CN1210465A - 治疗方法和药物组合物 - Google Patents

治疗方法和药物组合物 Download PDF

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CN1210465A
CN1210465A CN97192149A CN97192149A CN1210465A CN 1210465 A CN1210465 A CN 1210465A CN 97192149 A CN97192149 A CN 97192149A CN 97192149 A CN97192149 A CN 97192149A CN 1210465 A CN1210465 A CN 1210465A
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phenyl
sodium
montelukast sodium
loratadine
leukotriene antagonist
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S·E·达伦
E·M·斯科尔尼克
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Merck and Co Inc
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Abstract

一种治疗哮喘、变态反应和炎症的方法,包括以在分别独立的剂型或结合在单一药物制剂中的白三烯抑制剂和氯雷他定同时给药进行治疗。

Description

治疗方法和药物组合物
与本申请有关的文献
本申请以1996年2月8日递交的申请号为60/011328的申请为优先权基础。
发明背景
氯雷他定是一种具有H-受体拮抗剂特性的抗组胺药物，用于治疗变态反应，该化合物记载于美国专利4282233。
白三烯拮抗剂公知可用于治疗哮喘、变态反应和炎症。
本发明现提供一种采用两种药物联合治疗哮喘、变态反应和炎症的方法，该联合治疗较这两种药物自身有效。
发明概述
本发明涉及一种治疗哮喘、变态反应和炎症的方法，该方法通过基本上同时施用或混合在同一种药物组合物中的有效量的氯雷他定和有效量的白三烯拮抗剂实现，所述白三烯拮抗剂选自：A.1-(((R)-(3-(2-(7-氯-2-喹啉基)乙烯基)苯基)-3-(2-(2-羟基-2-丙基)苯基)硫代)甲基)环丙烷乙酸钠，EP 480717
Figure A9719214900041
蒙太露卡诗钠(Montelukast Sodium)B.1-(((R)-(3-(2-(6,7-二氟-2-喹啉基)乙烯基)苯基)-3-(2-(2-羟基-2-丙基)苯基)硫代)甲基)环丙烷乙酸钠，US 5270324
Figure A9719214900051
C.1-(((1(R)-(3-(2-(2,3-二氯噻吩并[3,2-b]吡啶-5-基)-(E)-乙烯-基)苯基)-3-(2-(1-羟基-1-甲基乙基)苯基)丙基)硫代)甲基)环丙烷乙酸或其钠盐，US 5472964
Figure A9719214900052
D.N-[4-氧代-2-(1H-四唑-5-基)-4H-1-苯并吡喃-8-基]-对-(4-苯基丁氧基)苯甲酰胺。EP 173516
Figure A9719214900053
皮安露卡诗(Pranlukast)E.3-[2-甲氧基-4-[(邻甲苯磺酰基)氨基甲酰基]苄基]-1-甲基吲哚-5-氨基甲酸环戊酯。EP199,543
Figure A9719214900061
加夫露卡诗(Zafirlukast)发明详述
本发明的新药物组合物含有联合施用的活性成分氯雷他定和选自上述A、B、C、D和E的白三烯拮抗剂，以及任意地含有适于肠道或非胃肠道给药的可药用载体。制剂可以呈固体形式，如片剂和胶囊；或呈液体形式，如糖浆、酏剂、乳剂和注射剂。在药物剂型的配制中，通常使用赋形剂，如水、明胶、乳糖、淀粉、硬脂酸镁、滑石、植物油、苄醇、胶类、聚链烷二醇类和凡士林。在下列实施例中仅描述优选的制剂。
在本发明的新的治疗方法中，氯雷他定和白三烯拮抗剂可以以分别独立的剂型或结合在本发明的新的药物制剂中基本上同时给药。
虽然所需的剂量取决于如患者年龄、性别、体重和所医治适应症的严重程度，但优选的人口服剂量是约5-20毫克氯雷他定，每日1-3次；优选约10毫克氯雷他定，每日一次。对于白三烯而言，人用剂量为约5-20毫克，每日1-3次；优选为约10毫克，每日一次。
实施例
蒙太露卡诗钠(Montelukast Sodium)10毫克和氯雷他定10毫克的膜包衣片每片含量           成分核
10.4毫克    Montelukast Sodium
10.0毫克    氯雷他定
66.6毫克    微晶纤维素，NF
100.0毫克    一水合乳糖，NF
6.0毫克     交联羧甲基纤维素钠，NF
(60.0)毫克  纯化水，USP
1.0毫克     硬脂酸镁，NF
200.0毫克   核芯片膜包衣
2.25毫克    羟丙甲基纤维素，6厘泊
1.25毫克    羟丙基纤维素LF
1.50毫克    二氧化钛
(33.5毫克)  纯化水
205.0毫克   膜包衣片

Claims (12)

1．一种药物制剂，含有活性成分氯雷他定和一种选自下述的白三烯拮抗剂：
(A)蒙太露卡诗钠(montelukast sodium)；
(B)1-(((1(R)-(3-(2-(6,7-二氟-2-喹啉基)乙烯基)苯基)-3-(2-(2-羟基-2-丙基)苯基)硫代)甲基)环丙烷乙酸钠；
(C)1-(((1(R)-(3-(2-(2,3-二氯噻吩并[3,2-b]吡啶-5-基)-(E)-乙烯基)苯基)-3-(2-(1-羟基-1-甲基乙基)苯基)丙基)硫代)甲基)环丙烷乙酸或其钠盐；
(D)皮安露卡诗(pranlukast)；和
(E)加夫露卡诗(zafirlukast)；
和可药用载体。
2．权利要求1的组合物，是设计为口服给药的。
3．权利要求2的组合物，含有10mg氯雷他定和10mg选自(A)、(B)、(C)、(D)和(E)的白三烯拮抗剂。
4．权利要求1的组合物，其中的白三烯拮抗剂是蒙太露卡诗钠(montelukast sodium)。
5．权利要求4的组合物，是设计为口服给药的。
6．权利要求5的组合物，两种活性成分的含量各为10mg。
7．一种治疗哮喘、变态反应和炎症的方法，包括对需此治疗的患者施用有效量的氯雷他定和有效量的选自下述的白三烯拮抗剂：
(A)蒙太露卡诗钠(montelukast sodium)；
(B)1-(((R)-(3-(2-(6,7-二氟-2-喹啉基)乙烯基)苯基)-3-(2-(2-羟基-2-丙基)苯基)硫代)甲基)环丙烷乙酸钠；
(C)1-(((1(R)-(3-(2-(2,3-二氯噻吩并[3,2-b]吡啶-5-基)-(E)-乙烯基)苯基)-3-(2-(1-羟基-1-甲基乙基)苯基)丙基)硫代)甲基)环丙烷乙酸或其钠盐；
(D)皮安露卡诗(pranlukast)；和
(E)加夫露卡诗(zafirlukast)；
两种活性成分以分别独立的剂型或结合在权利要求1的单一的药物制剂中基本上同时给药。
8．权利要求7的方法，其中的药物制剂被设计为是口服给药的。
9．权利要求7的方法，其中的分别独立剂型和单一药物制剂含有10mg氯雷他定和10mg选自(A)、(B)、(C)、(D)和(E)的白三烯拮抗剂。
10．权利要求7的方法，其中的白三烯拮抗剂是(A)蒙太露卡诗钠(montelukast sodium)。
11．权利要求10的方法，其中的分别独立剂型和单一药物制剂被设计为是口服给药的。
12．权利要求11的方法，其中的分别独立剂型和单一药物制剂中含有10mg氯雷他定和10mg(A)蒙太露卡诗钠(montelukastsodium)。
CN97192149A 1996-02-08 1997-02-04 治疗方法和药物组合物 Pending CN1210465A (zh)

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US1132896P 1996-02-08 1996-02-08
US60/011,328 1996-02-08
GB9608927.1 1996-04-29
GBGB9608927.1A GB9608927D0 (en) 1996-04-29 1996-04-29 Method of treatment and pharmaceutical composition

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EE9800234A (et) 1998-12-15
YU33298A (en) 1999-11-22
SK105698A3 (en) 1999-05-07

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