CN1549720A - 用于治疗头皮疾病的口服组合物 - Google Patents

用于治疗头皮疾病的口服组合物 Download PDF

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CN1549720A
CN1549720A CNA018235220A CN01823522A CN1549720A CN 1549720 A CN1549720 A CN 1549720A CN A018235220 A CNA018235220 A CN A018235220A CN 01823522 A CN01823522 A CN 01823522A CN 1549720 A CN1549720 A CN 1549720A
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F·迪皮耶罗
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Abstract

本发明涉及含有锯齿棕提取物和葡萄提取物作为活性成分、用于治疗和预防头皮疾病的药物和/或美容组合物。

Description

用于治疗头皮疾病的口服组合物
本发明涉及用于治疗和预防头皮疾病、含有植物来源成分的药物和/或美容口服组合物。
更具体而言，本发明涉及含有锯齿棕(Serenoa repens)和葡萄(Vitisvinifera)提取物作为活性成分、用于治疗和预防头皮疾病的药物和/或美容口服组合物。
头皮屑、皮脂溢和头发减少或脱发是最常见的头皮疾病。
尽管雄激素性脱发特别是在白种人中的发病频率非常高，使得所有旨在确定遗传方式的尝试都非常困难，但是大量研究已证实其是遗传易感个体中的一个生理过程。尽管这种遗传性相当程度上是常染色体导致的，但是所涉及基因的数量还没有被确定。
已有证据证明雄激素和雄激素性脱发的进展之间的关系：例如典型脱发(pattern alopecia)和毛发生长初期阶段的时间缩短有关，并且已知雄激素可导致处于头皮毛囊中的毛发生长初期阶段缩短，毛发变得较纤细且较稀少。组织雄激素、睾丸素和更强效的二氢睾丸素(DHT)可通过血液循环到达皮肤或可通过类固醇级联反应中特殊的酶在毛囊和皮脂腺中局部生成。在患有雄激素性脱发的男性和女性的头皮的人发毛囊和皮脂腺中，许多调节DHT、包括5-α-还原酶形成的酶的动力学常数已被计算出来；此外，在皮脂细胞(sebocyte)和人发中也已识别出特异性结合DHT的雄激素受体。
近来，结合研究显示：与正常受试者相比，脱发受试者的毛囊的真皮乳头含有更多的雄激素受体。由于该激素通道的存在，可出现皮脂分泌异常，这又可导致脱发进一步加重以及皮脂和头皮屑的生成过剩。
已知5-α-还原酶的两种同工型：1型和2型。前列腺含有2型同工酶，而皮肤和皮肤附属物(毛发和皮脂腺)同时含有1型和2型同工酶。一种最初用于治疗前列腺增生的2型5-α-还原酶抑制剂非那甾胺在雄激素性脱发的治疗中也显示出活性；此外，还观察到脱发的严重性和良性前列腺增生的严重性之间的关系。
除5-α-还原酶外，氧化压力(污染、大气物质等)和通过饮食所摄入的少量元素及含硫(sulfated)氨基酸(例如蛋氨酸、半胱氨酸和胱氨酸)过少也对毛发有不利影响。
目前市售可得的大多数用于治疗头皮屑和脱发的药物或美容制剂还没有令人满意地解决这些问题。
现已发现：含有植物来源活性成分的组合的药物和/或美容口服制剂在治疗头皮疾病、特别是脱发和头皮屑中可产生极好的结果，这是因为不同活性的各种成分的组合可发挥尤其是抗雄激素、抗自由基、抗衰老的活性。这也是本发明的目的。
本发明的组合物作用于促进所述头皮疾病进展的因素，特别是作用于雄激素、氧化压力、饮食中存在的少量元素和含硫氨基酸。
更具体而言，本发明涉及含有a)锯齿棕提取物、b)游离和/或磷脂复合物形式的标准葡萄提取物的口服药物和/或美容组合物。
本发明组合物的组分均是已知的且被用于药物和/或美容领域。然而，应当注意的是：当单独使用时，单一组分发挥的活性远低于其在本发明组合物中所发挥的活性，因为已发现组合物的各组分在预防和治疗头皮疾病中可发挥协同作用。
(a)锯齿棕提取物是一种因其抗雄激素作用而对良性前列腺增生有效的植物药。如EP 250,953所述，该产品含有使用超临界条件下的CO2自植物提取的特定的脂肪酸混合物，并且如使用放射性标记的3H-甲基三烯醇酮(3H-methyltrienolone)进行的置换实验所证实的，在对前列腺离体细胞进行“体外”实验时，锯齿棕提取物显示出对雄激素受体的强大的亲和性。
(b)GB 1,541,469公开的葡萄提取物包括没食子酸，以及游离的或与没食子酸酯化的儿茶素及表儿茶素的单体、二聚体、三聚体、四聚体、五聚体、六聚体和七聚体。广泛的研究证实：其具有许多特性：a)强大、全面的抗氧化谱，可清除更具活性的自由基，从而消除所有与自由基活动有关的现象；b)能够抑制黄嘌呤氧化酶并与Cu++及Fe++鳌和，因此阻止自由基因酶催化而被释放进入组织；c)能够抑制胶原酶、透明质酸酶、弹性蛋白酶和β-葡糖醛酸酶，因此保护血管和结缔组织免受紫外照射后、经受氧化压力后和炎症反应进展期间释放的蛋白水解酶引起的损害。
如上所述，葡萄提取物也可如US 4,963,527所公开以磷脂复合物的形式存在。
除上组分外，本发明的组合物可任选含有其它具有有用作用或至少具有补充作用的成分，例如少量元素如锌、铜、铁、硒、镁；氨基酸如L-赖氨酸、L-脯氨酸、L-羟脯氨酸、L-亮氨酸、L-异亮氨酸、L-蛋氨酸、L-半胱氨酸、L-胱氨酸；维生素如维生素B复合物、维生素E和维生素C。
根据常规方法，例如“雷明顿：药物科学与实践”Lippincott、Williams及Wilkins编辑，2000年12月所述的方法，可将本发明的组合物制成口服剂型。所述组合物可以是片剂、胶囊剂、口服制剂、粉剂、颗粒剂、锭剂、用于重构的粉剂、注射溶液剂或混悬剂，以及用于输注的液体制剂或栓剂的形式。
用于口服施用的片剂和胶囊剂通常以单一剂量形式存在，并且含有常规赋形剂如粘合剂、稀释剂、压片剂、润滑剂、崩解剂、染料、矫味剂及润湿剂。片剂可根据本领域已知的方法进行包衣。
根据本发明的一个实施方案，组合物可以以两个用于同时施用的胶囊的形式存在，其中一个胶囊含有本发明的提取物且另一个胶囊含有上述少量元素。
口服液体制剂可例如以水性或油性溶液剂或混悬剂、乳剂、糖浆剂或酏剂的形式存在，或为使用前用水或其它适宜载体重构的干燥产品。所述液体制剂可含有常规赋形剂如助悬剂、乳化剂、非水性载体、防腐剂、矫味剂或染料。
本发明的组合物可以以这样的剂型使用，所述剂型提供的组分日摄入量处于以下范围：
a)标准锯齿棕提取物(40至320mg/天)；
b)游离和/或磷脂复合物形式的标准葡萄提取物(分别为50至300mg/天和150至900mg/天)。
少量元素可以以提供日摄入量0.1至100mg的量存在。
本发明的组合物显示可有效治疗头皮疾病，对于trichogram、头皮屑、皮脂溢和脱发具有良好效果，并且可有效预防所述疾病，保证毛发健康。
药理学实验的结果报告如下：
对于头皮屑、皮脂生成及脱发的作用
将60位有头皮屑(头皮皮肤的脱落)的受试者随机分配至四组。第一组服用1粒根据实施例1制备的胶囊，每天一次，持续8周。在开始治疗前即刻、治疗结束时(8周后)及治疗终止后4周(随访)进行评价。第二组在同样实验条件下服用安慰剂。第三组和第四组分别服用25和80mg的葡萄提取物和锯齿棕提取物。
表1所显示的结果证实：治疗8周后脱落细胞的数量(根据Mac Ginley等人，J.Invest.Dermatol.，53，107，1969所述进行评价)自85个细胞/cm2降低至18个细胞/cm2。脱落细胞的数量在随访4周后仍旧保持显著降低(21个细胞/cm2)的水平。
                  表1-MAC GINLEY计数(细胞/cm2)
    治疗     开始     8周     12周
    安慰剂     83±3.7     85±3.1     86±3.6
    实施例1的胶囊     85±2.1     18±2.4     21±3.1
    25mg葡萄提取物     87±2.9     75±3.1     80±2.7
    80mg锯齿棕提取物     84±3.1     41±4.3     63±2.4
表2所显示的结果证实：使用本发明的胶囊进行治疗可显著地使头皮皮脂的平均值自105 U.S.(U.S.即任意皮脂计量单位(arbitrary SebometricUnits))降低至92 U.S.。特别值得注意的是皮脂计量单位的值甚至在治疗结束后4周仍旧保持显著降低的水平(95 U.S.)。
               表2-皮脂计量(SEBOMETRY)(U.S.)
    治疗   开始   8周   12周
    安慰剂   106±7.3   105±9.3   106±7.9
    实施例1的胶囊   104±8.1   92±6.4   95±9.3
    25mg葡萄提取物   107±8.3   100±6.6   103±9.1
    80mg锯齿棕提取物   105±7.9   97±7.1   99±8.4
通过trichogram评价对本发明组合物用于脱发的作用进行了研究，该研究是在每位受试者的额部高处和前侧处(antero-nucal)取足够数量(约50根)的头发(Bosse K.、Hautzart，18，35，1967；Bosse K.、Hautzart，18，218，1967)。通过显微镜于镜下观察每根头发的毛干，估算处于生长初期(生长期)、生长中期(成熟期)或生长终期(静止期)阶段的头发的比例。在此研究中还对所有营养不良的生长初期状态，即其中头发的毛干小型化的阶段进行了评价。处于生长终期阶段的头发的比例高于10至15％(被认为是正常值)是头发减少的临床病理状态的一个指标。表3所显示的结果证明：使用本发明的胶囊治疗8周后，处于生长初期阶段的毛球增加，营养不良的生长初期头发的数量减少，并且因此观察到生长终期阶段的毛球减少。这种效果在随访4周后仍旧显著。应当注意的是：在安慰剂组中，治疗结束时和随访4周后的临床情况均正好相反。
                        表3-对脱发的作用
    安慰剂     实施例1的胶囊
开始 生长初期82％生长中期1％生长终期17％营养不良的生长初期23％ 生长初期80％生长中期1％生长终期19％营养不良的生长初期20％
治疗8周后 生长初期81％生长中期2％生长终期17％营养不良的生长初期22％ 生长初期82％生长中期1％生长终期17％营养不良的生长初期16％
12周后(治疗终止后延迟4周) 生长初期80％生长中期1％生长终期19％营养不良的生长初期24％ 生长初期83％生长中期1％生长终期16％营养不良的生长初期17％
对脂溢性皮炎的作用
40位患有头皮脂溢性皮炎的受试者被随机分入两组。第一组服用1粒根据实施例1制备的胶囊，每日一次，持续8周。在开始治疗前即刻、治疗结束时(8周后)及治疗终止后4周(随访)进行皮脂计量仪器评价。第二组在同样实验条件下服用安慰剂。第三和第四组分别接受25和80mg的葡萄提取物和锯齿棕提取物。
表4所显示的结果清楚地表明：使用本发明的胶囊进行治疗显著降低了患有脂溢性皮炎、其皮脂值超过200 U.S.(U.S.即任意皮脂计量单位)的受试者的头皮皮脂平均值。在随访4周后该值仍旧保持显著降低的水平。
                  表4-皮脂计量(U.S.)
    治疗     开始     8周     12周
    安慰剂     233±13     210±16     240±15
    实施例1的胶囊     241±14     135±9     150±12
    25mg葡萄提取物     227±9     209±14     220±13
    80mg锯齿棕提取物     231±13     200±16     203±16
本发明组合物的实例报告如下。
实施例1-硬明胶胶囊
每粒胶囊326mg，含有：
锯齿棕提取物                               50.0mg
葡萄提取物                                 25.0mg
L-半胱氨酸                                 30.0mg
L-组氨酸                                   30.0mg
L-蛋氨酸                                   30.0mg
D-泛酸钙                                   15.0mg
柠檬酸锌(相当于3mg锌)                      10.0mg
柠檬酸铜(相当于0.8mg铜)                    2.3mg
β-胡萝卜素10％W.S.(相当于700 U.I.维生素A) 4.3mg
硅胶(Aerosil 200-DEGUSSA)                  30.0mg
微晶纤维素(Avicel PH 101-FMC)              30.0mg
麦芽糖糊精(Lycatab DSH-ROQUETTE)           30.0mg
预胶化淀粉(Amido STA 1500-COLORCON)        21.9mg
交联羧甲基纤维素钠(Ac-Of-Sol-FMC)          15.0mg
硬脂酸镁                                   2.5mg
实施例2-硬明胶胶囊
每粒胶囊326mg，含有：
锯齿棕提取物                               80.0mg
葡萄提取物                                 25.0mg
大豆多糖(Emcosoy-MENDELL)                  83.0mg
D-泛酸钙                                   15.0mg
葡糖酸锌(相当于3mg锌)                      23.84mg
葡糖酸铜(相当于0.8mg铜)                  5.7mg
硅胶(Aerosil 200-DEGUSSA)                6.2mg
微晶纤维素(Avicel PH101-FMC)             30.0mg
预胶化淀粉(STA 1500淀粉-COLORCON)        72.0mg
硬脂酸镁                                 2.5mg

Claims (11)

1.药物和/或美容口服组合物，其含有以下植物来源的成分：
a)锯齿棕提取物，
b)游离和/或磷脂复合物形式的葡萄提取物，以及常规赋形剂和载体。
2.权利要求1所述的药物和/或美容口服组合物，其还含有其它选自少量元素如锌、铜、铁、硒、镁；氨基酸如L-赖氨酸、L-脯氨酸、L-羟脯氨酸、L-亮氨酸、L-异亮氨酸、L-蛋氨酸、L-半胱氨酸、L-胱氨酸；维生素如维生素B复合物、维生素E和维生素C的活性成分。
3.权利要求2所述的药物和/或美容组合物，其中的其它活性成分以提供日摄入量0.1至100mg的量存在。
4.以上权利要求所述的药物和/或美容组合物，其为硬明胶胶囊的形式，含有：
锯齿棕提取物                                      50.0mg
葡萄提取物                                        25.0mg
L-半胱氨酸                                        30.0mg
L-组氨酸                                          30.0mg
L-蛋氨酸                                          30.0mg
D-泛酸钙                                          15.0mg
柠檬酸锌(相当于3mg锌)                             10.0mg
柠檬酸铜(相当于0.8mg铜)                           2.3mg
β-胡萝卜素10％W.S.(相当于700U.I.维生素A)         4.3mg
硅胶(Aerosil 200-DEGUSSA)                         30.0mg
微晶纤维素(Avicel PH 101-FMC)                     30.0mg
麦芽糖糊精(Lycatab DSH-ROQUETTE)                  30.0mg
预胶化淀粉(Amido STA 1500-COLORCON)               21.9mg
交联羧甲基纤维素钠(Ac-Of-Sol-FMC)                 15.0mg
硬脂酸镁                         2.5mg
5.以上权利要求所述的药物和/或美容组合物，其为硬明胶胶囊的形式，含有：
锯齿棕提取物                              80.0mg
葡萄提取物                                25.0mg
大豆多糖(Emcosoy-MENDELL)                 83.0mg
D-泛酸钙                                  15.0mg
葡糖酸锌(相当于3mg锌)                     23.84mg
葡糖酸铜(相当于0.8mg铜)                   5.7mg
硅胶(Aerosil 200-DEGUSSA)                 6.2mg
微晶纤维素(Avicel PH101-FMC)              30.0mg
预胶化淀粉(STA 1500淀粉-COLORCON)         72.0mg
硬脂酸镁                                   2.5mg
6.以上权利要求所述的药物和/或美容组合物，其为两个单独的用于同时施用的胶囊的形式，其中一个胶囊含有：a)锯齿棕提取物；和b)游离和/或磷脂复合物形式的葡萄提取物；另一个胶囊含有权利要求2所述的少量元素、氨基酸和维生素。
7.a)锯齿棕提取物；b)游离和/或磷脂复合物形式的葡萄提取物在制备用于治疗和预防头皮疾病的药物和/或美容组合物中的用途。
8.a)锯齿棕提取物；b)游离和/或磷脂复合物形式的葡萄提取物和其它活性成分在制备用于治疗和预防头皮疾病的药物和/或美容组合物中的用途，所述其它活性成分选自少量元素如锌、铜、铁、硒、镁；氨基酸如L-赖氨酸、L-脯氨酸、L-羟脯氨酸、L-亮氨酸、L-异亮氨酸、L-蛋氨酸、L-半胱氨酸、L-胱氨酸；维生素如维生素B复合物、维生素E和维生素C。
9.上述任意一项权利要求所述的美容组合物用于治疗和预防头皮疾病的用途。
10.权利要求9所述的美容组合物的用途，用于治疗脱发和/或头皮屑和/或皮脂溢。
11.权利要求9所述的药物和/或美容组合物的用途，用于治疗脂溢性皮炎。
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