CN101137377A - 四环氨基和甲酰胺基化合物及其用法 - Google Patents
四环氨基和甲酰胺基化合物及其用法 Download PDFInfo
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- CN101137377A CN101137377A CNA2006800060928A CN200680006092A CN101137377A CN 101137377 A CN101137377 A CN 101137377A CN A2006800060928 A CNA2006800060928 A CN A2006800060928A CN 200680006092 A CN200680006092 A CN 200680006092A CN 101137377 A CN101137377 A CN 101137377A
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- alkyl
- benzyl
- phenyl
- alkylidene
- halogen
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Abstract
本发明涉及四环氨基化合物和四环甲酰胺基化合物,含有有效量四环氨基化合物或四环甲酰胺基化合物的组合物以及用于治疗或预防炎性疾病、再灌注损伤、糖尿病、糖尿病并发症、由器官移植引起的复氧损伤、缺血性病症、帕金森病、肾衰竭、血管病、心血管病或癌症的方法,包括将有效量的四环氨基化合物或四环甲酰胺基化合物施用于需要其的主体。
Description
本申请要求2005年2月25日提交的目前在审查中的美国临时申请No.60/656,636为优先权,其在此整体引入作为参考。
技术领域
本发明涉及四环氨基化合物和四环甲酰胺基化合物,含有有效量四环氨基化合物或四环甲酰胺基化合物的组合物以及用于治疗或预防炎性疾病、再灌注损伤、糖尿病、糖尿病并发症、由器官移植引起的复氧损伤、缺血性病症、帕金森病、肾衰竭、血管病、心血管病或癌症的方法,包括将有效量的四环氨基化合物或四环甲酰胺基化合物施用于需要使用的主体。
背景技术
炎性疾病,诸如关节炎、结肠炎和自身免疫性糖尿病,一般表现为失调,它与再灌注损伤如中风和心脏病发作不同,并且在临床上表现为不同的症状。但是,这两类失调之间有共同的潜在机理。尤其是,炎性疾病和再灌注损伤可诱导促炎细胞因子和趋化因子的合成,其反过来可导致产生细胞毒自由基如氧化氮和过氧化物。NO与过氧化物可反应形成过氧亚硝酸盐(ONOO-)(Szabó等,Shock 6:79-88,1996)。
在炎性疾病和再灌注损伤中可观察到由ONOO-引发的细胞坏死,其包括将核酶聚(ADP-核糖)合成酶(PARS)活化。PARS的活化被认为是炎性疾病和再灌注损伤中观察到的细胞介导死亡的一个重要步骤(Szabó等,Trends Pharmacol.Sci.19:287-98,1998)。
在现有技术中已经描述了许多PARS抑制剂。参见,例如Banasik等,J.Biol.Chem.,267:1569-75,1992,以及Banasik等,Mol.Cell.Biochem.,138:185-97,1994;WO00/39104;WO00/39070;WO99/59975;WO99/59973;WO99/11649;WO99/11645;WO99/11644;WO99/11628;WO99/11623;WO99/11311;WO00/42040;Zhang等,Biochem.Biophys.Res.Commun.,278:590-98,2000;White等,J.Med.Chem.,43:4084-4097,2000;Griffin等,.Med.Chem.,41:5247-5256,1998;Shinkwin等,Bioorg.Med.Chem.,7:297-308,1999以及Soriano等,Nature Medicine,7:108-113,2001。Milan等在Science,223:589-591,1984中讨论了与施用PARS抑制剂有关的副作用。
现有技术中之前已经讨论了异喹啉化合物。例如,Cushman等在J.Med.Chem.,43:3688-3698,2300中和Cushman等在J.Med.Chem.42:446-57,1999中报道的细胞毒非喜树碱拓扑异构酶I抑制剂;Cushman等在WO00/21537中报道用茚并[1,2-c]异喹啉作抗肿瘤药剂以及Hrbata等在WO93/05023报道中用茚并[1,2-c]异喹啉作肿瘤抑制剂。
已经报道了异喹啉化合物的合成。例如,参见Wawzonek等,Org.Prep.Proc.Int.14:163-8,1982;Wawzonek等,Can,J.Chem.59:2833,1981;Andoi等Bull.Chem.Soc.Japan,47:1014-17,1974;Dusemund等,ArcH。Pharm(Weinheim,Ger),317:381-2,1984;以及Lal等,Indian,J.Chem.,Sect.B,38B:33-39,1999。
但是,现在仍然存在对用于治疗或预防炎性疾病、再灌注损伤、糖尿病、糖尿病并发症、由器官移植引起的复氧损伤、预防缺血性病症、帕金森病、肾衰竭、血管病、心血管病或癌症的化合物的需求。
在本申请的第2部分中引用的任何参考文献并不是承认该参考文献为现有技术。
发明概述
在本发明的一个方面提供了式(I)的化合物及其可药用盐:
其中
为氢;
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余基团同时为-H;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
在另一方面本发明提供式(II)的化合物及其可药用盐:
其中
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、或-C(O)NH2取代,或者N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
式(I)的化合物或其可药用盐(“四环氨基化合物”)和式(II)的化合物或其可药用盐(“四环甲酰胺基化合物”)可用于治疗或预防炎性疾病、再灌注损伤、糖尿病、糖尿病并发症、由器官移植引起的复氧损伤、缺血性病症、帕金森病、肾衰竭、血管病、心血管病或癌症(各自为“病症”)。
本发明还提供用于治疗或预防病症的方法,包括施用需要所述治疗或预防的主体有效量的四环氨基化合物。
本发明还提供了包括有效量的四环氨基化合物和可药用载体或介质的组合物。
本发明还提供用于治疗或预防病症的方法,包括施用需要所述治疗或预防的主体有效量的四环甲酰胺基化合物。
本发明还提供了包括有效量的四环甲酰胺基化合物和可药用载体或介质的组合物。
下面通过说明书对本发明进行具体的描述。
尽管现在描述了本发明的示例性方法和材料,但任何与此处所述的相似或等同的方法和材料都可用于实践或检验本发明。从说明书和权利要求书中可明显地看出本发明的其它特征、目的和优点。本说明书引用的所有专利和公开都通过引用结合到本文中。
发明详述
定义和缩写
下列定义与四环氨基化合物和四环甲酰胺基化合物有关:
本文使用的术语“-C1-C5烷基”是指含1-5个碳原子的直链或支链的非环状烃,其中烃的氢原子之一被单个键代替。示例性的直链-C1-C5烷基包括-甲基、-乙基、-正丙基、-正丁基和-正戊基。示例性的支链-C1-C5烷基包括-异丙基、-仲丁基、-异丁基、-叔丁基、-异戊基、-新戊基、1-甲基丁基、2-甲基丁基、3-甲基丁基、1,1-二甲基丙基和1,2-二甲基丙基。
本文使用的术语“-C1-C6烷基”是指含1-6个碳原子的直链或支链的非环状烃,其中烃的氢原子之一被单个键代替。示例性的直链-C1-C6烷基包括-甲基、-乙基、-正丙基、-正丁基、-正戊基和-正己基。示例性的支链-C1-C6烷基包括-异丙基、-仲-丁基、-异丁基、-叔-丁基、-异戊基、-新戊基、-1-甲基丁基、-异己基、-新己基、-2-甲基丁基、-3-甲基丁基、-1,1-二甲基丙基和-1,2-二甲基丙基。
本文使用的术语“-C1-C10烷基”是指含1-10个碳原子的直链或支链的非环状烃,其中烃的氢原子之一被单个键代替。示例性的-C1-C10烷基包括甲基、乙基、丙基、丁基、戊基、己基、庚基、辛基、壬基、癸基、异丙基、异丁基、仲丁基和叔丁基、异戊基、新戊基、异己基、异庚基、异辛基、异壬基和异癸基。
本文使用的术语“-C1-C5亚烷基-”是指含1-5个碳原子的直链或支链的非环状烃,其中烃中的两个氢原子分别被单个的键所代替。示例性的-C1-C5-亚烷基包括亚甲基、亚乙基、亚丙基、亚丁基和亚戊基。其它的-C1-C5-亚烷基包括-CH(CH3)-、-CH2CH(CH3)-、-CH2CH2CH(CH3)-、-CH2CH(CH3)CH2-、-CH(CH3)CH(CH3)-、-CH2CH2CH2CH(CH3)-、-CH2CH2CH(CH3)CH2-、-CH(CH3)CH(CH3)CH2-和-CH(CH3)CH2CH(CH3)-。
“含氮的3-7元单环杂环”是指单环的3-7元的芳香或非芳香的单环环烷基,其中环烷基环的碳原子之一被氮原子取代并且0-4个余下的环烷基环的碳原子可独立地被N、O或S原子代替。含氮的3-7元单环杂环可以通过氮、硫或碳原子连接。含氮的3-7元单环杂环的示例包括但不限于哌啶基、哌嗪基、吡咯基、噁嗪基、噻嗪基、二嗪基、三嗪基、四嗪基、咪唑基、四唑基、吡咯烷基、异噁唑基、吡啶基、噁唑基、噻唑基、吡唑基、三唑基、嘧啶基和吗啉基。在一个方案中,含氮的3-7元单环杂环被独立地选自以下的1-3个基团取代:C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基。
“卤素”为-F、-Cl、-Br或-I。
“主体”为哺乳动物,例如人、小鼠、大鼠、豚鼠、狗、猫、马、牛、猪,或非人类的灵长类动物,如猴、黑猩猩、狒狒或恒河猴。在一个实施方案中,主体为人。
代表性的“可药用盐”包括,例如水溶性和非水溶性盐,如醋酸盐、安索酸盐(4,4-二氨基芪-2,2-二磺酸盐)、苯磺酸盐、苯甲酸盐、碳酸氢盐、硫酸氢盐、酒石酸氢盐、硼酸盐、溴化物、丁酸盐、乙二胺四乙酸钙盐、右旋樟脑磺酸盐、碳酸盐、柠檬酸盐、克拉维酸盐、二盐酸盐、乙二胺四乙酸盐、乙二磺酸盐、依托酸盐、乙磺酸盐、延胡索酸盐、葡庚糖酸盐、葡糖酸盐、谷氨酸盐、乙醇酰阿散酸盐、六氟磷酸盐、己基间苯二酚盐、海巴明、氢溴酸盐、盐酸盐、羟基萘甲酸盐、碘化物、异硫代硫酸盐、乳酸盐、乳糖酸盐、月桂酸盐、苹果酸盐、马来酸盐、扁桃酸盐、甲磺酸盐、甲基溴化物、甲基硝酸盐、甲基硫酸盐、粘酸盐、萘磺酸盐、硝酸盐、N-甲基葡糖铵盐、3-羟基-2-萘甲酸盐、油酸盐、草酸盐、棕榈酸盐、双羟萘酸盐(1,1-亚甲基-双-2-羟基3-萘甲酸盐,einbonate)、泛酸盐、磷酸盐/二磷酸、苦味酸盐、聚半乳糖醛酸盐、丙酸盐、对甲苯磺酸盐、水杨酸盐、硬脂酸盐、碱式乙酸盐、琥珀酸盐、硫酸盐、磺基水杨酸盐(sulfosaliculate)、suramate、丹宁酸盐、酒石酸盐、8-氯茶碱盐、甲苯磺酸盐、三乙基碘化物和戊酸盐。水合物为可药用盐的另一个实例。
在一个方案中,可药用盐为甲磺酸盐。
在另一个方案中,可药用盐为樟脑磺酸盐。
四环氨基化合物或四环甲酰胺基化合物使用的“有效量”是指对治疗或预防所述病症的有效的量。
与其它的抗癌剂一起使用时的“有效量”是指对单独或与四环氨基化合物或四环甲酰胺基化合物联合治疗或预防癌症时有效的量。“一起”包括在相同组合物内和分开的组合物内的给药。在后一情况中,在当四环氨基化合物或四环甲酰胺基化合物发挥其预防或治疗作用期间施用抗癌剂,或反之亦然。
式(I)的四环氨基化合物
本发明提供如下所示的式(I)的四环氨基化合物:
及其可药用盐,
其中:
R1、R2、R3和R4的定义同上述的式(I)的化合物的定义。
在一个方案中,R2为-NH(CH2)n-N(R5)(R6)且R1、R3和R4各自为氢。
在另一实施方案中,R3为-NH(CH2)n-N(R5)(R6)且R1、R2和R4各自为氢。
在另一实施方案中,R4为-NH(CH2)n-N(R5)(R6)且R1、R2和R3各自为氢。
在又一实施方案中,n为2。
仍在另一实施方案中,n为3。
仍在另一实施方案中,n为4。
在又一实施方案中,n为5。
在又一实施方案中,n为6。
在另一实施方案中N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基。
在各实施方案中,-N(R5)(R6)为:
式(I)的四环氨基化合物的示例包括如下所示的式(Ia)的化合物:
及其可药用盐。
式(I)的四环氨基化合物的其它示例包括如下所示的式(Ib)的化合物:
及其可药用盐。
式(I)的四环氨基化合物的其它示例包括如下所示的式(Ic)的化合物:
及其可药用盐。
式(I)的四环氨基化合物的其它示例包括如下所示的式(Id)的化合物:
及其可药用盐。
式(II)的四环甲酰胺基化合物
本发明提供如下所示的式(II)的四环甲酰胺基化合物:
(II)
及其可药用盐,
其中:
R1、R2、R3和R4的定义同上式(II)的化合物的定义。
在一个方案中,R1为-C(O)NH-(CH2)n-N(R5)(R6)且R2、R3和R4各自为氢。
在又一实施方案中,R2为-C(O)NH-(CH2)n-N(R5)(R6)且R1、R3和R4各自为氢。
在又一实施方案中,R3为-C(O)NH-(CH2)n-N(R5)(R6)且R1、R2和R4各自为氢。
在另一实施方案中,R4为-C(O)NH-(CH2)n-N(R5)(R6)且R1、R2和R3各自为氢。
在又一实施方案中,n为2。
在另一实施方案中,n为3。
在另一实施方案中,n为4。
在又一实施方案中,n为5。
在另一实施方案中N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基。
在各实施方案中,-N(R5)(R6)为:
式(II)的四环甲酰胺基化合物的示例包括如下所示的式(IIa)的化合物:
及其可药用盐。
式(II)的四环甲酰胺基化合物的其它示例包括如下所示的式(IIb)的化合物:
及其可药用盐。
式(II)的四环甲酰胺基化合物的其它示例包括如下所示的式(IIc)的化合物:
及其可药用盐。
式(II)的四环甲酰胺基化合物的其它示例包括如下所示的式(IId)的化合物:
及其可药用盐。
制备四环氨基化合物或四环甲酰胺基化合物的方法
在以下的实施例和反应图解1-4中阐述可用于制备四环氨基化合物和四环甲酰胺基化合物的方法。
反应图解1
其中X各自独立地是-Cl或-Br,且n,R5和R6如上述对式(I)化合物所定义的。
存在碱例如胺类碱的情况下,高邻苯二酸酐1可与式2的硝基苯化合物偶联得到式3的四环硝基中间体。可利用例如使用铂或钯催化剂的催化氢化还原3的硝基,以提供式4的氨基化合物。然后式4的化合物可与化学计量过量的式5的酸性卤化物反应,以提供式6的氨基化合物。然后可通过式NH(R5)(R6)的胺取代6的氯原子或溴原子得到式7的氨基化合物。最后,可利用氢化铝锂还原式7化合物的酰胺部分得到式(I)的四环氨基化合物。
反应图解2
其中R是甲基或乙基,且n,R5和R6如上述对式(II)化合物所定义的。
存在碱例如胺类碱的情况下,高邻苯二酸酐1可与式2的苯酯化合物偶联得到式3的四环硝基中间体。可在碱性或酸性条件下水解3的酯基得到式4的羧酸化合物。然后式3或式4的化合物可与式5的二氨烷基化合物(其可市购得到,或可利用有机合成领域普通技术人员公知的方法,通过二卤代烷基化合物与各种胺的反应而制得)偶联得到式(II)的四环甲酰胺基化合物。
反应图解3
其中n,R5和R6如上述对式(IIc)化合物的定义。
可根据方案3的一般步骤制备式(IIc)的化合物。可在回流条件下使溴代羧酸1与甲醇和硫酸反应得到溴代酯2。利用例如Pd(OAc)2和K4[Fe(CN)6],可将所述的溴代酯2转化成氰基酯3。用N-溴代琥珀酰胺和过氧化苯甲酰处理化合物3得到溴代苄基化合物4。化合物4和高邻苯二酸酐在乙腈中的反应提供了化合物5的稠合环结构。化合物5的酯水解后,加入偶联剂和所需的胺,得到式(IIc)的四环甲酰胺基化合物。
反应图解4
其中n,R5和R6如上述对式(IId)化合物的定义。
可根据方案4的一般步骤制备式(IId)的化合物。在回流条件下使溴代羧酸1与甲醇和硫酸反应得到溴代酯2。利用例如Pd(OAc)2和K4[Fe(CN)6],可将所述的溴代酯2转化成氰基酯3。用N-溴代琥珀酰胺和过氧化苯甲酰处理化合物3得到溴代苄基化合物4。化合物4和高邻苯二酸酐在乙腈中的反应得到化合物5的稠合环结构。化合物5的酯水解后,加入偶联剂和所需的胺,得到式(IId)的四环甲酰胺基化合物。
四环氨基化合物或四环甲酰胺基化合物的应用
根据本发明,对需要治疗或预防所述病症的主体施用四环氨基化合物或四环甲酰胺基化合物。
炎性疾病的治疗或预防
四环氨基化合物或四环甲酰胺基化合物可用于治疗炎性疾病。炎性疾病可由身体组织发炎引起。这些包括局部炎性反应和全身发炎。利用四环氨基化合物或四环甲酰胺基化合物能治疗的或可预防的炎性疾病的例子包括但不限于,器官移植排斥;关节的慢性炎性疾病,包括关节炎、类风湿性关节炎、骨关节炎和与增加的骨吸收有关的骨病;炎症性肠病,例如回肠炎、溃疡性结肠炎、巴特综合症和克罗恩氏病;炎症性肺病,例如哮喘、成人呼吸窘迫综合征和慢性阻塞性气道疾病;眼的炎性疾病,包括角膜营养不良、沙眼、盘尾丝虫病、葡萄膜炎、交感神经性眼炎和内眼炎;齿龈的慢性炎性疾病,包括齿龈炎和牙周炎;肺结核;麻风病;肾的炎性疾病,包括尿毒症性并发症、肾小球肾炎和肾变病;皮肤的炎性疾病,包括硬化性皮炎、银屑病和湿疹;中枢神经系统的炎性疾病,包括神经系统的慢性脱髓鞘疾病、多发性硬化、AIDS相关的神经退行性病变和阿尔茨海默氏病、传染性脑膜炎、脑脊髓炎、亨廷顿氏病、肌萎缩性侧索硬化、和病毒或自身免疫性脑炎;以及可具有显著的炎症性组分的各种其它疾病,包括先兆子痫;慢性肝功能衰竭、脑和脊髓创伤。炎性疾病也可为身体的系统性炎症,例如革兰氏阳性菌致休克或革兰氏阴性菌致休克、出血性休克或过敏性休克、或响应于促炎细胞因子由癌症化学疗法诱导的休克,例如与促炎细胞因子有关的休克。这种休克可以由例如作为癌症治疗剂给药的化疗剂所诱导。
在一个实施方案中,所述炎性疾病为关节的炎性疾病、齿龈的慢性炎性疾病、炎性肠病、炎性肺病、中枢神经系统的炎性疾病、眼的炎性疾病、革兰氏阳性菌致休克、革兰氏阴性菌致休克、出血性休克、过敏性休克、外伤性休克或化疗致休克。
再灌注损伤的治疗或预防
所述四环氨基化合物或四环甲酰胺基化合物可用于治疗再灌注损伤。再灌注指局部缺血后如在血管受压或阻塞之后,血液重新在血管中流动的过程。在一个自然发生的事件(例如心脏梗塞、中风)之后,或在有意或无意阻止血液在血管中流动的手术过程中,都可导致再灌注损伤。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的再灌注损伤的例子包括但不限于,肠再灌注损伤、心肌再灌注损伤和由心肺分流手术、主动脉瘤修复手术、颈动脉内膜切除术或出血性休克引起的再灌注损伤。
在一个实施方案中,再灌注损伤由心肺分流术、胸腹动脉瘤修复术、颈动脉内膜切除术或出血性休克引起。
由器官移植引起的复氧损伤的治疗或预防
利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防由器官移植引起的复氧损伤。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的复氧损伤的例子包括但不限于以下器官的移植:心、肝、肾、胰腺、肠和角膜。
在一个实施方案中,由器官移植引起的复氧损伤在器官移植期间发生。
缺血性病症的治疗或预防
该四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防缺血性病症。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的缺血性病症的例子包括但不限于,稳定型心绞痛、不稳定型心绞痛、心肌缺血、肝缺血、肠系膜动脉缺血、缺血性心脏病、肠缺血、危象肢缺血、慢性危象肢缺血、脑缺血、急性心脏缺血和中枢神经系统的缺血性病症,如中风或脑缺血。
在一个实施方案中,所述局部缺血的病症为心肌缺血、稳定型心绞痛、不稳定型心绞痛、中风、缺血性心脏病或脑缺血。
肾衰竭的治疗或预防
该四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防肾衰竭。
在一个实施方案中,所述肾衰竭为慢性肾衰竭。
在另一个实施方案中,所述肾衰竭为急性肾衰竭
血管病的治疗或预防
所述四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防除心血管病外的血管病。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的血管病的例子包括但不限于,外周动脉阻塞、血栓闭塞性脉管炎、Reynaud氏疾病和病征、肢端发绀、红斑性肢痛病、静脉血栓形成、静脉曲张、动静脉瘘、淋巴水肿和脂肪水肿。
心血管病的治疗或预防
所述四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防心血管病。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的心血管疾病的例子包括但不限于:慢性心力衰竭、动脉粥样硬化、充血性心力衰竭、高胆固醇血症、循环休克、心肌病、心脏移植、心肌梗塞和心律失常,诸如心房纤维性颤动、室上性心动过速、心房扑动和阵发性房性心动过速。
在一个方案中,心血管疾病为慢性心力衰竭。
在又一实施方案中,心血管疾病为心律失常。
在另一实施方案中,心律失常为心房纤维性颤动、室上性心动过速、心房扑动或阵发性房性心动过速。
糖尿病或糖尿病并发症的治疗或预防
该四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防糖尿病或其并发症。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的糖尿病的例子包括但不限于,I型糖尿病(胰岛素依赖型糖尿病)、II型糖尿病(非胰岛素依赖型糖尿病)、妊娠期糖尿病、自身免疫糖尿病、胰岛素病(insulinopathies)、胰腺疾病引起的糖尿病、与其它的内分泌疾病有关的糖尿病(如Cushing’s综合症、肢端肥大症、嗜铬细胞瘤、胰升血糖素瘤、原发性醛甾酮增多症或生长抑素瘤(somatostatinoma))、A型胰岛素抗性综合症、B型胰岛素抗性综合症、脂萎缩(lipatrophic)糖尿病和由β-细胞毒素诱发的糖尿病。
该四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防糖尿病并发症。利用所述四环氨基化合物或四环甲酰胺基化合物能治疗或可预防的糖尿病或其并发症的例子包括但不限于,糖尿病内障、青光眼、视网膜病、肾病(诸如microaluminuria和渐进式糖尿病肾病)、多发性神经炎(polyneuropathy)、足坏疽、免疫复合物脉管炎、系统性红斑狼疮(SLE)、粥样硬化性关状动脉疾病、外周动脉病、高渗性非酮症昏迷、单神经病、自发神经病(autonomicNeuropathy)、足溃疡、关节病和皮肤或粘膜并发症(诸如传染病、胫斑(a shin spot)、念珠菌感染或类脂质渐进性坏死diabeticorumobesity)、高脂血症、高血压、胰岛素抗性综合症、冠状动脉病、视网膜病、糖尿病性神经病变、多发性神经病、单神经病、自主神经病、足溃疡、关节病、真菌感染、心肌病和细菌感染。
帕金森病的治疗或预防
四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防帕金森病。
癌症的治疗或预防
四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防癌症。
本发明提供治疗或预防癌症的方法,包括对需要其的主体施用如下的治疗或预防:(i)有效量的四环氨基化合物,和(ii)有效量的其它抗癌剂。
本发明提供治疗或预防癌症的方法,包括对需要其的主体施用如下的治疗或预防:(i)有效量的四环甲酰胺基化合物,和(ii)有效量的其它抗癌剂。
可使用四环氨基化合物或四环甲酰胺基化合物进行治疗或预防的癌症的例子包括但不限于下表1所列的那些及其转移性癌。
表1
实体瘤,包括但不限于:
纤维肉瘤
粘液肉瘤
脂肉瘤
软骨肉瘤
骨原性肉瘤
脊索瘤
血管肉瘤
内皮肉瘤
淋巴管肉瘤
淋巴管内皮肉瘤
滑膜瘤
间皮瘤
尤因氏肉瘤
平滑肌肉瘤
横纹肌肉瘤
结肠癌
结肠直肠癌
肾癌
胰腺癌
骨癌
乳腺癌
卵巢癌
前列腺癌
食道癌
胃癌
口腔癌
鼻癌
咽喉癌
鳞状细胞癌
皮肤基底细胞癌
腺癌
汗腺癌
皮脂腺癌
乳头状癌
乳头状腺癌
囊腺癌
髓样癌
支气管肺癌
肾细胞癌
肝细胞瘤
胆管癌
绒膜癌
精原细胞瘤
胚胎癌
维耳姆斯瘤
宫颈癌
子宫癌
睾丸癌
小细胞肺癌
膀胱癌
肺癌
皮肤癌
黑色素瘤
转移性黑色素瘤
成神经细胞瘤
成视网膜细胞瘤
血源性癌,包括但不限于:
急性淋巴性白血病(“ALL”)
急性淋巴性B细胞白血病
急性淋巴性T细胞白血病
急性成髓细胞性白血病(“AML”)
急性早幼粒细胞性白血病(“APL”)
急性单核细胞性白血病
急性红白血病
急性巨核细胞性白血病
急性髓单核细胞性白血病
急性非淋巴细胞性(nonlyinphocyctic)白血病
急性未分化性白血病
慢性脊髓性白血病(“CML”)
慢性淋巴细胞性白血病(“CLL”)
毛细胞白血病
多发性骨髓瘤
急性和慢性白血病:
淋巴细胞性
骨髓性
淋巴细胞性
骨髓性白血症
淋巴瘤:
霍奇金病
非霍奇金淋巴瘤
多发性骨髓瘤
瓦尔登斯特伦氏巨球蛋白血症
重链病
真性红细胞增多症
中枢神经系统淋巴瘤
CNS和脑癌:
神经胶质瘤
纤维性星形细胞瘤
星形细胞瘤
间变型星形细胞瘤
多形性成胶质细胞瘤
成神经管细胞瘤
颅咽管瘤
室管膜瘤
松果体瘤
成血管细胞瘤
听神经瘤
少突神经胶质瘤
脑膜瘤
前庭神经鞘瘤
腺瘤
转移性脑肿瘤
脑膜瘤
脊髓肿瘤
成神经管细胞瘤
在一个实施方案中所述癌为肺癌、乳腺癌、结肠直肠癌、前列腺癌、白血病、淋巴瘤、非霍奇金淋巴瘤、皮肤癌、脑癌、中枢神经系统癌、卵巢癌、子宫癌、胃癌、胰腺癌、食道癌、肾癌、肝癌或头颈癌。
在另一个实施方案中所述癌为转移性癌。
仍然在另一个实施方案中,所述主体之前已接受或目前正接受癌症治疗。所述之前的治疗包括但不限于,在先前的化疗、放射治疗、手术或免疫疗法,如癌症疫苗。
所述四环氨基化合物或四环甲酰胺基化合物还可用于由病毒引起的癌症的治疗或预防。所述病毒包括人乳头状瘤病毒,其可导致宫颈癌(参见,例如,Hernandez-Avila等.,Archives of Medical Research(1997)28:265-271);Epstein-Barr病毒(EBV),其可导致淋巴瘤(参见,例如,Herrmann等.,J Pathol(2003)199(2):140-5);乙型或丙型肝炎病毒,其可导致肝癌(参见,例如,El-Serag,J Clin Gastroenterol(2002)35(5Suppl 2):S72-8);人T细胞白血病毒(HTLV)-I,其可导致T细胞白血病(参见例如,Mortreux等.,Leukemia(2003)17(1):26-38);人疱疹病毒-8感染,其可引起Kaposi’s肉瘤(参见,例如,Kadow等.,Curr Opin Investig Drugs(2002)3(11):1574-9);和人免疫缺陷病毒(HIV)感染,其可导致免疫缺陷引起的癌症(参见,例如,Dal Maso等.,Lancet Oncol(2003)4(2):110-9)。
癌症的预防方法
所述四环氨基化合物或四环甲酰胺基化合物还可以被给药以预防癌症的发展,包括但不限于列于表1中的癌症。所述预防用途包括其中出现由增生、组织变形或最显著的发育异常组成的非-肿瘤细胞生长。
可选择地或除了存在以增生、组织变形或发育异常表征的异常的细胞生长之外,来自主体的细胞样品体内或体外呈现的转化表型或恶性表型的一种或多种特征的存在可指示所述四环氨基化合物或四环甲酰胺基化合物预防/治疗给药的适合程度。所述转化表型的特征包括形态变化、较松的基底附着、接触抑制的丧失、锚定依赖性的丧失、蛋白酶释放、提高的糖转运、降低的血清需求、胚胎性抗原的表达、250,000道尔顿细胞表面蛋白的消失等等。(也参见同上,在第84-90页,与转化或恶性表型有关的特征)。
在特定的实施方案中,根据本发明的方法可治疗或预防黏膜白斑病、呈现良性的表皮增生或发育异常病变或博文氏病、原位癌。
在另一个实施方案中,可通过本发明方法治疗或预防纤维囊肿性病(囊性增生、乳腺发育不良、显著腺病(良性的上皮细胞增生))。
在其它的实施方案中,表现出一种或多种以下恶性肿瘤发病诱因的主体可施用有效治疗或预防癌症的适量四环氨基化合物或四环甲酰胺基化合物:与恶性肿瘤有关的染色体易位(例如,慢性粒性白血病的费城染色体,滤泡性淋巴瘤的t(14;18));家族性息肉病或Gardner′s综合症;良性单克隆丙种球蛋白病;与具有呈现孟德尔(遗传)遗传模式的癌症或癌前期疾病的人的第一度亲属关系(例如,结肠的家族性息肉病、Gardner′s综合症、遗传的外生骨疣、多内分泌腺腺瘤病、具有淀粉样蛋白产生的甲状腺髓样癌和嗜铬细胞瘤、黑斑息肉综合征、Von Recklinghausen神经纤维瘤、成视网膜细胞瘤、颈动脉体瘤、皮肤黑素癌、眼内黑素癌、着色性干皮病、共济失调毛细血管扩张、齐-希二氏综合征、白化病、Fanconi′s再生障碍性贫血和Bloom′s综合症);以及暴露于致癌物(例如,吸烟、暴露于二手烟和吸入或接触某些化学试剂)。
用于癌症治疗的联合化学疗法
在一个实施方案中,本发明用于治疗癌症或预防癌症的方法进一步包括施用其它的抗癌剂。
在一个实施方案中,本发明提供了用于治疗或预防癌症的方法,该方法包括对需要其的主体施用有效量的:(i)四环氨基化合物和(ii)其它的抗癌剂。
在另一个实施方案中,本发明提供了用于治疗或预防主体癌症的方法,该方法包括对需要其的主体施用有效量的:(i)四环甲酰胺基化合物和(ii)其它的抗癌剂。
所述(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它抗癌剂可同时施用。在该实施方案中,所述(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它抗癌剂可以在相同的组合物内施用,或者可以从不同的组合物经由相同或不同的给药途径施用。
在另一实施方案中,所述四环氨基化合物或四环甲酰胺基化合物在其它抗癌剂发挥其预防或治疗作用期间施用,反之亦然。
在一个实施方案中,以当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用四环氨基化合物或其他抗癌剂。
在另一个实施方案中,以当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用四环甲酰胺基化合物或其他抗癌剂。
在一个实施方案中,以少于当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用四环氨基化合物或其他抗癌剂。
在另一个实施方案中,以少于当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用四环甲酰胺基化合物或其他抗癌剂。
在一个实施方案中,四环氨基化合物和其他抗癌剂协同作用并以少于当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用。
在另一个实施方案中,四环甲酰胺基化合物和其他抗癌剂协同作用并以少于当所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用。
所施用的四环氨基化合物或其它的抗癌剂的剂量以及剂量日程表取决于各种参数,包括但不限于,正治疗的癌症、患者的总体健康状况和执业医师的考虑。
所施用的四环甲酰胺基化合物或其它的抗癌剂的剂量以及剂量日程表取决于各种参数,包括但不限于,正治疗的癌症、患者的总体健康状况和执业医师的考虑。
四环氨基化合物或四环甲酰胺基化合物可在其它的抗癌剂施用于需要其的主体之前(例如,5分钟、15分钟、30分钟、45分钟、1小时、2小时、4小时、6小时、12小时、24小时、48小时、72小时、96小时、1周、2周、3周、4周、5周、6周、8周或12周之前)、同时、或之后(例如,5分钟、15分钟、30分钟、45分钟、1小时、2小时、4小时、6小时、12小时、24小时、48小时、72小时、96小时、1周、2周、3周、4周、5周、6周、8周或12周之后)施用。在不同的实施方案中,i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂相隔1分钟、相隔10分钟、相隔30分钟、相隔小于1小时、相隔1小时至2小时、相隔2小时至3小时、相隔3小时至4小时、相隔4小时至5小时、相隔5小时至6小时、相隔6小时至7小时、相隔7小时至8小时相隔8小时至9小时、相隔9小时至10小时、相隔10小时至11小时、相隔11小时至12小时、相隔不超过24小时或相隔不超过48小时施用。在一个实施方案中,i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂相隔3小时施用。在另一个实施方案中,i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂相隔1分钟至24小时施用。
在一个实施方案中,有效量的四环氨基化合物和有效量的其它的抗癌剂存在于同一组合物中。在一个实施方案中,该组合物可用于口服。在另一个实施方案中,该组合物可用于静脉内给药。
在一个实施方案中,有效量的四环甲酰胺基化合物和有效量的其它的抗癌剂存在于同一组合物中。在一个实施方案中,该组合物可用于口服。在另一个实施方案中,该组合物可用于静脉内给药。
通过施用(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂可治疗的或预防的癌症包括但不限于,表1中所述癌症的列表。
在一个实施方案中,癌症为脑癌。
在特定的实施方案中,脑癌为纤维性星形细胞瘤、星形细胞瘤、间变型星形细胞瘤、多形性成胶质细胞瘤或转移性脑癌。
在特定的实施方案中,癌症为黑色素瘤。
在一个实施方案中,癌症为转移性黑色素瘤。
所述(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂可加成或协同作用。(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂的协同组合可允许使用更低剂量的该制剂的一种或两种和/或更少频率给药所述制剂到癌症主体。利用低剂量的(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂的一种或两种和/或更低频率地施用该制剂的能力可降低与该制剂施用主体有关的任何毒性而不降低该制剂在癌症治疗中的效力。此外,协同效应可产生该制剂在癌症治疗中改进的效力和/或与任一单独使用有关的任何不利或不需要的副作用的减少。
在一个实施方案中,(i)四环氨基化合物或四环甲酰胺基化合物和(ii)一种或多种其它的抗癌剂当以在所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用时产生协同作用。在另一个实施方案中,(i)四环氨基化合物或四环甲酰胺基化合物和(ii)一种或多种其它的抗癌剂当以小于所述制剂用作癌症治疗的单一治疗时通常采用的剂量施用时产生协同作用。
在一个实施方案中,有效量的(i)四环氨基化合物或四环甲酰胺基化合物和(ii)有效量的其它的抗癌剂的施用抑制癌症对其它的抗癌剂的抗性。在一个实施方案中,癌症为肿瘤。
可用于本发明方法和组合物中的合适的其他抗癌剂包括但不限于,替莫唑胺、拓扑异构酶I抑制剂、丙卡巴肼、达卡巴嗪、吉西他滨(gemcitabine)、卡西他滨(capecitabine)、氨甲喋呤、紫杉酚、多烯紫衫醇(taxotere)、巯基嘌呤、硫鸟嘌呤、羟基脲、阿糖胞苷环磷酰胺、异环磷酰胺、亚硝基脲、顺氯氨铂、卡波氯氨铂、丝裂霉素、达卡巴嗪、procarbizine、鬼臼亚乙苷、鬼臼噻吩苷、campathecins、博来霉素、阿霉素、伊达比星、柔红霉素、放线菌素、普卡霉素、米托蒽醌、左天冬酰胺酶、阿霉素、表柔比星、5-氟尿嘧啶、紫杉烷如多烯紫杉醇和紫杉醇、亚叶酸、左旋咪唑、伊立替康、雌氮芥、鬼臼亚乙苷、氮芥、BCNU、亚硝基脲如亚硝脲氮芥和环己亚硝脲、长春花生物碱类如长春花碱、长春新碱和长春瑞宾(vinorelbine)、铂复合物如顺氯氨铂、卡波氯氨铂和奥沙利铂、imatinib甲磺酸盐、六甲蜜胺、拓扑替康、酪氨酸激酶抑制剂、tyrphostins除莠霉素A、染料木素、erbstatin和lavendustin A。
在一个实施方案中,其他抗癌剂包括但不限于,列于表2中的药物。
表2
烷化剂
氮芥: 环磷酰胺
异环磷酰胺
曲磷胺
苯丁酸氮芥
亚硝基脲: 亚硝脲氮芥(BCNU)
环己亚硝脲(CCNU)
烷基磺酸盐: 白消安
曲奥舒凡(Treosulfan)
三氮烯: 达卡巴嗪
丙卡巴肼
替莫唑胺
含铂复合物: 顺氯氨铂
卡波氯氨铂
Aroplatin
奥沙利铂
植物生物碱类
长春花生物碱类: 长春新碱
长春花碱
长春地辛
长春瑞宾
紫杉化合物: 紫杉醇
多烯紫杉醇
DNA拓扑异构酶抑制剂
Epipodophyllins: 鬼臼亚乙苷
鬼臼噻吩苷
拓扑替康(Topotecan)
9-氨基喜树碱
喜树碱
Crisnatol
丝裂霉素: 丝裂霉素C
抗-代谢物
抗-叶酸盐:
DHFR抑制剂: 氨甲喋呤
三甲曲沙(Trimetrexate)
IMP脱氢酶抑制剂: 麦可酚酸
噻唑呋林(Tiazofurin)
利巴韦林(Ribavirin)
EICAR
核苷酸还原酶抑制剂:羟基脲
去铁胺
嘧啶类似物:
尿嘧啶类似物: 5-氟尿嘧啶
氟尿苷(Fluoxuridine)
去氧氟尿苷(Doxifluridine)
Ralitrexed
胞嘧啶类似物: 阿糖胞苷(araC)
阿糖胞嘧啶
氟达拉滨
吉西他滨
卡西他滨
嘌呤类似物: 巯嘌呤
硫鸟嘌呤
DNA抗代谢物: 3-HP
2′-脱氧-5-氟尿苷
5-HP
α-TGDR
阿非迪霉素甘氨酸盐
ara-C
5-氮杂-2′-脱氧胞苷
β-TGDR
环胞苷
鸟嘌呤唑(guanazole)
肌苷葡糖二醛
macebecin II
吡唑并咪唑
(Pyrazoloimidazole)
激素疗法:
受体拮抗体:
抗-雌激素: 他莫昔芬
雷洛昔芬
甲地孕酮
LHRH激动剂: 戈舍瑞林(Goscrclin)
乙酸亮丙瑞林
抗-雄激素:氟他胺(Flutamide)
比卡鲁胺(Bicalutamide)
维生素A类/Deltoids
顺式-维生素A酸
维生素A衍生物: 全-反式维生素A酸
(ATRA-IV)
维生素D3类似物: EB 1089
CB 1093
KH 1060
光动力疗法: 苯并卟啉衍生物单酸
(Vertoporfin)(BPD-MA)
酞菁染料
光敏剂Pc4
脱甲氧基-hypocrellin A
(2BA-2-DMHA)
细胞因子: 干扰素-α
干扰素-β
干扰素-γ
肿瘤坏死因子
白介素-2
血管生成抑制剂: 血素(纤溶酶原片段)
抗血管生成抗凝血酶III
血管酶(Angiozyme)
ABT-627
Bay 12-9566
氟草胺
贝伐单抗(Bevacizumab)
BMS-275291
源自软骨的抑制剂(CDI)
CAI
CD59补体片段
CEP-7055
Col3
Combretastatin A-4
内皮抑素(胶原XVIII片段)
纤连蛋白片段
Gro-β
氢溴酸常山酮(Halofuginone)
肝素酶
肝素多聚己糖片段
HMV833
人绒毛膜促性腺激素(hCG)
IM-862
干扰素α/β/γ
干扰素诱导蛋白(IP-10)
白介素-12
Kringle 5(纤溶酶原片段)
马立马司他(Marimastat)
金属蛋白酶抑制剂(TIMPs)
2-甲氧雌甾二醇
MMI270(CGS 27023A)
MoAb IMC-1C11
Neovastat
NM-3
Panzem
PI-88
胎盘核糖核酸酶抑制剂
纤溶酶原激活物抑制剂
血小板因子-4(PF4)
Prinomastat
催乳激素16kD片段
增殖蛋白-相关蛋白质(PRP)
PTK 787/ZK222594
维生素A类
Solimastat
角鲨胺(Squalamine)
SS3304
SU5416
SU6668
SU11248
四氢皮醇-S
四硫代钼酸盐
镇静剂
凝血酶致敏蛋白-1(TSP-1)
TNP-470
转化生长因子-β(TGF-β)
抑血管素(Vasculostatin)
Vasostatin(钙网蛋白片段)
ZD6126
ZD6474
金合欢基转移酶抑制剂(FTI)
二膦酸盐
抗有丝分裂剂: 异秋水仙碱
软海绵素B
秋水仙碱
秋水仙碱衍生物
dolstatin10
美坦生
根瘤菌素
Thiocolchicine
三苯甲基半胱氨酸
其它:
异戊二烯化抑制剂:
多巴胺能神经毒素: 1-甲基-4-苯基吡葎离子
细胞周期抑制剂: 星状孢子素(Staurosporine)
放线菌素: 放线菌素D
放线菌素
博来霉素: 博来霉素A2
博来霉素B2
培洛霉素(Peplomycin)
蒽环素类: 柔红霉素
阿霉素
伊达比星
表柔比星
吡柔比星
佐柔比星
米托蒽醌
MDR抑制剂: 维拉帕米
Ca2+ATP酶抑制剂 毒胡罗萝素(Thapsigargin)
可用于本发明组合物和方法中的其它的抗癌剂包括但不限于:阿西维辛;阿克拉霉素;阿考达唑盐酸盐;阿克罗宁;阿多来新;阿地白介素;六甲蜜胺;二霉素;乙酸阿美蒽醌;氨基导眠能;安丫啶;阿那舒唑;恩霉素;天冬酰胺酶;曲林菌素;阿扎胞苷;阿扎替派;叠氮霉素;巴马司他;苯佐替派;白卡罗他迈;盐酸比生群;双奈法德二甲磺酸盐(Bisnafide Dimesylate);比折来新;硫酸博来霉素;布列奎钠;溴匹立明;白消安;放线菌素C;卡普睾酮;卡醋胺;卡贝替姆;卡波铂;亚硝基脲氮芥;盐酸去甲柔红霉素;卡折来新;西地芬戈;苯丁酸氮芥;西罗霉素;顺式铂氨;克拉利宾;Crisnatol Mesylate;环磷酰胺;阿糖胞苷;氮烯咪胺;更生霉素;盐酸道诺红霉素;地西他滨;右奥马铂;地扎胍宁;地扎胍宁甲磺酸盐;地吖醌;泰索帝;阿霉素;盐酸多柔比星;屈洛昔芬;柠檬酸屈洛昔芬;丙酸甲氢睾酮;偶氮霉素;依达曲沙;Eflomithine盐酸盐;依沙芦星;恩洛铂;恩普氨酯;依匹哌啶;盐酸表柔比星;厄布洛唑;盐酸依索比星;雌氮芥;磷雌莫司汀钠;依他硝唑;鬼臼亚乙苷;磷依托泊苷;Etoprine;盐酸法屈唑;法扎拉滨;芬维A胺;氟尿嘧啶脱氧核苷;磷酸氟达拉滨;氟尿嘧啶;氟西他滨;磷喹酮;磷曲星钠盐;吉西他滨;盐酸吉西他滨;羟脲;盐酸伊达比星;异环磷酰胺;伊莫福新;白介素2(包括重组白介素2或rIL2);干扰素α-2α;干扰素α-2β;干扰素α-n1;干扰素α-n3;干扰素β-Iα;γ-Iβ干扰素;异丙铂;盐酸伊立替康;醋酸兰瑞肽;来曲唑;醋酸亮丙瑞林;利阿唑盐酸盐;洛美曲索钠盐;洛莫司汀;盐酸洛索蒽醌;马索罗酚;美坦生;盐酸二氯甲基二乙胺;乙酸甲地孕酮;甲烯雌醇乙酸酯;苯丙氨酸氮芥;美诺立尔;巯嘌呤;甲氨蝶呤;甲氨蝶呤钠;Metoprine;美妥替哌;米丁度胺;Mitocarcin;丝裂红素;丝林霉素;丝林马菌素;丝裂霉素;米托司培;米托坦;盐酸米托蒽醌;麦可酚酸;诺考达唑;诺加霉素;奥马铂;亚磺酰吡啶;紫杉醇;培加帕酶;佩里霉素;戊氮芥;硫酸培洛霉素;派磷酰胺;哌泊溴烷;哌泊舒凡;盐酸吡罗蒽醌;普卡霉素;普洛美坦;卟吩姆钠;紫菜霉素;泼尼莫司汀;盐酸甲基苄肼;嘌呤霉素;盐酸嘌呤霉素;吡唑呋喃菌素;利波腺苷;罗谷亚胺;沙芬戈;沙芬戈盐酸盐;司莫司汀;辛曲秦;sparfosate Sodium;稀疏霉素;盐酸锗螺胺;螺莫司汀;螺铂;链黑菌素;链脲霉素;磺氯苯脲;他利霉素;Tecogalan Sodium;替加氟;盐酸替洛蒽醌;替莫卟吩;鬼臼噻吩苷;替罗昔隆;睾内酪;硫咪嘌呤;硫鸟嘌呤;硫替哌;噻唑呋啉;替拉扎明;枸橼酸托瑞米芬;乙酸甲诺酮;磷酸曲西立滨;三甲曲沙;三甲曲沙葡糖醛酸脂;曲谱瑞林;盐酸妥布氯唑;尿嘧啶氮芥;乌瑞替派;伐普肽;维速达尔;硫酸长春灭瘟碱哪;硫酸长春花新碱钠;长春地辛;硫酸长春地辛;硫酸长春匹定;硫酸长春甘酯;硫酸长春罗新;酒石酸长春瑞宾;硫酸长春罗定;硫酸长春利定;伏氯唑;折尼铂;净司他丁和盐酸佐柔比星。
可用于本发明方法和组合物的另外的抗癌药包括但不限于:20-表-1,25-二氢维生素D3;5-乙炔尿嘧啶;阿比特龙;阿克拉霉素;肠癌酰基富烯;腺环戊醇;阿多来新;白细胞介素-2;ALL-TK拮抗物;六甲蜜胺;氨莫司汀amidox;氨磷汀;氨基乙酰丙酸;氨柔比星;atrsacrine;阿那格雷;阿那舒唑;穿心莲内酯;血管发生抑制剂;拮抗物D;拮抗物G;antarelix;anti-doralizing形态发生蛋白-1;抗雄激素;前列腺癌;抗雌激素;抗肿瘤物质;反义寡核苷酸;甘氨酸蚜栖菌素;细胞程序性死亡基因调制剂;细胞程序性死亡调节子;脱嘌呤核酸;ara-CDP-DL-PTBA精氨酸脱氨酶;asulacrine;阿霉素碳;阿莫司汀;axinastatin1;axinastatin2;axinastatin3;阿扎司琼azatoxin;重氮酪氨酸;浆果赤霉素III衍生物;balanol;巴马司他;BCR/ABL拮抗物;benzochlorins;benzoylstaurosporineβ内酰胺衍生物;β-alethine;亚阿克拉霉素B;桦木酸;bFGH抑制剂;白卡罗他迈;比生群;bisaziridinylspermine;双奈法德;bistratene A;比折来新;breflate;溴匹立明;布度钛;丁基硫堇硫氧胺;大力士软膏;calphostin C;喜树碱衍生物;金丝雀痘IL-2;卡培他滨;氨甲酰-氨基-三唑;羧氨基三唑;CaRest M3;CARN700;cartilaga衍生的抑制剂;卡折来新;酪蛋白激酶抑制制(ICOS);栗树精胺;杀菌肽B;西曲瑞克;氢卟酚;氯喹喔啉磺胺;西卡前列素;顺卟啉;克拉屈滨;氯米分类似物;克霉唑;collismycin A;collismycin B combretastatin A4;combretastatin类似物;conagenin;crambescidin816;crisnatol;念珠藻环肽8;念珠藻环肽A衍生物;curacin A;cyclopentanthraquinones;cycloplatam;cypemycin;阿糖胞苷ocfosfate;细胞溶解因子;cytostatin;达昔单抗;地西他滨dehydrodidemnin B;地洛瑞林;右异环磷酰胺;右雷佐生;右维拉帕米;亚胺醌;膜海鞘素B;didox;二甲基去甲精胺(di乙基norspermine);二氢-5-氮胞苷;二氢紫杉醇,9-;二氨基乙二酰;二苯基螺莫司汀;二十二烷醇;多拉司琼;去氧氟尿苷;屈洛昔芬;屈大麻酚;duocannycin SA;依布硒啉;依考莫司汀;依地福新;依决洛单抗;依氟鸟氨酸;榄香烯;乙嘧替氟;表柔比星;爱普列特;雌氮芥类似物;雌激素激动剂;雌激素拮抗剂;依他硝唑;磷酸鬼臼亚乙苷;依曼适达;法屈唑;法扎拉滨;芬维A胺;非格司亭;fmasterideflavopiridol;flezelastine;fluasterone氟达拉滨fluorodaunorunicinhydrochloride;福酚美克;福美司坦;磷烯菌素;福莫司汀gadoliniumtaxaphyrin;硝酸镓;加洛他滨;加尼瑞克;明胶酶抑制剂21-去氧-21,21-二氟胞嘧啶;谷胱甘肽抑制剂hepsulfam;heregulin;六亚甲基二乙酰胺;金丝桃素;依班膦酸;伊达比星;艾多昔芬;伊决孟酮;伊莫福新;伊洛马司他imidazoacridones;咪喹莫特;免疫刺激肽;类胰岛素生长素-1受体抑制剂;干扰素激动剂;干扰素;白细胞介素;碘苄胍;iododoxorubicin;4-蕃薯宁;伊立替康;伊罗普拉;伊索拉定;isobengazole;isohomohalicondrin B伊他司琼;jasplakinolide;kahalalide F;lamellarin-N triacetate;兰瑞肽;leinamycin;来格司亭;硫酸蘑菇多糖leptolstatin;来曲唑;白血病抑制因子;白细胞α干扰素;亮丙瑞林+雌激素+孕酮;亮丙瑞林;左旋咪唑;利阿唑;线性多氨基类似物;亲脂性二糖肽;亲脂性铂化合物;lissoclinamide7;络铂;蚯蚓磷脂;洛美曲索;氯尼达明;洛索蒽醌;洛伐他汀;洛索立宾;勒托替康;德克萨斯卟啉镥;lysofylline裂解肽;美坦辛;制甘糖霉素A;马立马司他;马索罗酚;maspin;基质裂解素抑制剂;基质金属蛋白酶抑制剂;美诺立尔;麦尔巴隆;meterelin;甲硫氨酸酶;甲氧氯普胺;MIF抑制剂;米非司酮;米特福辛;mirimostin;错配双链RNA;米托胍腙;二溴卫矛醇;丝裂霉素类似物;米托萘胺;mitotoxin成纤维细胞生长因子-saporin;米托蒽醌;莫法罗汀;沙格司亭;单克隆抗体;人绒膜促性腺激素;单磷脂A十分枝杆菌细胞壁sk;莫哌达醇;多抗药性基因抑制剂;多肿瘤抑制剂1基本疗法;芥子抗癌剂;mycaperoxideB;分枝杆菌细胞壁提取物;myriaporone;N-乙酰地那林;N-取代的苯甲酰胺;那法瑞林;nagrestip;纳洛酮+潘他唑新;napavin;naphterpin;那托司亭;奈达泊汀;奈莫柔比星;奈立膦酸;中性内肽酶;尼鲁米特;nisamycin;氧化氮调制剂;硝基氧抗氧化剂;nitrullyn;O6-苄基鸟嘌呤;奥曲肽;okicenone;寡核苷酸;奥纳司酮;昂丹司琼;恩丹西酮;oracin;口服细胞因子诱导剂;奥马铂;奥沙特隆;oxaliplain;oxaunomycin;紫杉醇类似物;紫杉醇衍生物;palauamine;棕榈酰利索新;帕米膦酸;人参炔三醇;帕诺米芬;副球菌素;帕折普汀;培加帕酶;peldesine;戊聚糖多硫酸钠,戊制菌素;pentrozole;全氟溴烷;派磷酰胺;紫苏子醇;phenazinomycin;苯乙酸;磷酸酶抑制剂;picibanil;盐酸毛果碱;吡柔比星;吡曲克辛;placetin A;placetin B;溶酶原激活物抑制剂;铂复合物;铂化合物;铂三氨基复合物;泊非美钠;甲基丝裂霉素;丙基双-吖啶酮;前列腺素J2;蛋白酶体抑制剂;蛋白A基的免疫调制剂;蛋白激酶C抑制剂;蛋白激酶C抑制剂;微小藻类;蛋白酪氨酸磷酸酶抑制剂;嘌呤核苷磷酸化酶抑制剂;嘌呤;pyrazoloacridine;pyridoxylated血红蛋白聚氧乙烯交联物;raf拮抗剂;雷替曲塞;拉莫司琼;ras法呢酯蛋白转移酶抑制剂;ras抑制剂ras-GAP抑制剂;retelliptine demethylated;铼Re186etidronate;利索新;核酶;RII维甲胺;罗谷亚胺;rohitukine;罗莫肽;罗喹美克;rubiginone B1;ruboxyl;沙芬戈;saintopin;SarCNU;sarcophytol A;沙格司亭;Sdi1模拟物;司莫司汀;衰老衍生抑制剂1;有义链寡核苷酸;信号转导抑制剂;信号转导调节剂;单链抗原结合蛋白;西佐喃;索布佐生;硼卡钠;苯乙酸钠;solverol;生长调节素结合蛋白;索纳明;斯帕福斯酸;穗霉素D;螺莫司汀;splenopentin;海绵素1;角鲨烯胺;干细胞抑制剂;干细胞分裂抑制剂;stipiamide;溶基质素抑制剂;sulfmosine;超活跃的血管活性肠肽拮抗剂;suradista;苏拉明;苦马豆素;合成的糖胺聚糖;他莫司汀;三苯氧胺methiodide;牛磺莫司汀;他佐罗汀;tecogalan sodium;替加氟;tellurapyrylium;端粒酶抑制剂;替莫卟吩;帝盟多那买;表鬼臼毒噻吩糖苷;tetrachlorodecaoxide;tetrazomine;thaliblastine;沙利度胺;thiocoraline;血小板生成素;血小板生成素模拟物;日达仙(tm)胸腺1;胸腺生成素受体激动剂;胸腺曲南;促甲状腺激素;乙基初卟啉锡(tinethyl etiopurpurin);替拉扎明;二氯二茂钛;拓扑特肯;topsentin;脱瑞米芬;全能干细胞因子;翻译抑制剂;维A酸;三乙酰尿苷;曲西立滨;三甲曲沙葡糖醛酸脂;曲普瑞林;托烷司琼;妥罗雄脲;酪氨酸激酶抑制剂;酪氨酸磷酸化抑制剂UBC抑制剂;乌苯美司;尿生殖窦衍生生长抑制因子;尿激酶受体拮抗物;伐普肽;variolin B;载体系统;红细胞基因疗法;维拉雷琐;veramine;verdins;维特卟吩;长春瑞宾;vinxaltine;vitaxin;伏罗唑;扎诺特隆;折尼铂;亚苄维C和净司他丁斯酯等。
在另一个实施方案中,其它的抗癌剂为干扰素-α。
在另一个实施方案中,其它的抗癌剂为白介素-2。
在一个实施方案中,其它的抗癌剂为烷化剂,如氮芥、亚硝基脲、烷基磺酸盐、三氮烯或含铂制剂。
在另一个实施方案中,其它的抗癌剂为三氮烯烷化剂。
在特定的实施方案中,其它的抗癌剂为替莫唑胺。
替莫唑胺可以约60mg/m2(受试者的体表面积)至约250mg/m2以及约100mg/m2至约200mg/m2范围的剂量施用于受试者。在特定的实施方案中,替莫唑胺的剂量为大约10mg/m2,约1mg/m2,约5mg/m2,约10mg/m2,约20mg/m2,约30mg/m2,约40mg/m2,约50mg/m2,约60mg/m2,约70mg/m2,约80mg/m2,约90mg/m2,约100mg/m2,约110mg/m2,约120mg/m2,约130mg/m2,约140mg/m2,约150mg/m2,约160mg/m2,约170mg/m2,约180mg/m2,约190mg/m2,约200mg/m2,约210mg/m2,约220mg/m2,约230mgm2,约240mg/m2或约250mg/m2。
在特定的实施方案中,替莫唑胺口服施用。
在一个实施方案中,替莫唑胺以约150mg/m2至约200mg/m2范围的剂量口服施用于受试者。
在另一个实施方案中,替莫唑胺以约150mg/m2至约200mg/m2范围的剂量每天一次连续五天口服施用于受试者。
在特定的实施方案中,替莫唑胺在第1-5天以约150mg/m2至约200mg/m2范围的剂量每天一次连续五天口服施用受试者,随后再次在第28-32天以约150mg/m2至约200mg/m2范围的剂量每天一次连续五天口服施用,随后再次在第55-59天以约150mg/m2至约200mg/m2范围的剂量每天一次连续五天口服施用。
在特定的实施方案中,其它的抗癌剂为丙卡巴肼。
丙卡巴肼可以约50mg/m2(受试者的体表面积)至约100mg/m2以及约60mg/m2至约100mg/m2范围的剂量施用到受试者。在特定的技术方案中,丙卡巴肼的剂量为约10mg/m2,约1mg/m2,约5mg/m2,约10mg/m2,约20mg/m2,约30mg/m2,约40mg/m2,约50mg/m2,约60mg/m2,约70mg/m2,约80mg/m2,约90mg/m2,约100mg/m2,约110mg/m2,约120mg/m2,约130mg/m2,约140mg/m2,约150mg/m2,约160mg/m2,约170mg/m2,约180mg/m2,约190mg/m2,约200mg/m2,约210mg/m2,约220mg/m2,约230mg/m2,约240mg/m2,约250mg/m2,约260mg/m2,约270mg/m2,约280mg/m2,约290mg/m2,约300mg/m2,约310mg/m2,约320mg/m2,约330mg/m2,约340mg/m2,约350mg/m2,约360mg/m2,约370mg/m2,约380mg/m2,约390mg/m2,约400mg/m2,约410mg/m2,约420mg/m2,约430mg/m2,约440mg/m2,约450mg/m2,约460mg/m2,约470mg/m2,约480mg/m2,约490mg/m2,或约500mg/m2。
在特定的实施方案中,丙卡巴肼静脉内施用。
在一个实施方案中,丙卡巴肼以约50mg/m2至约100mg/m2范围的剂量静脉内施用受试者。
在另一个实施方案中,丙卡巴肼以约50mg/m2至约100mg/m2范围的剂量每天一次连续五天静脉内施用受试者。
在特定的实施方案中,丙卡巴肼在第1-5天以约50mg/m2至约100mg/m2范围的剂量每天一次连续五天静脉内施用受试者,随后再次在第28-32天以约50mg/m2至约100mg/m2范围的剂量每天一次连续五天静脉内施用,随后再次在第55-59天以约50mg/m2至约100mg/m2范围的剂量每天一次连续五天静脉内施用。
在另一个实施方案中,丙卡巴肼以约50mg/m2至约100mg/m2范围的剂量静脉内一次施用受试者。
在特定的实施方案中,其它的抗癌剂为达卡巴嗪。
达卡巴嗪可以约60mg/m2(受试者的体表面积)至约250mg/m2以及约150mg/m2至约250mg/m2范围的剂量施用受试者。在特定的实施方案中,达卡巴嗪的剂量为约10mg/m2,约1mg/m2,约5mg/m2,约10mg/m2,约20mg/m2,约30mg/m2,约40mg/m2,约50mg/m2,约60mg/m2,约70mg/m2,约80mg/m2,约90mg/m2,约100mg/m2,约110mg/m2,约120mg/m2,约130mg/m2,约140mg/m2,约150mg/m2,约160mg/m2,约170mg/m2,约180mg/m2,约190mg/m2,约200mg/m2,约210mg/m2,约220mg/m2,约230mg/m2,约240mg/m2,约250mg/m2,约260mg/m2,约270mg/m2,约280mg/m2,约290mg/m2,约300mg/m2,约310mg/m2,约320mg/m2,约330mg/m2,约340mg/m2,约350mg/m2,约360mg/m2,约370mg/m2,约380mg/m2,约390mg/m2,约400mg/m2,约410mg/m2,约420mg/m2,约430mg/m2,约440mg/m2,约450mg/m2,约460mg/m2,约470mg/m2,约480mg/m2,约490mg/m2,或约500mg/m2。
在特定的实施方案中,达卡巴嗪静脉内施用。
在一个实施方案中,达卡巴嗪以约150mg/m2至约250mg/m2范围的剂量静脉内施用受试者。
在另一个实施方案中,达卡巴嗪以约150mg/m2至约250mg/m2范围的剂量每天一次连续五天静脉内施用受试者。
在特定的实施方案中,达卡巴嗪在第1-5天以约150mg/m2至约250mg/m2范围的剂量每天一次连续五天静脉内施用受试者,随后再次在第28-32天以约150mg/m2至约250mg/m2范围的剂量每天一次连续五天静脉内施用,随后再次在第55-59天以约150mg/m2至约250mg/m2范围的剂量每天一次连续五天静脉内施用。
在一个实施方案中,达卡巴嗪以约150mg/m2至约250mg/m2范围的剂量静脉内一次施用受试者。
在一个实施方案中,其它的抗癌剂为拓扑异构酶I抑制剂,如鬼臼亚乙苷、鬼臼噻吩苷、拓扑替康、伊立替康、9-氨基喜树碱、喜树碱或crisnatol。
在特定的实施方案中,其它的抗癌剂为伊立替康。
伊立替康可以约50mg/m2(受试者的体表面积)至约150mg/m2以及约75mg/m2至约150mg/m2范围的剂量施用受试者。在特定的实施方案中,伊立替康的剂量为约10mg/m2,约1mg/m2,约5mg/m2,约10mg/m2,约20mg/m2,约30mg/m2,约40mg/m2,约50mg/m2,约60mg/m2,约70mg/m2,约80mg/m2,约90mg/m2,约100mg/m2,约110mg/m2,约120mg/m2,约130mg/m2,约140mg/m2,约150mg/m2,约160mg/m2,约170mg/m2,约180mg/m2,约190mg/m2,约200mg/m2,约210mg/m2,约220mg/m2,约230mg/m2,约240mg/m2,约250mg/m2,约260mg/m2,约270mg/m2,约280mg/m2,约290mg/m2,约300mg/m2,约310mg/m2,约320mg/m2,约330mg/m2,约340mg/m2,约350mg/m2,约360mg/m2,约370mg/m2,约380mg/m2,约390mg/m2,约400mg/m2,约410mg/m2,约420mg/m2,约430mg/m2,约440mg/m2,约450mg/m2,约460mg/m2,约470mg/m2,约480mg/m2,约490mg/m2,或约500mg/m2。
在特定的实施方案中,伊立替康静脉内施用。
在一个实施方案中,伊立替康以约50mg/m2至约150mg/m2范围的剂量静脉内施用受试者。
在另一个实施方案中,伊立替康以约50mg/m2至约150mg/m2范围的剂量每天一次连续五天静脉内施用受试者。
在特定的实施方案中,伊立替康在第1-5天以约50mg/m2至约150mg/m2范围的剂量每天一次连续五天静脉内施用受试者,随后再次在第28-32天以约50mg/m2至约150mg/m2范围的剂量每天一次连续五天静脉内施用,随后再次在第55-59天以约50mg/m2至约150mg/m2范围的剂量每天一次连续五天静脉内施用。
在一个实施方案中,本发明提供施用有效量的:(i)四环氨基化合物或四环甲酰胺基化合物(ii)一种或多种其它的抗癌剂。
在一个实施方案中,(i)四环氨基化合物或四环甲酰胺基化合物和(ii)一种或多种其它的抗癌剂协同作用并且以少于当所述制剂用作癌症治疗的单一治疗时通常采用的剂量来施用。
所施用的(i)四环氨基化合物或四环甲酰胺基化合物和(ii)一种或多种其它的抗癌剂的剂量以及剂量日程表取决于各种参数,包括但不限于,正在治疗的癌症、患者的总体健康状况和执业医师的考虑。
在一个实施方案中,其它的抗癌剂为O-6-苄基鸟嘌呤。
在另一个实施方案中,其它的抗癌剂为O-6-苄基鸟嘌呤和替莫唑胺。
在另一个实施方案中,其它的抗癌剂为O-6-苄基鸟嘌呤和丙卡巴肼。
在另一个实施方案中,其它的抗癌剂为O-6-苄基鸟嘌呤和达卡巴嗪。
癌症的多方式疗法
四环氨基化合物或四环甲酰胺基化合物可施用于已经接受或目前正接受一种或多种另外的抗癌疗法,包括但不限于手术、放射治疗或免疫疗法如癌症疫苗的主体。
在一个实施方案中,本发明提供用于治疗或预防癌症的方法,包括对需要其的主体施用(a)治疗或预防癌症有效的适量四环氨基化合物或四环甲酰胺基化合物;和(b)另一种抗癌疗法包括但不限于,手术、放射治疗或免疫疗法,如癌症疫苗。
在一个实施方案中,其它的抗癌疗法为放射疗法。
在另一个实施方案中,其它的抗癌疗法为手术。
仍然在另一个实施方案中,其它的抗癌疗法为免疫疗法。
在特定的实施方案中,用于治疗或预防癌症的本方法包括施用(i)有效量的四环氨基化合物或四环甲酰胺基化合物和(ii)放射疗法。放射疗法可在四环氨基化合物或四环甲酰胺基化合物的同时、之前或之后施用,在一个实施方案中,为四环氨基化合物或四环甲酰胺基化合物施用之前或之后的至少一小时、五小时、12小时、一天、一周、一个月,在另一个实施方案中,为几个月(例如,上至三个月)。
其中其它的抗癌疗法为放射疗法,取决于所治疗的癌症类型,可利用任何放射疗法方案。例如,而不是当作限制,可施用X射线辐射;尤其是,高能兆伏(大于1MeV能量的放射线)可用于深度肿瘤,并且电子束和中电压X射线辐射可用于皮肤癌。还可以施用γ-射线发射放射性同位素,如镭、钴和其他元素的放射性同位素。
另外,本发明提供利用四环氨基化合物或四环甲酰胺基化合物作为化学疗法或放射疗法的替代方案治疗癌症的方法,其中化学疗法或放射疗法在所治疗的主体中引起负面的副作用。所治疗的主体可选择性地用另一种抗癌疗法如手术、放射疗法或免疫疗法治疗。
四环氨基化合物或四环甲酰胺基化合物还可以体外或体内用于例如某些癌症的治疗,包括但不限于白血病和淋巴瘤,所述治疗包括自体干细胞移植。此可包括这样的过程,其中收集主体的自体造血干细胞以及清除所有癌细胞,随后通过施用四环氨基化合物或四环甲酰胺基化合物和/或放射线根除主体的残留的骨-骨髓细胞群,以及将生成的干细胞注回入主体。在骨髓功能恢复以及主体康复过程中可接着提供支持性的护理。
本发明组合物治疗性的/预防性的给药
由于四环氨基化合物和四环甲酰胺基化合物的活性,它们可有利地用于兽医学和人类医学领域。如上所示,四环氨基化合物或四环甲酰胺基化合物可用于治疗或预防需要其的主体中的所述病症。
所述四环氨基化合物或四环甲酰胺基化合物可以有效治疗或预防主体中所述病症的量施用。
当对主体给药时,所述四环氨基化合物或四环甲酰胺基化合物可以作为包括生理学可接受的载体或媒介物的组合物中的组分给药。本发明的包括所述四环氨基化合物或四环甲酰胺基化合物的组合物可以口服给药。所述四环氨基化合物或四环甲酰胺基化合物还可以任何其它方便的途径给药,例如,通过输注或浓集(bolus)注射,通过上皮或粘膜皮肤(例如口腔粘膜、直肠粘膜和肠粘膜)的吸收,并且可与其它的生物活性剂一同给药。给药可以是全身或局部的。可以使用各种已知的递送体系,例如可以给药在脂质体、微粒、微胶囊和胶囊中的囊封系统。
给药方法包括但不限于皮内、肌内、腹膜内、静脉内、皮下、鼻内、硬膜外、经口、舌下、脑内、阴道内、透皮、直肠给药,通过吸入给药,或局部给药,特别是对耳、鼻、眼或皮肤的局部给药。在有些情况下,给药将使四环氨基化合物或四环甲酰胺基化合物释放入血流中。
在一个实施方案中,口服施用所述四环氨基化合物或四环甲酰胺基化合物。
在其它实施方案中,理想地可将所述四环氨基化合物或四环甲酰胺基化合物局部给药。这可以通过例如以下的非限制性方式实现:在手术期间通过局部输注;局部施用(如在术后与创伤敷料结合使用);通过注射,借助于导管、借助于栓剂或灌肠剂、或借助于植入物,所述植入物为多孔性、非多孔性或凝胶状物质,包括膜如sialastic膜或纤维。
在某些方案中,理想地可通过任何适当的途径将所述四环氨基化合物或四环甲酰胺基化合物引入到中枢神经系统或胃肠道中,所述途径包括心室内、鞘内注射、硬膜外注射和灌肠剂。心室内注射可以通过心室内导管变得更为方便,所述导管如附着于容器如Ommaya容器的心室内导管。
还可使用经肺给药,例如使用喷雾器的吸入器、和与雾化剂一起配制,或通过在碳氟化合物或合成的肺表面活性剂中的灌注。在某些方案中,所述四环氨基化合物或四环甲酰胺基化合物可以与常规的粘合剂和赋形剂如甘油三酯配制成栓剂。
在另一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可以在小泡特别是脂质体中被递送(参见Langer,Science 249:1527-1533(1990)和Treat or prevent等人,Liposomes in the Therapy ofInfectious Disease and Cancer 317-327和353-365(1989))。
在其它方案中,所述四环氨基化合物或四环甲酰胺基化合物可以在控释系统或缓释系统中被递送(例如参见Goodson,Medical Applications ofControlled Release,supra,vol.2,pp.115-138(1984))。可使用在Langer,Science 249:1527-1533(1990)的综述中讨论的其它的控释或缓释系统。在一个方案中可使用泵(Langer,Science 249:1527-1533(1990);Sefton,CRC Crit.Ref.Biomed.Eng.14:201(1987);Buchwald等人,Surgery 88:507(1980);和Saudek等人,N.Engl.J Med.321:574(1989))。在另一个实施方案中,可使用聚合物材料(参见Medical Applications of ControlledRelease(Langer和Wise eds.,1974);Controlled Drug Bioavailability,DrugProduct Design and Performance(Smolen和Ball eds.,1984);Ranger和Peppas,J.Macromol.Sci.Rev.MCromol.Chem.,2:61(1983);Levy等人,Science228:190(1935);During等人,Ann.Neural.25:351(1989);和Howard等人,J.Neurosurg.71:105(1989))。
在另一方案中,可将控释或缓释体系置于所述四环氨基化合物或四环甲酰胺基化合物的目标附近,如脊柱、脑、皮肤、肺或胃肠道,因此仅需要全身剂量的一部分。
本发明的组合物可以任选包括适量的生理学可接受的赋形剂以提供用于适当施用于主体的形式。
这些生理学可接受的赋形剂可以是液体如水和油,包括石油、动物油、植物油或合成来源的油如花生油、大豆油、矿物油、芝麻油等。生理学可接受的赋形剂可以是盐水、阿拉伯树胶、明胶、淀粉糊、滑石、角蛋白、胶态氧化硅、脲等。另外,可使用辅助剂、稳定剂、增稠剂、润滑剂和着色剂。在一个方案中,生理学可接受的赋形剂当对主体给药时是无菌的。当所述四环氨基化合物或四环甲酰胺基化合物经静脉内给药时,水可以是特别有用的赋形剂。还可以使用盐水溶液和右旋糖水溶液和甘油溶液作为液体赋形剂,特别是注射液用液体赋形剂。合适的生理学可接受的赋形剂还包括淀粉、葡萄糖、乳糖、蔗糖、明胶、麦芽、米、面粉、白垩、硅胶、硬脂酸钠、单硬脂酸甘油酯、滑石、氯化钠、脱脂奶粉、甘油、丙二醇、水、乙醇等。如果需要,本发明的组合物还可包括少量的润湿剂或乳化剂或pH缓冲剂。
本发明的组合物可以是以下形式:溶液、悬浮剂、乳剂、片剂、丸剂、颗粒剂、胶囊、含有液体的胶囊、粉末剂、缓释剂、栓剂、乳剂、气雾剂、喷雾剂、混悬剂、或任何其它适于使用的剂型。组合物的一个方案是胶囊形式(例如参见美国专利5,698,155)。合适的生理学可接受的赋形剂的其它例子在并入本文作为参考的Remington’s PharmceuticalSciences 1447-1676(Alfonso R.Gennaro eds.,19th ed.1995)中描述。
在一个方案中,四环氨基化合物或四环甲酰胺基化合物根据常规过程配制为适于对人口服给药的组合物。口服给药的组合物可以是例如片剂、锭剂、水悬浮剂或油悬浮剂、粒剂、粉末剂、乳剂、胶囊、糖浆剂或酏剂的形式。口服给药的组合物可以含有一种或多种试剂,例如,甜味剂如果糖、阿斯巴甜或糖精;调味剂,如胡椒薄荷、冬青油或樱桃;着色剂;和防腐剂,以提供治疗学适口的制剂。另外,其中在片剂或丸剂形式中,组合物可以被包衣以延迟在胃肠道中的崩解和吸收,从而提供在延长时段内的持续作用。包绕的选择性渗透膜主动性驱动四环氨基化合物或四环甲酰胺基化合物也适于口服给药组合物。在这些后述平台中,得自胶囊周围环境的流体可以被驱动化合物吸入,其溶胀以移动药剂或药剂组合物通过孔,这些递送平台可以提供与立即释放制剂的尖峰曲线相对比的基本上为0级的递送曲线。还可以使用延时材料如单硬脂酸甘油酯或硬脂酸甘油酯。口服组合物可包括标准的赋形剂,如甘露醇、乳糖、淀粉、硬脂酸镁、糖精钠、纤维素和碳酸镁。在一个方案中,赋形剂为药用级的。
在另一个实施方案中,四环氨基化合物或四环甲酰胺基化合物可以配制用于静脉内给药。一般地,静脉内给药用组合物包括无菌的等渗的水性缓冲液。如果必要,该组合物也可包括增溶剂。静脉内给药用组合物可任选包括局部麻醉剂如利多卡因以减轻在注射部位的疼痛。通常,各成分可以分别供给、或在单位剂型中混合在一起被供给,例如作为在标明活性剂用量的密闭容器如安瓿或小瓶中的冻干粉末或无水浓缩物。当四环氨基化合物或四环甲酰胺基化合物通过输注给药时,它们可以使用例如含有无菌药用级的水或盐水的输液瓶进行分配。当四环氨基化合物或四环甲酰胺基化合物通过注射给药时,可以提供注射用无菌水或盐水的安瓿使得各成分在给药前可以混合。
四环氨基化合物和四环甲酰胺基化合物可以控释或缓释方式或通过本领域普通技术人员公知的递送装置进行给药。例子包括但不限于在美国专利3,845,770、3,916,899、3,536,809、3,598,123、4,008,719、5,674,533、5,059,595、5,591,767、5,120,548、5,073,543、5,639,476、5,354,556和5,733,556中所述的那些,每篇都专利作为参考并入本文。这些剂型可使用例如以下的物质用于提供一种或多种活性成分的控释释放或缓释释放:羟丙基甲基纤维素、其它聚合基质、凝胶、渗透膜、渗透系统、多层包衣、微粒、脂质体、微球体、或其组合,以提供不同比例的所需的释放曲线。本领域技术人员公知的适当的控释或缓释制剂包括本文所述的那些,可以容易地选择用于本发明的活性成分。因此,本发明包括适于口服给药的独立的单位剂型,例如但不限于片剂、胶囊、胶囊锭和适于控释或缓释的囊片。
在一个实施方案中,控释或缓释组合物包括最小量的四环氨基化合物或四环甲酰胺基化合物以在最小时段内治疗或预防所述病症。控释或缓释组合物的优点包括延长药物的活性、降低给药频率和增加主体的顺从性。另外,控释或缓释组合物可以有利地实现起作用时间或其它特征,如以所述四环氨基化合物或四环甲酰胺基化合物的血液水平,并因此可以降低各种副作用的发生。
控释或缓释组合物可以在最初释放一定量的四环氨基化合物或四环甲酰胺基化合物,其迅速产生所需的治疗或预防作用,并逐渐地和连续地释放其它量的四环氨基化合物或四环甲酰胺基化合物以在延长时段内维持这一治疗或预防作用的水平。为了维持四环氨基化合物或四环甲酰胺基化合物在体内的恒定水平,四环氨基化合物或四环甲酰胺基化合物可以以代替被新陈代谢掉和从体内排泄掉的四环氨基化合物或四环甲酰胺基化合物量的速率从所述剂型释放。活性成分的控释或缓释释放可以被各种条件刺激,所述条件包括但不限于pH改变、温度改变、酶的浓度或可用性、水的浓度或可用性、或其它生理条件或化合物。
有效用于治疗或预防所述病症的四环氨基化合物或四环甲酰胺基化合物的量可以通过标准临床技术测定。另外,可以任选地采用体外或体内试验以帮助鉴定最佳的剂量范围。使用的精确剂量还依赖于给药途径、治疗状况的严重性并且可根据保健医师的判断和每名主体的情况根据例如公开的临床研究进行判断。然而,合适的有效剂量可以为每4小时约10微克到约5克,尽管通常为每4小时约500毫克或更低。在一个方案中,有效剂量为每4小时约0.01mg、0.5mg、约1mg、约50mg、约100mg、约200mg、约300mg、约400mg、约500mg、约600mg、约700mg、约800mg、约900mg、约1g、约1.2g、约1.4g、约1.6g、约1.8g、约2.0g、约2.2g、约2.4g、约2.6g、约2.8g、约3.0g、约3.2g、约3.4g、约3.6g、约3.8g、约4.0g、约4.2g、约4.4g、约4.6g、约4.8g和约5.0g。可以经不同的时段给予相等的剂量,所述时段包括但不限于约每2小时、约每6小时、约每8小时、约每12小时、约每24小时、约每36小时、约每48小时、约每72小时、约每周、约每两周、约每三周、约每月和约每两月。本文所述的有效剂量是指总的给药量;也就是说,如果给予超过一次的四环氨基化合物或四环甲酰胺基化合物,则有效剂量相当于总的给药量。
组合物可以分别根据常规的混合、造粒或包衣方法制备,并且,在一个方案中,本发明的组合物可以包括约0.1%到约99%的重量比或体积比的四环氨基化合物或四环甲酰胺基化合物;在另一方案中,可以包括约1%到约70%的重量比或体积比的四环氨基化合物或四环甲酰胺基化合物。
可根据各种因素选择使用四环氨基化合物或四环甲酰胺基化合物的剂量方案,所述因素包括类型、物种、年龄、体重、性别和主体的病情;所治疗疾病的严重程度;给药途径;主体的肾或肝的功能;以及具体使用的四环氨基化合物或四环甲酰胺基化合物。本领域技术人员可很容易地确定用于治疗或预防所述病症所需药物的有效量。
所述四环氨基化合物或四环甲酰胺基化合物可以单一日剂量给药,或者总日剂量可以每天两次、三次或四次分开的剂量给药。此外,所述四环氨基化合物或四环甲酰胺基化合物可通过局部使用适合的鼻内载体的鼻内形式,或者通过透皮途径使用本领域人员熟知的那些透皮贴片的形式给药。对于经皮投递系统的给药形式来说,给药方案中剂量给药可以是连续的而不是间断的。其它示例性的局部制剂包括霜剂、膏剂、洗剂、气雾剂和凝胶剂,其中所述四环氨基化合物或四环甲酰胺基化合物的浓度为大约0.1%至大约15%w/w或w/v。
在一个实施方案中,该组合物包括一起将对治疗或预防癌症有效的一定量的(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂。在另一个实施方案中,(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂的量为联合化疗制剂组合物的重量比的至少约0.01%。当计划用于口服时,该量可在组合物的重量比的约0.1%至约80%的范围。一些口服组合物可包括约4%至约50%的(i)四环氨基化合物或四环甲酰胺基化合物和(ii)其它的抗癌剂。制备本发明的其他组合物以使肠胃外的剂量单位包含组合物重量比的约0.01%至约2%。
在用于人之前可在体外或体内测定该四环氨基化合物或四环甲酰胺基化合物所需的治疗或预防活性。动物模型系统可用于证实安全性和功效。
本发明用于治疗或预防需要其的主体中病症的方法可进一步包括将另一种预防剂或治疗剂施用于正施用四环氨基化合物或四环甲酰胺基化合物的主体。在一个实施方案中以有效量施用其它的预防剂或治疗剂。其它的预防剂或治疗剂包括但不限于,抗炎药、抗肾衰药、抗糖尿病药和抗心血管疾病药、抗呕剂、造血集落刺激因子、抗焦虑药和止痛药。
在一个方案中,其它的预防剂或治疗剂是可用于降低四环氨基化合物或四环甲酰胺基化合物的任何潜在副作用的药物。这些潜在的副作用包括但不限于恶心、呕吐、头痛、低白细胞计数、低红细胞计数、低血小板计数、头疼、发烧、慵懒、肌肉酸痛、全身疼痛、骨痛、注射部位疼痛、腹泻、神经病、搔痒、口疮、脱发、焦虑或抑郁。
在一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在消炎剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
在另一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在抗-肾衰竭制剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
仍然在另一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在抗-糖尿病制剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
在又一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在抗-心血管疾病制剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
在另外的实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在抗呕剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
在另一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在造血集落刺激因子之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时、72小时、1周、2周、3周或4周内施用。
在另一实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在鸦片样或非-鸦片样止痛剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
在又一个实施方案中,所述四环氨基化合物或四环甲酰胺基化合物可在抗焦虑制剂之前、同时或之后,或在同一天,或彼此的1小时、2小时、12小时、24小时、48小时或72小时内施用。
其它的预防剂或治疗剂的有效量为本领域技术人员熟知。然而,确定其它的预防剂或治疗剂的最有效量范围在技术人员的技能范围之内。在本发明的一个实施方案中,其中,施用主体另一种预防剂或治疗剂,所述四环氨基化合物或四环甲酰胺基化合物的有效量小于其中未施用另一种预防剂或治疗剂时的有效量。在这种情况下,不受理论束缚,认为所述四环氨基化合物或四环甲酰胺基化合物和其它的预防剂或治疗剂协同作用而治疗或预防所述病症。
可用于本发明方法中的抗炎药包括但不限于肾上腺类固醇,如皮质醇、可的松、氟氢可的松、脱氢可的松、氢化强的松、6α-甲基强的松龙、氟羟脱氢皮醇、倍他米松和地塞米松;以及非-类固醇抗炎药(NSAID),如阿斯匹林、醋氨酚、消炎痛、舒林酸、甲苯酰吡啶乙酸、二氯芬酸、酮咯酸、布洛芬、氟比洛芬、酮洛芬、非诺洛芬、噁丙秦、甲灭酸、甲氯灭酸、吡罗昔康、美洛昔康、萘丁酮、罗非昔布、塞来昔布、依托度酸和尼美舒利。
可用于本发明方法中的抗肾衰竭的药物包括但不限于ACE(血管紧张素转化酶)抑制剂,如卡托普利、依那普利拉、赖诺普利、贝那普利、福辛普利、群多普利、喹那普利和雷米普利;利尿药如甘露醇、甘油、利尿磺胺、toresemide、曲帕胺、氯噻嗪、甲氯噻嗪、吲达帕胺、阿米洛利和螺内酯;和苯氧酸药物,如氯贝丁酯、吉非贝齐、非诺贝特、环丙贝特和苯扎贝特。
可用于本发明方法中的抗糖尿病药物包括但不限于高血糖素;生长抑素;二氮嗪;磺酰脲类如甲苯磺丁脲、醋酸己脲、妥拉磺脲、chloropropamide、优降糖、格列吡嗪、格列齐特和格列美脲;胰岛素促泌剂,如瑞格列奈和那格列奈;双胍类,如二甲双胍和苯乙双胍;噻唑烷二酮类,如吡格列酮、罗格列酮和曲格列酮;和α-葡糖苷酶抑制剂,如阿卡波糖和米格列醇。
可用于本发明方法中的有用的抗心血管疾病药物的例子包括但不限于卡尼汀;硫胺;和毒蕈碱性受体拮抗剂,如阿托品、东莨菪碱、后马托品、托吡卡胺、哌仑西平、异丙托品、替沃托品和托特罗定。
可用于本发明方法中的有用的止吐药的例子包括但不限于甲氧氯普胺、多潘立酮、丙氯拉嗪、异丙嗪、氯丙嗪、曲美苄胺、昂丹司琼、格拉司琼、羟嗪、乙酰基亮氨酸单乙醇胺、阿立必利、阿扎司琼、苯喹胺、氨醇醋茶碱(bietanautine)、溴必利、布克力嗪、氯波必利、赛克力嗪、茶苯海明、地芬尼多、多拉司琼、美克洛嗪、美沙拉妥、美托哌丙嗪、大麻隆、oxyperndyl、匹哌马嗪、东莨菪碱、舒必利、四氢大麻酚、硫乙拉嗪、硫丙拉嗪、托烷司琼及其混合物。
可用于本发明方法中的有用的造血集落刺激因子包括但不限于非格司亭、沙格司亭、莫拉司亭、和阿法依泊汀(epoietin alfa)。
可用于本发明方法中的有用的鸦片样物质止痛剂包括但不限于吗啡、海洛因、氢吗啡酮、氢可酮、羟吗啡酮、羟考酮、美托酮、阿扑吗啡、去甲吗啡、埃托啡、丁丙诺啡、哌替啶、洛哌丁胺、阿尼利定、依索庚嗪、piminidine、倍他罗定、地芬诺酯、芬太尼、舒芬太尼、阿芬太尼、瑞芬太尼、左啡诺、右美沙芬、非那佐辛、喷他佐辛、环佐辛、美沙酮、异美沙酮和右丙氧芬。
可用于本发明方法中的有用的非鸦片样物质止痛剂包括但不限于阿司匹林、塞来昔布、罗非昔布、双氯芬酸(diclofinac)、diflusinal、依托度酸、非诺洛芬、氟比洛芬、布洛芬、酮洛芬、吲哚美辛、酮咯酸、甲氯胺苯酸、甲芬那酸(mefanamic acid)、萘丁美酮、纳普洛辛(naprosin)、萘普生、吡罗昔康、和舒林酸。
可用于本发明方法中的有用的抗焦虑药包括但不限于丁螺环酮和苯二氮桌类,如地西泮、劳拉西泮、奥沙西泮(oxazapam)、二钾氯氮卓、氯硝西泮、利眠宁和阿普唑仑。
试剂盒
本发明包括可简化四环氨基化合物或四环甲酰胺基化合物施用于主体的试剂盒。
本发明典型的试剂盒包括四环氨基化合物或四环甲酰胺基化合物的单位剂型。在一个实施方案中所述单位剂型为容器,其为无菌的,包含有效量的四环氨基化合物或四环甲酰胺基化合物和生理学可接受的载体或介质。该试剂盒可进一步包括标签或指导所述四环氨基化合物或四环甲酰胺基化合物用于治疗或预防病症的印刷的说明书。该试剂盒还可以进一步包括另一种预防剂或治疗剂的单位剂型,例如,含有有效量的另一种预防剂或治疗剂的容器。在一个实施方案中,该试剂盒包括含有有效量的四环氨基化合物或四环甲酰胺基化合物和有效量的另一种预防剂或治疗剂的容器。其它的治疗剂的例子包括但不限于,如上所列的那些。
本发明的试剂盒可进一步包括可用于施用单位剂型的装置。所述装置的例子包括但不限于,注射器、滴袋、膜片、吸入器和灌肠袋。
本发明进一步在以下的实施例中描述,所述实施例不限制在权利要求中所限定的本发明要求保护的范围。以下实施例可以阐明四环氨基化合物和四环甲酰胺基化合物治疗所述病症的用途。
实施例
实施例1
一般方法
使用Varian 300MHz光谱仪得到质子核磁共振谱(1H NMR),化学位移值(δ)单位为百万分率(ppm)。TLC使用预涂硅胶60F-254的薄层色谱板进行,制备TLC使用预涂的Whatman60A TLC板进行。所有的中间体和最终化合物根据1H NMR数据表征。
5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-10-羧酸甲酯(17a)的制备
在室温下搅拌2-溴甲基-3-氰基苯甲酸甲酯(14.1g,55.5mmol)和高邻苯二酸酐(22.5g,138.8mmol)在乙腈(150ml)中的混合物,并在1小时的周期内将三乙胺(23.2ml)在乙腈(100ml)中的溶液滴加入所述混合物中。在完成滴加后,回流得到的悬浮液4小时。然后冷却所述反应混合物至室温并过滤。用乙腈(100ml)和乙醇(2×100ml)充分洗涤过滤得到的固体并在50℃下真空干燥。得到化合物17a,收率为81%(13.1g)。1HNMR(DMSO-d6):δ12.21(s,1H);8.20(m,2H);7.83(d,J=7.5Hz,1H);7.71(m,2H);7.47(m,2H);4.07(s,2H);3.89(s,3H)。
5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-9-羧酸甲酯(18a)的制备
由3-溴甲基-3-氰基苯甲酸甲酯制备化合物18a,产率65%。根据制备5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-10-羧酸甲酯(17a)的步骤进行所述反应。1H NMR(DMSO-d6):δ12.35(s,1H);8.25(d,J=8.1Hz,1H);8.11(s,1H);8.06(d,J=7.8Hz,1H);7.98(d,J=8.1Hz,1H);7.75(m,2H);7.49(m,1H);3.95(s,2H);3.85(s,3H)。
5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-10-羧酸(18b)的制备
回流在甲醇和1M NaOH溶液的混合物中的化合物18a的悬浮液1小时。另外加入水,并另外回流得到的化合物1小时。将得到的清澈溶液冷却到室温,并搅拌加入1M HCl溶液。过滤得到的固体并用水和甲醇洗涤并干燥,以得到化合物18b。1H NMR(DMSO-d6):δ12.38(s,1H);8.25(d,J=7.8Hz,1H);8.11(s,1H);8.04(d,J=8.1Hz,1H);7.97(d,J=8.1Hz,1H);7.76(d,J=3.6Hz,2H);7.51(m,1H);3.97(s,2H)。
5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-9-羧酸的制备
根据制备5,6-二氢-5-氧代-11-H-茚并[1,2-c]异喹啉-10-羧酸(18b)的步骤制备上面的化合物,不同在于使用化合物18a取代化合物17a。1HNMR(DMSO-d6):δ12.34(s,1H);8.24(d,J=8.1Hz,1H);8.20(d,J=7.5Hz1H);7.88(d,J=7.8Hz,1H);7.77(m,2H);7.54(d,J=7.8Hz,2H);7.49(d,J=8.1Hz,1H);4.18(s,2H)。
将胺偶联到羧酸上的一般方法
将C9-或C10-COOH和碳二亚胺在二噁烷中的悬浮液在室温下搅拌10分钟。加入相关的胺并将所述反应混合物室温搅拌过夜。过滤得到的固体,用二噁烷洗涤并在真空烘箱中干燥3小时。下面的化合物示例性说明式(IIc)和(IId)的四环甲酰胺化合物的合成。
C9位置 | C10位置 | |
14a | CONH(CH2)吗啉 | H |
14b | CONH(CH2)3吗啉 | H |
13b | CONH(CH2)3NMe2 | H |
16a | H | CONH(CH2)吗啉 |
16b | H | CONH(CH2)吗啉 |
15a | H | CONH(CH2)2NMe2 |
15b | H | CONH(CH2)3NMe2 |
化合物14a:
1H NMR(DMSO-d6):δ8.25(d,J=8.1Hz,1H);8.09(s,1H);7.97(q,J=7.9Hz,2H);7.76(d,J=3.9Hz,2H);7.48(m,1H);3.94(s,2H);3.56(t,J=4.7Hz,4H);2.77(t,J=6.0Hz,2H);2.40-2.33(m,6H)。
化合物14b:
1H NMR(DMSO-d6):δ8.24(d,J=8.1Hz,1H);8.07(s,1H);7.92(m,2H);7.75(d,J=3.6Hz,2H);7.46(m,1H);3.91(s,2H);3.54(t,J=4.5Hz,4H);2.73(t,J=6.9Hz,2H);2.31(m,6H);1.62(t,J=6.9Hz,2H)。
化合物13b:
1H NMR(DMSO-d6):δ8.23(d,J=8.1Hz,1H);8.06(s,1H);7.90(m,2H);7.73(m,2H);7.45(m,1H);3.89(s,2H);2.71(t,J=6.9Hz,4H);2.23(t,J=6.6Hz,2H);2.09(s,6H);1.59(t,J=6.9Hz,2H)。
化合物16a:
1H NMR(DMSO-d6):δ8.23(d,J=8.1Hz,1H);8.03(d,J=7.5Hz,1H);7.80(d,J=7.8Hz,1H);7.74(m,2H);7.47-7.36(m,2H);4.15(s,2H);3.54(m,4H);2.78(t,J=6.0Hz,2H);2.41-2.30(m,6H)。
化合物16b:
1H NMR(DMSO-d6):δ8.22(d,J=7.8 Hz,1H);7.98(d,J=7.2Hz,1H);7.79(d,J=7.2Hz,1H);7.71(m,2H);7.42(m,1H);7.34(t,J=7.8Hz,1H);4.14(s,2H);2.82(t,J=6.9Hz,2H);2.29(m,6H);1.70(t,J=6.6Hz,2H)。
化合物15a:
1H NMR(DMSO-d6):δ8.22(d,J=8.1 Hz,1H);8.03(d,J=7.2Hz,1H);7.80(d,J=7.8Hz,1H);7.73(m,2H);7.44(m,1H);7.37(t,J=8.1Hz,1H);4.14(s,2H);2.79(t,2H);2.36(t,J=6.0 Hz,2H);2.14(s,6H)。
化合物15b:
1H NMR(DMSO-d6):δ8.24(d,J=7.8Hz,1H);8.01(d,J=7.2Hz,1H);7.80(d,J=8.1Hz,1H);7.73(d,J=3.3Hz,2H);7.44(m,1H);7.37(t,J=7.5Hz,1H);4.15(s,2H);2.77(t,J=6.9Hz,2H);2.26(t,J=6.9Hz,2H);2.10(s,6H);1.63(t,J=6.9Hz,2H)。
实施例2 说明性的四环氨基化合物和四环甲酰胺基化合物对体外PARS活性的作用
可以使用Virag等人,Br.J.Pharmacol.1999,126(3):769-77;和Immunology 1998,94(3):345-55中所述的方法证明说明性的四环氨基化合物或四环甲酰胺基化合物抑制PARS和预防过氧亚硝酸盐诱导的细胞毒性的能力。
细胞保护测定:
将未经处理的鼠科巨噬细胞用说明性的四环氨基化合物或四环甲酰胺基化合物处理15分钟,然后加入过氧亚硝酸盐(750μM),再维持15分钟。对于PARS活性的测量,除去培养基并且替换为包含0.01%毛地黄皂苷和3H-NAD(0.5μCi ml-1,缓冲剂中的NAD+的最终浓度为20nM/L)的0.5ml HEPES(pH7.5),维持20分钟。然后将细胞从孔中刮出并且置于包含200μl的50%(w/v)冰冷的三氯乙酸(TCA)的Eppendorf管中。然后将管置于4℃。在4小时之后,将管在1800g离心10分钟并且除去上层清液。将沉淀用500μl冰冷的5%TCA洗涤两次。将沉淀在包含2%SDS的250μlNaOH(0.1M)中在37℃溶液化过夜,然后通过用Wallac闪烁计数器测量结合的放射性测定PARS活性。将溶液化的蛋白质(250μl)与5ml的闪烁体(ScintiSafe Plus,Fisher Scientific)混合,然后计数10分钟。从剂量反应曲线计算EC50值。
表1:说明性的异喹啉化合物对细胞保护的抑制效果
C9位置 | C10位置 | EC50 M | |
14a | CONH(CH2)吗啉 | H | 1.1 |
14b | CONH(CH2)吗啉 | H | 1.1 |
13b | CONH(CH2)3NMe2 | H | 0.9 |
16a | H | CONH(CH2)吗啉 | >1.5 |
16b | H | CONH(CH2)吗啉 | >1.5 |
15a | H | CONH(CH2)2NMe2 | >1.5 |
15b | H | CONH(CH2)3NMe2 | >1.5 |
实施例3 四环氨基化合物和四环甲酰胺基化合物在细胞死亡的体外模型中的作用
使用体外的氧化剂刺激的胸腺细胞测定(在Virag等人,Immunology94(3):345-55,1998中详细描述),可以试验说明性的四环氨基化合物或四环甲酰胺基化合物预防细胞生活力的氧化剂诱导性抑制的能力。因而,这个测定代表了缺血性器官中再灌注有关的细胞死亡的体外模型。
四环氨基化合物和四环甲酰胺基化合物对炎性疾病的体内模型的作用
为了证明化合物在炎性疾病中的效能,可以使用细菌脂多糖(LPS)诱导的全身性炎症性模型测定说明性的四环氨基化合物或四环甲酰胺基化合物的作用,所述细菌脂多糖据报道用于在动物中引起再灌注损伤和炎性疾病,例如脓毒性休克和全身性炎症性反应综合症(参见Parrillo,N.Engl.J.Med.,328:1471-1478(1993)和Lamping,J.Clin.Invest.101:2065-2071(1998)。
测定四环氨基化合物和四环甲酰胺基化合物对再灌注损伤的体内模型的作用
可以根据Liaudet等人,Shock2000,14(2):134-41中所述的方法测定说明性的四环氨基化合物或四环甲酰胺基化合物在缺血性和再灌注内脏的小鼠模型中的效能。
在另一组实验中,可以如Abdelkarim等人,Int J Mol Med.2001,7(3):255-60中所述测定说明性的四环氨基化合物或四环甲酰胺基化合物在大脑中动脉阻塞/再灌注的大鼠模型中的作用。
说明性的四环氨基化合物和四环甲酰胺基化合物在糖尿病体内模型中的作用
已知PARS抑制剂和PARS缺乏减少糖尿病的进展并且降低糖尿病并发症的发生率。为了证实说明性的四环氨基化合物或四环甲酰胺基化合物在糖尿病模型中的效能,使用如Mabley等人,Br J Pharmacol.2001,133(6):909-9;和Soriano等人,Nat Med.2001,7(1):108-13所述进行的糖尿病的单次高剂量链脲佐菌素模型。简而言之,将160mg/kg的链脲佐菌素腹膜内注射到用介质(对照)或用说明性的四环氨基化合物或四环甲酰胺基化合物处理的小鼠中(3mg/kg),并且在3天后使用血糖计测定血糖水平。
本发明的范围不限于意在作为本发明的一些方面的例证的实施例中公开的特定实施方案,并且功能上等同的任何实施方案都在本发明范围内。实际上,除了本文中表示和描述的那些之外的对本发明的各种修饰对于本领域技术人员来说是显而易见的,其都落入随附的权利要求的范围内。
引用了许多参考文献,其全部公开都全部被并入本文作为参考。
Claims (82)
1.下式所示的化合物或其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余基团同时为-H;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、 -(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
2.权利要求1所述的化合物,其中R1为-NH(CH2)n-N(R5)(R6)。
3.权利要求1所述的化合物,其中R2为-NH(CH2)n-N(R5)(R6)。
4.权利要求1所述的化合物,其中R3为-NH(CH2)n-N(R5)(R6)。
5.权利要求1所述的化合物,其中R4为-NH(CH2)n-N(R5)(R6)。
6.权利要求1所述的化合物,其中R5和R6各自为C1-C6烷基。
7.权利要求6所述的化合物,其中R5和R6各自为甲基。
8.权利要求1所述的化合物,其中n为2。
9.权利要求1所述的化合物,其中n为3。
10.权利要求1所述的化合物,其中R5,R6和它们所连接的氮原子结合形成吗啉基。
11.下式所示的化合物或其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
12.权利要求11所述的化合物,其中R1为-C(O)NH(CH2)n-N(R5)(R6)。
13.权利要求11所述的化合物,其中R2为-C(O)NH(CH2)n-N(R5)(R6)。
14.权利要求11所述的化合物,其中R3为-C(O)NH(CH2)n-N(R5)(R6)。
15.权利要求11所述的化合物,其中R4为-C(O)NH(CH2)n-N(R5)(R6)。
16.权利要求11所述的化合物,其中R5和R6各自为C1-C6烷基。
17.权利要求16所述的化合物,其中R5和R6各自为甲基。
18.权利要求11所述的化合物,其中n为2。
19.权利要求11所述的化合物,其中n为3。
20.权利要求11所述的化合物,其中R5,R6和它们所连接的氮原子结合形成吗啉基。
21.具有下式所示结构的权利要求1所述的化合物或其可药用盐:
23.包括生理学可接受的载体或介质以及有效量的权利要求1所述的化合物或其可药用盐的组合物。
24.包括生理学可接受的载体或介质以及有效量的权利要求11所述的化合物或其可药用盐的组合物。
25.治疗癌症的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
26.治疗癌症的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
27.权利要求25所述的方法,其中所述癌症为肺癌、乳腺癌、结肠直肠癌、前列腺癌、白血病、淋巴瘤、非霍奇金淋巴瘤、皮肤癌、脑癌、中枢神经系统癌、卵巢癌、子宫癌、胃癌、胰腺癌、食道癌、肾癌、肝癌或头颈癌。
28.权利要求26所述的方法,其中所述癌症为肺癌、乳腺癌、结肠直肠癌、前列腺癌、白血病、淋巴瘤、非霍奇金淋巴瘤、皮肤癌、脑癌、中枢神经系统癌、卵巢癌、子宫癌、胃癌、胰腺癌、食道癌、肾癌、肝癌或头颈癌。
29.权利要求25所述的方法,还包括施用有效量的其它的抗癌剂。
30.权利要求26所述的方法,还包括施用有效量的其它的抗癌剂。
31.权利要求29所述的方法,其中所述其它的抗癌剂为替莫唑胺、丙卡巴肼、达卡巴嗪、白细胞介素-2、伊立替康、或其组合。
32.权利要求30所述的方法,其中所述其它的抗癌剂为替莫唑胺、丙卡巴肼、达卡巴嗪、白细胞介素-2、伊立替康、或其组合。
33.权利要求27所述的方法,其中所述癌症为脑癌或黑素瘤。
34.权利要求33所述的方法,其中所述脑癌为转移性脑癌或神经胶质瘤。
35.权利要求34所述的方法,其中所述神经胶质瘤为纤维性星形细胞瘤、星形细胞瘤、间变型星形细胞瘤或多形性成胶质细胞瘤。
36.权利要求28所述的方法,其中所述的癌症为脑癌或黑素瘤。
37.权利要求36所述的方法,其中所述脑癌为转移性脑癌或神经胶质瘤。
38.权利要求37所述的方法,其中所述神经胶质瘤为纤维性星形细胞瘤、星形细胞瘤、间变型星形细胞瘤或多形性成胶质细胞瘤。
39.治疗肾衰竭的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
40.治疗肾衰竭的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
41.权利要求39所述的方法,其中肾衰竭为慢性肾衰竭或急性肾衰竭。
42.权利要求40所述的方法,其中肾衰竭为慢性肾衰竭或急性肾衰竭。
43.治疗再灌注损伤的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
44.治疗再灌注损伤的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
45.权利要求43所述的方法,其中再灌注损伤是中风或心肌梗塞。
46.权利要求44所述的方法,其中再灌注损伤是中风或心肌梗塞。
47.治疗炎性疾病的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
48.治疗炎性疾病的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
49.权利要求47所述的方法,其中炎性疾病为关节的炎性疾病、齿龈的慢性炎性疾病、炎性肠病、炎性肺病、中枢神经系统的炎性疾病、眼的炎性疾病、革兰氏阳性菌致休克、革兰氏阴性菌致休克、出血性休克、过敏性休克、外伤性休克或化疗致休克。
50.权利要求48所述的方法,其中炎性疾病为关节的炎性疾病、齿龈的慢性炎性疾病、炎性肠病、炎性肺病、中枢神经系统的炎性疾病、眼的炎性疾病、革兰氏阳性菌致休克、革兰氏阴性菌致休克、出血性休克、过敏性休克、外伤性休克或化疗致休克。
51.治疗糖尿病的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
52.治疗糖尿病的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
53.权利要求51所述的方法,其中糖尿病为I型糖尿病或II型糖尿病。
54.权利要求52所述的方法,其中糖尿病为I型糖尿病或II型糖尿病。
55.治疗缺血性病症的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
56.治疗缺血性病症的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
57.权利要求55的方法,其中缺血性病症为心肌缺血、稳定型心绞痛、不稳定型心绞痛、中风、缺血性心脏病或脑缺血。
58.权利要求56所述的方法,其中缺血性病症为心肌缺血、稳定型心绞痛、不稳定型心绞痛、中风、缺血性心脏病或脑缺血。
59.治疗由器官移植引起的复氧损伤的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
60.治疗由器官移植引起的复氧损伤的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
61.治疗帕金森病的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
62.治疗帕金森病的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
63.治疗血管病的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
64.治疗血管病的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
65.权利要求63所述的方法,其中所述血管病为外周动脉阻塞、血栓闭塞性脉管炎、Reynaud氏疾病和病征、肢端发绀、红斑性肢痛病、静脉血栓形成、静脉曲张、动静脉瘘、淋巴水肿或脂肪水肿。
66.权利要求64所述的方法,其中血管病为外周动脉阻塞、血栓闭塞性脉管炎、Reynaud氏疾病和病征、肢端发绀、红斑性肢痛病、静脉血栓形成、静脉曲张、动静脉瘘、淋巴水肿或脂肪水肿。
67.治疗糖尿病并发症的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
68.治疗糖尿病并发症的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
69.治疗心血管疾病的方法,包括对需要其的主体施用有效量的权利要求1所述的化合物或其可药用盐。
70.治疗心血管疾病的方法,包括对需要其的主体施用有效量的权利要求11所述的化合物或其可药用盐。
71.权利要求69所述的方法,其中心血管疾病为慢性心力衰竭、心房纤维性颤动、室上性心动过速、心房扑动或阵发性房性心动过速。
72.权利要求70所述的方法,其中心血管疾病为慢性心力衰竭、心房纤维性颤动、室上性心动过速、心房扑动或阵发性房性心动过速。
73.组合物,包括:
有效量的替莫唑胺,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
74.组合物,包括:
有效量的丙卡巴肼,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
75.组合物,包括:
有效量的达卡巴嗪,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
76.组合物,包括:
有效量的伊立替康,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
77.组合物,包括:
有效量的白细胞介素-2,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
78.组合物,包括:
有效量的替莫唑胺,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
79.组合物,包括:
有效量的丙卡巴肼,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
80.组合物,包括:
有效量的达卡巴嗪,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
81.组合物,包括:
有效量的伊立替康,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6),且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
82.组合物,包括:
有效量的白细胞介素-2,
生理学可接受的载体或介质,和
有效量的下式所示的化合物及其可药用盐:
其中:
R1、R2、R3和R4基团之一为-C(O)NH(CH2)n-N(R5)(R6)且其余的基团同时为氢;
R5和R6独立地为-H、-C1-C6烷基、-苯基或苄基,其中-C1-C6烷基、-苯基或苄基未被取代或被一个或多个-卤素、-OH或-N(Z3)(Z4)取代,其中Z3和Z4独立地为-H或-C1-C5烷基,-C1-C5烷基未被取代或被一个或多个-卤素、-羟基或-NH2取代;或者,N、Z3和Z4结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、-卤素、-卤代C1-C5烷基、羟基、-O-C1-C5烷基、-N(Ra)2、-COOH、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;或者,N、R5和R6结合形成含氮的3-7元单环杂环,该杂环未被取代或被1-3个-C1-C5烷基、苯基、苄基、羟基取代的C1-C5烷基、-卤素、-卤代C1-C5烷基、卤代苯基、羟基、-O-C1-C5烷基、-(O-C1-C5-烷基)-取代的苯基、氰基取代的苯基、-N(Ra)2、-(C1-C5亚烷基)-N(Ra)2、-COOH、-(C1-C5亚烷基)-COOH、-(C1-C5亚烷基)-C(O)O-C1-C5烷基、-(C1-C5-亚烷基)-C(O)NH-C1-C5烷基、-C(O)O-(C1-C5烷基)、-OC(O)-(C1-C5烷基)、-C(O)NH2或-NO2取代,其中Ra的每次出现独立地为-H、-苄基或-C1-C10烷基;且
n为2-6的整数。
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US (2) | US7381722B2 (zh) |
EP (1) | EP1855676A4 (zh) |
JP (1) | JP2008531562A (zh) |
KR (1) | KR20070116011A (zh) |
CN (1) | CN101137377A (zh) |
AU (1) | AU2006219023A1 (zh) |
BR (1) | BRPI0606191A2 (zh) |
CA (1) | CA2598647A1 (zh) |
IL (1) | IL185259A0 (zh) |
MX (1) | MX2007010333A (zh) |
RU (1) | RU2007135362A (zh) |
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-
2006
- 2006-02-15 WO PCT/US2006/005291 patent/WO2006093667A1/en active Application Filing
- 2006-02-15 EP EP06748209A patent/EP1855676A4/en not_active Withdrawn
- 2006-02-15 JP JP2007557054A patent/JP2008531562A/ja active Pending
- 2006-02-15 CN CNA2006800060928A patent/CN101137377A/zh active Pending
- 2006-02-15 US US11/354,707 patent/US7381722B2/en not_active Expired - Fee Related
- 2006-02-15 KR KR1020077021930A patent/KR20070116011A/ko not_active Application Discontinuation
- 2006-02-15 RU RU2007135362/04A patent/RU2007135362A/ru unknown
- 2006-02-15 MX MX2007010333A patent/MX2007010333A/es not_active Application Discontinuation
- 2006-02-15 CA CA002598647A patent/CA2598647A1/en not_active Abandoned
- 2006-02-15 BR BRPI0606191-5A patent/BRPI0606191A2/pt not_active Application Discontinuation
- 2006-02-15 AU AU2006219023A patent/AU2006219023A1/en not_active Abandoned
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- 2007-08-14 IL IL185259A patent/IL185259A0/en unknown
- 2007-08-22 ZA ZA200707085A patent/ZA200707085B/xx unknown
- 2007-12-19 US US11/960,410 patent/US20080214593A1/en not_active Abandoned
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CA2598647A1 (en) | 2006-09-08 |
US20080214593A1 (en) | 2008-09-04 |
AU2006219023A1 (en) | 2006-09-08 |
BRPI0606191A2 (pt) | 2009-06-09 |
RU2007135362A (ru) | 2009-03-27 |
ZA200707085B (en) | 2009-05-27 |
WO2006093667A1 (en) | 2006-09-08 |
US20060287312A1 (en) | 2006-12-21 |
US7381722B2 (en) | 2008-06-03 |
EP1855676A4 (en) | 2008-05-21 |
IL185259A0 (en) | 2008-02-09 |
KR20070116011A (ko) | 2007-12-06 |
EP1855676A1 (en) | 2007-11-21 |
MX2007010333A (es) | 2007-11-06 |
JP2008531562A (ja) | 2008-08-14 |
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