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Pharmaceutical composition containing aspirin, clopidogrel and folic acid compound

A technology of aspirin and clopidogrel is applied in the direction of drug combination, pharmaceutical formula, medical preparation containing active ingredients, etc., to achieve the effect of reducing risks and reducing drug side effects

Inactive Publication Date: 2015-01-07
SHENZHEN AUSA PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to evidence-based medical research, although aspirin and clopidogrel have good preventive effects on thrombosis, they also have some disadvantages, and the most worrying side effect is the risk of bleeding [Sibbing D, et al. Antiplatelet effects of clopidogrel and bleeding in patients undergoing coronary stent placement. J Thromb Haemost, 2010; 8(2):250], this side effect is also related to the dosage and course of treatment; factors, while the pharmacological mechanisms of aspirin and clopidogrel do not involve vascular endothelial protection

Method used

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  • Pharmaceutical composition containing aspirin, clopidogrel and folic acid compound
  • Pharmaceutical composition containing aspirin, clopidogrel and folic acid compound
  • Pharmaceutical composition containing aspirin, clopidogrel and folic acid compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1. prepares compound aspirin / clopidogrel / folic acid sheet (1000 pieces amount)

[0028] Recipe:

[0029]

[0030]

[0031] Preparation method: pass the auxiliary materials through a 80-mesh sieve, and set aside. Take 100g of aspirin, 75g of clopidogrel, 0.8g of folic acid, 112g of microcrystalline cellulose, and 40g of lactose, mix them evenly, add an appropriate amount of 10% hypromellose, make soft materials, pass through a 20-mesh nylon sieve to make wet granules, 60 Dry at ±5°C for 2 hours, control the water content of the granules to be below 1.5%, sieve the granules with a 20-mesh sieve, mix them evenly with sodium stearyl fumarate, and press into tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packed in aluminum-plastic blisters and stored away from light. Each of the prepared compound tablets contains 100 mg of aspirin, 75 mg of clopidogrel and 0.8 mg of folic acid.

Embodiment 2

[0032] Embodiment 2. Preparation of compound aspirin / clopidogrel / 5-methyltetrahydrofolic acid film-coated tablets (1000 pieces)

[0033] Recipe:

[0034]

[0035] Coating prescription

[0036] Coating material: film coating premix 9g

[0037] Coating solvent: purified water 66g

[0038] Preparation method: Weigh aspirin, clopidogrel, 5-methyltetrahydrofolate and PEG6000 according to the prescription amount, and set aside. Add the weighed prescription amount of aspirin, clopidogrel, 5-methyltetrahydrofolate and PEG6000 into the granulator, and granulate at 50°C±5°C. Pass through a 30-mesh sieve for granulation to obtain drug granules, weigh hydroxypropyl cellulose, mannitol, lactose, microcrystalline cellulose and glyceryl behenate, put the weighed drug granules and auxiliary materials into a mixer and mix for 20 minutes, The material is discharged to obtain intermediate particles. The intermediate is inspected, and after passing the test, it is pressed into tablets, an...

Embodiment 3

[0039] Example 3. Preparation of Compound Aspirin / Clopidogrel / Folic Acid Capsules (1000 Capsules)

[0040] Recipe:

[0041]

[0042] Preparation method: Take the prescribed amount of folic acid, aspirin, and clopidogrel and mix them uniformly according to the method of equal increase, and set aside; then mix them evenly with mannitol, crospovidone, and calcium hydrogen phosphate, pass through a 80-mesh sieve, and add polyethylene glycol Alcohol 400, appropriate amount of 5% hypromellose solution, make soft material, granulate with 24 mesh sieve, dry at 50°C for about 6 hours, pass through 24 mesh sieve for granulation, control the water content of the granules to 2-3%, and dry the dried The granules are uniformly mixed with the hydrogenated castor oil and talcum powder in the prescribed amount, and the obtained granule intermediate is tested for content, and after passing the test, it is packed into a hollow capsule to obtain the product. Each prepared capsule contains 100...

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Abstract

The invention relates to a pharmaceutical composition containing aspirin, clopidogrel and a folic acid compound. According to the pharmaceutical composition disclosed by the invention, the folic acid compound is prepared from the following components including folic acid, 5-methyltetrahydrofolic acid, formyl tetrahydrofolic acid, folinic acid, calcium levofolinate and medicinal salts of folic acid. The pharmaceutical composition is preferentially prepared from the following components by weight: 50-150mg of aspirin, 50-100mg of clopidogrel and 0.4-2mg of folic acid compound. The invention also relates to an application of the pharmaceutical composition in preparing a medicament for preventing a thromboembolic disease. With the adoption of the pharmaceutical composition, the medicament prepared from the pharmaceutical composition has a remarkable effect of inhibiting formation of thrombus on the basis of effectively inhibiting platelet aggregation; in addition, a patient is convenient to take the pharmaceutical composition, and compliance is improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing aspirin, clopidogrel and folic acid compounds and its application, especially a pharmaceutical composition for preventing or delaying vascular embolism diseases, which belongs to the field of pharmacy. Background technique [0002] The incidence of cardiovascular and cerebrovascular diseases in my country is increasing year by year. According to the statistics of the Ministry of Health, there are about 70 million patients with stroke and its sequelae and 60 million patients with coronary heart disease in China. Thrombosis and embolism are the direct causes of cardiovascular and cerebrovascular events such as myocardial infarction and ischemic stroke. Thromboembolic diseases have become the main killer of human health, and antiplatelet therapy is an important intervention to prevent the occurrence of such diseases【 Gao Xuguang. Antiplatelet therapy for the prevention of ischemic stroke. Ch...

Claims

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Application Information

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IPC IPC(8): A61K31/616A61P7/02A61K31/4365A61K31/519
CPCA61K31/616A61K31/4365A61K31/519A61K2300/00
Inventor 张磊王存芳徐希平陈平田敏卿王滨燕
Owner SHENZHEN AUSA PHARMA
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