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PHARMACEUTICAL COMPOSITION CONTAINING FIMASARTAN AND HYDROCHLORothIAZIDE

机译:包含氟马沙坦和盐酸噻嗪的药物组合物

摘要

1. A pharmaceutical composition comprising: fimasartan, a pharmaceutically acceptable salt thereof, a hydrate thereof or a solvate thereof; hydrochlorothiazide, a pharmaceutically acceptable salt thereof, a hydrate thereof or a solvate thereof, a binder having a viscosity of from 20 mPa · s to 1000 mPa · s at 25 ° C.2. The pharmaceutical composition of claim 1, wherein the binder comprises at least one selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methyl cellulose and polyvinyl pyrrolidone. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is characterized by a relative standard deviation (RSD) of 4.0% or less in a content uniformity test. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is in tablet form. The pharmaceutical composition of claim 4, wherein the tablet comprises an uncoated tablet and a coating layer. The pharmaceutical composition according to claim 5, wherein the uncoated tablet has a crush strength of 7 kP or more. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is intended to treat hypertension. A method for producing a pharmaceutical composition containing timasartan, a pharmaceutically acceptable salt thereof, its hydrate or solvate thereof and hydrochlorothiazide, a pharmaceutically acceptable salt thereof, its hydrate or solvate thereof, the method comprising the steps of: preparing a mixture containing timasartan, a pharmaceutically acceptable salt thereof, its hydrate or its solvate and hydrochlorothiazide, its pharmaceutically acceptable salt, its hydrate or its solvate; obtaining granules by mixing the mixture with a binder solution in which the binder is dissolved substance possessing
机译:1.一种药物组合物,其包含:氟马沙坦,其药学上可接受的盐,其水合物或其溶剂化物;和氢氯噻嗪,其药学上可接受的盐,其水合物或其溶剂化物,在25°C下的粘度为20 mPa·s至1000 mPa·s的粘合剂。 2.根据权利要求1所述的药物组合物,其中,所述粘合剂包括选自由羟丙基纤维素,羟丙基甲基纤维素和聚乙烯吡咯烷酮组成的组中的至少一种。 2.根据权利要求1所述的药物组合物,其中,在含量均一性试验中,所述药物组合物的相对标准偏差(RSD)为4.0%以下。 2.根据权利要求1所述的药物组合物,其中所述药物组合物为片剂形式。 5.根据权利要求4所述的药物组合物,其中所述片剂包括未包衣的片剂和包衣层。 6.根据权利要求5所述的药物组合物,其中,所述未包衣片剂的压碎强度为7kP以上。 2.权利要求1的药物组合物,其中所述药物组合物旨在治疗高血压。一种制备包含替马沙坦,其药学上可接受的盐,其水合物或溶剂合物和氢氯噻嗪,其药学上可接受的盐,其水合物或溶剂合物的药物组合物的方法,该方法包括以下步骤:制备包含替马沙坦,其药学上可接受的盐的混合物。其药学上可接受的盐,其水合物或其溶剂化物和氢氯噻嗪,其药学上可接受的盐,其水合物或其溶剂化物;通过将混合物与粘合剂溶液混合得到颗粒,其中粘合剂是溶解的物质

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