Riboflavine sodium phosphate composition injection and preparation method thereof

The technology of sodium riboflavin phosphate and composition is applied in the field of medicines in the field of medicine, and can solve the problems of complex preparation process, difficulty in confirming stability, etc., and achieve the effects of no allergic reaction, stable quality and good clinical treatment.

Active Publication Date: 2009-12-16
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
Comparison scheme
Effect test

Embodiment 1

[0073] Formula: 1000ml divided into 500 pieces 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 prescription amount of citric acid, add proper amount of water for injection and stir to dissolve, adjust pH to 6.0 with sodium hydroxide, then add sodium chloride and stir to dissolve, add proper amount of water for injection, add riboflavone while stirring Sodium phosphate, after it is completely dissolved, make up with water for injection to the full amount, add 0.08% (w / v) activated carbon and stir for 23 minutes at a temperature of 60°C, filter, reflux, fill, fill with nitrogen, and seal at a high temperature of 121°C After sterilization for 10 minutes, light inspection, packaging and inspection after cooling, the riboflavin sodium phosphate composition injection is obtained.

Embodiment 2

[0081] Formula: 1000ml divided into 500 pieces 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 prescription amount of citric acid, add proper amount of water for injection and stir to dissolve, adjust the pH to 6.1 with sodium hydroxide, then add sodium chloride and stir to dissolve, add proper amount of water for injection, add riboflavone while stirring Sodium phosphate, when it is completely dissolved, make up with water for injection to the full amount, add 0.05% (w / v) activated carbon and stir for 20 minutes at a temperature of 55°C, filter, reflux, fill, fill with nitrogen, and seal at a high temperature of 121°C After sterilizing for 8 minutes, and after cooling down, light inspection, packaging and inspection, the riboflavin sodium phosphate composition injection is obtained.

Embodiment 3

[0089] Formula: 1000ml divided into 200 pieces 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 prescription amount of citric acid, add proper amount of water for injection and stir to dissolve, adjust pH to 5.9 with sodium hydroxide, then add sodium chloride and stir to dissolve, add proper amount of water for injection, add riboflavone while stirring Sodium phosphate, when it is completely dissolved, make up the full amount of water for injection, add 0.05% (w / v) activated carbon and stir at 55℃ for 20 minutes, after filtering, reflux, filling, nitrogen filling, melting and sealing, at high temperature 115℃ After being sterilized for 30 minutes, and after cooling, light inspection, packaging and inspection, the riboflavin sodium phosphate composition injection is obtained.

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PUM

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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 field of medicine, in particular to a riboflavin sodium phosphate composition injection with good clarity and stability without crystallization and a preparation method. Background technique [0002] Riboflavin is a component of the human body’s metabolic enzyme system, and it is also 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 flavin mononucleotide (FMN) and flavin purine dinucleotide (FAD) two flavin coenzymes. These two flavin coenzymes can form flavin proteins with a variety of proteins and participate in the biological oxidation reaction and energy of the organism. Metabolism, they are also a necessary component of the mixed-function oxidase system in the body's cells. This enzyme system is the main enzyme system for the metabolic activation or detoxification of che...

Claims

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Application Information

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Patent Type & Authority Applications(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
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