CN113368168B - 一种治疗男性勃起功能障碍的外用液体制剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗男性勃起功能障碍的外用液体制剂及其制备方法,适于复方中药技术领域。所述治疗男性勃起功能障碍的外用液体制剂的原料按重量份计包括:蛇床子15‑30份,公丁香12‑15份,红景天15‑30份,威灵仙15‑30份,毛冬青45‑60份,花椒12‑15份,红花9‑12份,三七粉3‑5份。本发明制备的治疗男性勃起功能障碍的外用液体制剂不仅能够达到持续的疗效,同时还能避免引发不良反应,辅以本发明提供的使用方法,更有助于提高疗效。
Description
技术领域
本发明涉及复方中药技术领域,特别涉及一种治疗男性勃起功能障碍的外用液体制剂及其制备方法。
背景技术
勃起功能障碍(erectile dysfunction,ED)是困扰男性的最常见的病症之一,一般是指由于阴茎不能正常勃起,或勃起不坚、坚而不久,以致不能完成正常性交的一种病症。1993年美国NIH对其表述为阴茎持续(至少6个月)不能达到和维持充分的勃起以获得满意的性生活。尽管ED是一种良性病变,但其影响患者的躯体和心理健康,并与患者的生活质量、性伴侣关系、家庭稳定密切相关。最近的一项流行病学调查发现,大约5%~20%的男性患有中到重度程度的ED,各个流行病学调查的差异与采用不同方法和研究人群的不同年龄及社会经济地位有关。根据美国马萨诸塞州男性增龄研究(Massachusetts male agingstudy,MMAS)的流行病学调查资料显示,ED的发病率随年龄的增长而增加。一般在男性30岁以后,逐渐开始出现,据统计,有30~70岁的男性中有52.8%存在着不同程度的ED,另有学者对中老年男性的流行病学调查结果显示,30岁开始,ED逐渐发生,40岁以上人群ED的发生率为73.1%,到70岁以上这一数据上升至86.3%。
目前较公认的研究认为ED的病因是多方面的,包括内分泌、神经、血管、全身性疾病、局部阴茎疾病、营养、心理因素以及与药品有关。现代基础研究认为ED主要有四方面病因:血管内皮功能障碍、NO-cGMP等信号通路的调控转导途径、激素在局部组织表达调控失常、心理压力等其他因素。其中血管内皮功能障碍是引发ED的一个病理生理机制已成为众多学者的共识,激素水平如睾酮缺乏可加速其发展,其他如胰岛素抵抗可通过影响信号转导途径而引发ED。尤其是在信号转导通路的层面已取得重大研究成果。现已证实NO-cGMP信号通路是ED发病的关键通路,该研究成果也已应用于临床,作为对环磷酸乌苷(cGMP)特异的5型磷酸二酯酶选择性抑制剂如西地那非、他达那非用于治疗ED均取得了显著临床效果。
治疗方面,虽然有阴茎内药物注射、真空负压吸引和假体植入等措施,但目前最常用的ED治疗是口服药物5型磷酸二酯酶(Phosphodiesterase V,PDE5)抑制剂,2010年欧洲泌尿外科学会(EuropeanAssociation ofUrology,EAU)指南正式将PDE5抑制剂列为治疗包括糖尿病ED、血管性ED、LOHED在内的所有ED的一线药物,他们包括西地那非(万艾可)、伐地那非(艾力达)和他达拉非(希爱力),值得注意的是,这些药物并不是自动引发勃起,而是需要性刺激后才能促进勃起,根据成功阴道插入情况严格评估疗效。不同PED5抑制剂的选择和偏爱取决于患者性交的频率(临时的或者规律的治疗,一周3~4次)和患者对于药物的体会。PED5抑制剂常见的副作用包括头痛、面色潮红、头晕、消化不良和鼻塞。据报道,西地那非(万艾可)和伐地那非(艾力达)约有不到2%的患者可能会出现暂时性视觉异常改变,而在他达拉非(希爱力)中,6%的患者会出现背痛和肌肉酸痛。这其中以心血管的副作用较为常见。虽然PED5抑制剂的出现开创了ED治疗的里程碑,其疗效得到公认,临床数据表明,单独使用该药物仅能对70-80%患者有效。这一比例在中老年ED患者,尤其在其中患有迟发型性腺功能减退综合症(LOHED)患者中还要低。如何找到一种副作用小又能有效改善这些LOHED,是目前男科学界研究的热点,传统中医药物的干预越来越受到重视,临床上,针对ED发生病因的复杂性,采用中药联合替代PDE5抑制剂治疗ED的模式,得到越来越多泌尿男科医生的认可。但现有的中医药治疗勃起功能障碍的多为药物口服治疗,常选用补肾壮阳的药物,虽然具有有效率高,见效快等优点,但是停药后难以维持疗效,且可能引发全身多个系统的不良反应。因此,如何克服目前的中药组合物停药后难以维持疗效,且可能引发全身多个系统不良反应的问题,是本领域亟待解决的技术难题。
发明内容
本发明的目的在于提供一种治疗男性勃起功能障碍的外用液体制剂及其制备方法,所提供的外用液体制剂不仅能够达到持续的疗效,同时还能避免引发不良反应,辅以本发明提供的使用方法,更有助于提高疗效。
为实现上述目的,本发明提供了如下技术方案:
本发明的技术方案之一:提供一种治疗男性勃起功能障碍的外用液体制剂,原料按重量份计包括:蛇床子15-30份,公丁香12-15份,红景天15-30份,威灵仙15-30份,毛冬青45-60份,花椒12-15份,红花9-12份,三七粉3-5份。
优选的,所述三七粉的粒径≤150μm。
本发明技术方案之二,提供一种上述治疗男性勃起功能障碍的外用液体制剂的制备方法,包括以下步骤:
按重量份称取各中药,将除三七外的其他中药用水煎煮,滤过,浓缩滤液,冷却,加入三七粉,搅拌均匀,即得。
优选的,所述水煎煮为加水煎煮2~3次;所述浓缩为将滤液浓缩至生药浓度为1~1.5g/mL。
本发明技术方案之三:提供一种治疗男性勃起功能障碍的外用淋洗液,所述外用淋洗液的制备步骤为:将上述治疗男性勃起功能障碍的外用液体制剂稀释至生药浓度为0.25~0.5g/mL,即得。
上述外用淋洗液使用时,将阴茎全体浸泡于外用淋洗液中5min,然后将饱含外用淋洗液的柔性织物敷塌于阴茎头、系带、冠状沟部、体部、根部,并用药液按照从近心端向远心端的方向进行淋洗,淋洗过程中进行挤捏,具体操作为:挤捏阴茎上下左右四个面,每个面挤捏15~25次;所述揉搓的具体造作为:采用姆食指相扣呈环状压紧整个阴茎依次从根部、体部、冠状沟部、系带、阴茎头路径上捋,整个过程15~20min。
本发明技术方案之四:提供一种真空勃起装置的辅助治疗药液,所述辅助治疗药液为权利要求1或2所述治疗男性勃起功能障碍的外用液体制剂稀释至生药浓度为0.25~0.5g/mL。
上述真空勃起装置的辅助治疗药液使用时,置于真空勃起装置的负压吸引管中。
本发明的有益技术效果如下:
本发明是从“心”,从“脉”治则下创立的协定方,由红景天,威灵仙,毛冬青,蛇床子,公丁香,花椒,红花、三七制成。其中红景天补气养心,散瘀理血,毛冬青活血通脉,素有“水火药”之称,二者相须为君药,以承“心脉治萎”之海派特色;威灵仙祛风湿,通经络;蛇床子温肾助阳,二者为臣药;公丁香具有强烈的芳香,有兴奋强身作用,红花、三七活血通经,散瘀止痛共为佐药;花椒祛风温中,引药透皮力专为使药。全方诸药合用,共奏活血通经,荣筋起痿之功。
公丁香,味辛,温。归脾、胃、肺、肾经,起到补肾助阳之功,临床主要用于治疗肾虚阳痿、脾胃虚寒等症。《日华子本草》中记载:治口气,反胃,疗肾气,奔豚气,阴痛,壮阳,暖腰膝。根据相关医学典籍可以明确,公丁香味辛,性温,禀纯阳之气以生,对机体的肾脏有极好的保养功效,可以壮阳事,暖阴户,其可以还可以辅助五倍子,入足少阴肾经。丁香酚是丁香的主要活动成分,其可以促进透皮吸收,而且丁香也具有良好的抑菌作用,对白色念珠菌、新型隐球菌均有良好的抑制作用,丁香外用还可以起到麻醉效果,这在早泄中对于阴茎表皮敏感性异常的原因可以很有效的控制。
蛇床子性辛、苦、温,主入肾经,有燥湿、祛风、温肾壮阳之功,既可以治疗早泄,又可以治疗阴囊潮湿等。蛇床子最早记载于《神农本草经》,其中提到“主妇人阴中肿痛,男子阴萎湿痒,除痹气,利关节”,而且蛇床子含有的蛇床子素是蛇床子的主要活动成分,其属于香豆素类物质,把其应用于机体,可以起到麻醉效果,研究还表明,该物质可以让内皮细胞的生理活动得到调节,从而使其可以释放大量的一氧化氮,导致机体中的磷酸二酯酶(PDE5)受到抑制,让海绵体组织中的cGMP大量增加,帮助机体勃起阴茎。
花椒,性辛、温,主入脾、胃、肾经,有温中行气、逐寒、止痛、杀虫等功效。治胃腹冷痛、呕吐、泄泻、血吸虫、蛔虫等症。又作表皮麻醉剂,外用时花椒总生物碱、多酚类物质具有显著的局部镇痛、抗炎、止痒作用,可以增强表皮组织耐受敏感刺激。
红花,性辛、温,主入心、肝经,有活血通经、祛瘀止痛等功效。治疗瘀滞腹痛、跌打损伤、癥瘕积聚等症。红花中的化学成分主要包括黄酮类、生物碱类和聚炔类等。药理活性主要集中于血管保护、改善血流动力学、抗血栓和抗炎镇痛等,可提高疼痛阈值,减轻敏感刺激。
三七,性甘、温、微苦,主入肝、胃经,有化瘀止血、消肿定痛之功。治疗瘀血肿痛、跌打损伤、痹痛、出血等症。三七总皂苷通过调节NO/cGMP信号通路和控制AGEs的积聚使阴茎海绵体内皮细胞功能恢复,能够抑制平滑肌细胞和血管内皮细胞的过度凋亡,保护平滑肌细胞及其功能,保护阴茎组织,有助于改善勃起功能。
红景天,性甘、苦、平,主入脾、肺、心经,有益气健脾、活血通脉、止咳平喘等功效。治疗气虚血瘀、倦怠气喘等症。其有效成分红景天苷具有抗疲劳、抗抑郁、增强免疫力等药理活性,能显著抑制缺氧引起的CCSMC合成型标志物骨桥蛋白(OPN)、TGF-β1、I型胶原、III型胶原表达升高,同时能有效抑制缺氧性损伤引起的CCSMC凋亡,有抗阴茎海绵体平滑肌纤维化的作用。
威灵仙,性辛、咸、温,主入膀胱经,有祛风除湿、通络止痛、消痰逐饮等功效。治疗风湿痹痛、痰饮积聚等症。威灵仙具有诸多药理活性,包括抗炎、镇痛、抗肿瘤、抗菌、免疫抑制作用等,与其含有多种化学成分如皂苷类、黄酮类、木脂素类、酚类等密切相关。威灵仙中总皂苷可能是通过清除超氧自由基发挥抗氧化作用,并抑制脂质过氧化物的生成,显著提高超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px)活力,降低氧化物含量以及调节机体免疫,起到了干预纤维化的作用。
毛冬青,性甘、凉,主入肝经,有活血止痛之功。治疗瘀血肿痛、跌打损伤等症。其中有效化学成分有毛冬青皂苷甲、毛冬青皂苷B、冬青素及毛冬青皂苷D等,具有抗血栓、改善微循环、调节免疫等功效,同时其有效成分黄酮苷有舒张血管及解除血管痉挛的作用,有助于阴茎血流灌注。
将以上中药通过合理的配比,使得各组分协同作用,达到治疗男性勃起功能障碍的效果。
此外,本发明所提供治疗男性勃起功能障碍的外用液体制剂的使用方法(挤捏、负压吸引)亦有助于起效,中药外用的现代研究机制是通过药物的湿敷的传导与物理作用(压力、真空负压吸引)可以使药物能够方便的进入到机体的皮肤中,让经络得到通畅,给予患者中药外用,可以让机体的淋巴管、血管的通透性得到改善,可以将中药更好的渗透到组织内,更好的发挥其活血通脉药性,加速局部血液循环,增加阴茎内皮细胞活性,改善阴茎局部动脉血流,起到一加一大于二的作用。
具体实施方式
现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。
另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
实施例1
治疗男性勃起功能障碍的外用液体制剂的制备方法:
称取蛇床子30g,公丁香15g,红景天15g,威灵仙20g,毛冬青50g,花椒12g,红花10g依次用10倍重量与5倍重量水煎煮,第一次煎煮1.5小时,第二次煎煮1小时,水煎液滤过,合并滤液,将滤液浓缩至150ml,常温冷却后,备用;另取粉碎后过100目筛的三七粉3g,加入浓缩液中,搅拌均匀,制得治疗男性勃起功能障碍的外用液体制剂。
实施例2
治疗男性勃起功能障碍的外用液体制剂的制备方法:
称取蛇床子15g,公丁香13g,红景天25g,威灵仙15g,毛冬青45g,花椒12g,红花12g,依次用10倍重量与5倍重量水煎煮,第一次煎煮1.5小时,第二次煎煮1小时,水煎液滤过,合并滤液,将滤液浓缩至100ml,常温冷却后,备用;另取粉碎后过100目筛的三七粉5g,加入浓缩液中,搅拌均匀,制得治疗男性勃起功能障碍的外用液体制剂。
实施例3
治疗男性勃起功能障碍的外用液体制剂的制备方法:
称取蛇床子15g,公丁香15g,红景天15g,威灵仙30g,毛冬青50g,花椒12g,红花10g,依次用10倍重量与5倍重量水煎煮,第一次煎煮1.5小时,第二次煎煮1小时,水煎液滤过,合并滤液,将滤液浓缩至150ml,常温冷却后,备用;另取粉碎后过100目筛的三七粉3g,加入浓缩液中,搅拌均匀,制得治疗男性勃起功能障碍的外用液体制剂,另以1:1配比蒸馏水,用作男性负压吸引性功能治疗仪的负压吸引液制剂。
临床治疗实验1
1.勃起功能障碍(ED)病例的选择标准:
1.1诊断标准为:勃起功能障碍(ED)诊断符合欧洲泌尿外科学会勃起功能障碍诊疗指南,即国际勃起功能指数问卷IIEF-5评分<22分,阴茎持续(至少6个月)不能达到和维持充分的勃起以获得满意的性生活。
1.2纳入标准为:①同时符合上述勃起功能障碍诊断标准;②年龄25~45岁,且有固定性伴侣;③病程6个月以上。
1.3排除标准为:①近7天内使用过其他治疗手段可能干扰疗效判定者;②伴有明显生殖器畸形、生殖系统感染者;③合并精神类疾患者;④合并心血管、肝、肾、造血系统严重原发性疾病者;⑤过敏体质或对本发明用药过敏者;⑥有活动性传染病史者;⑦未按规定治疗,无法判断疗效,或资料不全影响疗效或安全性判断者。
选取符合以上标准的患者60例,均为2017年9月至2020年9月上海中医药大学附属龙华医院泌尿男科门诊诊治的患者,年龄25~45岁,平均(31.53±6.04)岁;病程6~24月,平均(7.63±2.26)月,患者知情同意本研究。
2.治疗方法:
将实施例1制备的治疗男性勃起功能障碍的外用液体制剂150mL,用蒸馏水稀释至300~500mL,将阴茎头、系带、冠状沟及阴茎全体至根部浸泡在中药液中5min;然后将饱含中药液的纱布湿敷塌渍于阴茎头、系带、冠状沟部、体部、根部,并不断用中药液淋洗按照从近心端向远心端的方向挤捏揉搓,即根部→体部→冠状沟部、系带→阴茎头,挤捏时依次以阴茎上下左右四个面为重点挤捏,每个面约挤捏18次,以阴茎局部略感胀痛为度,然后采用姆食指相扣呈环状压紧整个阴茎从根部→体部→冠状沟部、系带→阴茎头路径上捋,力量逐渐加大,以阴茎局部略感胀痛为度,浸泡后的治疗过程持续15-20min,力度从轻到重,中途如有射精的冲动,即停止揉搓,如冲动仍无法减弱,可以采取纱布或纯棉麻织物紧握敏感部位,或操作手食拇指环握冠状沟及敏感部位同时配合思想意识转移,甚或可以通过舌尖抵住上牙膛的方式降低射精冲动,待冲动减弱后继续进行上述中药液挤捏揉搓上捋,直至达到时间。每天早晚各一次,连续8周,为2个月,一个疗程。
3.观察项目与方法:
3.1阴茎勃起硬度等级:治疗前后采用国际阴茎勃起硬度等级评定标准(EHGS),评价阴茎勃起硬度情况。I级:阴茎体积增大,硬度差;II级:较硬,但不能插入阴道;III级:能够插入阴道,但不完全坚硬;Ⅳ级:完全坚硬勃起并坚挺。
3.2安全性:治疗前后均检测血常规、尿常规、肝功能、肾功能、心电图、血压,试验期间观察记录与药物有关的不良反应情况。
3.4结果:
3.4.1患者治疗两个月后的情况见表1:
表1阴茎勃起硬度等级变化情况比较(例)
注:治疗前后比较,P<0.05。
3.4.2IIEF-5积分变化情况见表2:
注:与治疗前比较,*P<0.05。
3.4.3安全性比较:有1例出现轻度的一过性局部潮红,未作处理,未影响试验和观察;所有病例均未见明显的异常变化。60例患者治疗前后血常规、尿常规、肝功能、肾功能、心电图、血压均未见明显异常。
3.4.4治疗结束后嘱其保持治疗时规律性生活,4周后随访IIEF-5积分变化见表3:
注:与治疗前比较,*P<0.05。
上述临床治疗结果表明,本发明制备的治疗男性勃起功能障碍的外用液体制剂,在改善勃起功能障碍临床症状方面,具有良好的疗效,且使用安全,疗效具有维持性,具备临床推广价值。
临床治疗实验2
1.勃起功能障碍(ED)病例的选择标准:
1.1诊断标准为:勃起功能障碍(ED)诊断符合欧洲泌尿外科学会勃起功能障碍诊疗指南,即国际勃起功能指数问卷IIEF-5评分<22分,阴茎持续(至少3个月)不能达到和维持充分的勃起以获得满意的性生活。
1.2纳入标准为:①同时符合上述勃起功能障碍诊断标准;②年龄22~60岁,且有固定性伴侣;③病程6个月以上。
1.3排除标准为:①近7天内使用过其他治疗手段可能干扰疗效判定者;②伴有明显生殖器畸形、生殖系统感染者;③合并精神类疾患者;④合并心血管、肝、肾、造血系统严重原发性疾病者;⑤过敏体质或对本发明用药过敏者;⑥有活动性传染病史者;⑦未按规定治疗,无法判断疗效,或资料不全影响疗效或安全性判断者。
选取符合以上标准的患者72例,均为2017年1月至2020年10月上海龙华医院泌尿男科门诊诊治的患者,年龄22~60岁,随机分为治疗组、对照组,治疗组平均年龄(34.23±6.45)岁;平均病程(6.98±1.86)月。对照组平均年龄(33.87±6.51)岁;平均病程(6.85±2.04)月。两组基线资料比较,差异无统计学意义(P>0.05)。
2.治疗方法:
治疗组36例:将实施例3制备的治疗男性勃起功能障碍的外用液体制剂150mL,用蒸馏水稀释至300~500mL,加热至34.5℃,置于负压吸引管(男性功能康复负压吸引治疗仪,江苏三维医疗SW-3501)中,患者平卧位,进行中药负压吸引治疗,负压大小0.02MPa,治疗时间20min。一周2-3次,一个疗程15次。
对照组36例:取加热至34.5℃的医用蒸馏水300~500mL作为负压吸引液,置于负压吸引管(男性功能康复负压吸引治疗仪,江苏三维医疗SW-3501)中,患者平卧位,进行负压吸引治疗,负压大小0.02MPa,治疗时间20min。一周2-3次,一个疗程15次。
3.观察项目与方法:
3.1勃起功能评分:治疗前后采用国际勃起功能指数问卷(IIEF-5),IIEF-5评分结果作为ED分组及疗效评估指标。IIEF-5评分标准分级:22分~25分为阴茎勃起正常,12分~21分为轻度勃起障碍,8分~11分为中度勃起障碍,5分~7分为重度勃起障碍,治疗后IIEF评分作为评价依据。治疗后显效:勃起障碍等级改善2个等级及以上;有效:勃起障碍等级改善1个等级;无效:患者勃起功能障碍未得到明显改善或无效果。总有效率(%)=(显效+有效人数)/总人数×100%。
3.2安全性:治疗前后均检测血常规、尿常规、肝功能、肾功能、心电图、血压,试验期间观察记录与药物有关的不良反应情况。
3.3统计学方法:采用SPSS 21.0软件对相关数据进行统计分析,11EF-5评分结果用Mean±SD表示,均数间比较采用t检验,组间有效率比较采用x2检验,以P<0.05表示具有统计学意义。
3.4结果:
3.4.1治疗一个疗程后随访,治疗组与对照组疗效结果分析见表3:
表3两组阴茎勃起IIEF-5比较(例)
注:治疗组疗效与对照组疗效进行比较,*P<0.05。
3.4.2安全性比较:所有病例均未见明显的异常变化,72例患者治疗前后血常规、尿常规、肝功能、肾功能、心电图、血压均未见明显异常。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (6)
1.一种治疗男性勃起功能障碍的外用液体制剂,其特征在于,原料按重量份计为:蛇床子15-30份,公丁香12-15份,红景天15-30份,威灵仙15-30份,毛冬青45-60份,花椒12-15份,红花9-12份,三七粉3-5份。
2.根据权利要求1所述的治疗男性勃起功能障碍的外用液体制剂,其特征在于,所述三七粉的粒径≤150μm。
3.一种权利要求1或2所述的治疗男性勃起功能障碍的外用液体制剂的制备方法,其特征在于,包括以下步骤:
按重量份称取各中药,将除三七外的其他中药用水煎煮,滤过,浓缩滤液,冷却,加入三七粉,搅拌均匀,即得。
4.根据权利要求3所述的制备方法,其特征在于,所述水煎煮为加水煎煮2~3次;所述浓缩为将滤液浓缩至生药浓度为1~1.5g/mL。
5.一种治疗男性勃起功能障碍的外用淋洗液,其特征在于,所述外用淋洗液的制备步骤为:将权利要求1或2所述治疗男性勃起功能障碍的外用液体制剂稀释至生药浓度为0.25~0.5g/mL,即得。
6.一种真空勃起装置的辅助治疗药液,其特征在于,所述辅助治疗药液为权利要求1或2所述治疗男性勃起功能障碍的外用液体制剂稀释至生药浓度为0.25~0.5g/mL。
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