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Composition with losartan potassium and gliclazide and preparation method thereof

A kind of technology of losartan potassium and composition, applied in the field of losartan potassium and gliclazide composition and preparation thereof

Inactive Publication Date: 2019-03-08
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Losartan potassium and gliclazide form a compound preparation, which can exert the beneficial effect of losartan potassium on the treatment of hypertension combined with diabetes. The two synergistically exert the effect of lowering blood pressure and blood sugar, but there is no corresponding composition in the prior art can achieve the above therapeutic effect

Method used

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  • Composition with losartan potassium and gliclazide and preparation method thereof
  • Composition with losartan potassium and gliclazide and preparation method thereof

Examples

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Effect test

Embodiment 1

[0028] A composition of losartan potassium and gliclazide and its preparation method:

[0029] The composition includes: 40g of losartan potassium, 60g of gliclazide, 40g of microcrystalline cellulose, 20g of anhydrous calcium hydrogen phosphate, 60g of precrossified starch, 4g of silicon dioxide, and 2g of magnesium stearate;

[0030] Preparation method: Take 4.8g of precrossed starch and add 55.2g of water to make 60g of precrossed starch slurry with a concentration of 8% as a binder, add 40g of losartan potassium, 40g of microcrystalline cellulose, 55.2g of precrossed starch In the mixture composed of starch, make soft material and then granulate with 20-mesh sieve, dry at 40°C until the water content is 1%, and then granulate with 30-mesh sieve, then mix with 40g gliclazide, 20g anhydrous calcium hydrogen phosphate, 4g Silicon dioxide and 2 g of magnesium stearate were uniformly mixed together and then pressed into tablets to obtain losartan potassium and gliclazide compos...

Embodiment 2

[0032] A composition of losartan potassium and gliclazide and its preparation method:

[0033] The composition includes: 60g of losartan potassium, 80g of gliclazide, 60g of microcrystalline cellulose, 40g of anhydrous calcium hydrogen phosphate, 80g of precrossified starch, 8g of silicon dioxide, and 3g of magnesium stearate;

[0034] Preparation method: Take 10g of precrossed starch and add 90g of water to prepare 100g of precrossed starch slurry with a concentration of 10% as a binder, and add it to a mixture consisting of 60g of losartan potassium, 60g of microcrystalline cellulose and 70g of precrossed starch. In the mixture, the soft material is granulated with a 30-mesh sieve, dried at 70°C until the water content is 2%, and then granulated with a 30-mesh sieve, and then mixed with 80g gliclazide, 40g anhydrous calcium hydrogen phosphate, and 8g silicon dioxide , 3g of magnesium stearate were uniformly mixed together and then pressed into tablets to obtain losartan pota...

Embodiment 3

[0036] A composition of losartan potassium and gliclazide and its preparation method:

[0037] The composition includes: 50g of losartan potassium, 40g of gliclazide, 50g of microcrystalline cellulose, 25g of anhydrous calcium hydrogen phosphate, 65g of precrossified starch, 6g of silicon dioxide, and 2g of magnesium stearate;

[0038] Preparation method: Take 9.6g of precrossed starch and add 70.4g of water to prepare 80g of precrossed starch slurry with a concentration of 12% as a binder, add 45g of losartan potassium, 50g of microcrystalline cellulose, 55.4g of precrossed starch In the mixture composed of starch, make soft material and then granulate with 24 mesh sieve, dry at 50°C until the water content is 3%, and then granulate with 30 mesh sieve, then mix with 40g gliclazide, 25g anhydrous calcium hydrogen phosphate, 6g Silicon dioxide and 2 g of magnesium stearate were uniformly mixed together, and then directly compressed into tablets to obtain tablets of the composit...

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Abstract

The invention relates to a composition with losartan potassium and gliclazide and a preparation method thereof. The composition is prepared from the following components in parts by weight: 40-60 parts of losartan potassium, 60-100 parts of gliclazide, 40-60 parts of microcrystalline cellulose, 20-40 parts of anhydrous calcium hydrogen phosphate, 60-80 parts of pregelatinized starch, 4-8 parts ofsilicon dioxide and 2-4 parts of magnesium stearate. The preparation method comprises the following steps: taking part of pregelatinized starch, adding water into the part of pregelatinized starch toprepare a pregelatinized starch slurry with the concentration of 8-12%, taking the pregelatinized starch slurry as an adhesive, adding the adhesive into a mixture composed of losartan potassium, microcrystalline cellulose and the part of the pregelatinized starch to prepare a soft material, preparing the soft material into particles through a 20-30-mesh sieve, drying the particles at 40-70 DEG C till the water content of the particles is 1-3%, then neatening the particles through a 20-mesh sieve, then uniformly mixing the particles with gliclazide, anhydrous calcium hydrogen phosphate, silicondioxide and magnesium stearate, then directly tabletting to obtain tablets of the composition with losartan potassium and gliclazide. The composition is capable of exerting the beneficial effect of losartan potassium on treatment of hypertension with diabetes; losartan potassium and gliclazide are capable of synergistically exerting the effect of reducing blood pressure and blood glucose.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating hypertension combined with diabetes, in particular to a composition of losartan potassium and gliclazide and a preparation method thereof. Background technique [0002] Losartan Potassium Tablets, the world's first angiotensin II receptor antagonist (AIIA) for the treatment of hypertension, was officially launched in China in 1998. The results of a number of large-scale clinical studies have shown that the use of losartan can effectively lower blood pressure, reduce cardiovascular risk, and delay end-stage renal disease. The RENAAL study showed that losartan can significantly reduce the risk of ESRD by 28%; the LIFE study showed that losartan Potassium significantly reduced the primary composite cardiovascular endpoint by 13%. Big data analysis shows that angiotensin receptor blocker (ARB) is the drug of choice for the treatment of hypertension complicated with diabetes. Losartan potas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4178A61K31/64A61K47/38A61K47/36A61K47/02A61K47/04A61P3/10A61P9/12
CPCA61K9/2059A61K9/2009A61K9/2054A61K31/4178A61K31/64A61P3/10A61P9/12A61K2300/00
Inventor 朱德其肖波曾丹刘辉李雪梅
Owner CHENGDU HENGRUI PHARMA
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