CN113940915B - 一种阴道内用凝胶及其制备方法 - Google Patents
一种阴道内用凝胶及其制备方法 Download PDFInfo
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- CN113940915B CN113940915B CN202111485586.1A CN202111485586A CN113940915B CN 113940915 B CN113940915 B CN 113940915B CN 202111485586 A CN202111485586 A CN 202111485586A CN 113940915 B CN113940915 B CN 113940915B
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Abstract
本发明公开了一种阴道内用凝胶及其制备方法。所述阴道内用凝胶的原料包括以下成分：按质量百分比计，活性物载体1％～5％、保湿剂0.01％～5％、凝胶剂15％～37％、防腐剂0.01％～2.5％、调节剂0.1％～1.5％，余量均为纯化水。有益效果：当载药温敏聚合物溶液通过阴道给药后，能够迅速变成凝胶状态覆盖在黏膜上皮，负载的活性成分被储存在凝胶中从而达到长期控释给药的要求能长效缓释进行给药治疗，避免因药物突释导致的黏膜刺激性，对敏感娇嫩阴道黏膜无刺激无损伤。该凝胶可结合高频或其他治疗仪器设备治疗后即时给药的舒适性，冰敷，镇定。使用方便、舒适性好、能够延长药物在阴道内的滞留时间、价格低廉、长期使用安全可靠等特性。
Description
技术领域
本发明涉及妇科医疗护理技术领域，具体为一种阴道内用凝胶及其制备方法。
背景技术
女性阴道是由黏膜和肌肉组织构成的开放性腔道；内环境是以优势菌为主的动态环境，正常环境下阴道内环境呈现酸性(pH值为3.8～4.5)，具有自洁特性。内环境中会因阴道感染而破坏内环境中菌群平衡、酸碱平衡，造成妇科炎症产生。因此，改善阴道内环境，维持阴道动态平衡，提高阴道黏膜免疫力具有重要意义。
目前，市面上用于女性阴道的日常保健产品中多为卡波姆体系，但是该体系初始粘稠度较大，流动性低，给药时无法完整覆盖在阴道壁中。另一方面，泊洛沙姆由于具有特殊的反相热凝胶性质在给药体系中被广泛研究；其在低温时具有流动性，在温度达到临界胶束温度，发生凝胶化，在相转变过程中覆盖于黏膜上皮细胞表面以及黏膜破损位置，从而对黏膜形成保护作用。如专利CN201310562778.7一种双向可逆温敏凝胶及其制备方法、专利CN201510133260.0一种两亲性多糖衍生物/泊洛沙姆温敏型原位水凝胶及其制备方法中均涉及利用温度控制凝胶化，从而控制指定部位的给药。但是，现有技术中，由于女性阴道的酸性环境、温度、及其分泌物的影响，使得热敏凝胶的使用条件与女性阴道内环境不匹配，且延展性能不佳，在实际应用时无法很好地黏膜上皮细胞表面，造成给药均匀性差、凝胶粘附性低、药物吸收性低，影响使用效果。同时，市面上的产品大多为消字号消毒产品，消毒杀菌的特性在将有害菌种灭杀时也会影响有益菌群的日常生长，同样会影响女性阴道内环境的生态平衡。此外，市面上产品克重无定性，无法正确判断凝胶克重，影响使用效果。
综上所述，解决上述问题，制备一种阴道内用凝胶具有重要意义。
发明内容
本发明的目的在于提供一种阴道内用凝胶及其制备方法，以解决上述背景技术中提出的问题。
为了解决上述技术问题，本发明提供如下技术方案：
一种阴道内用凝胶，所述阴道内用凝胶的原料包括以下成分：按质量百分比计，活性物载体1％～5％、保湿剂0.01％～5％、凝胶剂15％～37％、防腐剂0.01％～2.5％、调节剂0.1％～1.5％，余量均为纯化水。其中，纯化水包括但不仅限于同等级别纯化水，还包括高于纯化水级别的水。
较为优化地，所述活性物载体中，活性成分的含量为≥0.5wt％；所述活性成分为白藜芦醇、百里香、葡萄柚、芦荟、薰衣草、苦参、迷迭香、大蒜发酵提取物、石榴、人参、积雪草、苹果、马齿苋、益母草、茶叶、透明质酸、藏红花、黄连、玫瑰、维生素、姜黄中一种或多种。其中，以上活性成分包括但不仅限于。
较为优化地，所述凝胶剂为洛沙姆407、泊洛沙姆188复配的组合物，两者的质量比为(15～28):(2～9)。
较为优化地，所述调节剂为壳聚糖、卡波姆、柠檬酸、黄原胶、卡拉胶、海藻酸钠、瓜尔胶、羧甲基纤维素钠中的一种或多种。
较为优化地，所述调节剂为壳聚糖或卡波姆中的一种或两种。
较为优化地，所述保湿剂为甘油、丙二醇、透明质酸钠、丁二醇、神经酰胺、山梨醇、木糖醇、乙基已基甘油、1-2已二醇中一种或多种。
较为优化地，所述防腐剂为对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、羟苯乙酯、苯甲酸钠、西吡氯铵、对羟基苯乙酮(PHA)、1-2已二醇、PC300、氯化钠、辛酰羟肟酸、异丙醇、苯甲醇、苯扎氯铵、三氯生、乙基已基甘油中的一种或多种。其中，以上防腐剂包括但不仅限于。
较为优化地，所述保湿剂还包括酪蛋白复合物，所述酪蛋白复合物占保湿剂的58％～65％。
较为优化地，所述酪蛋白复合物的制备方法为：(1)称取质量比为(1～1.5):1的胶束蛋白粉与藻酸丙二醇酯；(2)将藻酸丙二醇酯溶解在溶度为0.3g/L的碳酸氢钠溶液中，室温搅拌过夜，离心分离，得到20g/L的预处理液；将胶束酪蛋白加入至预处理液中，搅拌12～16小时；使用氢氧化钠溶液，调整溶液的pH＝10.8～11.2；搅拌1小时；使用柠檬酸调整溶液pH＝4.5～6，搅拌1小时，洗涤，冻干，得到酪蛋白复合物。
较为优化地，一种阴道内用凝胶的制备方法，包括以下步骤：
S1：将调节剂、保湿剂、防腐剂加入至纯化水中，搅拌均质化，得到防腐保湿水溶液；
S2：将凝胶剂加入至步骤S1的防腐保湿水溶液中，搅拌溶胀，得到凝胶基质；
S3：将活性物载体加入至纯化水中，搅拌均质化，得到稀释液；
S4：将步骤S3的稀释液加入至步骤S2的凝胶基质中，设置搅拌速度，混合均匀，得到阴道内用凝胶。
本技术方案中，以成年女性的阴道内环境为基础，制备了阴道内用凝胶。
(1)凝胶中聚合物的浓度影响凝胶在体内的胶凝温度，聚合物包括添加的凝胶剂、保湿剂、调节剂；因为聚合物浓度的增加，在分泌物稀释后胶凝温度增长至下降，体系粘度相应增大，因体系黏度过大不适于制备原位凝胶制剂，因此需要限定凝胶中各物质的比例。
(2)方案中以P407与P188复配形成的组合物作为主体，奠定凝胶化温度基础；由于受到阴道内环境中分泌物的影响，因此需要限定两者间的比例，因为在分泌物的影响下，比例的不同，会的使得凝胶化温度大于40℃，无法在体内顺利凝胶。
(3)单独加入保湿剂，其虽对凝胶稀释前的胶凝温度影响低，但是会提高稀释后凝胶的凝胶温度，使得凝胶体系无法在体内形成凝胶化，无法成胶。因此，需要选择加入较低含量的保湿剂；同时，通过使用粘度较低、可降低凝胶pH的调节剂进行调节，两者复配，更符合阴道内环境，且使得凝胶在体液稀释下，凝胶温度在37℃以下。如：使用甘油作为保湿剂，使用粘度较低的壳聚糖作为调节剂，两者在一定含量下调节复配，优化互补，使得凝胶在体液稀释下凝胶温度在≤37℃。
(4)为进一步提高凝胶后的粘附性，同时，进一步抑制保湿剂对吸收后凝胶温度的影响，加入了酪蛋白复合物。其中，酪蛋白具有酸性条件下，静电斥力减弱，聚集，具有一定凝胶性，但是，如果其直接加入会影响P407与P188复配形成的主体凝胶，提升凝胶温度，因此，需要一定处理，使用藻酸丙二醇酯复配形成复合物，然后进行pH处理，处理过程中蛋白质氨基和藻酸丙二醇酯中酯键断裂产生的酸基在碱性条件中形成共价偶联复合物，又在酸性条件下，将酪蛋白中钙离子释放，降低复合物的粒径，以及酪蛋白复合物的pH性，以此，由于酪蛋白复合物中含有丙二醇基具有保湿性、同时在酸性条件下可以产生空间斥力，抑制酪蛋白的聚集，增加酪蛋白复合物在分泌物稀释环境下的稳定性，可以均匀分散在主体凝胶中，与主体浸胶缠结。由于酪蛋白和P407具有良好的生物相容性，同时酪蛋白具有的双亲性增加了氢键作用、疏水作用以及范德华力，从而增强了凝胶的粘附性；同时由于其与活性组分间同样具有作用力，以及在水凝胶之间的缠结，增加了活性组分的迁移阻力，有效增强了缓释作用。
与现有技术相比，本发明所达到的有益效果是：
(1)该产品的使用克重为5g；产品在4～28℃下为流动液体状态；给药到阴道，在阴道内环境体液分泌物的稀释下，5～10分钟可发生胶凝化。
(2)利用养护类活性成分代替现有技术中的杀菌药物类，同时选用包载类的活性物载体。
(3)该产品具有良好的延展性可以很好地覆盖于黏膜上皮细胞表面以及黏膜破损位置，从而对黏膜形成保护作用；可以更好的铺展到阴道内壁的每个褶皱，同时具有良好的粘附性，日用5H流出量≤50％，夜用8H内流出量≤30％。
(4)根据不同生理周期，平均每24小时分泌物为1～4mL，在该基础上，当载药温敏聚合物溶液通过阴道给药后，能够迅速变成凝胶状态覆盖在黏膜上皮，负载的活性成分被储存在凝胶中从而达到长期控释给药的要求能长效缓释进行给药治疗，避免因药物突释导致的黏膜刺激性，对敏感娇嫩阴道黏膜无刺激无损伤。
(5)该凝胶可结合高频或其他治疗仪器设备治疗后即时给药的舒适性，冰敷，镇定。使用方便、舒适性好、能够延长药物在阴道内的滞留时间、价格低廉、长期使用安全可靠等特性。
附图说明
附图用来提供对本发明的进一步理解，并且构成说明书的一部分，与本发明的实施例一起用于解释本发明，并不构成对本发明的限制。在附图中：
图1是阴道内用凝胶的工艺设计图；
图2是日用凝胶流出比；
图3是夜用凝胶流出比。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
以下实施例中，以购买的白藜芦醇脂质体作为活性物载体。该物质的为粒径为纳米级，约210nm～600nm。该物质中的成分：按重量百分比计，甘油硬脂酸酯1％～5％、氢化软磷脂0.5％～5％、硬脂醇聚醚-215％～15％、硬脂醇聚醚-21％～5％、丙烯酸(酯)类共聚物1％～5％、白藜芦醇2.5～3.5％、EDTA二钠0.1％、1,2已二醇1％～5％、水50％～75％。
实施例1：
将0.8％的壳聚糖、2.5％的甘油、0.1％的对羟基苯甲酸甲酯加入至纯化水中，设置搅拌速度为1000rmp均质化，得到防腐保湿水溶液；将30％凝胶剂加入防腐保湿水溶液中，设置搅拌速度为300rmp搅拌溶胀，得到凝胶基质，备用；将2％白藜芦醇脂质体加入至纯化水中，设置搅拌速度为1000rmp均质化，得到稀释液；将稀释液加入至凝胶基质中，设置搅拌速度为500rmp混合均匀，得到阴道内用凝胶。
本技术方案中，凝胶剂为质量比为17:9凝胶剂为洛沙姆407、泊洛沙姆188复配的组合物。
实施例2：
将1.5％壳聚糖、2.5％甘油、2.5％丙二醇、0.18％对羟基苯甲酸甲酯加入至纯化水中，设置搅拌速度为1000rmp均质化，得到防腐保湿水溶液；将37％凝胶剂加入防腐保湿水溶液中，设置搅拌速度为300rmp搅拌溶胀，得到凝胶基质，备用；将5％白藜芦醇脂质体加入至纯化水中，设置搅拌速度为1000rmp均质化，得到稀释液；将稀释液加入至凝胶基质中，设置搅拌速度为500rmp混合均匀，得到阴道内用凝胶。
本技术方案中，凝胶剂为质量比为28:9凝胶剂为洛沙姆407、泊洛沙姆188复配的组合物。
实施例3：
将0.1％卡波姆、0.01％甘油、2.0％1,2已二醇、0.5％对羟基苯乙酮加入至纯化水中，设置搅拌速度为300rmp均质化，得到防腐保湿水溶液；将15％凝胶剂加入防腐保湿水溶液中，设置搅拌速度为300rmp搅拌溶胀，得到凝胶基质，备用；将1％白藜芦醇脂质体加入至纯化水中，设置搅拌速度为300rmp均质化，得到稀释液；将稀释液加入至凝胶基质中，设置搅拌速度为700～1000rmp混合均匀，得到阴道内用凝胶。
本技术方案中，凝胶剂为质量比为15:2凝胶剂为洛沙姆407、泊洛沙姆188复配的组合物。
实施例4：将实施例1中，使用的保湿剂甘油中，使用酪蛋白复合物替换60％的甘油；其余与实施例1相同；
其中，酪蛋白复合物的制备为：称取质量比为1.2:1的胶束蛋白粉与藻酸丙二醇酯；(2)将藻酸丙二醇酯溶解在溶度为0.3g/L的碳酸氢钠溶液中，室温搅拌过夜，离心分离，得到20g/L的预处理液；将胶束酪蛋白加入至预处理液中，搅拌12～16小时；使用氢氧化钠溶液，调整溶液的pH＝11；搅拌1小时；使用柠檬酸调整溶液pH＝4.8，搅拌1小时，洗涤，冻干，得到酪蛋白复合物。
对比例1：将实施例1中，甘油含量提高至6％；其余与实施例1相同。
对比例2：将实施例1中，壳聚糖的含量提高至3％，其余与实施例1相同。
对比例3：将实施例1中，凝胶剂的含量提高至40％；其余与实施例1相同；
对比例4：将实施例1中，凝胶剂中凝胶剂为洛沙姆407、泊洛沙姆188复配的质量比提高至30:9；其余与实施例1相同；
对比例5：将实施例1中，白藜芦醇脂质体的含量提高至6％；其余与实施例1相同；
实验1：将实施例、对比例中制备的阴道内凝胶进行表征。凝胶过程中，由于人体体液数量有限，无法收集，并且降解迅速，研究人员开发了一种模拟体液(SVF)，制备方法如下：向1L蒸馏水中加入NaCl(3.51g)、KOH(1.4g)、Ca(OH)2(0.22g)、牛血清白蛋白(0.018g)、乳酸(2.00g)、乙酸(1.00g)、甘油(0.16g)、尿素(0.4g)和葡萄糖(5.00g)并溶解，使用HCl将混合物的pH调整到4.2，得到模拟体液。由于5H内，约分泌0.2～0.83mL新的体液，因此，在5g凝胶中加适当的模拟体液，测量凝胶温度。所得数据如下表示：
| 实施例 | 稀释前pH | 稀释后pH | 凝胶温度 |
| 实施例1 | 5.00 | 4.63 | 36.3 |
| 实施例2 | 5.15 | 4.58 | 36.0 |
| 实施例3 | 5.03 | 4.75 | 35.8 |
| 实施例4 | 4.89 | 4.65 | 35.3 |
| 对比例1 | 4.91 | 4.51 | NG |
| 对比例2 | 5.25 | 4.58 | NG |
| 对比例3 | 5.35 | 4.65 | 19.5 |
| 对比例4 | 5.08 | 4.59 | NG |
| 对比例5 | 5.01 | 4.68 | NG |
结论：上述NG代表温度≥40℃；实施例1～4中的数据与实施例5～9的数据对比，结果表明：只有在特定含量比例下，才会在做接近成年女性阴道内环境的pH，且粘度适中，粘附性能好；而凝胶中物质比例变化，均会引起凝胶温度的变化，原因在于：凝胶中聚合物的浓度影响凝胶在体内的胶凝温度，在分泌物稀释后胶凝温度增长至下降，体系粘度相应增大，因体系黏度过大不适于制备原位凝胶制剂，因此需要限定凝胶中，各物质的比例。其中，单独加入保湿剂，会提高稀释后凝胶的凝胶温度，提高体系粘度，因此，需要选择加入较低含量的保湿剂，通过使用粘度较低调节剂，两者复配，优化保湿剂的缺点，调节剂进一步降低了凝胶的pH，使得两者复配粘度适中，方便使用，且用于内凝胶中降低保湿剂对稀释后凝胶温度的影响，可以使得稀释后的胶凝温度至37℃以下。此外，从实施例4中，可以看到，使用酪蛋白复合物，可以再次降低产品的胶凝温度，降低胶凝时间，因为其部分替代了保湿剂，可以抑制胶凝温度的上升。
实验2：将实施例1和实施例4中的凝胶与白藜芦醇的乙醇溶液进行的缓释对比，同时进行了经皮实验。
实验结果：缓释实验发现：实施例1、4与白藜芦醇乙醇溶液对比可以达到缓慢释放的效果，白藜芦醇乙醇溶液在4h之内完成释放，实施例1在12h之内还在缓慢释放，增加白藜芦醇的有效性，而实施例4中的释放速度低于实施例1，增加了活性组分的利用度。
而经皮实验发现：实施例1中白藜芦醇脂质体的凝胶在角质层的滞留量(36.47％)明显高于白藜芦醇乙醇溶液的滞留量(27.63％)；可以增加白藜芦醇的有效性；白藜芦醇脂质体温敏凝胶的渗透效果强于白藜芦醇乙醇溶液，促进白藜芦醇的皮肤渗透这种现象可归因于水凝胶增加皮肤的水合作用，导致渗透能力增强，并可能具有保湿特性。而实施例4中白藜芦醇脂质体的凝胶在角质层的滞留量(40.12％)高于实施例1的数据，表明：酪蛋白的缠结性增强了白藜芦醇脂质体皮肤的水合作用，加之释放速度缓慢，有效提高了活性成分利用度。
实验3：将实施例1中的阴道内用凝胶应用于人体。
(1)实验设计：选取公司内部有性生活女性10名，每个受试者安排两次实验，分别接受日用和夜用两次阴道内凝胶注射。日用为早晨12点前使用，夜用为至少间隔1天后睡前使用，每次阴道注射凝胶后臀部抬高10min。日用记录使用凝胶后5小时、6小时的凝胶流出量，夜用记录晨起后凝胶流出量，并记录第一次和最后一次凝胶外流时间、颜色以及不良反应。
(2)评价标准：A.日用记录使用凝胶后5小时、6小时凝胶流出量及比值；B.夜用记录晨起后凝胶流出量及比值；C.第一次和最后一次凝胶外流时间、颜色；D.不良反应。
(3)测试方法：第一阶段：日用：上午12点前使用，凝胶(含铝箔袋包装)注射前放入冰箱冷藏层(0～4℃)冷藏10min以上使其具有流动性；撕掉铝箔袋，取出凝胶后立即注射至阴道内，并臀部抬高10min；间隔1天后夜晚睡前使用阴道凝胶，测试方法同上。第二阶段：随访受试者第一次和最后一次凝胶外流时间和不良反应及反馈。
实验结果：
1.总收集样本量：选取公司内部有性生活女性10名(其中1名受试者由于个人原因未完成测试)。
2.受试者的月经周期及婚育情况：月经：1名受试者处于哺乳期月经未复潮，1名受试者人流后3月余月经未复潮，1名受试者月经不规律，余正常。婚育：1名受试者未婚未育，1名受试者已婚未育，余均已婚已育。
3.数据分析：
3.1日用及夜用凝胶流出量及比值
3.1.1测试受试者在早晨注射凝胶后5小时、6小时流出量：
第一片护垫放置时间为4h～5.53h，平均放置时间为5.03h，流出量为0.67g～5.69g，平均值为2.39g，其中2名受试者流出量超过5g(取下护垫时间分别是凝胶注射后5.5小时、5小时，该两名受试者日间活动量均较大)，每小时流出量为0.17g/h～1.14g/h，平均值为0.47g/h；第二片护垫放置时间为1h～1.38h，平均放置时间为1.1h，流出量为0.3g～1.66g，平均值为0.59g，每小时流出量为0.28g/h～1.24g/h，平均值为0.52g/h。
总结：日用护垫放置总时间为5h～6.87h，平均放置时间为6.13h，日用凝胶流出总量为0.99g～6.19g，平均值为2.99g，每小时流出量为0.49g/h～1.75g/h，平均值为0.99g/h；其中2名日用受试者凝胶流出量超过5g，随访获悉一名受试者接待客户走动较多，另一名受试者赶车出差。
3.1.2测试受试者在睡前注射凝胶后夜间流出量：
护垫放置时间为8h～10.53h，平均放置时间为9.23h，流出量为0.22g～3.53g，平均值为1.36g，每小时流出量为0.02g/h～0.26g/h，平均值为0.14g/h，夜用流出量均较少，其中一名受试者流出量高达3.53g，随访获悉夜间起床哺乳2次。
3.1.3日用凝胶流出比
如图2所示：凝胶日用过程中出现2名(2/9)受试者流出量超100％，6名(6/9)受试者流出量低于60％。
3.1.4夜用凝胶流出比
如图3所示：凝胶夜用过程中出现1名(1/9)受试者流出量超50％，6名(6/9)受试者流出量低于30％。
3.2第一次和最后一次凝胶外流时间、颜色
3.2.1第一次外流时间和最后一次外流时间
日用凝胶：8名受试者能感受到外流，均在1小时后才感觉外流，1名受试者未感觉到外流(该受试者未婚未育)；5名受试者后续再次感受有外流，最长可在注射后21.68小时后感受到，4名受试者未感受到外流，其中5和8号受试者第一片护垫取下时称重已超过5g(取下护垫时间分别是凝胶注射后5.5小时、5小时)，考虑凝胶已完全流出。
夜用凝胶：8名受试者能感受到外流，均在1小时后才感觉外流，1名受试者未感觉到外流(该受试者未婚未育)；4名受试者后续再次感受有外流，最长可在注射后21.8小时后感受到，5名受试者未感受到外流。
总结：不管是日用凝胶还是夜用凝胶流出时间均与活动量相关，且受主观感受影响大，但体内停留时间均不超过24小时。
3.2.2护垫上流出物颜色
凝胶原为透明物，测试发现护垫上流出物基本为淡黄色，考虑为阴道分泌物颜色所致。
3.3不良反应
2名受试者(2/9)出现轻微不适，其中一名处于哺乳期受试者日用期间出现轻微阴道刺激感，夜用无不适；另一名受试者日用后出现腹部轻微不适，考虑可能是着凉或者饮食所致，具体情况不详，但不排除凝胶不良反应可能性，夜用期间无不适。
综合结论：
(1)凝胶日用期间，正常活动6小时内凝胶流出量平均值为2.99g，每小时流出量平均值为0.99g/h，78％(7/9)的受试者阴道凝胶至少在体内停留6小时以上；夜用期间因卧床基本无活动量，流出量较少，睡前使用佳；活动量较大时会加速凝胶流出(根据被试数据活动量较大时可能在5-6小时内凝胶会完全流尽)，建议使用凝胶期间减少活动量以延长凝胶在阴道内停留时间。
(2)未婚未育者可能由于阴道环境佳没有明显凝胶外流感觉，不管是日用凝胶还是夜用凝胶流出时间均与活动量相关，但体内停留时间均不超过24小时，建议使用凝胶时间隔时间为24小时为佳。
(3)目前测试未见明显不良反应，建议临床使用后评估不良反应。
最后应说明的是：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (3)
1.一种阴道内用凝胶，其特征在于：所述阴道内用凝胶的原料包括以下成分：按质量百分比计，活性物载体1％～5％、保湿剂0.01％～5％、凝胶剂15％～37％、防腐剂0.01％～2.5％、调节剂0.1％～1.5％，余量均为纯化水；
所述凝胶剂为洛沙姆407、泊洛沙姆188复配的组合物，两者的质量比为(15～28):(2～9)；
所述保湿剂为甘油、丙二醇、丁二醇、乙基已基甘油、1-2已二醇中一种或多种与酪蛋白复合物的组合物；所述酪蛋白复合物占保湿剂的58％～65％；所述调节剂为壳聚糖或卡波姆中的一种或两种；
所述酪蛋白复合物的制备方法为：(1)称取质量比为(1～1.5):1的胶束酪蛋白粉与藻酸丙二醇酯；(2)将藻酸丙二醇酯溶解在溶度为0.3g/L的碳酸氢钠溶液中，室温搅拌过夜，离心分离，得到20g/L的预处理液；将胶束酪蛋白粉加入至预处理液中，搅拌12～16小时；使用氢氧化钠溶液，调整溶液的pH＝10.8～11.2；搅拌1小时；使用柠檬酸调整溶液pH＝4.5～6，搅拌1小时，洗涤，冻干，得到酪蛋白复合物；
所述活性物载体为白藜芦醇脂质体，具体成分如下：按重量百分比计，甘油硬脂酸酯1％～5％、氢化卵磷脂0.5％～5％、硬脂醇聚醚-21 5％～15％、硬脂醇聚醚-2 1％～5％、丙烯酸(酯)类共聚物1％～5％、白藜芦醇2.5～3.5％、EDTA二钠0.1％、1,2已二醇1％～5％、水50％～75％，各组分的总量为100%。
2.根据权利要求1所述的一种阴道内用凝胶，其特征在于：所述防腐剂为对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、羟苯乙酯、苯甲酸钠、西吡氯铵、对羟基苯乙酮、1-2已二醇、PC300、氯化钠、辛酰羟肟酸、异丙醇、苯甲醇、苯扎氯铵、三氯生、乙基已基甘油中的一种或多种。
3.根据权利要求1～2任意一项所述的一种阴道内用凝胶的制备方法，其特征在于：包括以下步骤：
S1：将调节剂、保湿剂、防腐剂加入至纯化水中，搅拌均质化，得到防腐保湿水溶液；
S2：将凝胶剂加入至步骤S1的防腐保湿水溶液中，搅拌溶胀，得到凝胶基质；
S3：将活性物载体加入至纯化水中，搅拌均质化，得到稀释液；
S4：将步骤S3的稀释液加入至步骤S2的凝胶基质中，设置搅拌速度，混合均匀，得到阴道内用凝胶。
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