Composition of statin medicine and 5-methyltetrahydrofolic acid, and application thereof

A technology of methyltetrahydrofolate and a composition, applied in the field of pharmacy, can solve the problems of elevated transaminase and the like, and achieve the effects of reducing the elevation of transaminase, improving compliance, and being convenient for taking medicine

Inactive Publication Date: 2013-08-07
SHENZHEN AUSA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 5-Methyltetrahydrofolate is used for the prevention and treatment of diseases related to abnormal liver function, especially in combination with statins for the treatment and prevention of side effects such as elevated transaminases and myopathy caused by long-term and / or high-dose statins , there is no related report

Method used

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  • Composition of statin medicine and 5-methyltetrahydrofolic acid, and application thereof
  • Composition of statin medicine and 5-methyltetrahydrofolic acid, and application thereof
  • Composition of statin medicine and 5-methyltetrahydrofolic acid, and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1. Preparation of atorvastatin 40mg / 5-methyltetrahydrofolate 0.8mg tablet

[0036] Recipe composition:

[0037]

[0038] Preparation method: crush the raw and auxiliary materials through an 80-mesh sieve, and dry for later use. Take 40g of atorvastatin and 0.8g of 5-methyltetrahydrofolate and mix evenly according to the method of equal increase, add 40g of sodium carboxymethyl starch and 180g of calcium hydrogen phosphate, mix evenly according to the method of equal increase, and add an appropriate amount of binder 10% povidone aqueous solution to make soft material, granulate with 30 mesh, dry at 40-45°C for 3 hours; granulate with 30 mesh, finally add appropriate amount of 1% magnesium stearate and mix evenly, after content determination, compress into tablets and pack. Pay attention to avoiding light during the preparation process. After the finished product passes the inspection, it will be packaged in aluminum-plastic blisters and stored away from li...

Embodiment 2

[0039] Example 2. Preparation of Atorvastatin 40mg / 5-Methyltetrahydrofolate 0.2mg Capsules

[0040] Recipe composition:

[0041]

[0042] Preparation method: crush the raw and auxiliary materials through an 80-mesh sieve, and dry for later use. Take 40g of atorvastatin and 0.2g of 5-methyltetrahydrofolate and mix uniformly according to the method of equal increase, add 80g of starch, 40g of microcrystalline cellulose, and 40g of sodium carboxymethyl starch, and mix uniformly according to the method of equal increase. Micro-powdered silica gel is made into a soft material, granulated with a 20-mesh sieve, dried at 60°C for about 2 hours, granulated with a 20-mesh sieve, and the moisture content of the granules is controlled to 2-3%, and the dried granules are mixed with 1% stearic acid in the prescribed amount The magnesium is mixed evenly, the semi-finished product is tested, the content is measured, and the hollow capsules are filled to obtain 1000 capsules. Protect from...

Embodiment 3

[0043] Example 3. Preparation of atorvastatin 20mg / 5-methyltetrahydrofolate 1.0mg granules

[0044] Recipe composition:

[0045]

[0046] Preparation process: Preparation process: crush the raw materials and auxiliary materials through a 120-mesh sieve, take 20 g of atorvastatin, 1.0 g of 5-methyltetrahydrofolate, 800 g of lactose, 40 g of starch, 5 g of gum arabic, 2 g of sweet orange essence, polyethylene glycol Glycol 5g is crushed and sun-dried, mixed evenly to make soft material, granulated, dried at 40-60°C, water content is about 3%, taken out, granulated, added appropriate amount of sodium carboxymethyl starch and mixed evenly, according to the conventional method It can be filled into granules. Each bag of the prepared compound tablet contains 20 mg of atorvastatin and 1.0 mg of 5-methyltetrahydrofolate.

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PUM

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Abstract

The invention relates to a medicine composition composed of 0.1-100mg of one of statin lipid regulation medicines, 0.1-5mg of 5-methyltetrahydrofolic acid, and a pharmaceutically acceptable carrier. The invention also provides an application of the medicine composition in preparing medicines used for treating diseases related to hyperlipidemia or dyslipidemia. The composition provided by the invention has the advantages that: with the medicine composition, statin lipid-regulation medicine treatment effect can be improved. The effect is substantially better than other independent-use statin lipid-regulation medicines in the respect of reducing side effects such as transaminase elevation and myopathy caused by long-term and/or large-dose applications of statin medicines, and toxicity is not increased. Also, the composition is more convenient to take. With the composition, medical cost is reduced, and patient compliance is improved.

Description

technical field [0001] The invention relates to a composition containing statin lipid-lowering drugs and 5-methyltetrahydrofolate, and its use in preparing and treating diseases related to hyperlipidemia or dyslipidemia. The present invention belongs to the field of pharmacy. Background technique [0002] Statins are currently the drug of choice for the treatment of hypercholesterolemia. After oral absorption, the hydrolyzate of statins competitively inhibits the rate-limiting enzyme-hydroxymethylglutaryl-CoA reductase in the process of cholesterol synthesis in vivo, which reduces the synthesis of cholesterol and also makes the low-density lipoprotein receptor Increased synthesis, the main site of action is in the liver, resulting in lower serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels, its ability to reduce TC is 20-30%, and the ability to reduce LDL-C is 30-35% %, moderately lowered serum triglyceride (TG) levels and increased high-de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P35/00A61K31/519A61P21/00A61P1/16A61P3/06A61K45/00A61P9/10
Inventor 白洁陈光亮张磊徐希平田敏卿王滨燕徐欣王存芳于多
Owner SHENZHEN AUSA PHARMA
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