A kind of argatroban injection and preparation method thereof

A technology for argatroban and injection, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing medication risk, difficulty in production, difficult control of product quality, and high production cost, and achieves easy large-scale production operation, high stability of liquid medicine, The effect of reducing losses in the production process
CN103463614BActive Publication Date: 2015-09-02ZHEJIANG TIANRUI PHARMA
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Patent Information

Authority / Receiving Office
CN Β· China
Patent Type
Patents(China)
Current Assignee / Owner
ZHEJIANG TIANRUI PHARMA
Publication Date
2015-09-02

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Abstract

The invention relates to an argatroban injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The argatroban injection contains 0.475-0.525 g of argatroban per 1000 ml of argatroban injection, and Sorbet Alcohol 50 ~ 60g, the balance is water for injection, the pH value of the argatroban injection is 5.0 ~ 6.0. The composition of the argatroban injection of the present invention is simple, which effectively reduces the risk of heat source increase caused by the addition of exogenous components. The stability of the liquid medicine is high. From the results of the accelerated test of the pilot test sample, it can be known that the appearance, pH value, visible foreign matter, related substances and content of the argatroban injection prepared by the present invention are in line with the existing ones under accelerated conditions. According to regulations, the content of argatroban has no obvious change with time, and the stability of the injection is good.
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Description

technical field

[0001] The invention relates to an argatroban injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique

[0002] Argatroban (Argatroban), the chemical name is (2R, 4R)-4-methyl-1-{(2S)-2-[(3RS)-3-methyl-1, 2, 3, 4-tetra Hydrogen-8-quinolinesulfonylamino]-5-guanidinopentanoyl}piperidine-2-carboxylic acid monohydrate with a molecular weight of 526.65. Argatroban is a highly active and highly selective thrombin inhibitor. Its anticoagulant effect does not depend on antithrombin in the body, but directly binds to free thrombin in the blood and inactivates it; In addition, due to the small molecular weight of argatroban, it can directly enter the thrombus, inactivate the thrombin that has been bound to fibrin, and indirectly inhibit the generation of thrombin. platelet aggregation reaction. Because argatroban can greatly reduce the level of thrombin-antithrombin complex in plasma and effect...

Claims

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