Torasemide pharmaceutical composition with stabilization and safety for injection

Abstract

The invention relates to a torasemide pharmaceutical composition with stabilization and safety for injection and its preparation method, especially relates to the torasemide pharmaceutical composition used for patients with requirement of rapid diuresis or congestive cardiac failure without oral diuresis, cirrhosis ascites, oedema caused by kidney diseases, the torasemide pharmaceutical composition is an injection preferably. The pharmaceutical composition is composed of active component torasemide, ethanol and polysorbate 80. The torasemide pharmaceutical composition for injection possesses stable pH value and low impurity content, and is capable of effectively raising the treatment effect of the products, minimizing the side reaction, raising the yield, reducing the cost and creating higher benefit.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a stable and safe pharmaceutical composition of torasemide for injection and a preparation method thereof. Background technique

[0002] Hypertension is one of the clinical frequently-occurring diseases, often accompanied by a variety of cardiovascular risk factors. my country has conducted three large-scale sampling surveys of hypertensive populations. The most recent survey was in 2002. The prevalence of hypertension among residents over the age of 18 in my country was 18.8%, and it showed an obvious upward trend. It is estimated that the number of hypertensive patients in my country exceeds 160 million.

[0003] Diuretics reduce the amount of sodium and water circulating in the body through natriuresis and diuresis, reducing blood volume and lowering blood pressure. According to their different action characteristics, they can be divided into thiazides, loop diur...

Examples

Embodiment 1

[0045] Torsemide 50g

[0046] Ethanol 2.5L

[0047] Polysorbate 80 10g

[0048] Water for injection 5L

[0049] Made 1000 pieces

[0050] The preparation method is:

[0051]In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and oth...

Embodiment 2

[0053] Torsemide 20g

[0054] Ethanol 1L

[0055] Polysorbate 80 4g

[0056] Water for injection 2L

[0057] Made 1000 pieces

[0058] The preparation method is:

[0059] In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and other...

Embodiment 3

[0061] Torsemide 10g

[0062] Ethanol 0.5L

[0063] Polysorbate 80 2g

[0064] Water for injection 1L

[0065] Made 1000 pieces

[0066] The preparation method is:

[0067] In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and oth...

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a stable and safe pharmaceutical composition of torasemide for injection and a preparation method thereof. Background technique

[0002] Hypertension is one of the clinical frequently-occurring diseases, often accompanied by a variety of cardiovascular risk factors. my country has conducted three large-scale sampling surveys of hypertensive populations. The most recent survey was in 2002. The prevalence of hypertension among residents over the age of 18 in my country was 18.8%, and it showed an obvious upward trend. It is estimated that the number of hypertensive patients in my country exceeds 160 million.

[0003] Diuretics reduce the amount of sodium and water circulating in the body through natriuresis and diuresis, reducing blood volume and lowering blood pressure. According to their different action characteristics, they can be divided into thiazides, loop diur...

Examples

Embodiment 1

[0045] Torsemide 50g

[0046] Ethanol 2.5L

[0047] Polysorbate 80 10g

[0048] Water for injection 5L

[0049] Made 1000 pieces

[0050] The preparation method is:

[0051]In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and oth...

Embodiment 2

[0053] Torsemide 20g

[0054] Ethanol 1L

[0055] Polysorbate 80 4g

[0056] Water for injection 2L

[0057] Made 1000 pieces

[0058] The preparation method is:

[0059] In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and other...

Embodiment 3

[0061] Torsemide 10g

[0062] Ethanol 0.5L

[0063] Polysorbate 80 2g

[0064] Water for injection 1L

[0065] Made 1000 pieces

[0066] The preparation method is:

[0067] In the clean area, first add the prescribed amount of polysorbate 80 into an appropriate amount of water for injection at 70-90°C, stir to dissolve, cool down, add the prescribed amount of ethanol, then add the prescribed amount of torasemide, and stir until completely dissolved. Adjust the pH value to 7.0-8.0, take 0.1%-0.5% (W / V) of activated carbon of the total solution, add an appropriate amount of water for injection and stir well, add water for injection until it is completely bright, stir and circulate for more than 15 minutes, and then coarsely filter After decarbonization, fine filtration through a microporous membrane (such as a 0.22um membrane). After fine filtration through a microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and oth...

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