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A kind of valsartan capsule and preparation method thereof

A valsartan and capsule technology, applied in the field of medicine, can solve the problems of unfavorable dissolution stability of valsartan preparation products, inconvenience for patients to take, slow dissolution speed, etc.

Active Publication Date: 2011-12-07
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such a high proportion of disintegrant content will inevitably lead to high hygroscopicity of the product, and the tablet is easy to absorb moisture during storage. As mentioned above, after the tablet absorbs moisture, the raw material of valsartan will become sticky when exposed to water, resulting in increased hardness. Difficulty in tablet disintegration and slow dissolution rate
Therefore, this technology is not conducive to ensuring the dissolution stability of valsartan preparation products, and a high proportion of disintegrant dosage will inevitably lead to an increase in the weight of the preparation product and larger tablet shape, which is inconvenient for patients to take.

Method used

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  • A kind of valsartan capsule and preparation method thereof
  • A kind of valsartan capsule and preparation method thereof
  • A kind of valsartan capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] prescription:

[0092]

[0093] Preparation:

[0094] (1) Adhesive preparation: Weigh the prescription amount of sodium lauryl sulfate and povidone K30, dissolve in water, and prepare a 10% povidone K30 solution;

[0095] (2) Sieving: the auxiliary materials of microcrystalline cellulose, crospovidone and magnesium stearate are passed through a 60-mesh sieve;

[0096] (3) Granulation and drying: Weigh the prescription amount of valsartan raw materials into a mixer, add the above-mentioned binder to make the soft material, and then granulate with a granulating machine; the wet granules are dried at 40℃~45℃ for 1~ After 3 hours, whole grain;

[0097] (4) Mixing: Put the above-mentioned granules in a mixer, add the prescribed amount of microcrystalline cellulose, crospovidone and magnesium stearate, mix for 30 minutes, take samples to determine the content and loss on drying;

[0098] (5) Filling: Calculate the average filling volume according to the results of the particle content ...

Embodiment 11

[0104] The pretreatment method of Example 11 is:

[0105] i) Dissolve 12g of valsartan in 100ml of ethanol to obtain a 0.12g / ml valsartan ethanol solution;

[0106] ii) Dissolve 5g of Povidone K30 in 100ml of water to prepare an aqueous solution of Povidone K30 with a concentration of 5%;

[0107] iii) Put the povidone K30 aqueous solution of step ii) in an ice water bath at 0-5°C, and add the valsartan ethanol solution dropwise at a rate of 1.2ml / min under the condition of ultrasound at a frequency of 0.4KW In the povidone K30 aqueous solution, until the solution system becomes turbid, let it stand at 0-5°C for 7 hours, filter, dry, and pulverize through an 80 mesh sieve.

Embodiment 12

[0108] The pretreatment method of Example 12 is:

[0109] i) Dissolve valsartan in ethanol to obtain an ethanol solution of valsartan;

[0110] ii) Dissolve povidone K30 in water to prepare an aqueous solution of povidone K30;

[0111] iii) Put the povidone K30 aqueous solution of step ii) in an ice water bath, add the valsartan ethanol solution dropwise to the povidone K30 aqueous solution at a uniform rate under ultrasonic conditions, until the solution system becomes turbid, stand still, filter, Dry, crush and sieve.

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Abstract

The invention relates to valsartan capsules and a preparation method thereof. The valsartan capsules comprise the following components in parts by weight: valsartan 50-200 parts, microcrystalline cellulose 30-160 parts, crosslinked povidone 1-10 parts, sodium dodecyl sulfate 0.8-4 parts, povidone K30 1-9 parts, and magnesium stearate 1-3 parts. The valsartan capsules provided by the invention canbe used for treating mild and moderate primary hypertension. The valsartan capsules have the advantages of reasonable formula, feasible process, stable and reliable quality, and good stability, dissolution and bioavailability. The valsartan capsules are prepared by using a wet granulation process, the addition method of solubilizer sodium dodecyl sulfate is proper, the concentration of the bonding agent is proper, and the granules have angle of repose smaller than 40 degrees, belong to powders with good fluidity and can meet the need of capsule filling. The valsartan capsules have short production process and low production costs, and are easy for industrial production.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a valsartan capsule and a preparation method thereof. Background technique [0002] Valsartan is a non-peptide angiotensin II receptor antagonist (ARB), which was first marketed in Germany after being successfully developed by Novartis of Switzerland. It was approved by the US FDA in December 1996 and was listed in the US in 1997 under the trade name "Diovan". In 1998, Novartis's valsartan was registered in China under the trade name "Diovan". After valsartan went on the market, Novartis has developed a valsartan compound preparation. In October 1997, after the successful development of the valsartan and hydrochlorothiazide compound preparation, it was approved for marketing by the FDA under the trade name "CoDiovan" (Fu Daiwen); in 2006, the newly developed valsartan / amlodipine compound preparation was also approved for marketing . [0003] Valsartan, Chinese chemical na...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/41A61K47/38A61P9/12
Inventor 马鹰军钟正明王小树罗韬
Owner HAINAN JINRUI PHARMA
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