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Clopidogrel tablet and preparation method thereof

A technology of clopidogrel tablets and clopidogrel tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as instability of damp heat

Inactive Publication Date: 2014-06-25
WUHAN SUNRISE BIO PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The present invention develops formulations around the three main problems of clopidogrel viscosity, damp heat instability, and dissolution behavior, and uses a mixed lubricant of sodium stearyl fumarate and talcum powder to solve the problems of stickiness and compatibility of raw and auxiliary materials. The preparation process of tablet method and the selection of diluent with low water content solve the problems of thermal instability and configuration transformation. By controlling and examining the prepared pressure, binder and disintegrant, the in vitro dissolution behavior and Plavix is ​​similar to ensure that the preparation is bioequivalent in vivo, thereby completing the present invention

Method used

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  • Clopidogrel tablet and preparation method thereof
  • Clopidogrel tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084]

[0085]Preparation method: (1) Clopidogrel hydrogen sulfate, sodium stearyl fumarate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone are pulverized separately, passed through a 30-mesh sieve, and set aside ; (2) Mix clopidogrel hydrogen sulfate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone evenly according to the prescription ratio, and set aside; (3) Stearin Sodium fumarate is added in the mixture of step (2), mix well; (4) measure the content of active ingredient in the mixed material, 8kg / mm 2 Press the tablet to get the plain tablet; (5) Coat the plain tablet obtained in step (4) with Opadry film, the coating temperature is 35°C-45°C, until the weight gain is 3% (the coating solution during the coating process It will be sprayed in the form of mist and equipped with a heating device, and the moisture in the coating solution will dry quickly. Therefore, the weight ga...

Embodiment 2

[0087]

[0088] Preparation method: (1) Clopidogrel hydrogen sulfate, sodium stearyl fumarate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone are pulverized separately, passed through a 30-mesh sieve, and set aside ; (2) Mix clopidogrel hydrogen sulfate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone evenly according to the prescription ratio, and set aside; (3) Stearin Sodium fumarate is added in the mixture of step (2), mix well; (4) measure the content of active ingredient in the mixed material, 8kg / mm 2 Press the tablet to obtain plain tablets; (5) Coat the plain tablets obtained in step (4) with Opadry film, and the coating temperature is 35°C to 45°C until the weight gain is 2.7%.

Embodiment 3

[0090]

[0091] Preparation method: (1) Clopidogrel hydrogen sulfate, sodium stearyl fumarate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone are pulverized separately, passed through a 30-mesh sieve, and set aside ; (2) Mix clopidogrel hydrogen sulfate, talcum powder, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone evenly according to the prescription ratio, and set aside; (3) Stearin Sodium fumarate is added in the mixture of step (2), mix well; (4) measure the content of active ingredient in the mixed material, 8kg / mm 2 Press the tablet to obtain plain tablets; (5) Coat the plain tablets obtained in step (4) with Opadry film, and the coating temperature is 35°C to 45°C until the weight gain is 3%.

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Abstract

The invention discloses a clopidogrel tablet and a preparation method thereof. The clopidogrel tablet is a coated tablet which consists of a clopidogrel table body and a coating material, wherein the clopidogrel table body comprises the following ingredients in parts by weight of clopidogrel free alkali: 75 parts of pharmaceutically acceptable salt of clopidogrel, 6-9 parts of sodium stearyl fumarate, 3-6 parts of talcum powder, 90-135 parts of diluent, 2-6 parts of bonding agent and 7-17 parts of disintegrating agent, wherein the diluent is made of combined mannitol and microcrystalline cellulose in a weight ratio of (2:1)-(1:1); the weight of the coating material accounts for 2.7-3.3% of the weight of the clopidogrel tablet. By adopting the clopidogrel tablet, not only is the problem of sticking in the tabletting process solved, but also the mixed lubricant and clopidogrel have good compatibility, the phenomena that active ingredients are degraded or the configuration is inversed are avoided, and the clopidogrel tablet is high in stability, good in quality, and high in similarity in dissolving behavior to that of an original triturate plavix.

Description

technical field [0001] The invention belongs to the field of biomedicine, and in particular relates to a clopidogrel tablet and a preparation method thereof. Background technique [0002] Clopidogrel bisulfate is an adenosine diphosphate (ADP) receptor blocker, which can bind to the ADP receptor on the surface of the platelet membrane, so that fibrinogen cannot bind to the glycoprotein GPⅡb / Ⅲa receptor, thereby inhibiting the platelet interaction. gather. Widely used clinically to prevent atherosclerotic thrombosis events: 1. Patients with myocardial infarction (from a few days to less than 35 days), patients with ischemic stroke (from 7 days to less than 6 months) or confirmed peripheral arterial disease 2. Patients with acute coronary syndrome; 3. Non-ST-segment elevation acute coronary syndrome (including unstable angina or non-Q wave myocardial infarction), including implantation after percutaneous coronary intervention For patients with stents, combined with aspirin; ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4365A61K47/12A61K47/38A61K47/02A61P7/02
Inventor 朱勤卢山陆毅马春兰约翰·卡特
Owner WUHAN SUNRISE BIO PHARMA SCI & TECH
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