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Clopidogrel bisulfate tablet and preparation method thereof

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. and other problems, to achieve the effect of improving stability, good process reproducibility, and good reproducibility

Active Publication Date: 2011-05-18
JIANGSU YABANG QIANGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This prescription process has been granulated twice, and because the raw material drug is relatively viscous, direct addition will cause sticking

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032] Clopidogrel bisulfate 25g (calculated as clopidogrel)

[0033] Mannitol 40g

[0034] Microcrystalline cellulose 80g (particle size is 400μm)

[0035] Sodium carboxymethyl starch 15g

[0036] PEG 6000 10g

[0037] Micropowder silica gel 2.5g (particle size is 5μm)

[0038] Stearic acid 2g

[0039]

[0040] A total of 1000 pieces were made

[0041] Preparation Process:

[0042] (1) Pretreatment: Take the remaining auxiliary materials in the prescription except microcrystalline cellulose and micropowder silica gel, pulverize them respectively and pass through an 80-mesh sieve for subsequent use; clopidogrel bisulfate passes through a 100-mesh sieve for subsequent use;

[0043] (2) Mixing: Weigh the prescribed amount of clopidogrel bisulfate, granular microcrystalline cellulose, micro-powder silica gel after airflow pulverization, and the rest of the internally added auxiliary materials, a...

Embodiment 2

[0048] prescription:

[0049] Clopidogrel bisulfate 50g (calculated as clopidogrel)

[0050] Mannitol 60g

[0051] Microcrystalline cellulose 60g (particle size is 400μm)

[0052] Sodium carboxymethyl starch 18g

[0053] PEG 6000 10g

[0054] Micropowder silica gel 5g (particle size is 5μm)

[0055] Stearic acid 2g

[0056]

[0057] A total of 1000 pieces were made

[0058] Preparation Process:

[0059] The preparation method of clopidogrel bisulfate tablets is the same as in Example 1.

Embodiment 3

[0061] prescription:

[0062] Clopidogrel bisulfate 75g (calculated as clopidogrel)

[0063] Mannitol 80g

[0064] Microcrystalline cellulose 60g (particle size is 400μm)

[0065] Sodium carboxymethyl starch 20g

[0066] PEG 6000 10g

[0067] Micropowder silica gel 10g (particle size is 5μm)

[0068] Stearic acid 2g

[0069]

[0070] A total of 1000 pieces were made

[0071] Preparation Process:

[0072] The preparation method of clopidogrel bisulfate tablets is the same as in Example 1.

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Abstract

The invention relates to a clopidogrel bisulfate tablet and a preparation method thereof. Each clopidogrel bisulfate tablet comprises 25-75 mg of clopidogrel bisulfate measured in the term of clopidogre, fillers, disintegrants, solubilizers, flow aids and lubricants. In the invention, the method of adding granular microcrystalline cellulose and aerosil through airflow crushing disposal to a prescription is adopted, therefore, the process of dry granulating is simple and feasible, reproducibility is good, prepared products have high stability, and the requirement of continuous large-scale production can be satisfied.

Description

technical field [0001] The invention relates to a clopidogrel bisulfate tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The number of people who die from cardiovascular-related diseases every year exceeds the sum of the four leading causes of death of cancer, chronic respiratory diseases, accidents and diabetes. Cardiovascular-related diseases include various types of stroke (such as embolic stroke, ischemic stroke, and transient ischemic attack), peripheral artery disease, blood clots (such as thrombus or embolism), and coronary artery disease, which can cause Myocardial infarction, angina, and heart failure. Blood clots can trigger heart attacks and strokes. While blood clots can form for a variety of reasons, a common cause is atherosclerosis. In atherosclerosis, fat and cholesterol build up in the arteries, hardening the walls and narrowing the arterial passages. These atherosclerotic build...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4365A61K47/32A61K47/36A61K47/38A61P7/02A61P9/10
Inventor 陈再新谢瑞丽毛白杨赵晓红王勇军孙海棠盖海涛王志刚郭雯
Owner JIANGSU YABANG QIANGSHENG PHARMA
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