Valsartan dispersible tablet and preparation method thereof

A technology of dispersible tablets and valsartan, which is applied in the field of valsartan dispersible tablets and its preparation, can solve problems such as product dispersibility differences, and achieve the effects of improving dispersibility, simple operation, and improving quality

Active Publication Date: 2014-09-17
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is precisely because of the difference in particle size distribution, bulk density and crystal form of valsartan raw materials produced by different manufacturers that when we use the same prescription and process to produce valsartan dispersible tablets, there are obvious differences in the dispersibility of the product

Method used

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  • Valsartan dispersible tablet and preparation method thereof
  • Valsartan dispersible tablet and preparation method thereof
  • Valsartan dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1 different particle size distribution valsartan crude drug

[0050] Get 5 kilograms of valsartan bulk drug without crushing after drying, be divided into 5 parts on average, each part of 1 kg, and do the following processing respectively: a portion of valsartan bulk drug crosses 20 mesh sieves to obtain valsartan bulk drug A; A portion of valsartan raw material passed through a 24-mesh sieve to obtain valsartan raw material B; another 3 parts of valsartan raw material were placed in a jet mill (model: QYF-100, manufacturer: Kunshan Miyou Powder Equipment Engineering Co., Ltd. company) carried out micronization for 15 minutes, 30 minutes, and 1 hour respectively, and obtained valsartan crude drug C, D, and E respectively. We used a Malvern particle size analyzer to detect the particle size distribution of the above five valsartan raw materials by dry method, and also tested their bulk density and compactness. The relevant parameters are sho...

Embodiment 2

[0054] The prescription screening and preparation of embodiment 2 valsartan dispersible tablets

[0055] Get the valsartan bulk drug E (D90=7.117um) through airflow pulverization, feed the ingredients according to the prescription listed in Table 2 respectively, mix in the wet granulator for 5 minutes, and gradually add the binder solution of 5% PVP K30 , and then add an appropriate amount of purified water, granulate for about 3 minutes, until the wet granules "hold into a ball, lightly knead and then disperse", pass through a 24-mesh sieve, put the wet granules in a tray, and spread them into a size of no more than 2cm. Thickness, dry in an oven at 55°C until the water content does not exceed 3%, and collect. The dried granules are granulated through 20 meshes, and mixed with additional crospovidone (PVPP), micronized silica gel and magnesium stearate for 15 minutes. Tablet compression, die ф8cm, each valsartan dispersible tablet contains 80mg of valsartan, and the hardness...

Embodiment 3

[0060] The valsartan crude drug of embodiment 3 different particle size distributions prepares valsartan dispersible tablet

[0061] Get each 80g of valsartan crude drug A, B, C, D, E of different particle size distributions, press the feed intake of raw and auxiliary materials listed in Table 3 prescription 6, prescription 7, prescription 8, prescription 9 and prescription 10 respectively, in wet Mix in the French granulator for 5 minutes, gradually add 5% PVP K30 binder solution, and then add an appropriate amount of purified water, and granulate for about 3 minutes until the wet granules "come into a ball by hand, and then disperse when gently pinched". Pass through a 24-mesh sieve, place the wet granules on a tray, spread out to a thickness of no more than 2cm, and dry in an oven at 55°C until the moisture content does not exceed 3%, then collect. The dried granules are granulated through 20 meshes, and mixed with additional crospovidone (PVPP), micronized silica gel and m...

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Abstract

The invention relates to medicine field, and particularly relates to an angiotensin II receptor antagonist valsartan dispersible tablet and a preparation method thereof. The prescription of the product comprises pharmaceutical adjuvants acceptable in pharmacy like valsartan bulk drug, a filler, a disintegrant, an adhesive, flow aid, a lubricant, and corrigent, and the dispersible tablet is prepared by a wet granulation method. The valsartan bulk drug needs to be micronized, and the diameter 90 is less than 75mu m, preferably, the diameter 90 is less than 10mu m. The size distribution of the valsartan bulk drug directly affects the dispersibility of the dispersible tablet. The valsartan has polymorphy, different crystal forms of valsartan have different size distribution, and the dispersibility of the valsartan dispersible tablet is more different. The size distribution of the valsartan bulk drug is controlled by virtue of the micronization technology, the diameter 90 is less than 75mu m, preferably, when the diameter 90 is less than 10mu m, the difference of size distribution of different crystal forms of valsartan bulk drug is eliminated, the dispersibility of the valsartan dispersible tablet is improved obviously, the drug dissolution rate of the valsartan dispersible tablet is improved, and the product quality is controllable and is improved remarkably.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a valsartan dispersible tablet and a preparation method thereof. Background technique [0002] Valsartan, also known as N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl-L- Valine, which has the following structure: [0003] [0004] Valsartan is an angiotensin II receptor antagonist, also known as an ARB antihypertensive drug. Due to its excellent antihypertensive effect and excellent drug safety, it was approved by the World Health Organization and my country's Hypertension in early 1999. Treatment guidelines listed hypertensive drugs as first-line treatment. The active hormone of the renin-angiotensin-aldosterone system (AAS) is angiotensin II, which is formed from angiotensin I by the action of angiotensin-converting enzyme (ACE). Angiotensin II is a potent vasoconstrictor that has a direct pressor effect, while also promoting sodium reabsorption and stimulating a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/41A61K47/38A61K47/36A61K47/32A61K47/26A61P9/12A61J3/10
Inventor 谢斌周爱新姜春来
Owner 珠海润都制药股份有限公司
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