Clopidogrel bisulfate tablet

A clopidogrel bisulfate tablet and a technology of clopidogrel bisulfate, which are applied in the field of medicine, can solve problems such as accelerating the degradation of clopidogrel, and achieve the effects of improving curative effect, avoiding sticking phenomenon and increasing stability

Active Publication Date: 2012-05-23
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the problem that magnesium stearate in clopidogrel bisulfate tablets accelerates the degradation of clopidogrel can b

Method used

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  • Clopidogrel bisulfate tablet
  • Clopidogrel bisulfate tablet
  • Clopidogrel bisulfate tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation of embodiment 1 clopidogrel bisulfate tablet

[0032] 1. Pill core prescription

[0033] Clopidogrel Bisulfate 98g

[0034] Hydroxypropyl Cellulose 294g

[0035] Lactose 97.02g

[0036] 3% polyvinylpyrrolidone absolute ethanol solution

[0037] 2. Coating prescription

[0038] Ball core 1000g

[0039] 5% HPMC70% ethanol solution appropriate amount

[0040] 2 to 3% weight gain is sufficient.

[0041] 3. Tablet prescription

[0042] Coated pellets 1000g

[0043] Magnesium Stearate 5g

[0044] Preparation Process:

[0045] On the premise of adopting the above prescription, the tablet can be prepared according to the conventional techniques of pellet preparation, coating and tabletting. For example: Take clopidogrel bisulfate, hydroxypropyl cellulose, lactose, add polyvinylpyrrolidone K30 ethanol solution to make soft material, extrude with 0.5mm aperture of extruder, extrusion speed is 60r min -1 , the rolling speed is 1000r·min -1 , rounded fo...

Embodiment 2

[0047] The preparation of embodiment 2 clopidogrel bisulfate tablet

[0048] 1. Pill core prescription

[0049] Clopidogrel Bisulfate 98g

[0050] Hydroxypropyl Cellulose 98g

[0051] Lactose 1.96g

[0052] Anhydrous ethanol amount

[0053] 2. Coating prescription

[0054] Ball core 1000g

[0055] 4% HPMC70% ethanol solution appropriate amount

[0056] 2 to 3% weight gain is sufficient.

[0057] 3. Tablet prescription

[0058] Coated pellets 1000g

[0059] Magnesium Stearate 4g

[0060] Preparation process: with the preparation process of embodiment 1.

Embodiment 3

[0061] The preparation of embodiment 3 clopidogrel bisulfate tablets

[0062] 1. Pill core prescription

[0063] Clopidogrel Bisulfate 98g

[0064] Hydroxypropyl Cellulose 200g

[0065] Lactose 20g

[0066] 5% povidone absolute ethanol solution appropriate amount

[0067] 2. Coating prescription

[0068] Ball core 1000g

[0069] 4% HPMC70% ethanol solution appropriate amount

[0070] 2 to 3% weight gain is sufficient.

[0071] 3. Tablet prescription

[0072] Coated pellets 1000g

[0073] Magnesium Stearate 4g

[0074] Preparation process: with the preparation process of embodiment 1.

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Abstract

The invention relates to a clopidogrel bisulfate tablet. A preparation method of the clopidogrel bisulfate tablet comprises the following steps of mixing clopidogrel bisulfate, lactose and hydroxy propyl cellulose according to a weight ratio of 1: (0.02 to 1): (1 to 3), preparing the mixture into pellets, dressing the pellets, and pressing the dressed pellets and an appropriate amount of magnesium stearate into tablets. Compared with the prior art, the preparation method adopts a pellet dressing and tabletting technology, improves product stability and curative effects, and prevents the sticking problem produced in drug tabletting.

Description

technical field [0001] The invention relates to a clopidogrel bisulfate tablet, which belongs to the technical field of medicine. Background technique [0002] Clopidogrel is a new generation of anti-platelet aggregation drug, which has good curative effect in preventing thromboembolic events, and can reduce the probability of recurrence in patients with ischemic heart disease, cerebrovascular disease and peripheral arterial disease. The large CAPRIE study showed that clopidogrel can significantly reduce the relative risk of vascular death, myocardial infarction and ischemic stroke by 8.7% compared with aspirin. The drug is administered in the form of bisulfate, soluble in methanol, ethanol, acetone and other organic solvents, but almost insoluble in neutral water, and its structural formula is as follows: [0003] [0004] At present, the main problems existing in the production process of clopidogrel bisulfate tablets are: (1) poor stability: clopidogrel bisulfate has ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K9/36A61K31/4365A61P7/02
Inventor 赵志全郝贵周韩忠丽
Owner SHANDONG NEWTIME PHARMA
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