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Solid preparation of angiotensin receptor inhibitor and amlodipine and new preparation method thereof

A technology of amlodipine and valsartan, applied in the field of new preparations of solid preparations, oral preparations and their new preparations, containing angiotensin receptor inhibitors and amlodipine, which can solve the complex preparation process and industrialization Difficulty, affecting drug dissolution and other issues

Inactive Publication Date: 2011-11-16
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Chinese patent CN 101237859 proposes a double-layer solid dosage form of valsartan amlodipine, the preparation process is complicated, and the industrialization is difficult
[0010] Due to the physical and chemical properties of the two main drugs, valsartan and amlodipine besylate, the conventional preparation process affects the dissolution and release of the drug, and the bioavailability is low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 80 / 5mg tablet

[0038] Pulverize valsartan and amlodipine respectively and pass through a 100-mesh sieve for later use; mix 80.0 g of valsartan, 45.0 g of microcrystalline cellulose, and 5.0 g of croscarmellose sodium, and prepare the mixture with an aqueous solution as a wetting agent. Soft material, granulated with a 30-mesh screen, ventilated and dried at 55°C, granulated, ready for use; 6.94g amlodipine besylate, 120.0g microcrystalline cellulose, 10.0g pregelatinized starch, croscarmellose Sodium 6.0g, 3% hydroxypropyl methylcellulose aqueous solution as wetting agent to make soft material, granulate with 30 mesh screen, ventilate and dry at 55°C, granulate, add 0.5g of micropowder silica gel, 1.0g of magnesium stearate and mix Evenly, pressed into about 1000 round tablets, namely compressed tablets.

Embodiment 2

[0040] 80 / 5mg capsule

[0041] Pulverize valsartan and amlodipine respectively and pass through a 100-mesh sieve for later use; mix 80.0 g of valsartan, 20.0 g of microcrystalline cellulose, and 5.0 g of croscarmellose sodium, and prepare the mixture with an aqueous solution as a wetting agent. Soft material, granulated with a 30-mesh screen, ventilated and dried at 55°C, granulated, ready for use; 6.94g amlodipine besylate, 70.0g microcrystalline cellulose, 8.0g pregelatinized starch, croscarmellose Sodium 6.0g is made of soft material with an aqueous solution as a wetting agent, granulated with a 30-mesh screen, ventilated and dried at 55°C, granulated, added with 0.5g of micro-powdered silica gel, 0.5g of magnesium stearate, mixed evenly, filled to obtain capsules, Instantly.

Embodiment 3

[0043] 80 / 5mg granules

[0044] Pulverize valsartan and amlodipine respectively and pass through a 100-mesh sieve for later use; 80.0 g of valsartan, 150.0 g of microcrystalline cellulose, 200.0 g of sucrose, 30.0 g of pregelatinized starch, and 30.0 g of croscarmellose sodium , mix evenly, use 2% hydroxypropyl methylcellulose aqueous solution as a wetting agent to make soft materials, granulate with a 20-mesh screen, ventilate and dry at 55°C, granulate, and set aside; 6.94g of amlodipine besylate, micro Crystalline cellulose 180.0g, sucrose 300.0g, croscarmellose sodium 30.0g use aqueous solution as wetting agent to make soft material, granulate with 30-mesh screen, ventilate and dry at 55°C, granulate, add micro-powder silica gel 1.0g , 1.0 g of magnesium stearate, mixed evenly, filled, and prepared into granules.

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PUM

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Abstract

The invention relates to an angiotensin receptor inhibitor and a solid preparation of amlodipine and a novel method for preparing the same. The method comprises the following steps that: 1, valsartan and amlodipine are screened respectively until the grain size of the valsartan and amlodipine is qualified; 2, the valsartan and amlodipine are added with proper amount of excipient respectively and the mixture is evenly mixed; and 3, the evenly mixed powder are added with proper amount of bonding agent or wetting agent respectively to obtain grain in proper grain size, and the grain is dried.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to oral preparations containing angiotensin receptor inhibitors and amlodipine and a new preparation method thereof. The invention relates to a new preparation method of the solid preparation. Background technique [0002] According to statistics, 1 / 4 of the world's population suffers from high blood pressure, but the control rate of blood pressure is not ideal, and patients often cannot reach the target recommended by the guidelines. WHO multi-country monitoring of cardiovascular disease incidence trends and determinants (MONICA study) confirmed that only 13% to 38% of males and 17% to 54% of female patients with hypertension between the ages of 35 and 64 received antihypertensive treatment However, many patients who received treatment did not reach the target, and the treatment target ratios of male and female patients were only 13%-67% and 12%-63%, respective...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K9/16A61K31/4422A61P9/12A61K31/41A61K47/26A61K47/36A61K47/38A61K47/34A61K47/04A61K47/12A61K47/32
Inventor 严洁
Owner TIANJIN HANKANG PHARMA BIOTECH
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