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Pharmaceutical composition containing oral anticoagulant and B vitamins and use thereof

A composition and anticoagulant technology, applied in the field of pharmacy, can solve the problem of high incidence of bleeding and achieve the effect of reducing the risk of stroke

Active Publication Date: 2016-08-17
SHENZHEN AUSA PHARM CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are still some problems in the clinical application of new oral anticoagulant drugs, and the more prominent one is still the inevitable bleeding tendency during treatment, especially when the dose is increased, the bleeding rate is relatively high, so further improvement is still needed

Method used

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  • Pharmaceutical composition containing oral anticoagulant and B vitamins and use thereof
  • Pharmaceutical composition containing oral anticoagulant and B vitamins and use thereof
  • Pharmaceutical composition containing oral anticoagulant and B vitamins and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1. Preparation of Compound Rivaroxaban / Folic Acid Tablets (1000 Tablets)

[0028]

[0029] Preparation method: Take the prescribed amount of folic acid and rivaroxaban and mix them uniformly according to the method of equal increase, and set aside; weigh the prescribed amount of microcrystalline cellulose, croscarmellose sodium, lactose, and sodium lauryl sulfate, Mix well with the mixed powder of raw materials, pass through 80-mesh sieve, add appropriate amount of 5% hypromellose solution to make soft material, granulate with 20-mesh sieve, dry at 50°C for about 6 hours, granulate with 20-mesh sieve, control the particle size The water content is 2-3%, the dried granules are uniformly mixed with the prescribed amount of magnesium stearate, the intermediate is tested, and the tablet is pressed. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packed in aluminum-plastic blisters. Each of the prepared compound...

Embodiment 2

[0030] Embodiment 2. prepare compound dabigatran etexilate / folic acid sheet (1000 amount)

[0031]

[0032]

[0033] Preparation method: Take the prescribed amount of folic acid and dabigatran etexilate and mix them uniformly according to the method of equal increase, and set aside; take the prescribed amount of microcrystalline cellulose, lactose, and gum arabic, fully mix them with the mixed powder of raw materials, and pass through 80 mesh Sieve, add appropriate amount of simethicone oil and 10% hydroxypropyl cellulose solution to make a soft material, granulate with a 20-mesh sieve, dry at 50°C for about 6 hours, granulate with a 20-mesh sieve, and control the water content of the granules to 2-3%. The dried granules are evenly mixed with the prescribed amount of talcum powder and magnesium stearate, the intermediates are tested, and then compressed into tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packe...

Embodiment 3

[0034] Example 3. Preparation of Compound Apixaban / 5-Methyltetrahydrofolate Tablets (1000 Tablets)

[0035]

[0036] Preparation method: the auxiliary material is a direct pressing auxiliary material, which is dried for later use. Take the prescribed amount of 5-methyltetrahydrofolic acid and microcrystalline cellulose and mix evenly to obtain powder mixing intermediate 1; weigh anhydrous lactose, croscarmellose sodium, sodium lauryl sulfate, and Pixaban was fully mixed to obtain the powder-mixed intermediate 2; the powder-mixed intermediate 1 and the powder-mixed intermediate 2 were mixed evenly with the prescribed amount of magnesium stearate according to the method of equal increments to obtain the final powder-mixed intermediate. Mixing powder intermediate, tableting. The prepared tablets need to be packaged in aluminum-plastic blisters, and each tablet contains 2.5 mg of apixaban and 0.45 mg of 5-methyltetrahydrofolate.

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Abstract

The invention relates to a pharmaceutical composition containing a novel oral anticoagulant drug and B vitamins. One or more of the B vitamins and a pharmaceutically acceptable carrier. Among them, new oral anticoagulants mainly include dabigatran etexilate, rivaroxaban, apixaban, and edoxaban, with a content of 2.5-200mg; B vitamins mainly include folic acid compounds (preferred), vitamin B 6 , Vitamin B 12 , content is 0.1 ~ 50mg. The present invention also relates to the use of the composition in the preparation of medicines for preventing apoplexy in patients with atrial fibrillation. The medicine made from the pharmaceutical composition provided by the invention has a better effect of preventing stroke; in addition, the invention can make it convenient for patients to take medicine and increase compliance.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing an oral anticoagulant and B vitamins for anticoagulant therapy for the prevention of cerebral apoplexy in patients with atrial fibrillation. The present invention belongs to the field of pharmacy. Background technique [0002] Atrial fibrillation (AF) is a cardiovascular "epidemic". Among the cardiovascular inpatients in my country during the same period, the proportion of patients with atrial fibrillation was close to 10%. Atrial fibrillation may lead to many adverse outcomes, and stroke is one of the most serious complications. Atrial fibrillation can increase the incidence of stroke by at least 4 to 5 times [Hu D, et al. Epidemiology, Risk Factors for Stroke, and Management of Atrial Fibrillation in China. J Am Coll Cardiol, 2008; 52:865]. Studies have shown that as many as 3 million people worldwide suffer from atrial fibrillation-related strokes each year. Atrial fibrilla...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K45/06A61P7/02A61P9/06A61P9/10A61K31/4439A61K31/5377A61K31/4415A61K31/519A61K31/714
Inventor 徐希平张磊王存芳
Owner SHENZHEN AUSA PHARM CO LTD
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