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Medicinal composite containing irbesartan

A technology of irbesartan and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, and pharmaceutical formulations, and can solve problems affecting the stability of pharmaceutical preparations, the impact of dissolution of pharmaceutical preparations, and the impact on product stability, etc. Achieve the effects of reducing production costs, simplifying prescriptions, and reducing potential safety hazards

Inactive Publication Date: 2010-12-15
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In addition, the content of disintegrants affects the stability of pharmaceutical preparations to a certain extent, too high or too low will have a great impact on the dissolution of pharmaceutical preparations
In the prior art, disintegrants are used in large amounts in prescriptions, which may affect the stability of their products

Method used

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  • Medicinal composite containing irbesartan
  • Medicinal composite containing irbesartan
  • Medicinal composite containing irbesartan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 Comparison experiment of different particle sizes of irbesartan:

[0037]

[0038] * Irbesartan adopts two particle sizes, the particle size of irbesartan used in prescription 1 is D(V, 0.9)=150 μm, and the particle size of irbesartan used in prescription 2 is D(V, 0.9)=312 μm.

[0039] Preparation process: Dissolve the prescribed amount of hypromellose in an appropriate amount of purified water to make an adhesive for later use; put irbesartan, lactose monohydrate, microcrystalline cellulose, and croscarmellose sodium into Mix in the granulation pot to obtain mixture A; add the reserved binder to the mixture A in the granulation pot to granulate to obtain wet granules, granulate the wet granules and dry to obtain dry granules B, and then add the prescribed amount of stearin Magnesium acid was added to dry granule B, and mixed evenly to obtain mixture C, and the angle of repose of mixture C was measured. Finally, mixture C was compressed into tablets o...

Embodiment 2

[0041] Embodiment 2 unilateral irbesartan tablet:

[0042]

[0043] * The particle sizes of irbesartan in prescriptions 3-5 were D(V, 90)=37 μm, D(V, 90)=200 μm, D(V, 90)=84 μm, respectively.

[0044] Preparation Process:

[0045] 1. Dissolve the prescribed amount of hypromellose in an appropriate amount of purified water to make an adhesive;

[0046] 2. Put the prescribed amount of irbesartan, lactose monohydrate, microcrystalline cellulose, and croscarmellose sodium into a granulation pot and mix to obtain a mixture A;

[0047] 3. Add the binder in step 1 to the mixture A in the granulation pot to granulate to obtain wet granules B;

[0048] 4. Sizing the wet granules and drying them to obtain dry granules C;

[0049] 5. Add the prescribed amount of magnesium stearate into the dry granule C, and mix well to obtain the dry granule D;

[0050] 6. Compressing the dry granule D to obtain a tablet with a corresponding tablet weight;

[0051] 7. Use a high-efficiency coat...

Embodiment 3

[0052] Embodiment 3 compound irbesartan tablets:

[0053]

[0054]

[0055] * The particle sizes of irbesartan in prescriptions 6-8 are D(V,90)=50 μm, D(V,90)=84 μm, D(V,90)=84 μm, respectively.

[0056] Preparation Process:

[0057] 1. Dissolve the prescribed amount of hypromellose in an appropriate amount of purified water to make an adhesive;

[0058] 2. Put the prescribed amount of irbesartan, hydrochlorothiazide, lactose monohydrate, microcrystalline cellulose, and croscarmellose sodium into a granulation pot and mix to obtain mixture A;

[0059] 3. Add the binder in step 1 to the mixture A in the granulation pot to granulate to obtain wet granules B;

[0060] 4. Sizing wet granule B and then drying to obtain dry granule C;

[0061] 5. Add the prescribed amount of magnesium stearate into the dry granule C, and mix well to obtain the dry granule D;

[0062] 6. Compressing the dry granule D to obtain a tablet with a corresponding tablet weight;

[0063] 7. A hig...

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Abstract

The invention relates to a medicinal composite containing irbesartan, comprising irbesartan accounting for 30-70 wt% of preparation and pharmaceutical usable salt thereof, wherein the particle diameter of irbesartan D (V, 0.9), which is measured by a laser particle method is less than or equal to 200 mu m, and the composite is substantially micro powder free silica gel. The method of the invention can obtain a product with good dissolution and stability. The invention has the advantages that the invention chooses the irbesartan with certain range of particle diameter and auxiliary material to pelletize so as to obtain the particle with good flowability; meanwhile, the sticking problem generated by the electrostatic interaction of irbesartan can be solved; silica gel powder does not need to be added in a prescription, which omits the micro powder silica gel screening step, simplifies production technology, lowers production cost, improves production efficiency, lowers the production potential safety hazard brought by the micro powder silica gel and is more suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating hypertension, more specifically to an irbesartan pharmaceutical composition. Background technique [0002] Irbesartan, namely 2-n-butyl-4-spirocyclopentane-1-[(2-(tetrazol-5-yl)biphenyl-4-yl)methyl]-2-imidazole Lin-5-one is a high-efficiency long-acting angiotensin II receptor antagonist, especially for the treatment of cardiovascular diseases such as hypertension and heart failure. Irbesartan has the following structure: [0003] [0004] Hydrochlorothiazide is a diuretic antihypertensive drug that causes activation of the sympathetic nervous system and the renin-angiotensin system, counteracts the antihypertensive effect, and lowers blood potassium levels. [0005] The combination of irbesartan and hydrochlorothiazide has a synergistic effect in the treatment of hypertension. Irbesartan can counteract the compensatory mechanism induc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61P9/12A61K31/549A61K9/20
Inventor 肖利思胡李斌彭俊清李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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