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Valsartan and amlodipine compound preparation and preparation method thereof

A valsartan-amlodipine compound formula and amlodipine technology are applied in the field of preparation of pharmaceutical preparations, can solve problems such as poor fluidity, great dissolution influence, unsuitability for industrialized production, and the like, and achieve the effects of simple process and low cost

Inactive Publication Date: 2011-06-15
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process is to directly granulate the active ingredients. However, due to the great influence of the particle size on the dissolution, it is necessary to strictly control the parameters of the granulation process, and the intermediate control of the product is relatively complicated.
[0018] Valsartan has a large proportion in tablets and has poor fluidity, so it is not suitable for production by direct compression method
When the materials are directly mixed and then filled into capsules, the fluidity of the materials is not good, which will lead to problems such as unqualified differences in the filling capacity of the capsules, and is not suitable for industrial production.

Method used

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  • Valsartan and amlodipine compound preparation and preparation method thereof
  • Valsartan and amlodipine compound preparation and preparation method thereof
  • Valsartan and amlodipine compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1: the preparation of valsartan amlodipine tablet

[0053] The material composition is shown in Table 2;

[0054] Table 2 Material Composition Ratio

[0055]

[0056]

[0057] Preparation of tablet cores: the valsartan and microcrystalline cellulose of prescription quantity, crospovidone, copovidone, micropowder silica gel and the magnesium stearate (1) of added part are mixed in total mixing barrel, adopt dry Granulate with French granulator (Alexander WP120V) to obtain dry granules. Pressure: 40bar, roller speed: 3rpm. The prescribed amount of amlodipine besylate is mixed with the above-mentioned dry granules, and an additional part of magnesium stearate (2) is added and mixed, and then compressed by a high-speed tablet machine.

[0058] Preparation of coated tablets: Weigh Ouba A coating solution is prepared to coat the plain tablets. Until the sheet has gained about 3% in weight. The indicators of the coated tablets meet the relevant regulati...

Embodiment 2

[0068] Embodiment 2: the preparation of valsartan amlodipine tablet

[0069] The material composition is shown in Table 6.

[0070] Table 6 Material Composition Ratio

[0071]

[0072]

[0073] Preparation of tablet cores: Mix the prescribed amount of valsartan and microcrystalline cellulose PH101, crospovidone, micropowder silica gel and the magnesium stearate (1) added in the total mixing tank, and use a dry granulator (Alexander WP120V) to obtain dry granules. Pressure: 60bar, roller speed: 5rpm. Mix the prescribed amount of amlodipine besylate and microcrystalline cellulose PH102, add to the above dry granules for mixing, then add an additional part of magnesium stearate (2) for mixing, and then use a high-speed tablet machine for tableting.

[0074] Preparation of coated tablets: Weigh Ouba A coating solution is prepared to coat the plain tablets. Until the sheet weight gain is 3%. The indexes of the coated tablets meet the relevant regulations, and the resul...

Embodiment 3

[0080] Embodiment 3: the preparation of valsartan amlodipine tablet

[0081] The material composition is shown in Table 9.

[0082] Table 9 Material Composition Ratio

[0083]

[0084] Prepare tablet core: the valsartan of recipe quantity and microcrystalline cellulose PH101, crospovidone, copovidone, micropowder silica gel and polyethylene glycol are mixed in total mixing tank, adopt dry granulator (Alexander WP120V ) granulation to obtain dry granules. Pressure: 60bar, roller speed: 3rpm. After mixing the amlodipine besylate and microcrystalline cellulose PH102 in the prescribed amount, they are added to the above dry granules for mixing, then magnesium stearate is added for mixing, and then the tablets are compressed with a high-speed tablet machine.

[0085] Preparation of coated tablets: Weigh Ouba A coating solution is prepared to coat the plain tablets. Until the weight gain of the tablet is about 3%, each index of the coated tablet meets the relevant regulatio...

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Abstract

The invention discloses valsartan and amlodipine compound preparation and a preparation method thereof. In the invention, valsartan or pharmaceutically acceptable salts thereof and amlodipine or pharmaceutically acceptable salts thereof are used as active ingredients, the valsartan and a pharmaceutical auxiliary material are mixed and rolled by a rolling process to form a pressed material; the pressed material is sieved to obtain a granular material; and the granular material is mixed with amlodipine to form tablets or capsules. In the invention, the valsartan and the auxiliary material are granulated first and then mixed with the amlodipine equally, so the liquidity of the material is improved; and the prepared product is very stable, and the process is simple and suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of a compound preparation composed of valsartan or a pharmaceutically acceptable salt thereof and amlodipine or a pharmaceutically acceptable salt thereof. Background technique [0002] The activator of the renin-angiotensin-aldosterone system (RAAS) is angiotensin II, which is formed from angiotensin I by the action of angiotensin-converting enzyme (ACE). Angiotensin II can bind to specific receptors on tissue cell membranes, and has many physiological functions, and can directly or indirectly participate in blood pressure regulation. Angiotensin II has a strong vasoconstrictive effect, has a direct boosting effect, can also promote sodium reabsorption, and stimulate aldosterone secretion. [0003] Valsartan is a highly specific angiotensin (AT) II receptor antagonist that acts selectively on the AT1 receptor subtype, which responds to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/20A61K9/48A61P9/00
Inventor 高慧燕舒佳妮李巧霞彭俊清胡功允
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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