Compound composition for treatment of high blood pressure and preparation method thereof

A composition and high blood pressure technology, applied in the field of medicine, can solve problems such as complicated process and unsuitable for large-scale industrial production, and achieve the effects of simplifying the preparation process, stabilizing the quality of preparations, and reducing manufacturing costs

Inactive Publication Date: 2015-04-15
TIANJIN CHANGSHOUYUAN HEALTH TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The technical problem to be solved by the present invention is to overcome the defects that the antihypertensive compound preparation containing three active ingredients of hydrochlorothiazide, amlodipine besylate and valsartan disclosed in the above-mentioned patent documents is complex in process and not suitable for large-scale industrial production, There is no need to make tablets or pellets of the three drugs, but to mix the three drugs with excipients in increments, increase the fluidity of the material through the granulation process, and add a specific amount of solubilizer polyoxygen to the specific prescription ratio Ethylene-polyoxypropylene copolymers such as poloxamers

Method used

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  • Compound composition for treatment of high blood pressure and preparation method thereof
  • Compound composition for treatment of high blood pressure and preparation method thereof
  • Compound composition for treatment of high blood pressure and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0031]

[0032] The preparation method adopts wet granulation, and the process includes:

[0033] Step 1: The main drug fine powder and auxiliary material fine powder according to the prescription amount, the main drug hydrochlorothiazide and amlodipine besylate are mixed with croscarmellose sodium (3 / 4 of the prescription amount) and passed through a 40-mesh sieve , then add microcrystalline cellulose equivalent to the weight of the above-mentioned mixed raw and auxiliary materials, pass through a 40-mesh sieve after mixing, then add the main drug valsartan equivalent to its weight, pass through a 40-mesh sieve after mixing, and then add the remaining microcrystalline After the cellulose and valsartan are mixed, pass through a 40-mesh sieve twice.

[0034] Step 2: Add an appropriate amount of 1.5% hydroxypropyl methylcellulose solution to the mixed fine powder obtained in step 1, prepare wet granules by passing through a 20-mesh sieve, and dry them by blasting at 45 ° C. T...

Embodiment approach 2

[0038]

[0039] The preparation method adopts wet granulation, and the process includes:

[0040] Step 1: The main drug fine powder and auxiliary material fine powder according to the prescription amount, the main drug hydrochlorothiazide and amlodipine besylate and cross-linked polyvinylpyrrolidone (3 / 4 of the prescription amount) are mixed and passed through a 40-mesh sieve, and then added Microcrystalline cellulose equivalent to the weight of the above mixed raw and auxiliary materials, after mixing, pass through a 40-mesh sieve, then add the main drug valsartan, which is equivalent to its weight, pass through a 40-mesh sieve after mixing, then add the remaining microcrystalline cellulose and After valsartan is mixed, pass through a 40-mesh sieve twice.

[0041] Step 2: Add an appropriate amount of 1.5% hydroxypropyl methylcellulose solution to the mixed fine powder obtained in step 1, prepare wet granules by passing through a 20-mesh sieve, and dry them by blasting at 4...

Embodiment approach 3

[0045]

[0046] The preparation method adopts wet granulation, and the process includes:

[0047] Step 1: the main drug fine powder and auxiliary material fine powder according to the prescription amount, the main drug hydrochlorothiazide and amlodipine besylate are mixed with cross-linked polyvinylpyrrolidone and passed through a 40-mesh sieve, and then add the equivalent weight of the above mixed raw materials Microcrystalline cellulose, after mixing, pass through a 40-mesh sieve, then add the main drug valsartan equivalent to its weight, pass through a 40-mesh sieve after mixing, then add the remaining microcrystalline cellulose and valsartan, mix and pass through twice 40 mesh screen.

[0048] Step 2: Add an appropriate amount of 1.5% hydroxypropyl methylcellulose solution to the mixed fine powder obtained in step 1, prepare wet granules by passing through a 20-mesh sieve, and dry them by blasting at 45 ° C. The moisture content of the granules is controlled at 2%-3%. ...

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Abstract

The invention discloses a compound oral preparation and a preparation method thereof. The compound oral preparation is used for treatment of high blood pressure and has significant effect. The preparation includes three anti-hypertensive drugs hydrochlorothiazide, amlodipine besylate, valsartan and pharmaceutical excipients. The three components all belong to hydrophobic drugs, so that the dissolution rate is one of the key indicators measuring the intrinsic quality of the preparation. A specific ratio of the raw materials to the excipients is adopted by the invention, especially a polyoxyethylene-polyoxypropylene copolymer is used, for instance poloxamer serves as a solubilizing agent, so that compared with the anti-hypertensive compound preparation EXFORGE HCT produced by American Novartis pharmaceutical company, the compound preparation has good similarity in terms of dissolution behavior. According to the invention, wet granulation or dry granulation is employed to effectively solve the problems of low bulk density, poor liquidity, strong moisture absorption, and sticking and picking of Valsartan. The preparation method of the compound preparation is simple and practical, and the product has stable quality, and good dissolution rate and content uniformity of each effective component, thus being suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preferred compound preparation for treating hypertension containing three active ingredients of hydrochlorothiazide, amlodipine besylate and valsartan and a preparation method thereof. Background technique [0002] High blood pressure is a serious health problem that, if not controlled, can lead to heart attack, stroke, heart and kidney failure, and death. In hypertensive patients, only 30% of patients can control their blood pressure to the target level with only one drug, while 70% of patients need to use two or more drugs in combination to achieve ideal control of blood pressure. In order to control blood pressure more effectively without causing obvious adverse reactions, small-dose drug combination has become one of the principles of modern hypertension treatment. [0003] The proportioning of three main medicines in the compound preparation provided by the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K47/34A61K47/38A61P9/12A61K31/41A61K31/4422A61K47/10
Inventor 梁劲松刘晓溪
Owner TIANJIN CHANGSHOUYUAN HEALTH TECH CO LTD
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