CN111789937A - 一种具有阴道紧缩功效的抑菌片 - Google Patents
一种具有阴道紧缩功效的抑菌片 Download PDFInfo
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- CN111789937A CN111789937A CN202010641829.5A CN202010641829A CN111789937A CN 111789937 A CN111789937 A CN 111789937A CN 202010641829 A CN202010641829 A CN 202010641829A CN 111789937 A CN111789937 A CN 111789937A
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- vagina
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- dried powder
- vaginal
- bacteriostatic
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Abstract
本发明涉及阴道修复技术，具体涉及一种具有阴道紧缩功效的抑菌片，由如下重量百分比的组分组成：AFGF冻干粉10～15％、BFGF冻干粉10～15％、四磷酸二鸟苷10～15％、硝呋太尔5～10％、粘附剂5～15％、填充剂30～50％、崩解剂2～10％和润滑剂2～10％。本发明的优点在于：提供所需的养分；充分滋养阴道细胞组织，让其充满活力；修复女性阴道粘膜，修复阴道，消炎杀菌，去除异味，改善女性自身清洁系统功能；能够快速修复断裂的纤维层，受损肌肉层；激发荷尔蒙分泌，促进胶原蛋白，弹性纤维的合成和分泌；富含性神经修复因子，能够有效提高性敏感度，增加快感，提升幸福敏感度。
Description
技术领域
本发明涉及阴道修复技术，具体涉及一种具有阴道紧缩功效的抑菌片。
背景技术
阴道松弛是女性随着年龄的增长出现的一种生理状况，主要人群为产后女性。阴道松弛严重者会降低夫妻生活质量，阴道与肛门由肛门括约肌、肛提肌和球海绵体肌呈“8”字形环绕，这些肌肉可维持肛门及阴道的收缩作用。由于分娩或外伤，可使这些肌肉撕裂或变薄，致使阴道收缩力下降、性快感减弱。
阴道松弛的病因主要来源于两方面，一是弹性纤维破损：正常阴道直径2.5厘米，长约8厘米，在阴道壁上有许多“弹性纤维”支撑着阴道伸缩弹性，无数条“弹性纤维”织成密实的阴道弹力纤维网，网住阴道内壁黏膜及许多皱襞，性生活时能增加摩擦力，使双方产生快感。随着年龄的增长，因为婚姻和生育，阴道会变得松弛，阴道弹性纤维断裂后，阴道口扩张、阴道壁变脆变薄，不仅病菌更容易入侵，也使阴道在交合时容易发生器质性的损伤。由于阴部弹性纤维网断裂、萎缩，使得阴部末梢神经敏感度降低，变得迟钝，从而造成性冷淡、性交疼痛等情况，阴道松弛症患者“弹性纤维”断裂、使阴道弹力纤维网破损，是导致阴道松弛的最主要原因。女性阴道壁发生撕裂性或经常的剧烈性运动，在性交、分娩、过频性生活、人流、药流中，阴道弹性纤维被一次次“拉伤”，“阴道弹力网”发生断裂，阴道被撑大后无力回缩，出现“阴道松弛”。二是某些疾病人群：有慢性疾病、体质弱、消瘦着者，她们的肌肉、筋膜、韧带等构造比较松弛，加重了阴道松弛。女性随年龄的增长雌激素减少，使得肌肉、筋膜、韧带及相关的支持构造发生退行性变，肌肉的张力降落，筋膜变薄，同时阴道黏膜呈现萎缩，加重了阴道的松弛。
目前，阴道松弛的治疗方式主要有以下几种：(1)药物：通过药物刺激引起阴道内壁充血而达到缩阴效果，但是副作用大、有依赖性、长期使用会造成阴道内膜变薄，自身收缩功能退化而永久性松弛。(2)手术：通过缝线或切割的手术达到缩阴效果，但需承受手术的风险和痛苦，而且不能再行生产。(3)运动食疗：时间长，效果慢，只能起到辅助作用。(4)注射：通过注射胶原类物质到阴道壁内，使阴道内壁膨胀而达到缩阴效果，此种方式会有异物进入体内，有诱发并发症的可能，并且效果保持时间有限。(5)生殖中药或养生精油：通过穴位刺激或按摩运动达到保养效果，但是疗程长，有一定效果效果不直接。
发明内容
根据以上现有技术的不足，本发明提供一种具有阴道紧缩功效的抑菌片，外用不口服，方便更安全，无依赖无副作用，吸收更迅速，根源紧缩，效果明显。
本发明所述的一种具有阴道紧缩功效的抑菌片，其特征在于，由如下重量百分比的组分组成：AFGF冻干粉10～15％、BFGF冻干粉10～15％、四磷酸二鸟苷10～15％、硝呋太尔5～10％、粘附剂5～15％、填充剂30～50％、崩解剂2～10％和润滑剂2～10％。
其中优选方案如下：
配方可以具体采用以下方案：由如下重量百分比的组分组成：AFGF冻干粉10％、BFGF冻干粉10％、四磷酸二鸟苷10％、硝呋太尔5％、粘附剂5％、填充剂50％、崩解剂5％和润滑剂5％。
配方还可以具体采用以下方案：由如下重量百分比的组分组成：AFGF冻干粉15％、BFGF冻干粉15％、四磷酸二鸟苷15％、硝呋太尔10％、粘附剂10％、填充剂30％、崩解剂2％和润滑剂3％。
所述生物粘附剂选用海藻酸盐、阿拉伯胶、虫胶、壳聚糖、果胶或琼脂。
所述填充剂选用淀粉及其衍生物、乳糖、糖粉、微晶纤维素、甘露醇或木糖醇中的一种或多种。
所述崩解剂选用交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠、羧甲基淀粉钠或羟丙基纤维素的一种或者多种。
所述润滑剂选用硬脂酸镁、微粉硅胶或滑石粉中的一种或者多种。
制备时，将上述各组分混合均匀，采用常规压片工艺。
该抑菌片每片的重量为600mg。
AFGF冻干粉中的主要成分为AFGF(重组人酸性成纤维细胞生长因子)，AFGF是人生长因子中的一种多肽；由154个氨基酸组成的活性多肽，作为一种强有力的体内体外细胞分裂因子，具有多种生物活性。一方面能够促进阴道内成纤维细胞、表皮细胞代谢、增殖和分化；激活细胞，加速细胞的新陈代谢，修复断裂的浅表皮成纤维细胞，对创面有突出的快速修复功能。另一方面促进细胞间质的形成，促进胶原蛋白的合成和分泌，促进弹性纤维合成和分泌，促进细胞间基质的增加，使皮肤细嫩健美、饱满有弹性，从而使阴道壁更有弹性。
BFGF冻干粉中的主要成分为BFGF(碱性成纤维细胞生长因子)，一种能够促进成纤维细胞生长的物质。一方面能够快速改善阴道细胞生长的微环境，促进弹性纤维和胶原蛋白的合成，促进阴道内成纤维细胞的生长发育，不断以新的细胞取代老化细胞，使阴道壁富有弹性，处于滑嫩的状态。另一方面能够刺激受损肌肉组织的形成和促进受损组织的上皮化，还可调节胶原降解及更新，从而缩短创伤愈合时间的作用。
四磷酸二鸟苷，可水解转化成三磷酸腺苷(ATP)，从而为细胞供给能量。使阴道内细胞在恶劣的环境下仍保持兴奋活力，使阴道内部保持光泽及弹性，促进各种人体蛋白合成，如角蛋白、丝角蛋白、胶原蛋白、牵连蛋白等等。
硝呋太尔是硝基呋喃衍生物，是一个广谱抗菌素，尤其对妇科感染的常见病原体如革兰氏阳性和阴性细菌、滴虫、霉菌、衣原体和支原体都有强的杀灭作用，而对有益菌乳酸杆菌无抑制作用。硝呋太尔抑制细菌的生长主要由于干扰其酶系统，与磺胺及抗生素没有交叉耐药性，口服后经胃肠道吸收，大部分通过肾脏排泄，在血、尿、生殖器组织浓度较高，故在泌尿系统中可产生强烈的抗菌作用，其代谢产物仍有抗菌活性，且自尿中排出。硝呋太尔制成阴道使用的栓剂，使用后只有微量的硝呋太尔被人体吸收，血浆中的浓度基本为零，可在不被吸收的情况下局部发挥抗真菌、抗滴虫和抗细菌的广谱治疗作用，对治疗混合性阴道感染，无法或不能及时明确诊断病原体的阴道感染患者均可使用，对较为严重的病例，可在口服片剂的同时外用栓剂，取得更好效果。硝呋太尔外用制剂在治疗妇女阴道感染方面具有抗菌谱广，使用方便，疗程短，患者依从性高，保护乳酸杆菌，改善阴道生态环境等突出优点，尤其具备疗效显著，无耐药现象，安全性高，适合孕妇期妇女阴道感染之特点，是一个在该病患中具有较大应用前景的药物。
本发明制备的抑菌片适用范围：(1)生育过后的女性：无论是顺产还是剖腹产，生育对女人的生理机构都会产生巨大的改变，阴道都会出现不同程度的松弛现象。特别是顺产，女性阴道更是会被撕裂性的撑大。(2)流产过后的女性：无论是人流还是药流，流程都等同于一次生产的过程，阴道弹性纤维会被损伤的同时，流产后也会有大量的毒素残留于体内，从而使得女性出现各种疾病，对身心造成众多的不良影响。(3)外阴暗黑的女性：外阴暗黑是由于性生活所导致的阴道被摩擦过多，从而造成黑色素沉淀，这会令阴道加速衰老，如果不及时对其进行保养，阴道就会越发的松弛老化，令性生活变得麻木无高潮。(4)性生活频繁的女性：女性阴道会因性生活而被撑大，正常情况下这是可以自行进行修复的。但性生活过于频繁而导致阴道被使用过度，那弹性纤维就会受伤并失去弹力，女性阴道就会变得松弛。
使用方法具体为：清洁双手和私处，取出一次性指套并戴在食指上，大拇指配合食指捏住抑菌片，利用食指将抑菌片推置阴道最底处即可。第一周：每天一片。第二周：两天一片。第三周：三天一片。第四周开始：每周1-2片巩固保养。
本发明的优点在于：
1.提供所需的养分；充分滋养阴道细胞组织，让其充满活力；
2.修复女性阴道粘膜，修复阴道，消炎杀菌，去除异味，改善女性自身清洁系统功能；
3.能够快速修复断裂的纤维层，受损肌肉层；
4.激发荷尔蒙分泌，促进胶原蛋白，弹性纤维的合成和分泌；
5.富含性神经修复因子，能够有效提高性敏感度，增加快感，提升幸福敏感度。
具体实施方式
以下结合实施例对本发明做进一步描述。
实施例1：
一种具有阴道紧缩功效的抑菌片，由如下重量百分比的组分组成：AFGF冻干粉10％、BFGF冻干粉10％、四磷酸二鸟苷10％、硝呋太尔5％、粘附剂5％、填充剂50％、崩解剂5％和润滑剂5％。
制备时，将上述各组分混合均匀，采用常规压片工艺。
该抑菌片每片的重量为600mg。
实施例2：
一种具有阴道紧缩功效的抑菌片，由如下重量百分比的组分组成：AFGF冻干粉15％、BFGF冻干粉15％、四磷酸二鸟苷15％、硝呋太尔10％、粘附剂10％、填充剂30％、崩解剂2％和润滑剂3％。
制备时，将上述各组分混合均匀，采用常规压片工艺。
该抑菌片每片的重量为600mg。
测试例：
一、稳定性试验
1、留样观察法：将药品置室温中，进行了初步稳定性试验，置温度37-40℃，相对湿度75％中，进行加速试验，考核指标试验项目为：性状、鉴别、装量差异、崩解时限、发泡量、含量测定、微生物限度检查。实施例1和实施例2制备的抑菌片样品置室温中考察6个月，考核项目指标与0月比较，无明显变化。实施例1和实施例2制备的抑菌片样品加速实验考察3个月，考核项目指标与0月比较，无明显变化。可见，本品质量稳定。
二、药效学试验
实施例1和实施例2制备的抑菌片样品对体外金黄葡萄球菌、大肠埃希氏菌等10株细菌及白色珠菌试验结果均有不同程度的抑菌抑菌作用；其体外抑菌作用强于其栓剂。对建立家兔霉菌性阴道炎模型引起的阴道充血、水肿、有很好的治疗作用；并能明显的抑制二甲苯所致小鼠耳肿胀和降低角叉菜胶所致大鼠足跖肿胀率；对棉球肉芽肿增生性炎症无显著的作用。说明本发明对急性渗出性炎症作用显著。明显提高磷酸组织胺的致痒阈，具有止痒作用。
三、缩阴效果试验
为了验证本发明抑菌片的缩阴、美白效果，组织100位志愿者试用，试用周期三个月，第一周：每天一片。第二周：两天一片。第三周：三天一片。第四周开始：每周1-2片巩固保养。结束后对产品的使用方便度、缩阴效果、美白效果、清洁效果填写志愿者问卷调查，按好、一般、无效果来评级，一般以上为通过，统计有效率，大于75％为合格，其中，美白效果的验证方法为：使用前让志愿者对私处拍照，三个月后再拍照，对比部位颜色变化。结果如下表所示：
Claims (7)
1.一种具有阴道紧缩功效的抑菌片，其特征在于，由如下重量百分比的组分组成：AFGF冻干粉10～15％、BFGF冻干粉10～15％、四磷酸二鸟苷10～15％、硝呋太尔5～10％、粘附剂5～15％、填充剂30～50％、崩解剂2～10％和润滑剂2～10％。
2.根据权利要求1所述的一种具有阴道紧缩功效的抑菌片，其特征在于，由如下重量百分比的组分组成：AFGF冻干粉10％、BFGF冻干粉10％、四磷酸二鸟苷10％、硝呋太尔5％、粘附剂5％、填充剂50％、崩解剂5％和润滑剂5％。
3.根据权利要求1所述的一种具有阴道紧缩功效的抑菌片，其特征在于，由如下重量百分比的组分组成：AFGF冻干粉15％、BFGF冻干粉15％、四磷酸二鸟苷15％、硝呋太尔10％、粘附剂10％、填充剂30％、崩解剂2％和润滑剂3％。
4.根据权利要求1～3任一项所述的一种具有阴道紧缩功效的抑菌片，其特征在于，所述生物粘附剂选用海藻酸盐、阿拉伯胶、虫胶、壳聚糖、果胶或琼脂。
5.根据权利要求1～3任一项所述的一种具有阴道紧缩功效的抑菌片，其特征在于，所述填充剂选用淀粉及其衍生物、乳糖、糖粉、微晶纤维素、甘露醇或木糖醇中的一种或多种。
6.根据权利要求1～3任一项所述的一种具有阴道紧缩功效的抑菌片，其特征在于，所述崩解剂选用交联聚乙烯吡咯烷酮、交联羧甲基纤维素钠、羧甲基淀粉钠或羟丙基纤维素的一种或者多种。
7.根据权利要求1～3任一项所述的一种具有阴道紧缩功效的抑菌片，其特征在于，所述润滑剂选用硬脂酸镁、微粉硅胶或滑石粉中的一种或者多种。
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| CN113116749A (zh) * | 2021-04-24 | 2021-07-16 | 杭州移联网络科技有限公司 | 一种用于修复女性阴道松弛的组合物配方及其配制方法 |
| CN113230383A (zh) * | 2021-05-10 | 2021-08-10 | 广州天恩药业科技有限公司 | 一种用于女性产后阴道损伤、松弛修复的配方 |
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