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Angiotensin II receptor blocker/thiazide diuretics/5-methyltetrahydrofolate pharmaceutical composition

An angiotensin and receptor blocker technology, applied in the field of pharmacy, can solve the problems of electrolyte and lipid metabolism disorders, and the protective effect of target organs has not been correspondingly enhanced or weakened, so as to achieve good results and reduce the risk of cerebrovascular events , the effect of preventing target organ damage

Inactive Publication Date: 2014-04-16
SHENZHEN AUSA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In short, due to the characteristics and adverse reactions of diuretics, the advantages and disadvantages of long-term or larger doses are more significant
[0005] The compound drug composed of ARB and (low dose) thiazide diuretics is outstanding in synergistic antihypertensive, and the hypokalemia caused by the latter can be partially offset by the side effect of elevated potassium caused by the former due to inhibition of RAAS, but long-term Disorders of electrolyte and lipid metabolism may still occur after application. More importantly, the protective effect of this combination on target organs has not been correspondingly enhanced. On the contrary, it may be weakened due to the influence on lipid metabolism.

Method used

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  • Angiotensin II receptor blocker/thiazide diuretics/5-methyltetrahydrofolate pharmaceutical composition
  • Angiotensin II receptor blocker/thiazide diuretics/5-methyltetrahydrofolate pharmaceutical composition
  • Angiotensin II receptor blocker/thiazide diuretics/5-methyltetrahydrofolate pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1. Preparation of Valsartan 80mg / Hydrochlorothiazide 12.5mg / 5-Methyltetrahydrofolate 0.8mg Tablets (1000 Tablets)

[0025]

[0026] Preparation method: crush the auxiliary materials through an 80-mesh sieve, and dry for later use. Take 80g of valsartan, 12.5g of hydrochlorothiazide, and 0.8g of 5-methyltetrahydrofolic acid and mix them uniformly according to the method of increasing the amount of equal amounts. % hydroxypropyl methylcellulose solution to make soft material, granulate with 20 mesh sieve, dry at 40°C for about 2 hours, granulate with 20 mesh sieve, control the water content of the granules to 2-3%, and mix the dried granules with hard Magnesium fatty acid and talcum powder are mixed evenly, and the semi-finished product is tested to determine the content, and compressed into 1000 tablets with a tablet machine. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packed in aluminum-plastic bliste...

Embodiment 2

[0027] Example 2. Preparation of Irbesartan 150mg / Hydrochlorothiazide 12.5mg / 5-Methyltetrahydrofolate 0.4mg Tablets (1000 Tablets)

[0028]

[0029]Preparation method: the auxiliary material is a direct pressing auxiliary material, which is dried for later use. Take 30 g of 5-methyltetrahydrofolate, hydrochlorothiazide, and microcrystalline cellulose in the prescribed amount and mix them uniformly according to the method of equal increase to obtain mixed powder 1; Cellulose sodium, silicon dioxide, and irbesartan are fully mixed by the method of equal increments to obtain mixed powder 2; mixed powder 1 and mixed powder 2 are mixed evenly with the prescribed amount of glyceryl behenate to obtain the final mixed powder Powder intermediate, test mixed powder intermediate, pressed into 1000 pieces. 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.

Embodiment 3

[0030] Example 3. Preparation of Telmisartan 40mg / Hydrochlorothiazide 12.5mg / 5-Methyltetrahydrofolate 0.8mg Tablets (1000 Tablets)

[0031]

[0032] Preparation method: crush the raw and auxiliary materials through an 80-mesh sieve, and dry for later use. Take 40g of telmisartan, 12.5g of hydrochlorothiazide, and 0.8g of 5-methyltetrahydrofolic acid and mix them uniformly according to the method of equal volume increase. Add lactose, microcrystalline cellulose and sodium carboxymethyl starch 9g respectively according to the prescription amount, mix well, and use 5% povidone K29 / 32-95% ethanol solution to make soft material, granulate with 20-mesh sieve, dry at 40°C for about 2 hours, granulate with 20-mesh sieve, control the water content of the granules to 2-3%. The granule is mixed homogeneously with remaining carboxymethyl starch sodium and magnesium stearate, and the semi-finished product is detected, measures content, is compressed into 1000 with tablet machine.

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Abstract

The invention relates to a pharmaceutical composition containing an angiotensin II receptor blocker (ARB) / thiazide diuretics / 5-methyltetrahydrofolate and an application of the pharmaceutical composition. The pharmaceutical composition comprises the ARB with pharmaceutical dosage, the thiazide diuretics with pharmaceutical dosage, the 5-methyltetrahydrofolate with pharmaceutical dosage, and a pharmaceutically acceptable carrier. The invention provides the application of the pharmaceutical composition in the preparation of medicines used for treating hypertension as well as preventing, treating or delaying target-organ damage caused by the hypertension. The invention also provides the application of the pharmaceutical composition in the preparation of medicines used for reducing the risk of cardiovascular and cerebrovascular events caused by the hypertension. Through the implementation of the invention, the pharmaceutical composition with the specific purposes is provided for patients, the medication compliance of the patients also can be increased, and the curative effect is improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition combined with an angiotensin II receptor blocker / thiazide diuretic / 5-methyltetrahydrofolate and its use, belonging to the field of pharmacy. Background technique [0002] Hypertension is one of the most common chronic diseases and the most important risk factor for cardiovascular and cerebrovascular diseases. Its main complications such as stroke, myocardial infarction, heart failure and chronic kidney disease have a high disability and fatality rate, which seriously consumes medical treatment. resources, which impose a heavy burden on families and society. The main goal of hypertension treatment is to minimize the overall risk of cardiovascular complications and death, and it is necessary to treat all reversible cardiovascular risk factors, subclinical target organ damage, and various coexisting clinical diseases [Chinese Hypertension Prevention and Treatment]. Guidelines Revision Committee. Chine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61P9/12A61P9/14A61P9/00A61P13/12A61K31/519
Inventor 徐希平张磊王存芳
Owner SHENZHEN AUSA PHARMA
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