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Preparation method of compound preparation for treating high blood pressure

A high blood pressure and compound technology, which is applied in cardiovascular system diseases, capsule delivery, active ingredients of heterocyclic compounds, etc., can solve the problems of low oral bioavailability of valsartan, complicated production processes, and low oral bioavailability of hydrochlorothiazide

Inactive Publication Date: 2014-01-01
SHENYANG PHARMA UNIVERSITY +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this method needs to prepare three kinds of microtablets, then packs in the capsule, and the production process is various; In the prescription, the alkaline lubricant magnesium stearate that adds for tabletting can react with amlodipine besylate so as to affect its stability and Dissolution test results
[0012] In conclusion, the existing products have not solved the problem of low oral bioavailability of amlodipine besylate and hydrochlorothiazide, especially valsartan

Method used

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  • Preparation method of compound preparation for treating high blood pressure
  • Preparation method of compound preparation for treating high blood pressure

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Capsules of valsartan, amlodipine and hydrochlorothiazide were prepared using the ingredients listed in Formulation 1 below.

[0063] Prescription 1

[0064] Valsartan 160g

[0065] Hydrochlorothiazide 12.5g

[0066] Amlodipine besylate 5g (Amlodipine meter)

[0067]

[0068] 1000 capsules

[0069] The valsartan, amlodipine and hydrochlorothiazide are respectively pulverized with a pulverizer (such as a jet mill) or a ball mill to a powder with a particle size of 100nm~60μm. Take prescription amount of valsartan, hydrochlorothiazide and amlodipine besylate powder, mix evenly, pack into capsules, and obtain the product.

Embodiment 2

[0071] Capsules of valsartan, amlodipine and hydrochlorothiazide were prepared using the ingredients listed in Formulation 2 below.

[0072] Prescription 2

[0073] Valsartan 160g

[0074] Hydrochlorothiazide 12.5 g

[0075] Amlodipine besylate 5g (Amlodipine meter)

[0076] Microcrystalline Cellulose 10g

[0077] Colloidal silicon dioxide 3g

[0078]

[0079] 1000 capsules

[0080]Grind valsartan, amlodipine and hydrochlorothiazide with a pulverizer (such as a jet mill) or a ball mill respectively to powders with a particle size of 100nm~60μm. Get the prescription amount of valsartan, hydrochlorothiazide and amlodipine besylate powder and mix evenly with auxiliary materials. Pack into capsules and get ready.

[0081]

Embodiment 3

[0083] Capsules of valsartan, amlodipine and hydrochlorothiazide were prepared using the ingredients listed in Formulation 3 below.

[0084] Prescription 3

[0085] Valsartan 160 g

[0086] Hydrochlorothiazide 12.5 g

[0087] Amlodipine besylate 5g (Amlodipine meter)

[0088] 10% starch slurry appropriate amount

[0089] Crospovidone 40g

[0090]

[0091] 1000 capsules

[0092] Grind valsartan, amlodipine and hydrochlorothiazide with a pulverizer (such as a jet mill) or a ball mill respectively to powders with a particle size of 100nm~60μm. Take prescription amount of valsartan, hydrochlorothiazide and amlodipine besylate powder and mix uniformly with auxiliary materials, and perform wet granulation to obtain dry granules. Pack into capsules to obtain capsules.

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Abstract

The invention discloses a preparation method of a compound preparation for treating high blood pressure. The compound preparation is prepared by making valsartan and / or amlodipine and / or hydrochlorothiazide into nanometer or micrometer powder with an average particle size of 100 nanometers-60 micrometers by means of air flow crushing or grinding. According to an adopted solid dispersion technique, valsartan and / or amlodipine and / or hydrochlorothiazide and at least one pharmaceutic adjuvant are made into a solid dispersion, which is obtained by carrying out spray drying or grinding on the drugs and the adjuvant. The drugs are dispersed in the adjuvant in a nanometer or micrometer state. The prepared valsartan, amlodipine and hydrochlorothiazide micropowder or the solid dispersion material can be individually encapsuled or mixed with a pharmaceutically acceptable adjuvant and then encapsuled, or can be made into particles by a preparation technology and then encapsuled.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a method for preparing compound capsules for treating hypertension; in particular, the capsules of valsartan, amlodipine and hydrochlorothiazide are prepared by nanotechnology, micronization technology or solid dispersion technology. Background technique [0002] Valsartan is a new type of non-peptide, orally effective angiotensin II (AT) receptor antagonist, which can competitively antagonize AT, mediate physiological effects, dilate blood vessels, improve ventricular and vascular remodeling, Inhibit aldosterone, thereby lowering blood pressure, suitable for mild and moderate essential hypertension. Valsartan is very slightly soluble in acidity, which largely affects the absorption of the drug at the main absorption site in the body, so valsartan only has an absolute oral bioavailability of about 25% (10-35% in a wide range). Utilization. [0003] Amlodipine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K9/48A61P9/12A61K31/4422A61K31/41
Inventor 孙长山刘健郁洋
Owner SHENYANG PHARMA UNIVERSITY
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