CN1822848A - 作用于血管的物质的组合产品及其在性功能障碍治疗中的应用 - Google Patents

作用于血管的物质的组合产品及其在性功能障碍治疗中的应用 Download PDF

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CN1822848A
CN1822848A CNA2004800198252A CN200480019825A CN1822848A CN 1822848 A CN1822848 A CN 1822848A CN A2004800198252 A CNA2004800198252 A CN A2004800198252A CN 200480019825 A CN200480019825 A CN 200480019825A CN 1822848 A CN1822848 A CN 1822848A
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E·邦巴尔代利
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Abstract

本发明涉及用于治疗与局部供血不足和/或润滑不够有关的性功能障碍的作用于血管的物质的组合产品。上述活性化合物选自：－七叶苷或维司那定；－弗司扣林或含有它的提取物，或者也可以选自番薯属植物的纯化的亲脂性提取物；－西门木炔酸的酯；－任选的至少一种选自下列的化合物：淫羊藿苷或其衍生物或含有它的提取物、穗花杉双黄酮和银杏二聚黄酮。将上述作用于血管的物质的组合产品掺入应用于生殖器官的凝胶和洗剂。这些制剂用于诱导男性和女性性器官的勃起并提升性高潮和性能力。上述制剂特别用于治疗女性性功能障碍。

Description

作用于血管的物质的组合产品及其在性功能障碍治疗中的应用
本发明涉及用于治疗与局部供血不足和/或润滑不够有关的性功能障碍的作用于血管的物质的组合产品。
对于男性来说，勃起能力降低对于患者的生理、感情和社交活动具有非常负面的影响。当这种性功能障碍出现时，无论何时进行性交男性总是想象着另一次“失败”，所以产生了一种特殊的心理状态，最初只是生理上的问题，但现在既是产生问题的原因也是最后的结果。
因为性行为是夫妻间交流的重要手段，所以勃起能力的衰退导致配偶间出现感情紧张并进而使得他们的关系恶化。各种程度的勃起能力和润滑的降低或缺乏也造成女性的严重问题，并在配偶关系间产生负面影响。多种介质和受体参与了男性和女性生殖器官的膨胀。例如，乙酰胆碱(Ach)是最常见的副交感神经系统的神经递质。在体外，该物质使得先前被去甲肾上腺素收缩的平滑肌条纹松弛并使得平滑肌细胞隔离群收缩。这表明Ach的主要作用是收缩平滑肌并决定着导致海绵体松弛的物质的释放。除Ach外，副交感神经也释放其它神经递质，包括一氧化氮(NO)、VIP和CGRP(降钙素基因相关肽)。
一氧化氮(NO)是通过NOs酶(一氧化氮合酶)的作用由L-精氨酸而合成的。阴茎和阴蒂中NO的两种来源是由副交感神经末梢和内皮产生，通过不同的NOs酶合成：包括nNOs(神经元NOs)和eNOs(内皮NOs)，nNOs存在于副交感神经细胞质中，eNOs发现于血管和小梁组织的内皮，似乎主要与细胞膜结合。许多实验证明刺激副交感神经导致NO的释放，这是神经末梢直接作用的结果(nNOs催化的反应)和由副交感神经释放的Ach作用于血管内皮、同时刺激eNOs的间接作用结果。还有证据支持内皮紧张时释放NO并且与氧分压有关。实际上，氧分压较低时，如软弱无力的情况，阶段的长短与NOs活性降低有关。最后一点，各种研究已经证明了其它物质也具有决定内皮释放NO的能力，尽管它们的生理学重要性还没有确定。NO在阴茎勃起中起重要作用的临床依据包括观察到在海绵体内注射促NO释放物质能够在阳痿男性以及性能力正常的男性中产生勃起。
副交感神经纤维释放的Ach与内皮细胞膜和平滑肌细胞膜上的毒蕈碱受体结合。在内皮中，该结合提高了eNOs的激活，并进而释放NO并对去甲肾上腺素(NA)产生抑制。NA释放的抑制对勃起的生理学意义是非常重要的。交感神经末梢释放的NA与α1-肾上腺素能膜受体(在海绵体组织中，α类型受体数量超过β类型受体，比例为10∶1)结合导致磷脂酶C(PLC)活性增加，将磷脂酰肌醇(PIP)转化为三磷酸肌醇(IP3)和二酰甘油(DAG)。IP3诱导钙离子自肌质网中释放，DAG刺激蛋白激酶C(PKC)。通过打开L-型钙通道并关闭钾通道，上述酶能够使细胞质内钙浓度增加，导致平滑肌收缩。
副交感神经末梢和内皮释放的NO为亲脂性分子，所以能够通过平滑肌细胞膜。
尽管其半衰期较短(约5秒)，但到达肌细胞细胞质后它就刺激其受体(鸟苷酸环化酶)，将鸟苷三磷酸(GTP)转化为第二活化信使环一磷酸鸟苷(cGMP)。cGMP在细胞质内的水平是由一氧化氮能刺激(nitrergic stimulus)的程度和磷酸二酯酶V(PDE)的分解代谢速率来控制的。一旦受到刺激；cGMP就激活蛋白激酶G(PKG)，它能够关闭L-型钙通道并开放钾通道。像前列腺素类(PGE1)一样，VIP主要通过特异性受体作用于平滑肌细胞的表面，从而刺激腺苷酸环化酶(一种细胞膜酶)。该酶将ATP转化为环AMP(cAMP)，从而导致细胞内钙浓度降低，平滑肌松弛。
目前已经发现通过将七叶苷(esculoside)或维司那定(visnadine)、淫羊藿苷(icarin)及其衍生物或含有它的提取物、穗花杉双黄酮(amentoflavone)、银杏(Gingko biloba))二聚物、弗司扣林(forskolin)或毛喉鞘蕊花(Coleus forskolii)的纯化提取物、番薯(Ipomea)属植物的纯化提取物和西门木炔酸酯组合，可以改善生理上迟钝或改变的参数，发挥活性成分间的协同作用，非常有效地恢复生殖器官的功能。
本发明特别涉及作用于血管的物质的组合产品，用于治疗与男性和女性性器官局部血液供应不足相关的性功能障碍。
本发明的局部用组合物包括：
-七叶苷或维司那定；
-弗司扣林或含有它的提取物；或者为番薯属植物的纯化的亲脂性提取物；
-西门木炔酸酯；
-任选的至少一种选自下列的化合物：淫羊藿苷或其衍生物或含有它的提取物、穗花杉双黄酮和银杏二聚黄酮。
维司那定为主要发现于阿密茴香(Ammi visnaga)(传统上用于治疗咽峡疾病的植物)种子中的香豆素。该化合物最近在药学领域被用作冠状动脉扩张剂。申请人已经证明在不同情况下当该化合物局部应用时对前毛细血管动脉和小动脉具有很强的血管动力(vasokinetic)作用，增加血流和组织灌注(EP0418806)。动脉血液向勃起组织的供给能够诱导勃起并且只要组织中有化合物存在就可以保持勃起。维司那定也具有抗磷酸二酯酶的活性，用于维持环核苷酸。
七叶苷为一种存在于许多植物(如七叶树(Aesculus hippocastanum)、白蜡树(Fraxinus communis)等)中的一种香豆素糖苷，对静脉和动脉均具有血管动力(vasokinetic)作用和venotropic活性。
淫羊藿苷及其衍生物作用于cGMP磷酸二酯酶V。为保持男性和女性生殖器官的勃起并完成性交需要较高水平的cGMP。淫羊藿苷衍生物包括7-羟基乙基淫羊藿苷或7-氨基乙基淫羊藿苷、7-羟基乙基-3-O-鼠李糖苷-淫羊藿苷、7-氨基乙基-7-去糖(desgluco)-3-鼠李糖苷-淫羊藿苷、8-二氢-淫羊藿苷及其在7和3位的糖苷和7-羟基乙基-7-去糖-淫羊藿苷。
穗花杉双黄酮为以中等量存在于许多植物(如银杏叶(Gingko biloba)、Brakeringea zanguebarica和Taxus sp)中的双黄酮。在某些制剂中加入穗花杉双黄酮特别有效，为本发明的主题之一，因为它对磷酸二酯酶具有非常强的抑制作用并有使催产素释放的作用，已知它在低剂量作为催欲药。
弗司扣林及其含有它的提取物为已知的腺苷酸环化酶激动剂。特别优选毛喉鞘蕊花(Coleus forskolii)的纯化提取物。
番薯属植物提取物对腺苷酸环化酶也具有显著的活性；特别优选Ipomca hederacea、Ipomea parassitica和番薯(Ipomea batatas)的标准亲脂性提取物。
本发明的制剂能够改善性能力，特别是在女性中。例如，将含有1％七叶苷、0.2％弗司扣林和1％西门木炔酸的凝胶形式的组合产品给药于一组10位育龄女性志愿者。有效性试验(其中外生殖器血流参数经非侵入法测定(激光多普勒(Laser Doppler)和光学探测毛细管显微镜检查(opticalprobe videocapillaroscopy)))证明血流较基础值增加了多至200％；关于主观感觉，患者反映在半小时内总体良好并有性兴奋。在男性中，施用基于本发明的制剂能够导致快速勃起并能持续至足够完成性交。
用下列实施例说明本发明。
实施例1
七叶苷                                        1.00g
西门木炔酸乙酯                                2.00g
鞘蕊花纯化提取物＞80％                        0.20g
聚乙烯400                                     10.00g
乙基二甘醇醚(Transcutol-Gattefossé)           10.00g
辛酸/癸酸PEG-6甘油酯                          10.00g
(Softigen 767-Huls)
山梨糖醇                                      10.00g
聚山梨糖酸酯20                                8.00g
卡波姆(Ultrez 10-BF Goodrich)                 1.00g
咪唑烷基脲                                    0.30g
黄原胶(Keltrol TF-Kelco)                      0.30g
对羟基苯甲酸甲酯                              0.20g
EDTA二钠                                      0.10g
丁基化羟基甲苯                                0.05g
10％氢氧化钠水溶液                            2.001g
香料(Jenny-Dragoco)                           0.01g
水                                        适量至100g
实施例2
维司那定                                  1.00g
西门木炔酸乙酯                            2.00g
鞘蕊花纯化提取物＞80％                    0.20g
聚乙烯400                                 10.00g
乙基二甘醇醚(Transcutol-Gattefossé)       10.00g
辛酸/葵酸PEG-6甘油酯                      10.00g
(Softigen 767-Huls)
山梨糖醇                                  10.00g
聚山梨糖酸酯20                            8.00g
卡波姆(Ultrez 10-BF Goodrich)             1.00g
咪唑烷基脲                                0.30g
黄原胶(Keltrol TF-Kelco)                  0.30g
对羟基苯甲酸甲酯                          0.20g
EDTA二钠                                  0.10g
丁基化羟基甲苯                            0.05g
10％氢氧化钠水溶液                        2.00g
香料(Jenny-Dragoco)                       0.01g
水                                        适量至100g
实施例3
维司那定                                  1.00g
7-羟乙基-7-去糖-淫羊藿苷                  1.00g
弗司扣林                                  0.20g
穗花杉双黄酮                              0.20g
西门木炔酸乙酯                            2.00g
聚乙烯400                                 10.00g
乙基二甘醇醚(Transcutol-Gattefossé)             10.00g
辛酸/葵酸PEG-6甘油酯                            10.00g
(Softigen 767-Huls)
山梨糖醇                                        10.00g
聚山梨糖酸酯20                                  8.00g
卡波姆(Ultrez 10-BF Goodrich)                   1.00g
咪唑烷基脲                                      0.30g
黄原胶(Keltrol TF-Kelco)                        0.30g
对羟基苯甲酸甲酯                                0.20g
EDTA二钠                                        0.10g
丁基化羟基甲苯                                  0.05g
10％氢氧化钠水溶液                              2.00g
香料(Jenny-Dragoco)                             0.01g
水                                              适量至100g
实施例4
七叶苷                                          1.00g
7-羟乙基-7-去糖-淫羊藿苷                        1.00g
Ipomea hederacea亲脂性标准提取物                0.20g
银杏二聚黄酮                                    0.20g
西门木炔酸乙酯                                  1.00g
聚乙烯400                                       10.00g
乙基二甘醇醚(Transcutol-Gattefossé)             10.00g
辛酸/葵酸PEG-6甘油酯                            10.00g
(Softigen 767-Huls)
山梨糖醇                                        10.00g
聚山梨糖酸酯20                                  8.00g
卡波姆(Ultrez 10-BF Goodrich)                   1.00g
咪唑烷基脲                                      0.30g
黄原胶(Keltrol TF-Kelco)                    0.30g
对羟基苯甲酸甲酯                            0.20g
EDTA二钠                                    0.10g
丁基化羟基甲苯                              0.05g
10％氢氧化钠水溶液                          2.00g
香料(Jenny-Dragoc0)                         0.01g
水                                          适量至100g。

Claims (9)

1.局部用组合物，它含有：
-七叶苷或维司那定；
-弗司扣林或含有它的提取物；或者为番薯属植物的纯化的亲脂性提取物；
-西门木炔酸酯；
-任选的至少一种选自下列的化合物：淫羊藿苷或其衍生物或含有它的提取物、穗花杉双黄酮和银杏二聚黄酮。
2.权利要求1的组合物，其中淫羊藿苷衍生物包括7-羟乙基-7-去糖-淫羊藿苷、7-羟乙基-淫羊藿苷、7-氨基乙基-淫羊藿苷、7-羟基乙基-3-O-鼠李糖苷-淫羊藿苷、7-氨基乙基-3-鼠李糖苷-淫羊藿苷、8-二氢-淫羊藿苷及其在7和3位的糖苷。
3.权利要求1的组合物，其中银杏二聚黄酮包括穗花杉双黄酮。
4.权利要求1的组合物，其中西门木炔酸酯为乙酯。
5.权利要求1的组合物，它包含维司那定、毛喉鞘蕊花的纯化提取物、西门木炔酸乙酯、润滑剂和抗刺激赋形剂。
6.权利要求1的组合物，它包含七叶苷、毛喉鞘蕊花的纯化提取物、西门木炔酸乙酯。
7.权利要求1的组合物，它含有维司那定、弗司扣林西门木炔酸乙酯。
8.权利要求1的组合物，其中番薯属植物纯化的提取物选自Ipomeahederacea、Ipomea parassitica、甘薯。
9.含有下列成分的组合产品在制备用于治疗性功能障碍的局部用组合物中的用途：
-七叶苷或维司那定；
-弗司扣林或含有它的提取物；或者为番薯属植物的纯化的亲脂性提取物；
-西门木炔酸酯；
-任选的至少一种选自下列的化合物：淫羊藿苷或其衍生物或含有它的提取物、穗花杉双黄酮和银杏二聚黄酮。
CN2004800198252A 2003-07-11 2004-07-06 作用于血管的物质的组合产品及其在性功能障碍治疗中的应用 Expired - Fee Related CN1822848B (zh)

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CN112546453A (zh) * 2020-10-15 2021-03-26 西安蓝极医疗电子科技有限公司 基于激光照射治疗男性勃起功能障碍的发光体组件及装置

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