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Riboflavine sodium phosphate composition injection and preparation method thereof

A technology of riboflavin sodium phosphate and injection, which is applied in the field of riboflavin sodium phosphate composition injection and preparation, can solve the problems of difficulty in confirming stability, complicated preparation process, etc., and achieves stable quality, no allergic reaction, reduced The effect of blood lipids on cardiac function

Active Publication Date: 2010-09-15
江西制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Utilize β-cyclodextrin in the present invention to carry out the technology that riboflavin sodium phosphate is included, although can effectively increase the solubility and the dissolving speed of riboflavin sodium phosphate in water, but its preparation process is complicated, whether to improve its stability sex is also difficult to confirm

Method used

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  • Riboflavine sodium phosphate composition injection and preparation method thereof
  • Riboflavine sodium phosphate composition injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0073] Recipe: 1000ml divided into 500 tubes 2ml: 5mg

[0074] Riboflavin Sodium Phosphate 2.5g

[0075] Citric acid 2.1g

[0076] Sodium chloride 2g

[0077] Sodium hydroxide 0.4g

[0078] Add water for injection to 1000ml

[0079] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 6.0 with sodium hydroxide, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and add nuclear yellow while stirring Sodium phosphate sodium, add water for injection to the full amount after it is completely dissolved, add 0.08% (w / v) activated carbon and stir at a temperature of 60°C for 23 minutes, filter, reflux, fill, fill with nitrogen, melt seal, and heat at a high temperature of 121°C After sterilizing for 10 minutes, inspecting the lamp after cooling down, packing and inspecting, the riboflavin sodium phosphate composition injection is ob...

Embodiment 2

[0081] Recipe: 1000ml divided into 500 tubes 2ml: 10mg

[0082] Riboflavin Sodium Phosphate 5g

[0083] Citric acid 2.1g

[0084] Sodium chloride 1g

[0085] Sodium hydroxide 0.4g

[0086] Add water for injection to 1000ml

[0087] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 6.1 with sodium hydroxide, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and add nuclear yellow while stirring Sodium phosphate sodium, add water for injection to the full amount after it is completely dissolved, add 0.05% (w / v) activated carbon and stir at a temperature of 55°C for 20 minutes, filter, reflux, fill, fill with nitrogen, melt seal, and heat at a high temperature of 121°C After sterilizing for 8 minutes, inspecting the lamp after cooling down, packing and inspecting, the riboflavin sodium phosphate composition injection is obta...

Embodiment 3

[0089] Recipe: 1000ml divided into 200 tubes 5ml: 15mg

[0090] Riboflavin Sodium Phosphate 3g

[0091] Citric acid 2.1g

[0092] Sodium chloride 1g

[0093] Sodium hydroxide 0.4g

[0094] Add water for injection to 1000ml

[0095] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 5.9 with sodium hydroxide, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and add nuclear yellow while stirring Sodium phosphate sodium, add water for injection to the full amount after it is completely dissolved, add 0.05% (w / v) activated carbon and stir at a temperature of 55°C for 20 minutes, filter, reflux, fill, fill with nitrogen, melt seal, and heat at a high temperature of 115°C After sterilizing for 30 minutes, inspecting the lamp after cooling down, packaging and testing, the riboflavin sodium phosphate composition injection is obta...

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Abstract

The invention discloses a riboflavine sodium phosphate composition injection and a preparation method thereof. The riboflavine sodium phosphate composition injection comprises riboflavine sodium phosphate, citric acid, sodium hydroxide and sodium chloride. Each injection contains 5 to 15mg of riboflavine sodium phosphate, 2.1mg of citric acid, 2 to 4mg of sodium hydroxide and 0.6 to 0.8mg of sodium chloride. The preparation method comprises the following steps: adding water used for injection into the citric acid for stirring and dissolving; adjusting the pH to about 6.2 with sodium hydroxide; adding sodium chloride for stirring to dissolve the sodium chloride; adding the water used for injection and 1g of active carbon; adding riboflavine sodium phosphate while stirring; after the riboflavine sodium phosphate is completely dissolved, complementing the water for injection until the total amount is completely complemented; performing filtering, refluxing, filling, nitrogen charge, melting to seal, sterilizing at a high temperature; and after reducing the temperature, detecting with lamps, packing and checking, and obtaining the finished product. The riboflavine sodium phosphate composition injection does not crystallize, has good clarity and stability, and is helpful for improving the yield of the product, reducing the market rick of the product and is better applied to clinical treatment.

Description

technical field [0001] The invention relates to medicines in the medical field, in particular to a riboflavin sodium phosphate composition injection that does not produce crystals and has good clarity and stability and a preparation method thereof. Background technique [0002] Riboflavin is an integral part of the metabolic enzyme system of the human body and one of the indispensable vitamins in biological life activities. It is closely related to the metabolism of carbohydrates, fats, proteins, and nucleic acids in the human body. The activity is two flavin coenzymes, flavin mononucleotide (FMN) and flavin dinucleotide (FAD). These two flavin coenzymes can form flavoproteins with various proteins, and participate in the biological oxidation reaction and energy of living organisms Metabolism, they are also necessary components of the mixed-function oxidase system in the body's cells, which is the main enzyme system for the metabolic activation or detoxification of chemical ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/525A61K47/12A61P3/02A61P7/10A61P35/00A61P3/06A61P9/00
Inventor 周晓东
Owner 江西制药有限责任公司