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Riboflavin sodium phosphate freeze-dried powder injection and preparation method thereof

A riboflavin sodium phosphate, freeze-dried powder injection technology, applied in freeze-dried delivery, powder delivery, pharmaceutical formulations and other directions, can solve the problems of increasing unpredictable risks, easy turbidity of the solution, poor clarity, etc. The freeze-drying process is reasonable and feasible, the appearance is full, and the effect of reducing the risk of adverse reactions

Active Publication Date: 2010-11-03
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that riboflavin sodium phosphate injection has poor stability, and it is prone to defects such as poor clarity and cloudy solution during storage; and the clinical safety of β-cyclodextrin used as injection excipients needs to be evaluated. The situation is that the clinical use greatly increases the unpredictable risk

Method used

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  • Riboflavin sodium phosphate freeze-dried powder injection and preparation method thereof
  • Riboflavin sodium phosphate freeze-dried powder injection and preparation method thereof
  • Riboflavin sodium phosphate freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Riboflavin sodium phosphate 5g (calculated as riboflavin)

[0022] Mannitol 50.0g

[0023] Ammonia amount

[0024] Add water for injection to 1000ml

[0025] Made 1000 pieces

[0026] Preparation process: operate in the dark, weigh the prescribed amount of riboflavin sodium phosphate and mannitol, dissolve in an appropriate amount of water for injection, stir and dissolve, adjust the pH of the solution to 5.9 with ammonia solution, and add water for injection to the full amount; Then add activated carbon accounting for 0.1% (W / V) of the liquid amount, stir and decolorize for 20 minutes, recirculate and stir for 10 minutes, filter and decarbonize with a titanium filter stick, and then fine filter through a microporous membrane (0.22 μm membrane); The filtrate was tested for content, density, endotoxin, acidity, clarity, etc. After passing the test, it was filled in brown vials; the subpackaged samples were placed in a freeze-drying box, and -40°C was used as the pre-f...

Embodiment 2

[0028] Riboflavin sodium phosphate 10g (calculated as riboflavin)

[0029] Mannitol 100.0g

[0030] Ammonia amount

[0031] Add water for injection to 1000ml

[0032] Made 1000 pieces

[0033]Preparation process: operate in the dark, weigh the prescribed amount of riboflavin sodium phosphate and mannitol, dissolve in an appropriate amount of water for injection, stir and dissolve, adjust the pH of the solution to 6.0 with ammonia solution, and add water for injection to the full amount; Then add activated carbon accounting for 0.2% (W / V) of the liquid amount, stir and decolorize for 20 minutes, recirculate and stir for 10 minutes, filter and decarbonize with a titanium filter stick, and then finely filter through a microporous membrane (0.22 μm membrane); The filtrate was tested for content, density, endotoxin, acidity, clarity, etc. After passing the test, it was filled in brown vials; the subpackaged samples were placed in a freeze-drying box, and -40°C was used as the pr...

Embodiment 3

[0035] Riboflavin sodium phosphate 5g (calculated as riboflavin)

[0036] Mannitol 60.0g

[0037] Add water for injection to 1000ml

[0038] Made 1000 pieces

[0039] Preparation process: operate in the dark, weigh the prescribed amount of riboflavin sodium phosphate and mannitol and dissolve in an appropriate amount of water for injection, stir and dissolve, and measure the pH value of the solution to 5.9 (within the required range, the pH value of ammonia water is not used) , add water for injection to the full amount; then add activated carbon accounting for 0.1% (W / V) of the liquid amount, stir and decolorize for 20 minutes, recirculate and stir for 10 minutes, decarbonize with a titanium filter stick, and then pass through a microporous membrane (0.22 μm filter membrane) for fine filtration; take the filtrate for content, density, endotoxin, acidity, clarity and other tests, and fill it in a brown vial after passing the test; put the subpackaged sample into a freeze-dry...

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Abstract

The invention relates to a riboflavin sodium phosphate freeze-dried powder injection and a preparation method thereof. The injection is characterized by comprising a riboflavin sodium phosphate dehydrate, mannitol and / or ammonia water. The injection is sensitive to light, so a brown amoxicillin bottle is used as the inner package of the injection. The riboflavin sodium phosphate freeze-dried powder injection has the following advantages: (1) single and clear auxiliary materials in the formula can meet the requirement of industrialized batch production; (2) medicinal injection grade raw and auxiliary materials accord with the medication requirement of human intravenous injection, so that potential adverse reaction risk in clinical application can be greatly reduced; (3) long-term stability tests prove that the preparation can be preserved for 2 years at the temperature below 30 DEG C, so that stability of the medicament in circulation and safety of clinical medication can be ensured; and (4) special safety tests, such as irritability, haemolysis, vascular stimulation and the like, prove that haemolysis, agglutination, stimulation and anaphylaxis reactions are not found.

Description

technical field [0001] The invention relates to a riboflavin sodium phosphate freeze-dried powder injection and a preparation method thereof, which are used for treating diseases such as angular cheilitis, cheilitis, glossitis, conjunctivitis and scrotal inflammation caused by riboflavin deficiency. It belongs to the technical field of pharmaceutical preparations. Background technique [0002] Riboflavin sodium phosphate is a vitamin drug, riboflavin (vitamin B 2 ) is an important nutrient for the human body and plays a key role in energy metabolism. Riboflavin sodium phosphate is a prodrug of flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), and FMN and FAD are important cofactors of the flavin enzyme family. Flavozymes catalyze many biochemical reactions, the most typical being redox reactions, which are key factors of cellular respiration. FAD and FMN deliver hydrogen in the mitochondrial turning chain, generating cellular energy in the process. When ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/675A61K47/10A61P3/02A61P1/02A61P27/02A61P15/00
Inventor 张志宏龙娇朱玉王欣
Owner HAINAN LEVTEC PHARMA
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