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Valsartan and hydrochlorothiazide composition, and its preparation method

A technology of hydrochlorothiazide and valsartan, which is applied in the field of compound tablets of valsartan and hydrochlorothiazide, which can solve the problems of high noise, large amount of dust produced by dry granulation, and insufficient popularity

Inactive Publication Date: 2012-08-01
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the dry granulation has high requirements for the raw material drug, which requires uniform particle size, uniform density, and good fluidity, the valsartan raw material of most manufacturers currently has extremely poor fluidity, and it is difficult to meet the requirements of dry granulation; and dry granulation The amount of dust produced by granules is large, the noise is high, and the equipment cost is high. Therefore, the current dry granulation and tableting equipment is not popular enough in the production field.

Method used

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  • Valsartan and hydrochlorothiazide composition, and its preparation method
  • Valsartan and hydrochlorothiazide composition, and its preparation method
  • Valsartan and hydrochlorothiazide composition, and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Preparation Process:

[0035] i) Weigh the granule components and add them to the high-speed stirring granulator, start the agitation to make the mixture uniform; ii) add 10% ethanol-water solution to granulate; iii) use the fluidized bed to dry the obtained granules, and the drying temperature is controlled at 30-40 ℃; iv) passing the dried granules through a 20-mesh sieve for granulation; v) mixing the granules with additional auxiliary materials evenly; vi) pressing them into tablets.

[0036]Carry out each detection according to the requirement of " Chinese Pharmacopoeia " 2010 editions, and wherein stripping condition is: adopt the device of dissolution assay method (Chinese Pharmacopoeia 2010 edition two appendices XC second method), take pH6.8 phosphate buffer saline 1000ml as Dissolution medium, the speed is 50r min -1 , operate according to the law, take 10ml of the solution at 5min and 30min respectively, filter with a 0.45μm microporous membrane,...

Embodiment 2

[0040]

[0041] Preparation process: i) weigh the granule components and add them to the high-speed stirring granulator, start the machine and stir to make the mixture even; ii) add 15% ethanol-water solution to granulate; iii) use the fluidized bed to dry the obtained granules, and the drying temperature is controlled at 30-40°C; iv) passing the dried granules through a 20-mesh sieve for granulation; v) mixing the granules with additional auxiliary materials evenly; vi) pressing them into tablets.

[0042] Test results:

[0043]

Embodiment 3

[0045]

[0046] Preparation process: i) Weigh the granule components and add them to the high-speed stirring granulator, start the machine and stir to mix evenly; ii) add 12% ethanol-water solution to granulate; iii) use the fluidized bed to dry the obtained granules, and the drying temperature is controlled at 30-40°C; iv) passing the dried granules through a 20-mesh sieve for granulation; v) mixing the granules with additional auxiliary materials evenly; vi) pressing them into tablets.

[0047] Test results:

[0048]

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PUM

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Abstract

The invention relates to a valsartan and hydrochlorothiazide composition, and its preparation method. According to the invention, valsartan and hydrochlorothiazide are taken as active components, an auxiliary material comprises a disintegrating agent, a filling agent and a lubricant, the component composition is simple, less amount of disintegrating agent is capable of acquiring satisfied disintegrating time limit and performing good dissolution effect; an employed wet granulating process enables wide industrialized production.

Description

technical field [0001] The invention relates to a compound preparation of valsartan and hydrochlorothiazide, in particular to a compound tablet of valsartan and hydrochlorothiazide. Background technique [0002] The activator of the renin-angiotensin-aldosterone system (RAAS) is angiotensin (AT) II, which is formed from angiotensin I by the action of angiotensin-converting enzyme (ACE). AT II is a strong vasoconstrictor that exerts a direct pressor effect, promotes sodium reabsorption, and stimulates aldosterone secretion. [0003] Valsartan is an orally effective and specific AT II receptor antagonist, it can selectively act on the AT 1 receptor subtype but does not have any partial agonist activity on the AT1 receptor, the AT1 receptor subtype The type responds to the known effects of AT II. [0004] Hydrochlorothiazide is a traditional antihypertensive drug and belongs to the middle-effect diuretic; it acts on the distal renal tubule and activates the renin-angiotensin ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K31/41A61K9/20A61P9/12
Inventor 张志宏辛伟孔德志陈勇军金丽丽白英
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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