Pharmaceutical composition containing ivabradine and ranolazine

Abstract

The present invention provides a pharmaceutical composition containing active ingredients ivabradine or a pharmacologically acceptable salt thereof and ranolazine or a pharmacologically acceptable salt thereof. Through research, the present invention finds that the combined use of ivabradine and ranolazine effectively alleviates myocardial ischemia, and shows a good synergistic effect on myocardial ischemia diseases such as angina pectoris and coronary heart disease. Therefore, a method for treating myocardial ischemic diseases with better effect and lower adverse reactions has been found, and a good solution has been found for the unsatisfactory treatment effect of myocardial ischemic diseases in clinical practice.

Description

technical field

[0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition for treating myocardial ischemic diseases containing active ingredients ivabradine or a pharmaceutically acceptable salt thereof and ranolazine or a pharmaceutically acceptable salt thereof. Background technique

[0002] The traditional treatment of myocardial ischemic diseases is mainly symptomatic treatment. Nitrates, adrenergic β-receptor blockers, calcium channel antagonists, etc. improve the hemodynamics of the heart and the whole body, increase myocardial energy supply, The purpose of reducing myocardial energy consumption is the main drug for the treatment of myocardial ischemia. However, there are still some patients whose symptoms cannot be well controlled after receiving sufficient above-mentioned drug treatment. With further clinical research and understanding, a new concept of treating ischemic heart disease by intervening in the metabol...

Examples

Embodiment 1

[0014] Embodiment 1 common tablet

[0015] Ivabradine Hydrochloride 3.5g

[0016] Ranolazine Dihydrochloride 35g

[0017] Microcrystalline Cellulose 160g

[0018] Lactose 80g

[0019] 10% starch slurry appropriate amount

[0020] Magnesium Stearate 1.5g

[0021] Preparation process: Weigh the prescribed amount of ivabradine hydrochloride, ranolazine dihydrochloride, microcrystalline cellulose, and lactose and mix evenly. In addition, add an appropriate amount of 10% starch slurry to the mixed powder, mix evenly, make soft material, pass through a 18-mesh nylon sieve to make wet granules, and dry at about 60°C. The moisture content of the dry granules should be controlled below 1.5%. Sieve through a 20-mesh sieve, mix with magnesium stearate, and press into tablets.

Embodiment 2

[0022] Embodiment 2 common tablet

[0023] Ivabradine Hydrochloride 1.0g

[0024] Ranolazine Dihydrochloride 65g

[0025] Starch 140g

[0026] Dextrin 20g

[0027] 50% ethanol appropriate amount

[0028] Magnesium Stearate 1.0g

[0029] Preparation process: Weigh the prescribed amount of ivabradine hydrochloride, ranolazine dihydrochloride, starch, and dextrin and mix evenly. In addition, add an appropriate amount of 50% ethanol to the mixed powder, mix evenly, make soft material, pass through a 18-mesh nylon sieve to make wet granules, and dry at about 60°C. The moisture content of the dry granules should be controlled below 1.5%. Sieve through a 20-mesh sieve, mix with magnesium stearate, and press into tablets.

Embodiment 3

[0030] Embodiment 3 Dispersible tablets

[0031]Ivabradine Hydrochloride 0.1g

[0032] Ranolazine Dihydrochloride 300g

[0033] Croscarmellose Sodium 10g

[0034] Microcrystalline Cellulose 140g

[0035] Polyvinylpyrrolidone 5.5g

[0036] 5% PVP dissolved in 60% ethanol

[0037] liquid

[0038] Micronized silica gel 5g

[0039] Preparation process: Take ivabradine hydrochloride and ranolazine dihydrochloride according to the prescription, use microcrystalline cellulose as filler, cross-linked sodium carboxymethyl cellulose and polyvinylpyrrolidone as disintegrants, 5 %PVP 60% ethanol solution is used as binder, micronized silica gel is used as flow aid, granulated by fluidized bed in one step, and then compressed into tablets.

technical field

[0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition for treating myocardial ischemic diseases containing active ingredients ivabradine or a pharmaceutically acceptable salt thereof and ranolazine or a pharmaceutically acceptable salt thereof. Background technique

[0002] The traditional treatment of myocardial ischemic diseases is mainly symptomatic treatment. Nitrates, adrenergic β-receptor blockers, calcium channel antagonists, etc. improve the hemodynamics of the heart and the whole body, increase myocardial energy supply, The purpose of reducing myocardial energy consumption is the main drug for the treatment of myocardial ischemia. However, there are still some patients whose symptoms cannot be well controlled after receiving sufficient above-mentioned drug treatment. With further clinical research and understanding, a new concept of treating ischemic heart disease by intervening in the metabol...

Examples

Embodiment 1

[0014] Embodiment 1 common tablet

[0015] Ivabradine Hydrochloride 3.5g

[0016] Ranolazine Dihydrochloride 35g

[0017] Microcrystalline Cellulose 160g

[0018] Lactose 80g

[0019] 10% starch slurry appropriate amount

[0020] Magnesium Stearate 1.5g

[0021] Preparation process: Weigh the prescribed amount of ivabradine hydrochloride, ranolazine dihydrochloride, microcrystalline cellulose, and lactose and mix evenly. In addition, add an appropriate amount of 10% starch slurry to the mixed powder, mix evenly, make soft material, pass through a 18-mesh nylon sieve to make wet granules, and dry at about 60°C. The moisture content of the dry granules should be controlled below 1.5%. Sieve through a 20-mesh sieve, mix with magnesium stearate, and press into tablets.

Embodiment 2

[0022] Embodiment 2 common tablet

[0023] Ivabradine Hydrochloride 1.0g

[0024] Ranolazine Dihydrochloride 65g

[0025] Starch 140g

[0026] Dextrin 20g

[0027] 50% ethanol appropriate amount

[0028] Magnesium Stearate 1.0g

[0029] Preparation process: Weigh the prescribed amount of ivabradine hydrochloride, ranolazine dihydrochloride, starch, and dextrin and mix evenly. In addition, add an appropriate amount of 50% ethanol to the mixed powder, mix evenly, make soft material, pass through a 18-mesh nylon sieve to make wet granules, and dry at about 60°C. The moisture content of the dry granules should be controlled below 1.5%. Sieve through a 20-mesh sieve, mix with magnesium stearate, and press into tablets.

Embodiment 3

[0030] Embodiment 3 Dispersible tablets

[0031]Ivabradine Hydrochloride 0.1g

[0032] Ranolazine Dihydrochloride 300g

[0033] Croscarmellose Sodium 10g

[0034] Microcrystalline Cellulose 140g

[0035] Polyvinylpyrrolidone 5.5g

[0036] 5% PVP dissolved in 60% ethanol

[0037] liquid

[0038] Micronized silica gel 5g

[0039] Preparation process: Take ivabradine hydrochloride and ranolazine dihydrochloride according to the prescription, use microcrystalline cellulose as filler, cross-linked sodium carboxymethyl cellulose and polyvinylpyrrolidone as disintegrants, 5 %PVP 60% ethanol solution is used as binder, micronized silica gel is used as flow aid, granulated by fluidized bed in one step, and then compressed into tablets.

Images