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Water-soluble vitamin pharmaceutical composition for injection

A technology for water-soluble vitamins and water for injection, which is applied in the field of medicine, can solve the problems of increasing insoluble particles, increasing the risk of drug safety for patients, and the stability of water-soluble vitamins is not well solved, and achieves the effect of improving stability.

Active Publication Date: 2017-01-11
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

[0003] For a long time, the diseases caused by vitamin deficiency have been high. Reasonable supplementation of vitamins has attracted widespread attention. Therefore, injection of water-soluble vitamins has become a nutritional drug widely used by the masses. Strictly sealed and stored at low temperature, and as the storage time increases, the various raw materials of water-soluble vitamins for injection will decrease, impurities will increase, and insoluble particles will increase, thereby increasing the risk of drug safety for patients
The prior art has been trying to improve this problem, but the stability of water-soluble vitamins for injection has not been well resolved

Method used

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  • Water-soluble vitamin pharmaceutical composition for injection
  • Water-soluble vitamin pharmaceutical composition for injection
  • Water-soluble vitamin pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation of embodiment 1 injection water-soluble vitamin pharmaceutical composition

[0049]

[0050] Process:

[0051] 1. Poloxamer 188, sodium lactate, L-malic acid, thiamine nitrate, nicotinamide, sodium pantothenate, biotin, vitamin B12, disodium edetate, riboflavin sodium phosphate, Add pyridoxine hydrochloride, vitamin C sodium, folic acid, glycine, and methyl p-hydroxybenzoate into 1400ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly.

[0052] 2. Add 0.10g / 100ml of activated carbon to step 1, stir for 25 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume, and divide into half-stoppered liquids.

[0053] 3. Freeze-drying:

[0054] ① Pre-freezing: place the aliquot in a freezer that has been cooled to -32°C in advance, and keep it for 3 hours;

[0055] ②Sublimation: Turn on the vacuum device, adjust the vacuum degre...

Embodiment 2

[0057] The preparation of embodiment 2 injection water-soluble vitamin pharmaceutical composition

[0058]

[0059] Process:

[0060]1. Poloxamer 188, sodium lactate, L-malic acid, thiamine nitrate, nicotinamide, sodium pantothenate, biotin, vitamin B12, disodium edetate, riboflavin sodium phosphate, Add pyridoxine hydrochloride, vitamin C sodium, folic acid, glycine, and methyl p-hydroxybenzoate into 1400ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly.

[0061] 2. Add 0.10g / 100ml of activated carbon to step 1, stir for 25 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume, and divide into half-stoppered liquids.

[0062] 3. Freeze-drying:

[0063] ① Pre-freezing: Place the aliquot in a freezer that has been cooled to -42°C in advance and keep it for 2 hours;

[0064] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree ...

Embodiment 3

[0066] The preparation of embodiment 3 injection water-soluble vitamin pharmaceutical compositions

[0067]

[0068] Process:

[0069] 1. Poloxamer 188, sodium lactate, L-malic acid, thiamine nitrate, nicotinamide, sodium pantothenate, biotin, vitamin B12, disodium edetate, riboflavin sodium phosphate, Add pyridoxine hydrochloride, vitamin C sodium, folic acid, glycine, and methyl p-hydroxybenzoate into 1400ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly.

[0070] 2. Add 0.10g / 100ml of activated carbon to step 1, stir for 25 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume, and divide into half-stoppered liquids.

[0071] 3. Freeze-drying:

[0072] ① Pre-freezing: place the aliquot in a freezer that has been cooled to -37°C in advance, and keep it for 3 hours;

[0073] ②Sublimation: Turn on the vacuum device, adjust the vacuum degr...

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Abstract

The invention relates to a water-soluble vitamin pharmaceutical composition for injection. The water-soluble vitamin pharmaceutical composition for injection is prepared from 3.1g of thiamine mononitrate, 40g of nicotinamide, 16.5g of sodium pantothenate, 60mg of biotin, 5.0mg of vitamin B12, 0.5g of disodium ethylene diamine tetraacetate, 4.9g of riboflavin sodium phosphate, 4.9g of pyridoxine hydrochloride, 113g of sodium vitamin C, 0.4g of folic acid, 300g of glycine, 0.5g of methyl parahydroxybenzoate, 1.2g of poloxamer 188, 0.5g of sodium lactate, 1.0g of L-malic acid and water for injection, wherein the water for injection is added until the total volume is 2000ml. The water-soluble vitamin pharmaceutical composition for injection, disclosed by the invention, is good in stability and greatly improved in medication safety.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an injectable water-soluble vitamin pharmaceutical composition. Background technique [0002] Water-soluble vitamins are a class of organic nutritional molecules that can dissolve in water. These include B vitamins and vitamin C, which play an important role in the catalysis of enzymes. Water-soluble vitamins include vitamin B complex (vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, biotin), vitamin C and choline. [0003] For a long time, the diseases caused by vitamin deficiency have been high. Reasonable supplementation of vitamins has attracted widespread attention. Therefore, injection of water-soluble vitamins has become a nutritional drug widely used by the masses. Strictly sealed and stored at low temperature, and as the storage time increases, various raw materials of water-soluble vitamins for injection will decrease, impurities w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/714A61K47/34A61K47/12A61P3/02A61K31/519A61K31/455A61K31/4188A61K31/375A61K31/198A61K31/197A61K31/51A61K31/4415A61K31/525
Inventor 李美林马虹胡成忠
Owner 湖北美林药业有限公司
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