CN101347431A - 弗利班西林在治疗性障碍中的用途 - Google Patents
弗利班西林在治疗性障碍中的用途 Download PDFInfo
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- CN101347431A CN101347431A CNA2008101316858A CN200810131685A CN101347431A CN 101347431 A CN101347431 A CN 101347431A CN A2008101316858 A CNA2008101316858 A CN A2008101316858A CN 200810131685 A CN200810131685 A CN 200810131685A CN 101347431 A CN101347431 A CN 101347431A
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- 229960002053 flibanserin Drugs 0.000 title claims abstract description 26
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Reproductive Health (AREA)
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- Endocrinology (AREA)
- Gynecology & Obstetrics (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
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Abstract
本发明是关于弗利班西林(FLIBANSERIN)在制备用于治疗性需求疾病的药物中的用途。
Description
此案是申请日为2002年10月4日、中国申请号为02820828.5、发明名称为“弗利班西林在治疗性障碍中的用途”的发明申请的分案申请。
发明领域
本发明涉及弗利班西林(flibanserin)在用于制备治疗性需求用的药物中的用途。
发明叙述
欧洲专利申请案EP-A-526434中公开了以盐酸盐的形式的化合物1-[2-(4-(3-三氟甲基-苯基)哌嗪-1-基)乙基]-2，3-二氢-1H-苯并咪唑-2-酮(弗利班西林)，且其化学结构如下：
弗利班西林呈现对5-HT1A及5-HT2受体的亲合力。因此可用作治疗各种疾病如抑郁、精神分裂及焦虑的治疗用药剂。
在遭遇性功能障碍的男性或女性患者的研究中，已发现视情况以药物可接受的酸加成盐形式的弗利班西林呈现出提高性需求的性质。因此，本发明是关于视情况以药物可接受的酸加成盐形式的弗利班西林的应用，以制备治疗性需求的疾病用的药物。
本发明优选的实施方案是关于使用视情况以药物可接受的酸加成盐形式的弗利班西林在制备治疗选自性需求过低疾病、性需求丧失、性需求缺乏、性需求下降、性需求抑制、丧失性欲、性欲混乱及性冷淡的疾病的药物上的用途。
本发明最佳的为视情况以药物上可接受的酸加成盐形式的弗利班西林在制备治疗选自性需求过低疾病、性需求丧失、性需求缺乏、性需求下降、性需求抑制疾病的药物上的用途。
尤其是本发明最佳实施方案是关于视情况以药物上可接受的酸加成盐形式的弗利班西林在制备治疗选自性需求过低疾病及性需求丧失疾病的药物上的用途。
弗利班西林所发现的作用可在男人及女人中得到。然而，据本发明另一目的，优选的为视情况以药物上可接受的酸加成盐形式的弗利班西林在制备治疗女性性功能障碍的药物上的用途。
对于不管是终身存在的困扰或需求，及与病原学上无关的(器官-物理及药物两者引导的-，精神性的，组合器官-物理及药物两者诱导的-及精神上的，或未知)，均可发现弗利班西林的有利作用。
弗利班西林可视情况以其药物上可接受的酸加成盐的形式使用。适宜的酸加成盐包含例如选自丁二酸、氢溴酸、乙酸、富马酸、马来酸、甲苯磺酸、乳酸、磷酸、盐酸、硫酸、酒石酸、及柠檬酸的酸加成盐。也可使用上述酸加成盐的混合物。由上述的酸加成盐，优选的为盐酸盐及氢溴酸盐，尤其是盐酸盐。
视情况以其药物可接受的酸加成盐形式使用的弗利班西林可以固态、液态或喷雾形式加入一般的药物制剂中。该组合物例如可以以适于口服、直肠、非肠胃投药或鼻子吸入的形式存在；优选包含例如胶囊、片剂、糖衣片、安瓿、栓剂及鼻腔喷雾剂的形式。
活化成分可加入于一般用于药物组合物的赋形剂或载体中，例如滑石、阿拉伯胶、乳糖、明胶、硬脂酸镁、玉米淀粉、水性或非水性载体、聚乙烯基吡咯烷酮、脂肪酸的半合成甘油酯、氯苄烷铵、磷酸钠、EDTA、吐温80。组合物优选调制成剂量单位的形式，各剂量单位是适用于供给活化成分的单一剂量。每日可施用的剂量范围为0.1至400、优选1.0至300，更好为2至200毫克。
各剂量单位通常可含0.01毫克至100毫克，优选0.1至50毫克。
适用的片剂可通过例如使活性物质与已知赋形剂(例如惰性稀释剂，如碳酸钙、磷酸钙或乳糖)、崩解剂(如玉米淀粉或藻酸)、粘合剂如淀粉或明胶、润滑剂如硬脂酸镁或滑石及/或用于延迟释出的制剂(如羧甲基纤维素、乙酸邻苯二甲酸纤维素，或聚乙酸乙烯脂)混合制备。片剂也可包含许多层。
包衣片剂可通过以通常用于片剂包衣用的物质涂布在与片剂制造类似的芯上而制备，例如可力酮(collidone)或虫胶、阿拉伯胶、滑石、二氧化钛或糖。为达到延迟释出或避免不相容性，芯也可包含许多层。同样，片剂包衣可包含许多层，以达到延迟释出，且对片剂可使用上述的赋形剂。
含本发明活性物质或其组合物的糖浆或酏剂可另外含有增甜剂、如糖精、甘味剂、甘油或糖，及提味剂，例如加味剂如香草醛或橙萃取液。其也可含有悬浮助剂或增稠剂，如羧基甲基纤维素钠、润湿剂如脂肪醇与环氧乙烷的缩合产物，或防腐剂如对-羟基苯甲酸酯。
注射用溶液是依一般方式制备，例如添加防腐剂如对-羧基苯甲酸酯、或稳定剂如乙二胺四乙酸的碱金属盐，且移入注射小瓶或安瓿中。
含一种或多种活性物质或活性物质组合物的胶囊可例如通过使活性物质与惰性载体如乳糖或山梨糖醇混合，且将其装于明胶胶囊中而制备。
适用的栓剂例如可通过与提供本目的用的载体如天然脂肪或聚乙二醇或其衍生物混合而制备。
以下实施例说明本发明，但并不限制其范围：
药物调配制剂的实施例
A)片剂 每一片剂
弗利班西林盐酸盐 100毫克
乳糖 240毫克
玉米淀粉 340毫克
聚乙烯基吡咯烷酮 45毫克
硬脂酸镁 15毫克
740毫克
将细研磨的活性物质、乳糖及部分玉米淀粉一起混合，将混合物过筛，接着以含聚乙烯基吡咯烷酮的水溶液润湿，经捏合、湿润造粒且干燥。将颗粒、剩下的玉米淀粉及硬脂酸镁过筛并一起混合。压制混合物以制成适当形状及尺寸的片剂。
B)片剂 每一片剂
弗利玉西林盐酸盐 80毫克
玉米淀粉 190毫克
乳糖 55毫克
微结晶纤维素 35毫克
聚乙烯基吡咯烷酮 15毫克
钠-羧基甲基淀粉 23毫克
硬脂酸镁 2毫克
400毫克
将细磨的活性物质，部分玉米淀粉、乳糖、微结晶纤维素及聚乙烯基吡咯烷酮一起混合，混合物过筛且与剩余玉米淀粉及水掺合，形成颗粒，接着干燥且过筛。添加钠-羧基甲基淀粉及硬脂酸镁并混合，将混合物压制以形成适当尺寸的片剂。
C)包衣片 每一包衣片
弗利班西林盐酸盐 5毫克
玉米淀粉 41.5毫克
乳糖 30毫克
聚乙烯基吡咯烷酮 3毫克
硬脂酸镁 0.5毫克
80毫克
使活性物质、玉米淀粉、乳糖及聚乙烯基吡咯烷酮充分混合，且以水润湿。将润湿的物质推向1毫米目的筛，在45℃下干燥，且使颗粒通过相同的筛。硬脂酸镁混合于其中后，于造粒机中压制成直径6毫米的凸面片剂芯。依已知方式，以基本上包含糖及滑石覆盖剂涂覆产生的片剂芯。以蜡抛光最终的包衣片。
D)胶囊 每一胶囊
弗利班西林盐酸盐 150毫克
玉米淀粉 268.5毫克
硬脂酸镁 1.5毫克
420毫克
使物质及玉米淀粉混合且以水润湿。润湿的物质过筛且干燥。干燥的颗粒过筛并与硬脂酸镁混合。将最终混合物装入1号大小的硬质明胶胶囊中。
B)安瓿溶液
弗利班西林盐酸盐 50毫克
氯化钠 50毫克
注射用水 5毫升
在其本身pH下或视情况在pH5.5至6.5下将活性物质溶于水中，且添加氯化钠以形成等渗。过滤所得溶液使不含热原，且在无菌条件下将滤液转移入安瓿中，接着消毒且融化密封。
(F)栓剂
弗利班西林盐酸盐 50毫克
固态脂肪 1650毫克
1700毫克
将硬质脂肪融化。且在40℃下将研磨的活性物质均匀分散于其中。冷却至38℃，且倒入稍冷却的栓剂模具中。
Claims (6)
1.弗利班西林的用途，视情况以其药物可接受的酸加成盐的形式存在其用于制备治疗性需求失调的药物制剂。
2.如权利要求1的用途，其特征为性需求失调是选自性需求过低疾病、性需求丧失、性需求缺乏、性需求下降、抑制性性需求、性欲丧失、性欲混乱及性冷淡。
3.如权利要求1或2的用途，其特征为性需求失调是选自性需求过低疾病、性需求丧失、性需求缺乏、性需求下降、抑制性性需求。
4.如权利要求1的用途，其用于制备治疗女性性功能障碍的药物。
5.如权利要求1、2、3或4的用途，其特征为弗利班西林是以选自通过酸形成的盐的药物可接受的酸加成盐的形式使用，其中酸选自丁二酸、氢溴酸、乙酸、富马酸、马来酸、甲苯磺酸、乳酸、磷酸、盐酸、硫酸、酒石酸、柠檬酸及其混合物。
6.如权利要求1或2的用途，其特征为弗利班西林的使用剂量为每日0.1至400毫克。
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