CN114028484A - 一种用于男性性功能障碍的壮阳补肾凝胶及其制备方法 - Google Patents
一种用于男性性功能障碍的壮阳补肾凝胶及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种用于男性性功能障碍的壮阳补肾凝胶，以100mL所述凝胶计，药用成分由以下组分组成：淫羊藿提取液0.25‑10ml、雄蚕蛾提取物0.05‑2g、蛹虫草菌丝体提取液0.25‑10ml、车前子0.5‑5g、富氢水0.5‑50ml、魔芋胶5‑20g、蜂房0.5‑5g、熟地黄0.5‑2g、山茱萸3‑5g、泽泻2‑3g、川牛膝3‑5g、菊花3‑5g、钩藤2‑5g、水蛭0.05‑1g、白芍2‑4g。本发明专门适用于高血压、糖尿病等并发症患者的男性性功能障碍改善。
Description
技术领域
本发明涉及医疗卫生技术领域，具体涉及一种用于男性性功能障碍的壮阳补肾凝胶及其制备方法。
背景技术
男性性功能障碍是男性的常见疾病，研究表明，男性性功能障碍与职业、年龄、社会因素、生活等外因，以及心理、心血管疾病、内分泌等内在因素关联。糖尿病性男性勃起功能障碍是临床上常见的糖尿病并发症，其发生率为30-60％。随着糖尿病患者病程的延长和年龄的增长，其男性性功能障碍的发生风险也会不断升高。有调查研究结果表明，我国30-60岁的男性是糖尿病性男性勃起功能障碍的高发群体。
另外，人类进入高龄期后血压升高，往往服用各种降压药，这也是造成阳痿的原因之一。不少中壮年男性患者因畏惧长期服用降压药所导致性功能障碍而抗拒降压治疗。CN110585328A为发明人早前申请的一种用于男性功能障碍的壮阳补肾凝胶，该产品仅针对单一的男性性功能障碍疾病进行调理，并未考虑患者兼有的其他并发症。因此，改善男性高血压、糖尿病患者勃起功能障碍，有助于提高男性患者对上述病症治疗药物长期治疗的依赖性，从而提高疗效，这就是研发既能缓解慢性病病症，又能维持或改善男性性功能的新药具有了重要意义。
发明内容
本发明的目的是提供一种新型的疗效显著的适用于高血压、糖尿病等并发症患者的男性性功能障碍改善凝胶，克服目前现有壮阳产品存在的不足。
为实现上述目的，本发明提供如下技术方案：
一种用于男性性功能障碍的壮阳补肾凝胶，以100mL所述凝胶计，药用成分由以下组分组成：淫羊藿提取液0.25-10ml、雄蚕蛾提取物0.05-2g、蛹虫草菌丝体提取液0.25-10ml、车前子0.5-5g、富氢水0.5-50ml、魔芋胶5-20g、蜂房0.5-5g、熟地黄0.5-2g、山茱萸3-5g、泽泻2-3g、川牛膝3-5g、菊花3-5g、钩藤2-5g、水蛭0.05-1g、白芍2-4g。
优选地，所述淫羊藿提取液采用如下方法制备：以1g粉碎后的淫羊藿计，加入体积分数为60％的乙醇30ml，水浴回流提取176min，提取温度为78℃，提取液冷却至室温后过滤定容至30mL。
淫羊霍为小果科多年生草本植物，淫羊霍、心叶淫羊霍或前叶淫羊辈的茎叶，又名仙灵脾，始载于《神农本草经》。现代药理研究证明，淫羊霍含有特殊的化学成分和显著的生物活性物质，具有良好的补肝肾、强筋骨、桂风湿、抗衰老、提高免疫力、抑制肿瘤等药理作用。主治阳萎早泄，腰酸腿痛，四肢麻木，半身不遂。
采用该特定的提取方式，可以有效去除淫羊藿提取液中的亚硝酸根，降低提取液中致癌物质的含量。经检测，亚硝酸根的去除率可达75％以上。
优选地，所述雄蚕蛾提取物采用如下方法制备：选用初羽化的鲜活柞蚕雄蛾为原料，加入75％的食用酒精，用粉碎机打碎成浆状，在25℃下浸提60h，然后过滤、离心脱脂；然后置于旋转蒸发仪中在60℃、真空条件下加热浓缩，然后置于-18℃下低温浓缩至原体积的1/8后，再离心去除脂肪。
雄蚕蛾具有补肾壮阳的功效，还能增强自身免疫力和抗疲劳的作用，其含有大量活性物质和雄性激素，可用于治疗肾虚引起的阳痿早泄和肾功能下降，同时对于性冷淡和遗精少精也能起到缓解效果。
优选地，所述蛹虫草菌丝体提取液采用如下方法制备：以1g蛹虫草菌丝干粉计，将其加入到500ml乙醇提取液中，其中乙醇提取液按照水：乙醇为1:3(V/V)的比例配制而成，调整提取液的pH值至8，采用微波提取的方式进行提取，功率为800W，提取时间为30min，然后浓缩至50ml，过滤，静置24h。
蛹虫草，又名北冬虫夏草、北虫草、蝠蛹，为子囊菌纲肉座菌目麦角菌科虫草属模式种，是蛹虫草真菌寄生在鳞翅目夜峨科昆虫蛹体上形成的子座与蛹体的结合体。其子实体和菌丝体中含有虫草多糖和虫草素等多种生物活性物质，与冬虫夏草具有相似的药理功能。
车前子：性味甘，微寒，是以为常用的中药，其主治功能是清热利尿；渗湿止泻；明目；祛痰。主小便不利；淋浊带下；水肿胀满；暑湿泻痢；目赤障翳；痰热咳喘。
熟地黄：滋阴，补血。治阴虚血少，腰膝痿弱，劳嗽骨蒸，遗精，崩漏，月经不调，消渴，溲数，耳聋，目昏。
富氢水：氢气在水中的饱和浓度大约是1.62PPM，浓度大于1.6PPM的富氢水就是过饱和氢水。氢气浓度在1.2PPM以上称为富氢水。饱和浓度的富氢水必须采用特殊的工艺强制性将氢气溶入水中。本发明使用的富氢水为高压富氢水机制造的富氢水，氢水浓度为1.5-1.6ppm，较高的氢分子浓度在制剂和人体都会产生较好的生物学效应。
魔芋胶：魔芋胶是白色或奶油至淡棕黄色粉末。淡黄至褐色粉末。基本无臭、无味。魔芋胶其水溶液有很强的拖尾现象，稠度很高，对纤维物质有一定分解能力。其可制成降血脂、降血糖、减肥、通便等药物。
川牛膝：味甘、微苦，性平。归肝、肾经。用于经闭症瘕，胞衣不下，跌扑损伤，风湿痹痛，足痿筋挛，尿血血淋等证。
蜂房：性味甘平、微咸苦，无毒，有祛风定痉、解毒疗疮、散痛止痒、兴阳除痹的功效，具有抑菌抗炎、利尿降压等作用。
山茱萸：心下邪气寒热，温中，逐寒湿痹，去三虫。久服轻身(《寒热疝瘕，头风风气去来，鼻塞目黄，耳聋面，下气出汗，强阴益精，安五脏，通九窍，止小便利。久服，明目强力长年(《别录》)。治脑骨痛，疗耳，添精髓，止老人尿不节，治面上疮，能发汗，止月水不定(甄权)。暖腰膝，助水脏，除一切风，逐一切气，破症结，治酒渣(大明)。温肝(元素)。
菊花：具有疏散风热，平抑肝阳，清肝明目，清热解毒的功效。主治风热感冒，温病初起，肝阳眩晕，肝风实证，目赤昏花，疮痈肿毒。在本发明的配方中主要起到降血压的功效。
泽泻：味甘、淡，性寒，归肾、膀胱经；用于小便不利，水肿胀满，泄泻尿少，痰饮眩晕，热淋涩痛，高脂血症。
钩藤：性凉，味甘。归肝经、心包经。清热平肝、息风定惊。属平肝息风药下属分类的息风止痉药。在本发明的配方中主要起到降血压的功效。
水蛭：水蛭药性咸、苦、平，有小毒，归于肝经，属于破血消癥药物，具有破血痛经、逐瘀消癥的功效。此药在临床上可以用来治疗血瘀经闭、癥瘕痞块、跌扑损伤、心腹疼痛等疾病。
白芍:属于补虚药，药性酸、苦、微寒，归肝、脾经。功效主要有养血敛阴、柔肝止痛、平抑肝阳。
作为本发明的另一发明目的，本发明还提供了上述凝胶的制备方法，包括如下步骤：
(1)将车前子、蜂房、熟地黄、山茱萸、泽泻、川牛膝、菊花、钩藤、水蛭、白芍加入到纯化水中，煎煮，过滤得到中草药提取物的混合溶液，60℃浓缩滤液，其量相当于各生药量的三十分之一；
(2)向富氢水中加入淫羊藿提取液、雄蚕蛾提取物、蛹虫草菌丝体提取液和步骤(1)中的浓缩液，搅拌均匀；
(3)再加入魔芋胶，高速搅拌均匀，放置24小时，使其充分膨胀溶解，静置24小时，即得。
优选地，将凝胶可分装于5ml/支无菌肛门专用推注器，然后封装于无菌铝箔或医药级灭菌塑料袋中，5-10℃冷藏备用。
与现有技术相比，本发明具有以下优点：
(1)本发明采用天然中草药提取的精华成分，以中西医结合理论为基础，以补肾阳、生肾精为主，通过壮阳补肾、扶正固本、滋阴生精、行气活血，扩张阴茎血管，增加性器官的血流量，提高男性荷尔蒙水平，从而达到增强性欲，提升性能力，从根本上治疗阳痿早泄等性功能障碍。
(2)本发明针对兼有高血压、糖尿病等慢性病，因长期服药诱发的男性性功能障碍的患者，有别于传统的单一治疗药物，在改善男性性功能障碍的同时兼有改善高血压、糖尿病的有益效果。
(3)在使用方法上，本发明使用专门推注器将凝胶过肛门推入直肠给药，推入深度6-8公分，使药物更大面积的接触粘膜，通过直肠粘膜丰富的毛细血管网快速的渗透吸收，致使生殖系统组织器官快速吸收到较高浓度的药物，从而发挥良好的治疗效果。
(4)本发明多为纯天然的中草药成分，且局部外用给药，长期使用无任何毒副作用。
具体实施方式
下面将结合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。
在以下实施例中，所述淫羊藿提取液采用如下方法制备：以1g粉碎后的淫羊藿计，加入体积分数为60％的乙醇30ml，水浴回流提取176min，提取温度为78℃，提取液冷却至室温后过滤定容至30mL。
雄蚕蛾提取物采用如下方法制备：选用初羽化的鲜活柞蚕雄蛾为原料，加入75％的食用酒精，用粉碎机打碎成浆状，在25℃下浸提60h，然后过滤、离心脱脂；然后置于旋转蒸发仪中在60℃、真空条件下加热浓缩，然后置于-18℃下低温浓缩至原体积的1/8后，再离心去除脂肪。
蛹虫草菌丝体提取液采用如下方法制备：以1g蛹虫草菌丝干粉计，将其加入到500ml乙醇提取液中，其中乙醇提取液按照水：乙醇为1:3(V/V)的比例配制而成，调整提取液的pH值至8，采用微波提取的方式进行提取，功率为800W，提取时间为30min，然后浓缩至50ml，过滤，静置24h。
凝胶的制备方法如下：
(1)将车前子、蜂房、熟地黄、山茱萸、泽泻、川牛膝、菊花、钩藤、水蛭、白芍加入到纯化水中，煎煮，过滤得到中草药提取物的混合溶液，60℃浓缩滤液，其量相当于各生药量的三十分之一；
(2)向富氢水中加入淫羊藿提取液、雄蚕蛾提取物、蛹虫草菌丝体提取液和步骤(1)中的浓缩液，搅拌均匀；
(3)再加入魔芋胶，高速搅拌均匀，放置24小时，使其充分膨胀溶解，静置24小时，即得。
(4)将凝胶可分装于5ml/支无菌肛门专用推注器，然后封装于无菌铝箔或医药级灭菌塑料袋中，5-10℃冷藏备用。
本发明的各实施例配方如下表所示：
表1本发明各实施例各组分配比表
本发明的应用：将本发明产品采用推管从肛门推入6～8cm深，然后俯卧30分钟。每次5mL，每晚使用一次，15天为一个疗程。
本发明临床应用研究示例
一、对患有高血压的男性性功能障碍改善的研究
1、一般资料
选择临床症状基本相似的高血压病性功能障碍患者48例，按治疗组、对照组1和对照组2例数比例2:1:1，用计算机随机分配各组患者。
2、对照方法
以尼群地平10mg Tid(波依定)、倍他乐克25mg Bid、HCT 12.5mg Qd为基础用药，以≤140/90mmHg为目标血压逐步控制血压，可视血压控制情况选用其中药物及用量。治疗组加用实施例3的凝胶外用药物；对照组1加用CN110585328A专利中权利要求5制备的凝胶药物(其中在每100毫升凝胶中，投入的人参、淫羊藿、巴戟天、东革阿里、育亨宾提取物分别为1g，投入的熟地黄、肉苁蓉、沙苑子、韭菜籽、当归、黄芪提取物分别为2.5g，汉生胶3％)；对照组2仅采用基础治疗。
3、疗效判定指标
症状记分：治疗前后根据主要症状头痛、眩晕、心悸、耳鸣、失眠、烦躁、腰酸腿软等程度，按轻、中、重分别记33、66、100分，无症状或症状消失记0分。
症状疗效：显效：治疗后积分较治疗前减少≥60％；有效：治疗后积分较治疗前减少30％～60％；无效：治疗后积分较治疗前减少≤30％；治疗后症状积分减少百分数＝(治疗前一治疗后)/治疗前积分X100％。
4、统计方法
统计数据采用x±S表示，两组数据差别的显著性比较采用T检验，率的比较采用x2检验，统计采用SPSSll.5数据统计软件处理，以P<0.05为差别显著标准，P<0.01为差别极显著标准，P>0.05为差异不显著指标。
5、治疗前后对勃起功能障碍疗效的比较
表2治疗组和对照组治疗前后对勃起功能障碍疗效的比较结果
注：▲表示治疗组与对照组比较P>0.05，◆表示治疗组与对照组比较P<0.05。*表示治疗前后自身比较P<0.01。说明治疗前组间各项比较无明显统计学差别，具有可比性。治疗后治疗组勃起功能指数及每月性交次数明显增高，且P<0.01，有显著统计学意义。对照组1治疗后治疗组勃起功能指数及每月性交次数也有明显增高，且P<0.01，有显著统计学意义。而对照组2治疗前后勃起功能指数及每月性交次数无明显增高。
6、治疗前后降压效果的比较
表3治疗组和对照组治疗前后降压效果的比较结果
▲表示治疗组与对照组比较P>0.05。*表示治疗前后自身比较P<0.01。说明治疗前两组血压水平相当，具有可比性。治疗后治疗组与对照组血压均明显下降并达到≤l40/90mmHg，且P<0.01，具有明显的统计学意义。治疗组的药物辅助降压功效，降压较为平缓，患者舒适度更佳。
7、治疗前后中医症状疗效的比较
表4治疗前后中医症状疗效的比较结果
| 显著 | 有效 | 无效 | 总有效 | |
| 治疗组 | 66.67％◆ | 29.17％ | 4.16％ | 95.84％▲ |
| 对照组1 | 33.33％◆ | 50％ | 16.67％ | 83.33％▲ |
| 对照组2 | 25％ | 41.67％ | 33.33％ | 66.67％ |
◆表示治疗组与对照组比较P<0.05。▲表示治疗组与对照组比较P>0.05。
本发明对高血压男性阳痿中医症状治疗有效率高达95.83％，疗效高于单一治疗男性阳痿药物。
8、治疗前后精液不液化疗效的比较
5天为一个疗程，全部病例均治疗2个疗程。每个疗程结束立即取精液一次进行精液检查。参照《中药新药临床研究指导原则》及WHO对男性不育及精液不液化制定的标准。痊愈：30分钟内液化完全；有效：60分钟内完全液化；无效：60分钟精液状态较前无明显变化。
表5治疗前后中医症状疗效的比较结果
| 显著 | 有效 | 无效 | 总有效 | |
| 治疗组 | 83.33％◆ | 12.5％ | 4.16％ | 95.84％▲ |
| 对照组1 | 75％◆ | 16.67％ | 8.33％ | 91.67％▲ |
| 对照组2 | 16.67％ | 25％ | 58.33％ | 14.67％ |
◆表示治疗组与对照组比较P<0.05。▲表示治疗组与对照组比较P>0.05。
Claims (6)
1.一种用于男性性功能障碍的壮阳补肾凝胶，其特征在于，以100mL所述凝胶计，药用成分由以下组分组成：淫羊藿提取液0.25-10ml、雄蚕蛾提取物0.05-2g、蛹虫草菌丝体提取液0.25-10ml、车前子0.5-5g、富氢水0.5-50ml、魔芋胶5-20g、蜂房0.5-5g、熟地黄0.5-2g、山茱萸3-5g、泽泻2-3g、川牛膝3-5g、菊花3-5g、钩藤2-5g、水蛭0.05-1g、白芍2-4g。
2.根据权利要求1所述的一种用于男性性功能障碍的壮阳补肾凝胶，其特征在于，所述淫羊藿提取液采用如下方法制备：以1g粉碎后的淫羊藿计，加入体积分数为60％的乙醇30ml，水浴回流提取176min，提取温度为78℃，提取液冷却至室温后过滤定容至30mL。
3.根据权利要求1所述的一种用于男性性功能障碍的壮阳补肾凝胶，其特征在于，所述雄蚕蛾提取物采用如下方法制备：选用初羽化的鲜活柞蚕雄蛾为原料，加入75％的食用酒精，用粉碎机打碎成浆状，在25℃下浸提60h，然后过滤、离心脱脂；然后置于旋转蒸发仪中在60℃、真空条件下加热浓缩，然后置于-18℃下低温浓缩至原体积的1/8后，再离心去除脂肪。
4.根据权利要求1所述的一种用于男性性功能障碍的壮阳补肾凝胶，其特征在于，所述蛹虫草菌丝体提取液采用如下方法制备：以1g蛹虫草菌丝干粉计，将其加入到500ml乙醇提取液中，其中乙醇提取液按照水：乙醇为1:3(V/V)的比例配制而成，调整提取液的pH值至8，采用微波提取的方式进行提取，功率为800W，提取时间为30min，然后浓缩至50ml，过滤，静置24h。
5.权利要求1-4所述的一种用于男性性功能障碍的壮阳补肾凝胶的制备方法，其特征在于，包括如下步骤：
(1)将车前子、蜂房、熟地黄、山茱萸、泽泻、川牛膝、菊花、钩藤、水蛭、白芍加入到纯化水中，煎煮，过滤得到中草药提取物的混合溶液，60℃浓缩滤液，其量相当于各生药量的三十分之一。
(2)向富氢水中加入淫羊藿提取液、雄蚕蛾提取物、蛹虫草菌丝体提取液和步骤(1)中的浓缩液，搅拌均匀。
(3)再加入魔芋胶，高速搅拌均匀，放置24小时，使其充分膨胀溶解，静置24小时，即得。
6.根据权利要求5所述的一种用于男性性功能障碍的制备方法，其特征在于，将凝胶可分装于5ml/支无菌肛门专用推注器，然后封装于无菌铝箔或医药级灭菌塑料袋中，5-10℃冷藏备用。
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