Diovan compound preparation and preparation method thereof

A compound preparation and valsartan technology, applied in the field of pharmaceutical preparations and valsartan compound preparations, can solve problems such as being unsuitable for industrial production, poor powder fluidity, poor material fluidity and the like

Active Publication Date: 2009-07-22
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0022] Not suitable for production by direct compression due to poor fluidity of the powder
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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  • Diovan compound preparation and preparation method thereof
  • Diovan compound preparation and preparation method thereof
  • Diovan compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Embodiment 1: the preparation of valsartan amlodipine tablet

[0078] The material composition is shown in Table 1;

[0079] Table 1. Ratio of material composition

[0080]

[0081] Preparation of tablet cores: the whole valsartan bulk drug of the prescribed amount is granulated by a dry granulator (Alexander WP120V) to obtain valsartan bulk drug granules. Pressure: 40bar, roller speed: 3rpm. The granules are mixed with amlodipine besylate in the prescribed amount, optimized microcrystalline cellulose, crospovidone, sodium carboxymethyl starch, micropowder silica gel, and magnesium stearate, and then compressed by a high-speed tablet machine.

[0082] Preparation of coated tablets: the coating powder is formulated into a coating solution, and the plain tablets are coated. Until the weight gain of the tablet is 2-5%, all indexes of the coated tablet meet the relevant regulations. The results are shown in Table 2.

[0083] Table 2. Test results of valsartan and am...

Embodiment 2

[0085] Embodiment 2: the preparation of valsartan amlodipine tablet

[0086] The material composition is shown in Table 3;

[0087] Preparation of tablet cores: the whole valsartan bulk drug of the prescribed amount is granulated by a dry granulator (Alexander WP120V) to obtain valsartan bulk drug granules. Pressure: 40bar, roller speed: 3rpm. The granules are mixed with amlodipine besylate in the prescribed amount, optimized microcrystalline cellulose, crospovidone, sodium carboxymethyl starch, micropowder silica gel, and magnesium stearate, and then compressed by a high-speed tablet machine.

[0088] Table 3. Ratio of material composition

[0089]

[0090]

[0091] Preparation of coated tablets: the coating powder is formulated into a coating solution, and the plain tablets are coated. Until the weight gain of the tablet is 2-5%, all indexes of the coated tablet meet the relevant regulations, and the results are shown in Table 4.

[0092] Table 4. Test results of v...

Embodiment 3

[0094] Embodiment 3: the preparation of valsartan amlodipine capsule

[0095] The material composition is shown in Table 3;

[0096] Preparation steps: use a dry granulator (Alexander WP120V) to granulate all the valsartan raw materials in the prescription to obtain valsartan raw drug granules. Pressure: 40bar, roller speed: 3rpm. The granule is mixed with amlodipine besylate of the prescribed amount, optimized microcrystalline cellulose, crospovidone, sodium carboxymethyl starch, micropowder silica gel, and magnesium stearate, and then capsule filling is performed by a capsule filling machine. And the weight difference, disintegration time limit and dissolution of the capsules were detected. The results are shown in Table 5.

[0097] Table 5 Test results of valsartan and amlodipine capsules

[0098]

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Abstract

The invention discloses a valsartan compound preparation and a method for preparing the same. In the method, the valsartan or pharmacologically accepted salts of the valsartan and amlodipine or pharmacologically accepted salts of the amlodipine are used as active ingredients, and the active ingredients are pressed to prepare a compact by a rolling method; the compact is screened to prepare granules; and the granules are mixed with pharmaceutic adjuvants to prepare a tablet or a capsule. The method pretreats the active ingredients, so that materials have good fluidity; and the valsartan compound preparation and the method have the characteristics of simple process, low cost and suitability for industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a valsartan compound preparation, in particular to a compound preparation consisting of valsartan or a pharmaceutically acceptable salt thereof and amlodipine or a pharmaceutically acceptable salt thereof and a preparation method 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 A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/41A61K31/4422A61J3/10A61J3/07A61P9/00A61P9/10A61P9/12
Inventor 彭俊清葛光华李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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