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Novel medicament composition for resisting thrombosis

An antithrombotic and composition technology is applied in the field of antithrombotic pharmaceutical compositions and their preparation, which can solve problems such as limitations and achieve the effects of reducing irritation, improving medication safety, and reducing costs

Active Publication Date: 2010-12-15
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All of the above limit the application of combination preparations of clopidogrel and aspirin

Method used

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  • Novel medicament composition for resisting thrombosis
  • Novel medicament composition for resisting thrombosis
  • Novel medicament composition for resisting thrombosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The drug compatibility test of embodiment 1 clopidogrel and indobufen

[0048] The purpose of this experiment is to verify whether the two drugs, clopidogrel and indobufen, are physically and chemically compatible. The two drugs, clopidogrel and indobufen, were prepared and stored in three different temperature and humidity environments, namely 25°C / 10%RH; 30°C / 60%RH; 40°C / 75%RH. Drugs were divided into a mixed group and an unmixed group as controls, which were respectively placed at these three temperatures. Samples were evaluated on day 1, day 2, day 7, day 14, day 30 for color, physical properties, chemical stability (by chromatography), and activity of each active ingredient under all storage conditions The degree of recovery (% mixed group / % control group) was 94.3%-103.7% for clopidogrel and 96.2%-104.4% for indobufen. During the observation, there was no obvious difference between the mixing group and the control group in the analysis of physical shape and chem...

Embodiment 2

[0050] Example 2 Compound Tablet Containing Clopidogrel 25mg and Indobufen 100mg

[0051] 1) Prescription:

[0052]

[0053]

[0054] 2) Preparation method: powder direct compression method

[0055] Mix 25g of clopidogrel, 40g of compressible starch, 40g of β-anhydrous lactose and 0.7g of anhydrous colloidal silicon dioxide; mix 100g of indobufen, 40g of β-anhydrous lactose and 40g of microcrystalline cellulose. Add hydrogenated castor oil and talcum powder, mix thoroughly together, pass through a 12-mesh nylon sieve for granulation, after the content of the granules is qualified, punch the granule powder with a 12mm punch and directly compress it into tablets to obtain the product.

Embodiment 3

[0056] Example 3 Compound Tablet Containing Clopidogrel 50mg and Indobufen 150mg

[0057] 1) Prescription:

[0058]

[0059] 2) Preparation method: powder direct compression method

[0060] Stir clopidogrel, indobufen and macrogol6000 in a rapid mixing granulator for 15 minutes and mix evenly; add hydrogenated castor oil, continue stirring for 5 minutes to mix evenly, pass through a 12-mesh nylon sieve for granulation. After the granules pass the content determination, the final mixture powder is directly compressed into tablets according to the mass of the unit dose to obtain about 1000 tablets.

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PUM

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Abstract

The invention relates to a medical composition, in particular to a novel antithrombotic medical composition and a preparation method and a purpose thereof. The novel antithrombotic medical composition comprises ADP receptor antagonist with an effective dose of 25-500mg and Indobufen with an effective dose of 50-400mg. The invention reduces the spread effect to gastrointestinal tract and the severe bleeding probability that appears in the application of ticlopidine-aspirin composition and Clopidogrel-aspirin medical composition, more particularly reduces the bleeding incidence rate of the gastrointestinal tract, improves the medication compliance of patients and the clinical medication safety and healing efficiency and has favorable using value.

Description

technical field [0001] The present invention relates to a pharmaceutical composition, specifically a new antithrombotic pharmaceutical composition composed of an ADP receptor antagonist, indobufen and one or more appropriate pharmaceutical excipients and Its preparation method and use. Background technique [0002] Cardiovascular and cerebrovascular diseases are the most serious diseases that threaten human health in the world today, and their incidence has surpassed tumors and ranked first. Platelet aggregation plays a key role in hemostasis and thrombosis. Various substances can cause platelet activation and aggregation through their specific receptors. Thrombosis caused by platelet aggregation is an important cause of cardiovascular and cerebrovascular diseases (Mills DCD.Thromb Haemost, 1996, 76:835-856). Currently on the market commonly used antithrombotic drugs are aspirin, indobufen, ticlopidine, clopidogrel and so on. [0003] Long-term use of low-dose aspirin (As...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/404A61K31/4365A61P7/02
Inventor 黄璐钱志强周建明郭亚兵朱毅
Owner GRAND PHARM (CHINA) CO LTD
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