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Vitamin B6 injection filled in plastic ampoule and preparation method of vitamin B6 injection

A vitamin and injection technology, applied in the field of medicine, can solve the problems of high temperature resistance, easy damage, and low risk of contamination, and achieve the effects of low insoluble particle count and increased stability.

Active Publication Date: 2020-08-18
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinically, vitamin B6 injection is a commonly used drug, but vitamin B6 injection is unstable, easily destroyed by light or alkali, and not resistant to high temperature. These shortcomings limit the safe use of vitamin B6 injection, and at the same time, it is used as a packaging material for small-volume injection In recent years, compared with traditional glass ampoules, plastic ampoules have developed rapidly due to their advantages of more convenient use, lower insoluble particles, and lower risk of bacterial contamination. great value

Method used

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  • Vitamin B6 injection filled in plastic ampoule and preparation method of vitamin B6 injection
  • Vitamin B6 injection filled in plastic ampoule and preparation method of vitamin B6 injection
  • Vitamin B6 injection filled in plastic ampoule and preparation method of vitamin B6 injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation of Vitamin B6 Injection (2ml: 0.1g)

[0038] prescription:

[0039] Vitamin B6: 50g

[0040] Edetate Calcium Sodium: 4.2g

[0041] Sodium dihydrogen phosphate: 5.5g

[0042] Add water for injection to 1000ml

[0043] Made of 500

[0044] Preparation:

[0045] (1) Dissolve the prescribed amount of calcium sodium edetate and disodium hydrogen phosphate in 600ml of water for injection at 35°C in sequence;

[0046] (2) Keep the temperature of the solution in step (1) at 35°C, add the prescribed amount of vitamin B6 and stir to dissolve, add water for injection to 1000ml;

[0047] (3) Measure the pH value and content of the solution in step (2), filter it with a 0.22µm filter membrane, fill it in a polypropylene ampoule according to the specifications, and then sterilize it at 121°C for 15 minutes to obtain vitamin B6 filled with a plastic ampoule Injection.

Embodiment 2

[0048] Example 2 Preparation of Vitamin B6 Injection (2ml: 0.1g)

[0049] prescription:

[0050] Vitamin B6: 50g

[0051] Edetate Calcium Sodium: 4.2g

[0052] Sodium dihydrogen phosphate: 5.5g

[0053] Add water for injection to 1000ml

[0054] Made of 500

[0055] Preparation:

[0056] (1) Dissolve the prescribed amount of calcium sodium edetate and disodium hydrogen phosphate in sequence in 600ml of water for injection at 40°C;

[0057] (2) Keep the temperature of the solution in step (1) at 40°C, add the prescribed amount of vitamin B6 and stir to dissolve, add water for injection to 1000ml;

[0058] (3) Measure the pH value and content of the solution in step (2), filter it with a 0.22µm filter membrane, fill it in a polypropylene ampoule according to the specifications, and then sterilize it at 121°C for 15 minutes to obtain vitamin B6 filled with a plastic ampoule Injection.

Embodiment 3

[0059] Example 3 Preparation of vitamin B6 injection (2ml: 0.1g)

[0060] prescription:

[0061] Vitamin B6: 50g

[0062] Edetate Calcium Sodium: 4.2g

[0063] Sodium dihydrogen phosphate: 5.5g

[0064] Add water for injection to 1000ml

[0065] Made of 500

[0066] Preparation:

[0067](1) Dissolve the prescribed amount of calcium sodium edetate and disodium hydrogen phosphate in sequence in 600ml of water for injection at 38°C;

[0068] (2) Keep the temperature of the solution in step (1) at 38°C, add the prescribed amount of vitamin B6 and stir to dissolve, add water for injection to 1000ml;

[0069] (3) Measure the pH value and content of the solution in step (2), filter it with a 0.22µm filter membrane, fill it in a polypropylene ampoule according to the specifications, and then sterilize it at 121°C for 15 minutes to obtain vitamin B6 filled with a plastic ampoule Injection.

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Abstract

The invention relates to a vitamin B6 injection filled in a plastic ampoule and a preparation method of the vitamin B6 injection. Every 1000 ml of the injection contains 50 g of vitamin B6 and 50 g ofvitamin B6. The composition also contains sodium calcium edetate and sodium dihydrogen phosphate; preferably, 4.2 g of sodium calcium edentate and 5.5 g of disodium hydrogen phosphate are contained in every 1000 ml of the vitamin B6 injection, a polypropylene ampoule is preferably adopted for filling, and the vitamin B6 injection prepared according to the prescription process has extremely high quality stability, improves the medication safety and is obviously superior to the prior art.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a plastic ampoule-filled vitamin B6 injection and a preparation method thereof. Background technique [0002] Vitamin B6, also known as pyridoxine, includes pyridoxine, pyridoxal and pyridoxamine. It exists in the form of phosphate in the body and is a water-soluble vitamin. Vitamin B6 is a colorless crystal, soluble in water and ethanol, stable in acid, easily destroyed in lye, pyridoxine is heat resistant, pyridoxal and pyridoxamine are not resistant to high temperature. Vitamin B6 is more abundant in yeast, liver, grains, meat, fish, eggs, beans and peanuts. Vitamin B6 is a component of certain coenzymes in the human body and participates in a variety of metabolic reactions, especially closely related to amino acid metabolism. Vitamin B6 injection is a common dosage form of vitamin B6 preparations, clinically applicable to: 1. Prevention and treatment of vitam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4415A61K47/02A61K47/18A61P3/02A61J1/06
CPCA61K31/4415A61K9/08A61K9/0019A61K47/02A61K47/183A61P3/02A61J1/06
Inventor 胡成忠干志华
Owner 湖北美林药业有限公司
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