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Valsartan dispersible tablet preparation method and valsartan dispersible tablet

A technology of dispersible tablets and valsartan, applied in the field of dispersible tablets, can solve problems such as slow disintegration speed, unsuitable for diabetic patients, and poor particle fluidity

Pending Publication Date: 2021-05-18
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a method for preparing valsartan dispersible tablets and valsartan dispersible tablets, which are used to solve the problem of poor particle fluidity and slow disintegration speed in the prior preparation process of valsartan dispersible tablets. Lactose monohydrate is used as a filler Technical issues not applicable to diabetics

Method used

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  • Valsartan dispersible tablet preparation method and valsartan dispersible tablet
  • Valsartan dispersible tablet preparation method and valsartan dispersible tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0034] For ease of understanding, see figure 1 , an embodiment of a preparation method of a valsartan dispersible tablet provided by the present invention, the types of components included in the valsartan dispersible tablet and the weight ratio of each component are:

[0035]

[0036] The unit of the above parts by weight is mg / tablet. Crospovidone XL includes 1.5 parts by weight of externally added crospovidone XL and 10.5 parts by weight of internally added crospovidone XL; magnesium stearate includes 0.6 parts by weight of externally added magnesium stearate and 3.9 parts by weight added magnesium stearate.

[0037] Include the following steps:

[0038] (1) Mixing for the first time: adding valsartan, silicon dioxide and internally added magnesium stearate to the first mixer, and mixing for 10 minutes to obtain the first mixing material;

[0039] (2) sieving and mixing: the first mixture is passed through an 80-mesh sieve to obtain the second mixture;

[0040] (3) T...

Embodiment 2

[0049] As a further improvement to Example 1, the preparation process is as follows:

[0050] (1) Mixing for the first time: adding valsartan, silicon dioxide and internally added magnesium stearate to the first mixer, and mixing for 10 minutes to obtain the first mixing material;

[0051] (2) Screening and mixing: the first mixture is placed in a YK-250 type oscillating granulator, and sieved with an 80-mesh sieve to obtain the second mixture;

[0052] (3) The second mixing: sequentially pass the internally added crospovidone XL and microcrystalline cellulose through an 80-mesh sieve, and then add them to the second mixing machine together with the second mixing material, and mix for 10 minutes to obtain the third mixing material;

[0053] (4) Granulation: Add the mixed material into a dry granulator for granulation to obtain dry granules; sieve the dry granules and side leakage materials with a vibrating screen of 30 mesh and 80 mesh respectively, and collect 30 mesh Parti...

Embodiment 3

[0075] The application also provides an embodiment of the valsartan dispersible tablet prepared according to the method for preparing the valsartan dispersible tablet of embodiment 1 or embodiment 2, the type of components and the weight of each component included in the valsartan dispersible tablet The ratio is:

[0076]

[0077] Among them, microcrystalline cellulose is microcrystalline cellulose SH101; crospovidone XL includes externally added crospovidone XL and internally added crospovidone XL; magnesium stearate includes externally added magnesium stearate and internally added Magnesium stearate.

[0078] It should be noted that the internally added crospovidone XL is 10.5 parts by weight, the externally added crospovidone XL is 1.5 parts by weight; the internally added magnesium stearate is 3.9 parts by weight, and the externally added magnesium stearate is 0.6 parts by weight .

[0079] A kind of valsartan dispersible tablet provided by the invention, silicon diox...

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Abstract

The invention discloses a valsartan dispersible tablet preparation method and a valsartan dispersible tablet. Raw materials and auxiliary materials are added into a mixing machine in batches in a premixing mode to be mixed, and the particle fluidity in the mixing process is improved. The invention also provides the valsartan dispersible tablet. The valsartan dispersible tablet comprises the following components in parts by weight of 80 parts of valsartan, 54 parts of microcrystalline cellulose, 12 parts of cross-linked povidone XL, 0.5 part of silicon dioxide, 4.5 parts of magnesium stearate and 1 part of silicon dioxide SH-CD3, wherein the silicon dioxide and the magnesium stearate jointly increase the flowability in the mixing process, and the microcrystalline cellulose and the cross-linked povidone XL jointly act to enhance the disintegration speed of the valsartan dispersible tablet. The valsartan dispersible tablet provided by the invention solves the technical problems that the existing valsartan dispersible tablet is poor in particle fluidity and slow in disintegration speed in the preparation process, and is not suitable for diabetics by taking lactose monohydrate as a filling agent.

Description

technical field [0001] The invention belongs to the technical field of dispersible tablets, in particular to a method for preparing valsartan dispersible tablets and valsartan dispersible tablets. Background technique [0002] Valsartan is an orally effective and specific angiotensin II (AT1) receptor antagonist that selectively acts on AT1 receptor subtypes, blocking the binding of Ang II to AT1 receptors (its specificity The effect of antagonizing the AT1 receptor is about 20,000 times greater than that of the AT2 receptor), thereby inhibiting vasoconstriction and the release of aldosterone, producing a hypotensive effect, and can treat mild and moderate essential hypertension. In addition, valsartan can also be used in the treatment of diabetic nephropathy, which has a good curative effect, helps to reduce blood pressure, reduce proteinuria, improve renal function, and has high drug safety, which can promote the early recovery of patients. promote. [0003] Dispersible ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/04A61K47/12A61K47/38A61K47/32A61K31/41A61P9/12A61P3/10A61P13/12
CPCA61K9/2095A61K9/2009A61K9/2013A61K9/2054A61K9/2027A61K31/41A61P9/12A61P3/10A61P13/12
Inventor 陈益智史江永
Owner HAINAN HUALON PHARM