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Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof

A technology of clopidogrel bisulfate aspirin and clopidogrel bisulfate, which is applied in the field of tablets containing clopidogrel bisulfate and aspirin active ingredients and its preparation field, and can solve the problems that do not involve the preparation process and do not mention other drug excipients. Questions such as the preparation process of the dosage of the form

Inactive Publication Date: 2015-02-25
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] This product is not yet listed in China. The original research patent CN97192393.0 discloses a new composition containing clopidogrel and an active ingredient of an antithrombotic drug, but does not mention the dosage of other pharmaceutical excipients and the dosage of this product. Preparation process; patent CN201110150257.1 discloses a dispersible tablet containing clopidogrel and aspirin, and does not involve a specific preparation process

Method used

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  • Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof
  • Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof
  • Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription

[0024]

[0025]

[0026] Preparation process (dry granulation and tabletting)

[0027] (1) Pretreatment of raw and auxiliary materials: crush the clopidogrel hydrogen sulfate raw material through a 100-mesh sieve, crush the aspirin raw material through a 60-mesh sieve, pass through a 80-mesh sieve for mannitol, microcrystalline cellulose, and cornstarch, and set aside;

[0028] (2) Weighing: Weigh the raw and auxiliary materials according to the prescription amount

[0029] (3) Preparation of granules: dry granulate with 20 mesh sieve after mixing clopidogrel bisulfate and its internally added excipients evenly, then dry granulate with 20 mesh sieve after aspirin and its internally added excipients are mixed evenly;

[0030] (4) Calculate the yield of granules after dry granulation, then add the converted disintegrant, glidant and other excipients to the clopidogrel bisulfate granules and mix evenly, then add the converted disintegration to the asp...

Embodiment 2

[0035] prescription

[0036]

[0037] Preparation process (dry granulation and tabletting)

[0038] (1) Pretreatment of raw and auxiliary materials: crush the clopidogrel hydrogen sulfate raw material through a 100-mesh sieve, crush the aspirin raw material through a 60-mesh sieve, pass through a 80-mesh sieve for mannitol, microcrystalline cellulose, and cornstarch, and set aside;

[0039] (2) Weighing: Weigh the raw and auxiliary materials according to the prescription amount

[0040] (3) Preparation of granules: dry granulate with 20 mesh sieve after mixing clopidogrel bisulfate and its internally added excipients evenly, then dry granulate with 20 mesh sieve after aspirin and its internally added excipients are mixed evenly;

[0041] (4) Calculate the yield of granules after dry granulation, then add the converted disintegrant, glidant and other excipients to the clopidogrel bisulfate granules and mix evenly, then add the converted disintegration to the aspirin granule...

Embodiment 3

[0046] prescription

[0047]

[0048] Preparation process (dry granulation and tabletting)

[0049] (1) Pretreatment of raw and auxiliary materials: crush the clopidogrel hydrogen sulfate raw material through a 100-mesh sieve, crush the aspirin raw material through a 60-mesh sieve, pass through a 80-mesh sieve for mannitol, microcrystalline cellulose, and cornstarch, and set aside;

[0050] (2) Weighing: Weigh the raw and auxiliary materials according to the prescription amount

[0051] (3) Preparation of granules: dry granulate with 20 mesh sieve after mixing clopidogrel bisulfate and its internally added excipients evenly, then dry granulate with 20 mesh sieve after aspirin and its internally added excipients are mixed evenly;

[0052] (4) Calculate the yield of granules after dry granulation, then add the converted disintegrant, glidant and other excipients to the clopidogrel bisulfate granules and mix evenly, then add the converted disintegration to the aspirin granule...

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Abstract

The invention relates to a tablet containing clopidogrel sulfate and aspirin active compositions and a preparation method thereof, and belongs to the technical field of medicines. The prescription is mainly composed of the active compositions clopidogrel sulfate and aspirin and other auxiliary materials. The usage amount of raw materials and auxiliary materials in per 1000 clopidogrel-sulfate aspirin tablets: 98 g of clopidogrel sulfate, 50.0 g-100.0 g of aspirin, 110.2 g-130.0 g of mannitol 200SD, 30.0 g-60.0 g of corn starch, 60.0 g-80.0 g of microcrystalline cellulose, 3.0 g-6.0 g of polyethylene glycol 6000, 2.0 g-4.0 g of hydrogenated castor oil, 3.0 g-6.0 g of stearic acid, 8.0 g-12.0 g of micropowder silica gel, and 15.0 g-20.0 g of low-substituted hydroxy propyl cellulose. The preparation technology of the prescription comprises weighing all raw materials and all internally-added compositions, mixing uniformly and granulating by using a dry process, adding all externally-added compositions after the dry-process granulating yield is calculated out, then utilizing a double-layer tablet press for tablet pressing, and finally employing an alcohol water solvent (alcohol / water=80 / 20) to prepare a dressing liquid for dressing. Compared with common single prescriptions clopidogrel sulfate tablet and aspirin tablet, the disclosed tablet containing clopidogrel sulfate and aspirin active compositions helps to reduce drug administration frequency of a patient, improve adaptability of a patient, and has synergic effect and relatively good curative effect by simultaneously using the two active compositions.

Description

technical field [0001] The invention relates to a tablet containing active ingredients of clopidogrel hydrogen sulfate and aspirin and its preparation process. In particular, the prescription uses mannitol 200SD as a filler, which can well solve the sticking and dissolution problems of the tablet during the production process. At the same time, the two active ingredients are all granulated by dry method, and the plain tablets are coated with a coating solution prepared by alcohol and water solvent, which can minimize the increase of related substances and greatly improve the safety of the drug while ensuring the curative effect. field of medical technology. Background technique [0002] According to the latest data of the U.S. pharmaceutical industry, clopidogrel (Plavix, trade name Plavix) is now the top-selling drug in the U.S. pharmaceutical market. Previously the United States Pfizer The pharmaceutical company's Lipitor drug reclusive throne, but since the patent prote...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/616A61K9/28A61P9/10A61P7/02A61K31/4365
Inventor 徐彬彬邹巧根
Owner NANJING HEALTHNICE MEDICAL TECH
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