鼠李糖等组成，故有抗炎、抗菌、消毒等功用。
龙舌兰茎提取物具有强力锁水保湿作用，舒缓干燥肌肤，保持皮肤弹性，能增强皮屏障作用，促进胶原蛋白生成，同时抑制胶原蛋白分解，提高皮肤自我防御能力，达到修复皮肤作用。
胶原蛋白由于具有低免疫原性、纤维的再形成性、强的机械性能和生物可降解性等优点。
赤藓醇有强烈的保湿和吸湿性,与甘油一样可用作化妆品的保湿剂,但没有甘油似的腻黏感。
羟脯氨酸作为水溶性胶原蛋白,增加化妆品的粘度；还可以滋润细胞,改善表皮细胞的弹性和光泽。
本发明还提供了上述修复抑菌液a的制备方法，修复抑菌液a具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取蛇床子提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、β葡聚糖、库拉索芦荟提取物、马齿苋提取物、赤芝提取物、灰树花子实体提取物加入配液灌中，搅拌均匀；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
养护抑菌液b的制备方法具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素、甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取角豆提取物、红三叶草提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、白芨根提取物、东洋参提取物、互生叶白千层提取物加入配液灌中，搅拌均匀，藻糖、霍霍巴油加入；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
抑菌喷剂c的制备方法，抑菌喷剂c具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸、水解胶原、羥脯氨酸，用甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水继续搅拌，澄清透明即可；
S2、益生元、母菊花提取物、龙舌兰茎提取物加入配液罐中，继续搅拌；
S3、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
本发明还提供一种上述用于调节女性阴道微生态平衡的含益生元的药物组合的使用方法，修复抑菌液a、养护抑菌液b隔天用于患者阴道的清洗，抑菌喷剂c每天进行患者阴道喷雾用。
本发明通过研发含益生元调节女性阴道微生态平衡的抑菌液，抑制、修复阴道微生态正常环境，有效地解决传统妇科洗液在杀灭致病菌的同时杀灭了益生菌，导致阴道内菌群失调、免疫力低，致使阴道炎反复发作的问题。
具体实施方式
下面结合具体实施方式对本发明作进一步详细的说明。
下述实施例中的原材料均为市售常规产品。
具体实施方式一：一种用于调节女性阴道微生态平衡的含益生元的药物组合，由修复抑菌液a、养护抑菌液b以及抑菌喷剂c组成，且修复抑菌液a、养护抑菌液b以及抑菌喷剂c组合使用，其中，修复抑菌液a包括如下重量百分比的原料：
益生元10.0％，库拉索芦荟提取物6％、β葡聚糖(Beta-glucan)5％、马齿苋提取物3％、赤芝提取物3％、香菇菌丝体提取物2％、灰树花子实体提取物2％、蛇床子提取液3％、透明质酸钠1％、乳酸0.2％-0.6％；
养护抑菌液b包括如下重量百分比的原料：
益生元10％、角豆提取物5％、白芨根提取物5％、红三叶草提取物3％、东洋参提取物3％、海藻糖2％、霍霍巴油2％、互生叶白千层提取物2％、乳酸0.2％-0.6％；
抑菌喷剂c包括如下重量百分比的原料：
益生元10％、母菊花提取物5％、龙舌兰茎提取物5％、水解胶原3％、赤藓醇2％、羟脯氨酸1％、透明质酸钠0.5％、乳酸0.1％-0.3％；
该修复抑菌液a、养护抑菌液b以及抑菌喷剂c还包括水，所述的水为纯化水。
所述益生元包括65％菊粉与20％α-葡聚糖寡糖的生态营养液。
具体实施方式二：提供了上述修复抑菌液a的制备方法，修复抑菌液a具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取蛇床子提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、β葡聚糖、库拉索芦荟提取物、马齿苋提取物、赤芝提取物、灰树花子实体提取物加入配液灌中，搅拌均匀；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
养护抑菌液b的制备方法具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素、甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取角豆提取物、红三叶草提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、白芨根提取物、东洋参提取物、互生叶白千层提取物加入配液灌中，搅拌均匀，藻糖、霍霍巴油加入；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
抑菌喷剂c的制备方法，抑菌喷剂c具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸、水解胶原、羥脯氨酸，用甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水继续搅拌，澄清透明即可；
S2、益生元、母菊花提取物、龙舌兰茎提取物加入配液罐中，继续搅拌；
S3、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
上述修复抑菌液a、养护抑菌液b以及抑菌喷剂c组合使用用于调节女性阴道微生态平衡，其使用方法为：月经干净后，隔天分别使用修复抑菌液a、养护抑菌液b进行阴道清洗，连续用20天，抑菌喷剂c每天使用，喷于外阴。
体外抑菌试验采用的包括克氏库克菌益生菌、金黄色葡萄球菌病原菌，测试方法为在含有0.5％上述益生元的培养介质中，同时接种益生菌和病原菌，20小时后益生菌呈100倍增长，病原菌呈20倍减少；试验结果也表明该组合对于引起阴道炎的白色念珠菌、金黄色葡萄球菌、戊糖乳杆菌致病菌的抑制和杀灭作用显著。
最后应当说明的是，以上实施例仅用以说明本发明的技术方案，而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细地说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的实质和范围。
Claims (7)
1.一种用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，由修复抑菌液a、养护抑菌液b以及抑菌喷剂c组成，且修复抑菌液a、养护抑菌液b以及抑菌喷剂c组合使用，其中，修复抑菌液a包括如下重量百分比的原料：
益生元10.0％，库拉索芦荟提取物6％、β葡聚糖5％、马齿苋提取物3％、赤芝提取物3％、香菇菌丝体提取物2％、灰树花子实体提取物2％、蛇床子提取液3％、透明质酸钠1％、乳酸0.2％-0.6％；
养护抑菌液b包括如下重量百分比的原料：
益生元10％、角豆提取物5％、白芨根提取物5％、红三叶草提取物3％、东洋参提取物3％、海藻糖2％、霍霍巴油2％、互生叶白千层提取物2％、乳酸0.2％-0.6％；
抑菌喷剂c包括如下重量百分比的原料：
益生元10％、母菊花提取物5％、龙舌兰茎提取物5％、水解胶原3％、赤藓醇2％、羟脯氨酸1％、透明质酸钠0.5％、乳酸0.1％-0.3％。
2.根据权利要求1所述的用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，该修复抑菌液a、养护抑菌液b以及抑菌喷剂c还包括水，水为纯化水。
3.根据权利要求2所述的用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，所述益生元包括65％菊粉与20％α-葡聚糖寡糖的生态营养液。
4.根据权利要求1所述的用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，修复抑菌液a的制备方法，修复抑菌液a具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取蛇床子提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、β葡聚糖、库拉索芦荟提取物、马齿苋提取物、赤芝提取物、灰树花子实体提取物加入配液灌中，搅拌均匀；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
5.根据权利要求1所述的用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，养护抑菌液b的制备方法具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸钠原料，用羟乙基纤维素、甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水升温,继续搅拌，澄清透明无块状即可；
S2、冷却至至45℃后称取角豆提取物、红三叶草提取物依次加入配液罐中，继续搅拌；
S3、继续降温至40℃，称取益生元、白芨根提取物、东洋参提取物、互生叶白千层提取物加入配液灌中，搅拌均匀，藻糖、霍霍巴油加入；
S4、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
6.根据权利要求1所述的用于调节女性阴道微生态平衡的含益生元的药物组合，其特征在于，抑菌喷剂c的制备方法，抑菌喷剂c具体包括以下步骤：
S1、采用纯化水对配液罐进行数次清洗后，称取透明质酸、水解胶原、羥脯氨酸，用甘油、丁二醇对其进行分散出来，搅拌均匀，直无块状出现为止,加入纯化水继续搅拌，澄清透明即可；
S2、益生元、母菊花提取物、龙舌兰茎提取物加入配液罐中，继续搅拌；
S3、采用乳酸对其进行PH值调节，将溶液的PH控制在3.8-5.5范围内。
7.一种权利要求1-6任一所述用于调节女性阴道微生态平衡的含益生元的药物组合的使用方法，其特征在于，修复抑菌液a、养护抑菌液b隔天用于患者阴道的清洗，抑菌喷剂c每天进行患者阴道喷雾用。
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