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Stable candesartan cilexetil pharmaceutical solid composition and preparation method thereof

A technology of candesartan cilexetil and solid composition, which is applied in the field of candesartan cilexetil pharmaceutical solid composition and its preparation, can solve the problems of difficult pH regulator full contact, uncertainty of inhibitory effect, and difficulty in practical application and other problems, to achieve the effects of not easy crystal transformation, lower energy consumption, and strong productivity

Pending Publication Date: 2021-06-15
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since candesartan cilexetil is usually made into solid preparations such as tablets, in a solid environment, the materials are mainly in contact with each other in a solid state. On the one hand, the contact area is limited, and on the other hand, the materials are not easily electrolyzed due to lack of moisture. Uncertainty about inhibition of candesartan cilexetil degradation
In addition, candesartan cilexetil has strong hydrophobicity, which makes it difficult to fully contact with pH regulators that are usually soluble in water, making this solution more difficult for practical use

Method used

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  • Stable candesartan cilexetil pharmaceutical solid composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] 2 parts of Cantaisa, 0.2 glycerol, 0.2 sodium citrate, 6000 polyethylene glycol, 93.6 lactose, 20 corn starch, 4 hydroxypropylene, 5.6 copies of carboxymethylcarboxymethyl. 0.4 sq.

[0052] The preparation steps of the stable ceiling salty ester drug solid composition of the first example are as follows:

[0053] Step 1: 2 purified water formation in the mixture of sodium sodium citrate, glycerol and ceilica.

[0054] Step 2: The paspect is added to a solution made of hydroxypropylene cellulose, polyethylene glycol, and stirred at room temperature;

[0055] Step 3: Use a atomized spray gun into the fluidized bed containing lactose, corn starch and produce particles at a material temperature of 20 to 50 ° C;

[0056] Step 4: Take a tablet drug under the pressure of carboxymethylcalfolium calcium and magnesium stearate after drying particles.

Embodiment 2

[0058] 2 parts of Canthaisa, 0.4 glycerol, 0.4 sodium citrate, 6000 polyethylene glycol, 89.2 lactose, 20 corn starch, 4 hydroxypropylene, 5.6 copies of carboxymethyl cellulose calcium 0.4 sq.

[0059] Step 1: 4 purified water formation of a paste in a mixture of sodium sodium citrate, glycerol and ceilifier, and other steps of preparing a stable celycetha drug solid composition in the second embodiment. Similarly to the first example, details are not described herein.

Embodiment 3

[0061] 4 parts of Cantaisa, 0.4 glycerol, 0.4 sodium citrate, 6000 polyethylene glycol, 91.2 lactose, 20 parts of corn starch, 4 hydroxypropylene, 5.6 copies of carboxymethylca calcium 0.4 sq.

[0062] Step 1: 4 purified water formation of a psychedelic substrate to the mixture of sodium sodium citrate, glycerol and celycetan, and other steps of preparing a stable celycetha drug solid composition of the third embodiment Similarly to the first example, details are not described herein.

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Abstract

The invention relates to a stable candesartan cilexetil pharmaceutical solid composition and a preparation method thereof, the pharmaceutical solid composition comprises candesartan cilexetil, glycerin, sodium citrate and other pharmaceutically acceptable auxiliary materials, and the preparation method comprises the following steps: mixing sodium citrate, glycerin and purified water according to a weight ratio to obtain a mixed solution; mixing the mixed solution with candesartan cilexetil according to a weight ratio to obtain paste; adding the paste into a prepared solution, and stirring to obtain a suspension; spraying the suspension into a fluidized bed containing an excipient by using an atomizing spray gun to prepare particles, and drying the particles; and adding a disintegrating agent and a lubricating agent into the dried particles, and tabletting to obtain a tablet medicine. The process characteristics of low temperature and low grinding are adopted in the preparation process, and compared with a candesartan cilexetil pharmaceutical preparation in the prior art, the pharmaceutical solid composition has the advantages of being high in pharmaceutical stability and hardness and easy to produce.

Description

Technical field [0001] The present invention belongs to the technical field of pharmaceutical preparations, and is relate to a stable ceiling sandhavine drug solid composition and a preparation method thereof. Background technique [0002] Cantaisartan (sometimes called * # * active components * # *) is angiotensin IIAT 1 Receptor antagonist, hydrolyzed in vivo as an active metabolitanon dihatan, through the vascular smooth muscle AT 1 The receptor combined with antagonistic angiotensin II vascular contraction, thereby reducing the vessel resistance of the last tip. The drug has been long-term clinical practice, which has been confirmed to have a reliable step-down effect, and the poisonous side effect is small, the incidence of adverse reactions is low, and the impact of metabolic organs while reducing blood pressure, therefore becomes a kind of high blood pressure Common drugs for patients with long-term buck. [0003] As is well known, it is important to ensure that the drug m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4184A61K47/10A61K47/12A61P9/12
CPCA61K31/4184A61K9/2027A61K9/2013A61P9/12
Inventor 王衍成吴敏刘泳曦黄传利汪依伦贾永兵杨轶群傅红燕谭胜连
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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