Orally-taken solid medicinal composition containing trandolapril and preparation method thereof

Abstract

The invention discloses an orally-taken solid medicinal composition containing trandolapril and a preparation method thereof. The orally-taken solid medicinal composition comprises the following bulk drug components in percentage by weight: 0.1-0.9 percent of trandolapril, 15-65 percent of filling agent, 10-40 percent of bonding agent, 5-40 percent of disintegrating agent and 1-8 percent of glidant. The orally-taken solid medicinal composition containing the trandolapril, which is disclosed by the invention, is suitable for treating hypertensive diseases with various degrees and is formed by processing through a scientific and reasonable production process. The orally-taken solid medicinal composition has the advantages of definite functions, controllable quality and safety in taking. The orally-taken solid medicinal composition is simple in preparation method and can be prepared by conventional equipment.

Description

technical field

[0001] The invention belongs to the field of medicines, in particular to an oral solid pharmaceutical composition containing trandolapril and a preparation method thereof. Background technique

[0002] Hypertension is defined as elevated arterial systolic and / or diastolic blood pressure at rest. Hypertension is a systemic disease characterized by elevated arterial pressure, which may be accompanied by functional or organic changes in the heart, blood vessels, brain, kidneys and other organs. It has primary hypertension and secondary hypertension points. There are many reasons for the onset of hypertension, which can be divided into two aspects: genetic and environmental.

[0003] The blood pressure standard recommended by the World Health Organization (Who) is: the systolic blood pressure of a normal adult should be less than or equal to 140mmHg (18.6kPa), and the diastolic blood pressure should be less than or equal to 90mmHg (12kPa), that is, the systolic...

Examples

Embodiment 1

[0023] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0024] a) Formulation:

[0025] Trandolapril 0.5g

[0026] Dry starch 209.5g

[0027] Sucrose 60g

[0028] Sodium Low-Substituted Hydroxypropyl Cellulose 100g

[0029] Magnesium Stearate 20g

[0030] Distilled water 10g

[0031] Compressed into 1000 tablets, 0.4g / tablet, specification 0.5mg / tablet.

[0032] b) Pass the above-mentioned trandapril, dry starch, sucrose, and low-substituted hydroxypropyl cellulose sodium in step a) through a 20-100 mesh sieve;

[0033] c) Mix step b) trandolapril and dry starch uniformly by equal increment method, then mix uniformly with sucrose and low-substituted hydroxypropyl cellulose sodium, and add distilled water to make soft material;

[0034] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0035] e) 10-60 mesh sieve for granulation, add the above weight magnesium stea...

Embodiment 2

[0038] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0039] a) Formulation:

[0040] Trandolapril 1g

[0041] Microcrystalline Cellulose 219g

[0042] Sodium Carboxymethyl Cellulose 40g

[0043] Sodium carboxymethyl starch 100g

[0044] Magnesium Stearate 20g

[0045] 65% ethanol solution 20g

[0046] Pressed into 1000 tablets, 0.4g / tablet, specification 1mg / tablet.

[0047] b) Pass the above-mentioned trandapril, microcrystalline cellulose, carboxymethylcellulose sodium and carboxymethyl starch sodium in step a) through a 20-100 mesh sieve;

[0048] c) Mix step b) trandolapril and microcrystalline cellulose evenly with the method of equal increments, then mix evenly with sodium carboxymethylcellulose and sodium carboxymethyl starch, and add 65% ethanol solution to make a soft material;

[0049] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0050] e) 10-60...

Embodiment 3

[0053] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0054] a) Formulation:

[0055] Trandolapril 2g

[0056] Microcrystalline Cellulose 258g

[0057] Crospovidone 40g

[0058] Sodium carboxymethyl starch 60g

[0059] Magnesium Stearate 20g

[0060] Distilled water 20g

[0061] Pressed into 1000 tablets, 0.4g / tablet, specification 1mg / tablet.

[0062] b) Pass the above-mentioned trandapril, microcrystalline cellulose, crospovidone, and sodium carboxymethyl starch in step a) through a 20-100 mesh sieve;

[0063] c) Mix step b) trandolapril and microcrystalline cellulose uniformly with the method of equal increments, then mix them with crospovidone and sodium carboxymethyl starch, and add distilled water to make a soft material;

[0064] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0065] e) 10-60 mesh sieve for granulation, add the above weight magnes...

technical field

[0001] The invention belongs to the field of medicines, in particular to an oral solid pharmaceutical composition containing trandolapril and a preparation method thereof. Background technique

[0002] Hypertension is defined as elevated arterial systolic and / or diastolic blood pressure at rest. Hypertension is a systemic disease characterized by elevated arterial pressure, which may be accompanied by functional or organic changes in the heart, blood vessels, brain, kidneys and other organs. It has primary hypertension and secondary hypertension points. There are many reasons for the onset of hypertension, which can be divided into two aspects: genetic and environmental.

[0003] The blood pressure standard recommended by the World Health Organization (Who) is: the systolic blood pressure of a normal adult should be less than or equal to 140mmHg (18.6kPa), and the diastolic blood pressure should be less than or equal to 90mmHg (12kPa), that is, the systolic...

Examples

Embodiment 1

[0023] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0024] a) Formulation:

[0025] Trandolapril 0.5g

[0026] Dry starch 209.5g

[0027] Sucrose 60g

[0028] Sodium Low-Substituted Hydroxypropyl Cellulose 100g

[0029] Magnesium Stearate 20g

[0030] Distilled water 10g

[0031] Compressed into 1000 tablets, 0.4g / tablet, specification 0.5mg / tablet.

[0032] b) Pass the above-mentioned trandapril, dry starch, sucrose, and low-substituted hydroxypropyl cellulose sodium in step a) through a 20-100 mesh sieve;

[0033] c) Mix step b) trandolapril and dry starch uniformly by equal increment method, then mix uniformly with sucrose and low-substituted hydroxypropyl cellulose sodium, and add distilled water to make soft material;

[0034] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0035] e) 10-60 mesh sieve for granulation, add the above weight magnesium stea...

Embodiment 2

[0038] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0039] a) Formulation:

[0040] Trandolapril 1g

[0041] Microcrystalline Cellulose 219g

[0042] Sodium Carboxymethyl Cellulose 40g

[0043] Sodium carboxymethyl starch 100g

[0044] Magnesium Stearate 20g

[0045] 65% ethanol solution 20g

[0046] Pressed into 1000 tablets, 0.4g / tablet, specification 1mg / tablet.

[0047] b) Pass the above-mentioned trandapril, microcrystalline cellulose, carboxymethylcellulose sodium and carboxymethyl starch sodium in step a) through a 20-100 mesh sieve;

[0048] c) Mix step b) trandolapril and microcrystalline cellulose evenly with the method of equal increments, then mix evenly with sodium carboxymethylcellulose and sodium carboxymethyl starch, and add 65% ethanol solution to make a soft material;

[0049] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0050] e) 10-60...

Embodiment 3

[0053] A kind of oral solid pharmaceutical composition containing trandolapril is made by following steps:

[0054] a) Formulation:

[0055] Trandolapril 2g

[0056] Microcrystalline Cellulose 258g

[0057] Crospovidone 40g

[0058] Sodium carboxymethyl starch 60g

[0059] Magnesium Stearate 20g

[0060] Distilled water 20g

[0061] Pressed into 1000 tablets, 0.4g / tablet, specification 1mg / tablet.

[0062] b) Pass the above-mentioned trandapril, microcrystalline cellulose, crospovidone, and sodium carboxymethyl starch in step a) through a 20-100 mesh sieve;

[0063] c) Mix step b) trandolapril and microcrystalline cellulose uniformly with the method of equal increments, then mix them with crospovidone and sodium carboxymethyl starch, and add distilled water to make a soft material;

[0064] d) Soft materials are granulated with a 10-40 mesh sieve, and air-dried at 50-60°C;

[0065] e) 10-60 mesh sieve for granulation, add the above weight magnes...