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Valsartan tablet and preparation method thereof

A valsartan tablet and prescription technology, applied in the field of valsartan tablet and its preparation, can solve problems such as unreasonable component matching, unstable product quality, complicated preparation process, etc., to avoid insufficient tablet weight, improve The effect of drug dissolution rate and short process flow

Inactive Publication Date: 2018-02-13
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a valsartan tablet and a preparation method thereof, which solves the problems of irrational matching of valsartan preparation components, complex preparation process, long production cycle and unstable product quality in the prior art

Method used

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

Examples

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Effect test

preparation example Construction

[0024] The preparation method of a kind of valsartan tablet of the present invention, comprises the following steps: (1) mixing material a, get respectively microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate of 20-50% recipe quantity , and take the micropowder silica gel of prescription quantity, under the rotating speed of 5-15rpm, mix 3-10min, cross the sieve of 8-12 order, get the first mixture; Viketone and the remaining microcrystalline cellulose in the prescription amount are passed through a 16-22 mesh screen, and mixed at a speed of 8-12rpm for 8-12min to obtain the second mixture; c. Add the first mixture obtained in step a Add the second mixture obtained in step b, and mix at a speed of 8-15rpm for 10-20min to obtain the initial material; The material is pressed into embryo flakes of 7-15Kp; (3) granulation Add the embryo flakes obtained in step (2) into a pulverizer, and the mesh number of the pulverizer is 8-12 mesh to obtain primary grains; (...

Embodiment 1

[0030] Valsartan tablets are prepared by:

[0031] (1) Feed

[0032] Weigh 3.20Kg of valsartan, 3.88Kg of microcrystalline cellulose, 0.7Kg of crospovidone, 0.12Kg of micropowder silica gel, 0.1Kg of magnesium stearate, and 0.002Kg of sodium lauryl sulfate;

[0033] (2) Mixing

[0034] a. Take a part of microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate of the above prescription, for example: take microcrystalline cellulose 1.552Kg, magnesium stearate 0.05Kg, sodium lauryl sulfate 0.001Kg , take the above-mentioned total prescription amount of micropowder silica gel, that is, 0.12Kg, add it to the mixer, 10rpm, mix for 5 minutes, add it to the comill sieve and sieve, the comill sieve is 0.062 inches, and the "F" type sieve, to obtain the first mixture;

[0035] B, get the valsartan raw material medicine of above-mentioned prescription quantity i.e. 3.20Kg and crospovidone i.e. 0.7Kg, and get the remaining microcrystalline cellulose in the above-mentione...

Embodiment 2

[0048] Valsartan tablets are prepared by:

[0049] (1) Feed

[0050] Weigh 3.20Kg of valsartan, 4.00Kg of microcrystalline cellulose, 0.55Kg of crospovidone, 0.15Kg of micropowder silica gel, 0.1Kg of magnesium stearate, and 0.001Kg of sodium lauryl sulfate;

[0051] (2) Mixing

[0052] a. Take a part of microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate of the above prescription, for example: take microcrystalline cellulose 1.672Kg, magnesium stearate 0.05Kg, sodium lauryl sulfate 0.0005Kg , take the above-mentioned all prescription amount of micropowder silica gel, namely 0.15Kg, add it to the mixer, 10rpm, mix for 5min, put it into the comill sieve and sieve, the comill sieve is 0.062 inches, "F" type sieve, to get the first mixture;

[0053] B, get the valsartan crude drug of the above-mentioned prescription quantity i.e. 3.20Kg and crospovidone i.e. 0.55Kg, and get the remaining microcrystalline cellulose i.e. 2.328Kg in the above-mentioned treatme...

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Abstract

The invention discloses a valsartan tablet and a preparation method thereof, and belongs to the technical field of blood pressure lowering medicine. The valsartan tablet is prepared from the followingingredients in parts by weight: 320 parts of valsartan raw medicine, 350 to 400 parts of microcrystalline cellulose, 40 to 80 parts of polyvinylpolypyrrolidone, 10 to 15 parts of superfine silica gelpowder, 5 to 15 parts of magnesium stearate and 0.1 to 0.5 part of sodium dodecyl sulfate; the valsartan tablet is obtained from the raw materials through material mixing, blank sheet pressing, palletization, mixing, tabletting and coating. The valsartan tablet has the advantages that the raw material matching is scientific and reasonable; the absorption is fast; the preparation method is simple;the flow process is short; the production efficiency is greatly improved. By the production method, high-temperature operation is not needed; the influence of high-temperature environment on the product quality is avoided; the material adding, mixing, palletization and tabletting processes are reasonably controlled; the material fluidity is improved; the weight of each tablet is fully ensured; the product performance is good; the quality is stable; the requirement of scale production is met.

Description

technical field [0001] The invention belongs to the technical field of antihypertensive drugs, in particular to a valsartan 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, white crystal or white, off-white powder, hygroscopic; easily soluble in ethanol, easily soluble in methanol, slightly soluble in ethyl acetate, almost insoluble in water. [0003] Valsartan is an orally effective and specific angiotensin II (ATII) receptor antagonist for mild and moderate essential hypertension. It has a new antihypertensive mechanism, stable antihypertensive effect, and Long duration of action, good patient tolerance and other advantages. [0004] Valsartan selectively acts on the AT1 receptor subtype, and the affinity with the AT1 receptor is 20,000 times stronger than the affinity with the AT2 receptor; the AT1 receptor subtype mediates the physiological respons...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/41A61K47/38A61K47/32A61K47/20A61K47/04A61K47/12A61P9/12
CPCA61K9/2866A61K9/2009A61K9/2013A61K9/2027A61K9/2054A61K31/41
Inventor 陆宇李继仁叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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