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Preparation method of fructose diphosphate sodium powder injection

A technology of sodium fructose diphosphate and powder injection, which is applied in the field of drug preparation, can solve problems such as unfavorable storage and transportation, influence of drug effect, poor stability, etc., and achieve the effects of saving resources, improving drug stability and mild process conditions

Inactive Publication Date: 2011-01-26
SHANGHAI NEW ASIA PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are 4 dosage forms of sodium fructose diphosphate in clinical use, which are solution, powder injection, capsule and tablet. Tablets and capsules of sodium fructose diphosphate are poorly absorbed and their efficacy is affected. And the solution of sodium fructose diphosphate, although administration is more convenient than powder injection, because sodium fructose diphosphate itself has the characteristic of carbohydrate substance, the stability of liquid state is relatively poor, also is unfavorable for storage and transportation, so in recent years powder The use of injections is on the rise year by year, which lays the foundation for the production of powder injections

Method used

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  • Preparation method of fructose diphosphate sodium powder injection
  • Preparation method of fructose diphosphate sodium powder injection
  • Preparation method of fructose diphosphate sodium powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Add 150 g of sodium fructose diphosphate into a 2L reactor containing 300 ml of water for injection, stir to dissolve, add 2 g of activated carbon at the same time, filter and decolorize for 30 minutes, and wash the carbon cake with 450 ml of 75% ethanol aqueous solution, and filter the filtrate through a 0.45 μ filter. 0.22μ filter for fine filtration and sterilization, pump it into the crystallization pot in the sterile room, add 150ml of absolute ethanol under stirring, first crystallize at room temperature 20℃~26℃, filter, wash the crystals with 200ml of absolute ethanol 4 times, 40℃~ Dry at 50°C to obtain 132 g of sterile sodium fructose diphosphate powder, with a yield of 88%. The obtained aseptic sodium fructose diphosphate powder can be divided into 2.5 grams, 5 grams, 7.5 grams or 10 grams of infusion bottles of different specifications.

Embodiment 2

[0024] Add 54g of sodium fructose diphosphate into a 1L reactor containing 150ml of distilled water, stir to dissolve, add 5g of activated carbon, filter and decolorize for 30min, and wash the carbon cake with 120ml of acetone aqueous solution, filter the filtrate through a 0.45μ filter, and then filter through a 0.22μ Fine filter and sterilize, pump into the crystallization pot of the aseptic room, add 200L acetone under stirring, first crystallize at room temperature 25°C, filter, wash the crystal twice with an appropriate amount of acetone, and dry at 40°C to obtain sterile sodium fructose diphosphate powder of about 46g, yield 85%.

[0025] The obtained aseptic sodium fructose diphosphate powder can be divided into 2.5 grams, 5 grams, 7.5 grams or 10 grams of infusion bottles of different specifications.

Embodiment 3

[0026] The character test of embodiment 3 sodium fructose diphosphate

[0027] Experimental observation freeze-drying drying method (commercially available Italian imported product) and the sodium fructose diphosphate aseptic powder product that the solvent crystallization method of embodiment 1 makes hygroscopicity in air, and its result is as follows

[0028] 1. Freeze-dried sodium fructose diphosphate is a white powder with strong hygroscopicity in the air, see Table 2

[0029] Exposure time in air (minutes)

[0030] 2. The sodium fructose diphosphate crystallized by the solvent of Example 1 is a white crystalline powder, the surface is not easily bonded, the fluidity is good, and the hygroscopicity in the air is small, see Table 3

[0031] Table 3 Sodium fructose diphosphate hygroscopicity in air

[0032] time (hours)

[0033] 24

[0034] Conclusion: The hygroscopicity of sodium fructose diphosphate in the air is related to the water content...

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Abstract

The invention discloses a preparation method of a fructose diphosphate sodium powder injection, comprising the following steps of: decoloring, degerming, roughly filtering and finely filtering a fructose diphosphate sodium water solution; and punching, separating and crystallizing with ethanol or acetone and filling to obtain the aseptic powder injection. The fructose diphosphate sodium powder injection prepared by the method has higher purity, fewer impurities and more stable quality compared with the traditional products and is convenient to store and transport. The invention is simple to operate, has mild process condition and low cost and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine preparation. Specifically relates to a preparation method of sodium fructose diphosphate powder for injection. Background technique [0002] Sodium fructose diphosphate is an adjuvant therapeutic drug for myocardial ischemia. It is an intermediate product of glucose metabolism in the body. It produces pharmacological effects by regulating the activity of several enzymes in glucose metabolism. Exogenous fructose 1,6-diphosphate can increase the concentration of intracellular adenosine triphosphate and creatine phosphate, promote the influx of potassium ions, increase the content of diphosphoglycerate in red blood cells, inhibit the release of oxygen free radicals and histamine, etc. It can reduce the damage caused by ischemia and hypoxia, especially for ischemic heart disease. Sodium fructose diphosphate is basically the same as glucose, which has the effect of directly supplying heat energy, re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/7024A61P9/10A61P9/04A61P9/06A61P9/00A61P3/02A61P39/02
Inventor 练美华张丽春
Owner SHANGHAI NEW ASIA PHARMA
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