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Valsartan/hydrochlorothiazide pharmaceutical composition and preparation method thereof

A technology of hydrochlorothiazide and composition is applied in the field of pharmaceutical composition containing valsartan and hydrochlorothiazide and its preparation field, which can solve the problems of unsatisfactory, large difference in tablet weight, drug disintegration and dissolution, etc. Fast, fluid results

Inactive Publication Date: 2015-01-14
JIANGXI SHIMEI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the problems existing in the above-mentioned prior art, the first object of the present invention is to provide a new pharmaceutical composition of valsartan and hydrochlorothiazide, by optimizing the composition and ratio of auxiliary materials, it solves the problem of unsatisfactory drug disintegration and dissolution, Technical problems such as large differences in tablet weight improve drug stability and dissolution rate, and are suitable for industrialized large-scale production

Method used

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  • Valsartan/hydrochlorothiazide pharmaceutical composition and preparation method thereof
  • Valsartan/hydrochlorothiazide pharmaceutical composition and preparation method thereof
  • Valsartan/hydrochlorothiazide pharmaceutical composition and preparation method thereof

Examples

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Embodiment 1

[0049] 1. Prescription

[0050]

[0051] 2. Preparation process

[0052] 1) Carry out micronization treatment with valsartan and hydrochlorothiazide, control particle size to be no more than 50 microns, take by prescription quantity, standby;

[0053] 2) Prepare 3% hydroxypropyl cellulose aqueous solution, and take a small part to add the prescribed amount of poloxamer, stir to dissolve;

[0054] 3) Weighing valsartan, hydrochlorothiazide, lactose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose according to the prescription amount, and mixing them uniformly to obtain a mixed powder;

[0055] 4) Slowly add the above-mentioned 3% hydroxypropyl cellulose aqueous solution containing poloxamer to the mixed powder, mix well, then add an appropriate amount of 3% hydroxypropyl cellulose aqueous solution to make soft material, granulate with a 20-mesh sieve, Dry at 80°C, and sieve with 18 meshes to obtain granules;

[0056] 5) The prescription amount of sil...

Embodiment 2

[0058] 1. Prescription

[0059]

[0060] 2. Preparation process

[0061] 1) Carry out micronization treatment with valsartan and hydrochlorothiazide, control particle size to be no more than 50 microns, take by prescription quantity, standby;

[0062] 2) Prepare 3% hydroxypropyl cellulose aqueous solution, and take a small part to add the prescribed amount of poloxamer, stir to dissolve;

[0063] 3) Weighing valsartan, hydrochlorothiazide, lactose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose according to the prescription amount, and mixing them uniformly to obtain a mixed powder;

[0064] 4) Slowly add the above-mentioned 3% hydroxypropyl cellulose aqueous solution containing poloxamer to the mixed powder, mix evenly, then add an appropriate amount of 3% hydroxypropyl cellulose aqueous solution to make soft material, granulate with a 40-mesh sieve, Dry at 80°C, and sieve with 40 mesh to obtain granules;

[0065] 5) The prescription amount of s...

Embodiment 3

[0067] 1. Prescription

[0068]

[0069] 2. Preparation process

[0070] 1) Carry out micronization treatment with valsartan and hydrochlorothiazide, control particle size to be no more than 50 microns, take by prescription quantity, standby;

[0071] 2) Prepare 3% hydroxypropyl cellulose aqueous solution, and take a small part to add the prescribed amount of poloxamer, stir to dissolve;

[0072] 3) Weighing valsartan, hydrochlorothiazide, lactose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose according to the prescription amount, and mixing them uniformly to obtain a mixed powder;

[0073] 4) Slowly add the above-mentioned 3% hydroxypropyl cellulose aqueous solution containing poloxamer to the mixed powder, mix well, then add an appropriate amount of 3% hydroxypropyl cellulose aqueous solution to make a soft material, granulate with a 24-mesh sieve, Dry at 70°C, and sieve through a 20-mesh sieve to obtain granules;

[0074] 5) The prescription ...

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Abstract

The invention relates to a valsartan / hydrochlorothiazide pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is composed of the following components in parts by weight: 80 parts of valsartan, 12.5 parts of hydrochlorothiazide, 20-80 parts of lactose, 20-80 parts of microcrystalline cellulose, 2-10 parts of poloxamer, 4-20 parts of low substituted hydroxypropyl cellulose, a moderate amount of hydroxypropyl cellulose, 0.4-2 parts of silicon dioxide, and 0.5-5 parts of sodium stearyl fumarate. The pharmaceutical composition is prepared through the processes of carrying out micronization on the components in advance, controlling the particle sizes of raw materials, adding a moderate amount of cosolvent, granulating by using a common wet method, and tabletting. The pharmaceutical composition is simple in production process, effectively improves the dissolution rate of drugs, and has the advantages of fast disintegration, quick dissolution, good stability, and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition containing valsartan and hydrochlorothiazide and a preparation method thereof. Background technique [0002] Hypertension (hypertensive disease) is a chronic disease characterized by continuous increase in arterial blood pressure, which often causes lesions in the heart, brain, kidney and other important organs with corresponding consequences. Hypertension is the most common cardiovascular disease and a major public health problem worldwide. [0003] At present, the clinically used antihypertensive drugs alone can achieve less than 50% of the antihypertensive target (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg) rate, and most patients need to use combination drugs. The results of the study confirmed that the clinical demand for single use of antihypertensive drugs is decreasing, and the combination of drugs for ...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K47/38A61K47/34A61K9/20A61P9/12A61K31/41
CPCA61K31/549A61K9/20A61K31/41A61K47/34A61K47/38
Inventor 江鸿杨大龙
Owner JIANGXI SHIMEI PHARM CO LTD
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