Irbesartan and hydrochlorothiazide pharmaceutical composition and preparation method thereof

A technology of hydrochlorothiazide and composition, which is applied in the direction of drug combination, pharmaceutical formula, medical preparations of non-active ingredients, etc., can solve the problems of unavailable tablet products, unreasonable prescription dosage, and low density of irbesartan, etc., and achieve Excellent dissolution performance, good quality stability, not easy to decompose and deteriorate

Active Publication Date: 2008-12-24
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The analysis may show that irbesartan raw material drug has low density and poor fluidity, and the scheme disclosed in this patent uses an unreasonable prescription ratio, so that qualified tablet products cannot be obtained
[0008] Chinese patent application 200510097977 discloses another dispersible tablet solution of the pharmaceutical composition, in which mannitol is used as a filler, and when mannitol is used to prepare tablets, the problem of drug tablet breakage often occurs
After testing,

Method used

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  • Irbesartan and hydrochlorothiazide pharmaceutical composition and preparation method thereof
  • Irbesartan and hydrochlorothiazide pharmaceutical composition and preparation method thereof
  • Irbesartan and hydrochlorothiazide pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Prescription: Irbesartan 150g

[0050] Hydrochlorothiazide 12.5g

[0051] Microcrystalline Cellulose 40g

[0052] Lactose monohydrate 40g

[0053] Croscarmellose Sodium 20g

[0054] Micronized silica gel 5g

[0055] Magnesium Stearate 2g

[0056] Hypromellose 3g

[0057] Mix irbesartan with 3 / 8 croscarmellose sodium and grind it into 500 mesh powder, then mix hydrochlorothiazide, 3 / 8 croscarmellose sodium and microcrystalline cellulose Grind to a 500-mesh powder, then mix the two powders and lactose monohydrate evenly, the speed of the mixer is 15 rpm, and the mixing time is 30 minutes. Then the hydroxypropyl methylcellulose was dissolved in 50% ethanol to prepare a 2% hydroxypropylmethylcellulose solution. Get the mixed powder obtained above and add it to the hydroxypropyl methylcellulose solution, mix evenly, the speed of the mixer is 30 rpm, and the mixing time is 25 minutes. Then use a 24-mesh sieve to granulate, dry...

Embodiment 2

[0059] Prescription: Irbesartan 150g

[0060] Hydrochlorothiazide 12.5g

[0061] Microcrystalline Cellulose 20g

[0062] Lactose monohydrate 60g

[0063] Croscarmellose Sodium 15g

[0064] Micronized silica gel 2g

[0065] Magnesium Stearate 1g

[0066] Hypromellose 3g

[0067] Mix irbesartan with 3 / 8 croscarmellose sodium and grind it into 400 mesh powder, then mix hydrochlorothiazide, 3 / 8 croscarmellose sodium and microcrystalline cellulose Grind to 400 mesh powder, then mix the two powders and lactose monohydrate evenly, the speed of the mixer is 20 rpm, and the mixing time is 25 minutes. Then the hydroxypropyl methylcellulose was dissolved in 50% ethanol to prepare a 2% hydroxypropylmethylcellulose solution. Get the mixed powder obtained above and add it to the hydroxypropyl methylcellulose solution, mix evenly, the speed of the mixer is 25 rpm, and the mixing time is 30 minutes. Then use a 24-mesh sieve to granulate, dry a...

Embodiment 3

[0069] Prescription: Irbesartan 150g

[0070] Hydrochlorothiazide 12.5g

[0071] Microcrystalline Cellulose 60g

[0072] Lactose monohydrate 20g

[0073] Croscarmellose Sodium 22g

[0074] Micronized silica gel 3g

[0075] Magnesium Stearate 1g

[0076] Hypromellose 5g

[0077] Mix irbesartan with 3 / 8 croscarmellose sodium and grind it into 500 mesh powder, then mix hydrochlorothiazide, 3 / 8 croscarmellose sodium and microcrystalline cellulose Grind to a 500-mesh powder, then mix the two powders and lactose monohydrate evenly, the speed of the mixer is 10 rpm, and the mixing time is 30 minutes. Then the hydroxypropyl methylcellulose was dissolved in 50% ethanol to prepare a 2% hydroxypropylmethylcellulose solution. Get the mixed powder obtained above and add it to the hydroxypropyl methylcellulose solution, mix evenly, the speed of the mixer is 35 rpm, and the mixing time is 20 minutes. Then use a 24-mesh sieve to granulate, dry...

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Abstract

The invention relates to a medicinal composite of Irbesartan hydrochlorothiazide. The medicinal composite is composed of 150 portions of Irbesartan, 12.5 portions of hydrochlorothiazide, 20 portions to 60 portions of microcrystalline cellulose, 20 portions to 60 portions of lactose monohydrate, 15 portions to 25 portions of crosslinked sodium carboxymethyl cellulose, 1 portion to 10 portions of hydroxypropylmethyl cellulose, 2 portions to 7 portions of SiliciiDoxydum, 1 portion to 3 portions of magnesium stearate. The major medicinal ingredients are mixed with part of the crosslinked sodium carboxymethyl cellulose and the microcrystalline cellulose, and the mixture is crushed down and then added with the lactose monohydrate for mixing; the mixture obtained from the former step is added with 50 percent of ethanol solvent containing 2 percent of hydroxypropylmethyl cellulose for even mixing, then the mixture is screened, made into integral grains which are then dried; the dry grains are mixed with the SiliciiDoxydum, the magnesium stearate and the residual crosslinked sodium carboxymethyl cellulose, and the mixture then undergoes tabletting and coating so as to obtain the medicinal composite. The prescription of the medicinal composite of the invention is reasonable, the quality is stable and reliable, and the medicinal composite has a satisfactory dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating hypertension and a preparation method thereof, more specifically an irbesartan hydrochlorothiazide medicinal composition and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases that endanger human health and is a major public health problem worldwide. At present, the control rate of hypertension in major countries in the world is not high. The National Nutrition and Health Status Survey released by the Ministry of Health of China in 2002 showed that there were nearly 160 million hypertensive patients in China, and the control rate of blood pressure was only 6.16%. A large number of evidence-based medical studies have confirmed that with the increase of blood pressure, the risk of cardiovascular events will increase significantly, so improving the control rate of blood p...

Claims

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Application Information

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IPC IPC(8): A61K31/4184A61K31/5415A61K47/38A61P9/12
Inventor 罗韬
Owner HAINAN JINRUI PHARMA
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