Fat-soluble vitamin freeze-dried injection and preparation method thereof

Abstract

The invention relates to the field of medicinal preparations and discloses a fat-soluble vitamin freeze-dried injection and a preparation method thereof, so as to solve the problems of clarity and stability of the fat-soluble vitamin for injection in the prior art. The freeze-dried injection contains vitamin A palmitate, vitamin D2, vitamin E, vitamin K1, ethanol, polysorbate 80, tween-20, mannitol and sodium hydroxide. The clarity and stability of the fat-soluble vitamin freeze-dried injection disclosed by the invention are greatly improved, and the medicine risk is reduced.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, in particular to a fat-soluble vitamin freeze-dried injection and a preparation method thereof. Background technique

[0002] Fat-soluble vitamins are essential nutrients for the human body. Clinically, critically ill patients need to be supplemented to maintain normal daily metabolism. Since fat-soluble vitamins are insoluble in water and have low bioavailability when administered orally, they are generally prepared as injections.

[0003] Fat-soluble vitamins include vitamin A, vitamin D2, vitamin E, and vitamin K1. Except for vitamin E, which is relatively stable, the other three components are unstable to light, heat, and air, and are easily degraded. There are stability issues in both. In terms of storage and transportation, freeze-dried preparations have more advantages; secondly, due to the high temperature process of sterilization, the water needle will be degraded to a certai...

Examples

Embodiment 1

[0076] prescription:

[0077] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0078] Vitamin A Palmitate 1980IU 19.8 million IU

[0079] Vitamin D2 120IU 1.2 million IU

[0080] Vitamin K1 90μg 0.900g

[0081] Vitamin E 5.005mg 50.05g

[0082] Ethanol 20μl 200ml

[0083] Polysorbate 80 100mg 1000g

[0084] Tween-20 500ug 5.0g

[0085] Mannitol 150mg 1500g

[0086] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.02

[0087]

[0088] Add water for injection to 1ml 10,000ml

[0089] (1) Take vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add polysorbate 80, Tween-20, ethanol in prescription quantity, stir;

[0090] (2) Weigh the prescribed amount of mannitol, add 50% of the total prepared amount of water for injection and stir to dissolve, cool to room temperature, slowly add the prescribed amount of mannitol solution into the abo...

Embodiment 2

[0097] prescription:

[0098] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0099] Vitamin A Palmitate 16.50IU 16.5 million IU

[0100] Vitamin D2 100IU 1 million IU

[0101] Vitamin K1 75μg 0.750g

[0102] Vitamin E 4.55mg 45.5g

[0103] Ethanol 10μl 100ml

[0104] Polysorbate 80 50mg 500g

[0105] Tween-20 300ug 3.0g

[0106] Mannitol 130mg 1300g

[0107] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.54

[0108]

[0109] Add water for injection to 1ml 10,000ml

[0110] (1) Take prescription quantity vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add prescription quantity Polysorbate 80, Tween-20, ethanol, stir;

[0111] (2) Weigh the prescribed amount of mannitol, add 80% of the total prepared amount of water for injection, stir to dissolve, and cool to room temperature. Slowly add the prescribed amount of mannitol solution i...

Embodiment 3

[0118] prescription:

[0119] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0120] Vitamin A Palmitate 15.70IU 15.7 million IU

[0121] Vitamin D2 95IU 950,000IU

[0122] Vitamin K1 70μg 0.700g

[0123] Vitamin E 4.20mg 42.0g

[0124] Ethanol 2μl 20ml

[0125]Polysorbate 80 40mg 400g

[0126] Tween-20 200ug 2.0g

[0127] Mannitol 110mg 1100g

[0128] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.99

[0129]

[0130] Add water for injection to 1ml 10,000ml

[0131] (1) Take prescription quantity vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add prescription quantity Polysorbate 80, Tween-20, ethanol, stir;

[0132] (2) Weigh the prescribed amount of mannitol, add 60% of the total prepared amount of water for injection, stir to dissolve, and cool to room temperature. Slowly add the prescribed amount of mannitol solution into t...

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, in particular to a fat-soluble vitamin freeze-dried injection and a preparation method thereof. Background technique

[0002] Fat-soluble vitamins are essential nutrients for the human body. Clinically, critically ill patients need to be supplemented to maintain normal daily metabolism. Since fat-soluble vitamins are insoluble in water and have low bioavailability when administered orally, they are generally prepared as injections.

[0003] Fat-soluble vitamins include vitamin A, vitamin D2, vitamin E, and vitamin K1. Except for vitamin E, which is relatively stable, the other three components are unstable to light, heat, and air, and are easily degraded. There are stability issues in both. In terms of storage and transportation, freeze-dried preparations have more advantages; secondly, due to the high temperature process of sterilization, the water needle will be degraded to a certai...

Examples

Embodiment 1

[0076] prescription:

[0077] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0078] Vitamin A Palmitate 1980IU 19.8 million IU

[0079] Vitamin D2 120IU 1.2 million IU

[0080] Vitamin K1 90μg 0.900g

[0081] Vitamin E 5.005mg 50.05g

[0082] Ethanol 20μl 200ml

[0083] Polysorbate 80 100mg 1000g

[0084] Tween-20 500ug 5.0g

[0085] Mannitol 150mg 1500g

[0086] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.02

[0087]

[0088] Add water for injection to 1ml 10,000ml

[0089] (1) Take vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add polysorbate 80, Tween-20, ethanol in prescription quantity, stir;

[0090] (2) Weigh the prescribed amount of mannitol, add 50% of the total prepared amount of water for injection and stir to dissolve, cool to room temperature, slowly add the prescribed amount of mannitol solution into the abo...

Embodiment 2

[0097] prescription:

[0098] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0099] Vitamin A Palmitate 16.50IU 16.5 million IU

[0100] Vitamin D2 100IU 1 million IU

[0101] Vitamin K1 75μg 0.750g

[0102] Vitamin E 4.55mg 45.5g

[0103] Ethanol 10μl 100ml

[0104] Polysorbate 80 50mg 500g

[0105] Tween-20 300ug 3.0g

[0106] Mannitol 130mg 1300g

[0107] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.54

[0108]

[0109] Add water for injection to 1ml 10,000ml

[0110] (1) Take prescription quantity vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add prescription quantity Polysorbate 80, Tween-20, ethanol, stir;

[0111] (2) Weigh the prescribed amount of mannitol, add 80% of the total prepared amount of water for injection, stir to dissolve, and cool to room temperature. Slowly add the prescribed amount of mannitol solution i...

Embodiment 3

[0118] prescription:

[0119] Raw and auxiliary materials Single prescription quantity 10,000 pieces of feeding quantity

[0120] Vitamin A Palmitate 15.70IU 15.7 million IU

[0121] Vitamin D2 95IU 950,000IU

[0122] Vitamin K1 70μg 0.700g

[0123] Vitamin E 4.20mg 42.0g

[0124] Ethanol 2μl 20ml

[0125]Polysorbate 80 40mg 400g

[0126] Tween-20 200ug 2.0g

[0127] Mannitol 110mg 1100g

[0128] Sodium hydroxide (1M) Adjust pH to 7.0~8.0 Adjust pH to 7.99

[0129]

[0130] Add water for injection to 1ml 10,000ml

[0131] (1) Take prescription quantity vitamin A palmitate, vitamin E, vitamin K1, vitamin D2 by prescription quantity, add prescription quantity Polysorbate 80, Tween-20, ethanol, stir;

[0132] (2) Weigh the prescribed amount of mannitol, add 60% of the total prepared amount of water for injection, stir to dissolve, and cool to room temperature. Slowly add the prescribed amount of mannitol solution into t...

Images