CN1652807A - 用于治疗男性和女性性无能的制剂 - Google Patents
用于治疗男性和女性性无能的制剂 Download PDFInfo
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- CN1652807A CN1652807A CNA038105292A CN03810529A CN1652807A CN 1652807 A CN1652807 A CN 1652807A CN A038105292 A CNA038105292 A CN A038105292A CN 03810529 A CN03810529 A CN 03810529A CN 1652807 A CN1652807 A CN 1652807A
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- Prior art keywords
- extract
- herba epimedii
- arginine
- treatment
- weight ratio
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Abstract
包含重量比分别为1.5-3.5∶1-2∶0.1-0.4的刺蒺藜、朝鲜淫羊藿、肉桂的提取物和任选的精氨酸或其生理上等效的酯、盐或前体的药物组合物。本发明的组合物可用于治疗男性和女性性功能障碍。
Description
发明描述
本发明涉及可用于治疗男性和女性性功能障碍的制剂。
性功能障碍相当重要,并且成为密集的生物医学研究努力的主题。根据最新统计,各种形式的性无能问题(性欲缺乏和勃起功能障碍)影响着约70%的年龄在50岁左右及以上的人口。各种形式的性无能的程度在严重性上有显著差异,特别是在老年人中,其通常在生理上伴有其它异常例如心脏或肾脏疾病。
目前可用于治疗所述功能障碍,特别是勃起功能障碍的药物包括激素例如睾酮、血管活性肠肽(VIP)、前列腺素衍生物(PG)和心血管药物例如罂粟碱、苯氧苄胺和酚妥拉明。
然而,由于它们引起的副作用和例如使用罂粟碱和前列腺素E2(PGE2)时需要海绵体内或尿道内注射,因而这些药物中没有一个提供对所述问题的令人满意的、持久的解决办法。
最近开发出了cGMP磷酸二酯酶抑制剂,它们尤其可用于治疗性无能,并且口服有效。这些药物之一,被称为西地那非(WO94/28902)的,已经上市。
但是,其副作用同样不可忽略,因此仍强烈需要更安全和更有效的治疗方法。
目前正在通过现代药理学对众多的天然来源的产品(主要基于植物,但也包括动物)进行研究,在得自传统药物的适应症的基础上对其经验性使用的可能的科学基础进行评价。
生物化学研究已经证实了和性行为有关的生理过程所涉及的复杂的机制,例如阴茎和阴蒂勃起、阴道润滑、射精和性高潮。
介质例如一氧化氮(NO)、cAMP和cGMP信使的代谢所涉及的酶因子、平滑肌细胞膜的肾上腺素能受体、多巴胺能神经递质和PG或其它激素的受体是性无能和其它性功能障碍的药理学治疗的可能的靶点。
显然,对这种特殊的问题提供一个令人满意的解决办法是困难的,部分原因在于除了纯粹的生物化学和生理学方面的问题外,还存在可使患有性功能障碍的患者的临床情况更加复杂的环境和心理因素。
目前已经发现,具有特殊性质的药用植物的提取物以一定的用量比组合,在男性和女性性功能障碍的治疗中可以提供特别令人满意的治疗结果。
具体地讲,本发明涉及药物组合物,其包含:
●重量比分别为1.5-3.5∶1-2∶0.1-0.4的刺蒺藜(Tribulus Terrestris)、朝鲜淫羊藿(epimedium koreanum)、肉桂(cinnamon cassia)的提取物;和任选的
●精氨酸或其生理上等效的酯、盐或前体和适宜的载体或赋形剂。
刺蒺藜、朝鲜淫羊藿、肉桂的提取物是已知的并且已经为同样的目的而被用于某些类型的传统药物中,但是它们的联合使用是未知的,特别是在按如上规定的具体用量比联合使用时。
具体地讲,已知刺蒺藜提取物可诱导睾酮(负责刺激男女性欲的激素)的合成;朝鲜淫羊藿提取物富含异戊二烯化的类黄酮,具有通过NO释放介导的扩血管作用,因而该提取物具有对动脉和小动脉的血管舒张活性;肉桂提取物通过作用于愉悦相关性多巴胺受体间接地刺激性欲。
然而,使用本发明的组合物所获得的治疗效果不能单独根据各提取物的活性来解释;事实上,已令人惊奇地发现:当按不同于上述规定的用量比联用所述提取物时,它们是无活性的,甚至可能使所述障碍加重。因此,性行为的真正增强只可能通过按精确的比例使用各种植物的提取物而获得,其既增强性欲又增加血液对生殖器官的供应。
刺蒺藜、朝鲜淫羊藿、肉桂提取物的重量比优选为2.5∶1.5∶0.2。
当使用精氨酸、其盐、酯或前体时,其和植物提取物的用量比在0.5至1.5之间,优选为1。
通过常规技术例如用溶剂或超临界液体萃取而获得前述药用植物的提取物可被用于本发明的目的。
然而,优选使用用预先测定的所述提取物的某种典型成分的含量标准化的提取物:例如,刺蒺藜提取物可以含有约40%的以薯蓣皂苷表示的皂苷;朝鲜淫羊藿提取物优选为类黄酮含量(以淫羊霍表示)约60%的提取物;肉桂提取物优选含有约70%的肉桂醛。
当制备这些提取物时,植物的各个部分均可使用,尽管它们含有不同浓度的活性成分。
特别地,习惯上使用整个植物制备朝鲜淫羊藿提取物;刺蒺藜提取物优选自植物的地上部分和种子中获得。两种情况中,均优选使用40%的乙醇/水混合物在25至85℃的温度下、优选50℃下进行萃取。
肉桂提取物优选通过在150至300巴、优选为210巴的超临界压力条件下使用二氧化碳自树干皮进行萃取而制备。
蒺藜和淫羊藿提取物可通过用水不混溶的溶剂对浓缩的水提取物进行反萃取而进一步浓缩其活性成分,该萃取分别对类黄酮或皂苷具有充分的选择性。适宜的水不混溶或部分混溶的溶剂优选为乙酸乙酯或正丁醇;干燥后,将所用溶剂浓缩至干或浓缩至少量,用活性成分在其中不溶解的非质子溶剂例如脂肪族醚或脂肪族或芳香族烃稀释。将活性成分在非质子溶剂中沉淀可以除去不想要的惰性物质并浓缩活性成分。
由于萃取系统有充分的选择性,肉桂提取物的纯化是不必要的。
本发明还涉及重量比分别为1.5-3.5∶1-2∶0.1-0.4的刺蒺藜、朝鲜淫羊藿和肉桂的提取物和任选的精氨酸或其生理上等效的酯、盐或前体在制备用于治疗男性和女性性功能障碍、特别是用于治疗性无能、勃起功能障碍、性欲障碍、性冷淡和性快感缺乏的药物中的用途。
作为植物提取物的替换物,也可使用相应的分离出的活性成分,特别是薯蓣皂苷、淫羊霍和肉桂醛的组合。所述组合在制备用于治疗性无能、勃起功能障碍、性欲障碍、性冷淡和性快感缺乏的药物中的用途以及包含所述组合的药物是本发明的另一个目的。
本发明的提取物混合物必须长期服用,而不是在性交前即刻服用,尽管在某些个体中在第一次治疗时,在服药30分钟内即产生了反应。
本发明组合物的长期给药不引起任何显著的副作用,耐受良好,并且不改变精密的激素平衡,特别是雄性激素/雌激素平衡,其调节男性和女性的重要生理事件例如男性更年期(andropause)和绝经期。
本发明组合物的适宜的给药形式的实例包括含有100至300mg的单位剂量的刺蒺藜提取物和根据前述重量比确定的单位剂量的其它成分的片剂、软和硬明胶胶囊、栓剂和可饮用制剂。特别优选固态制剂,例如未改变释放特性的片剂或耐胃液的片剂,或可饮用液体形式。
下列实施例用来说明本发明而非限制其范围。
实施例1-包衣片的制备
每片700mg的包衣片包含:
刺蒺藜 250.00mg
朝鲜淫羊藿 150.00mg
肉桂 20.00mg
L-精氨酸 100.00mg
大豆多糖 55.00mg
二氧化硅 14.00mg
硅化微晶纤维素 92.00mg
硬脂酸镁 4.00mg
羟丙基甲基纤维素 6.40mg
滑石 5.20mg
二氧化钛 2.00mg
甘油 0.12mg
聚山梨醇酯80 0.80mg
喹啉 0.43mg
靛蓝 0.05mg
实施例2-硬明胶胶囊的制备
每粒340mg的胶囊包含:
刺蒺藜 125.00mg
朝鲜淫羊藿 75.00mg
肉桂 10.00mg
L-精氨酸 50.00mg
大豆多糖 25.00mg
二氧化硅 7.00mg
硅化微晶纤维素 45.00mg
硬脂酸镁 1.50mg
滑石 1.50mg
实施例3-软明胶胶囊的制备
每粒700mg的软明胶胶囊包含:
刺蒺藜 125.00mg
朝鲜淫羊藿 75.00mg
肉桂 10.00mg
L-精氨酸 50.00mg
大豆卵磷脂 20.00mg
中链甘油三酯 100.00mg
聚山梨醇酯80 10.00mg
豆油 300.00mg
胶态二氧化硅 10.00mg
实施例4-可饮用溶液的制备
每10ml的小瓶包含:
刺蒺藜 250.00mg
朝鲜淫羊藿 150.00mg
肉桂 20.00mg
盐酸L-精氨酸 100.00mg
甘油 3000.00mg
聚山梨醇酯20 800.00mg
丙二醇 1000.00mg
丁磺氨钾 175.00mg
糖精钠 40.00mg
新橙皮苷二氢查耳酮DC(Neohesperidine DC) 2.50mg
矫味剂 300.00mg
山梨酸钾 11.70mg
对羟基苯甲酸甲酯 8.30mg
纯化水 足量至10.00mL
实施例5-可溶性颗粒的制备
每5000mg的小袋包含:
刺蒺藜 250.00mg
朝鲜淫羊藿 150.00mg
肉桂 20.00mg
盐酸L-精氨酸 100.00mg
聚山梨醇酯20 500.00mg
丁磺氨钾 175.00mg
糖精钠 40.00mg
新橙皮苷二氢查耳酮DC 2.50mg
矫味剂 300.00mg
菊粉 1000.00mg
甘露醇 2412.50mg
Claims (8)
1.药物组合物,其包含:
●重量比分别为1.5-3.5∶1-2∶0.1-0.4的刺蒺藜、朝鲜淫羊藿、肉桂的提取物;和任选的
●精氨酸或其生理上等效的酯、盐或前体和适宜的载体或赋形剂。
2.如权利要求1所述的组合物,其中刺蒺藜、朝鲜淫羊藿和肉桂的提取物的重量比为2.5∶1.5∶0.2。
3.如权利要求1或2所述的组合物,其含有重量比分别为1.5-3.5∶1-2∶0.1-0.4∶0.5-1.5的刺蒺藜、朝鲜淫羊藿、肉桂的提取物和L-精氨酸或盐酸L-精氨酸。
4.如权利要求3所述的组合物,其中刺蒺藜、朝鲜淫羊藿、肉桂的提取物和L-精氨酸或盐酸L-精氨酸的重量比为2.5∶1.5∶0.2∶1。
5.重量比分别为1.5-3.5∶1-2∶0.1-0.4的刺蒺藜、朝鲜淫羊藿、肉桂的提取物和任选的精氨酸或其生理上等效的酯、盐或前体在制备用于治疗男性和女性性功能障碍的药物中的用途。
6.如权利要求5所述的用途,用于治疗性无能、勃起功能障碍、性欲障碍、性冷淡和性高潮缺乏。
7.包含有效量的薯蓣皂苷、淫羊霍和肉桂醛以及适宜的载体或赋形剂的药物组合物。
8.薯蓣皂苷、淫羊霍和肉桂醛在制备用于治疗男性和女性性功能障碍的药物中的用途。
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1989990B (zh) * | 2005-12-27 | 2010-09-01 | 郭凯 | 一种治疗勃起功能障碍的药物及其制备方法 |
CN104000198A (zh) * | 2014-06-13 | 2014-08-27 | 上海赫尔伯生物科技有限公司 | 一种具有补肾填精、益神兴阳作用的复方胶囊及其制备方法 |
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WO2013106647A1 (en) * | 2012-01-13 | 2013-07-18 | Dharma Biomedical, Llc | Supercritical guggul extracts and uses thereof |
RU2496491C1 (ru) | 2012-08-20 | 2013-10-27 | Общество С Ограниченной Ответственностью "Парафарм" | Способ восстановления полового влечения (либидо) у мужчин путем применения биологически активной добавки к пище для восстановления полового влечения (либидо) у мужчин |
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KR0148511B1 (ko) * | 1993-09-14 | 1998-11-02 | 최형기 | 성신경과민증 예방 및 치료용 의약조성물 |
FR2765483B1 (fr) * | 1997-07-04 | 2000-02-04 | Philippe Gorny | Medicament destine a traiter les dysfonctions erectiles |
US6007824A (en) * | 1998-07-09 | 1999-12-28 | Duckett; Melvin J. | Natural composition and method for the treatment of sexual dysfunction |
CN1199647C (zh) * | 1999-06-17 | 2005-05-04 | 北京东方百奥医药开发有限公司 | 淫羊藿甙在制备用于预防或治疗勃起功能障碍的药物中用途 |
US20020013280A1 (en) * | 2000-06-16 | 2002-01-31 | Zhongcheng Xin | Pharmaceutical composition for preventing and treating sexual dysfunction and vasculargenic disease comprising icariin |
US6702733B1 (en) * | 1999-07-01 | 2004-03-09 | 40 J's Llc | Expanded clitoral sensitizing compounds with methods and apparatus for the delivery of these compounds |
KR20010009653A (ko) | 1999-07-12 | 2001-02-05 | 유제경 | 성기능 장애를 위한 치료용 조성물 |
US20010008638A1 (en) | 1999-07-14 | 2001-07-19 | Brian J. Wilding | Nutritional supplement comprising at least one prohormone and at least one anti-estrogen compound in a time-release dosage form |
US6343258B1 (en) | 1999-08-13 | 2002-01-29 | ALEXIS Brian | Method for testing for readiness for harvesting of tribulus terrestris l. having high steroidal saponin content |
US6399579B1 (en) | 2000-08-15 | 2002-06-04 | Hauser, Inc. | Compositions comprising icariside I and anhydroicaritin and methods for making the same |
US6803060B2 (en) * | 2000-09-07 | 2004-10-12 | Joe Reyes | Composition to boost libido |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1989990B (zh) * | 2005-12-27 | 2010-09-01 | 郭凯 | 一种治疗勃起功能障碍的药物及其制备方法 |
CN104000198A (zh) * | 2014-06-13 | 2014-08-27 | 上海赫尔伯生物科技有限公司 | 一种具有补肾填精、益神兴阳作用的复方胶囊及其制备方法 |
CN104000198B (zh) * | 2014-06-13 | 2016-03-23 | 上海赫尔伯生物科技有限公司 | 一种具有补肾填精、益神兴阳作用的复方胶囊及其制备方法 |
CN107847476A (zh) * | 2015-07-13 | 2018-03-27 | 协和发酵生化株式会社 | 含高浓度精氨酸的片剂 |
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