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Medicine composition containing fructose sodium diphosphate compound

A technology of sodium fructose diphosphate and its composition, which is applied in the field of medicine and can solve problems such as pain discomfort, pain, and vascular smooth muscle spasm

Active Publication Date: 2013-04-24
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oral preparations have defects such as not being easily absorbed by the human body, slow onset of action, etc., and auxiliary materials such as starch and dextrin and flavoring agents such as sugar are usually added to oral preparations, which affect the use of patients such as diabetes
[0004] The common problem of sodium fructose diphosphate injection in intravenous infusion is pain. The main reason may be that sodium fructose diphosphate is an acidic liquid, which can cause spasm of vascular smooth muscle, resulting in pain and discomfort in local or punctured limbs; Sodium phosphate contains 5 hydrogen radicals. Due to the release of the pain-causing substance hydrogen ions, the hydrogen ions act on the nerve endings to generate pain-causing afferent impulses, so the incidence of pain is extremely high; fructose diphosphate sodium is a hypertonic sugar. It can dehydrate tissue cells, increase intercellular fluid, tissue edema, compress and stimulate peripheral nerves, and cause pain; in addition, particles in the liquid are also an important factor that causes infusion pain
So far, there is no effective solution to the pain of sodium fructose diphosphate infusion

Method used

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  • Medicine composition containing fructose sodium diphosphate compound
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  • Medicine composition containing fructose sodium diphosphate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1 sodium fructose diphosphate pharmaceutical composition (injection)

[0018] Formula 1: 30g of sodium fructose diphosphate, 0.5g of sodium bisulfite, 30g of mannitol, and 500ml of water for injection.

[0019] Formula 2: 10 g of sodium fructose diphosphate, 0.1 g of sodium bisulfite, 10 g of mannitol, and 100 ml of water for injection.

[0020] Formula 3: 50 g of sodium fructose diphosphate, 1 g of sodium bisulfite, 50 g of mannitol, and 1000 ml of water for injection.

[0021] Formula 4: sodium fructose diphosphate 20g, sodium bisulfite 0.8g, mannitol 40g, water for injection 200ml.

[0022] Formula 5: 35g of sodium fructose diphosphate, 0.5g of sodium bisulfite, 25g of mannitol, and 600ml of water for injection.

[0023] The preparation method is as follows:

[0024] Stir and dissolve sodium fructose diphosphate, sodium bisulfite, and mannitol in sequence with water for injection, add 0.3% activated carbon by weight of the solution, stir for 20 minutes ...

Embodiment 2

[0026] 1. Vascular stimulation experiment

[0027] Samples: Experimental groups 1-5 are Fructose Diphosphate Sodium Injection formulated in Formulas 1-5 of Example 1, and the negative control group is 0.9% Sodium Chloride Injection.

[0028] Test method: Japanese big-eared white rabbits, weighing 2-2.5kg, were raised in the animal room for one week before the experiment to adapt to the environment. Five rabbits were used, and the experimental group was injected with 5 mL / kg in the right ear vein of the rabbits, and the negative control with the same injection amount was injected into the left ear vein. Use a No. 6 scalp needle to inject into the ear vein. The direction of the needle point to puncture the blood vessel is from the distal end to the proximal end, and the administration speed is 2-3mL / min. Dosing once a day for 7 consecutive days. The animals and injection sites were observed visually before administration and 48 hours after the last administration, and histopat...

Embodiment 3

[0037] Embodiment 3 stability test

[0038] The sample of embodiment 1 configuration 1~5 gained and the sample of contrast 1 (in embodiment 1 configuration 2 do not add mannitol), according to the requirement of national drug standard WS1-(X-063)-2001Z, carry out appearance, clarity, relevant Substance (free phosphate) and content detection and long-term stability test.

[0039] Take the samples of configurations 1 to 5 in Experimental Example 1, place them for 6 months at a temperature of 40°C ± 2°C, and a relative humidity of 75% ± 5%, and conduct an accelerated test to determine the content of active ingredients. The results are shown in Table 1.

[0040] Table 2 Accelerated test results

[0041]

[0042] Through six months of accelerated observation at constant temperature, the related substances and contents of the sodium fructose diphosphate injections in configurations 1 to 5 of Example 1 were all qualified, and all other inspections were in compliance with the regu...

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PUM

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Abstract

The invention provides a medicine composition containing a fructose sodium diphosphate compound, comprising fructose sodium diphosphate, sodium hydrogen sulfite, mannitol and water for injection. A preparation method for the medicine composition comprises the following steps of: sequentially dissolving fructose sodium diphosphate, sodium hydrogen sulfite and mannitol with the water for injection by stirring; adding active carbon to decolour; filtering and removing carbon; and filtering and removing bacteria. The fructose diphosphate medicine composition provided by the invention is simple in prescription, high in stability, capable of alleviating pain during injection, and conducive to application and popularization for fructose sodium diphosphate injection solution clinically. Additionally, high-temperature sterilization is avoided in the preparation method disclosed by the invention, the generation of related substances can be reduced, and the safety is improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition containing sodium fructose diphosphate compound and a preparation method thereof. Background technique [0002] Fructose diphosphate (fructose-1,6-diphosphate, FDP) is a cell metabolite present in the human body, which can regulate the activity of various enzyme systems in glucose metabolism, improve the state of cell hypoxia and ischemia, and is beneficial to damage Recovery of liver cells. When the phosphate concentration in the circulating blood is lower than the normal concentration, it will cause phosphorus metabolism disorder, usually showing symptoms such as hemolysis, fatigue, weakness and convulsions, which is called hypophosphatemia (hypophosphatemia, also known as hypophosphatemia) ). There are many reasons for hypophosphatemia. Long-term infusion (glucose) can increase the uptake of phosphate by cells, which can lead to hypophosphatemia...

Claims

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Application Information

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IPC IPC(8): A61K31/7024A61K47/10A61K47/02A61P9/10A61P39/00
Inventor 罗诚
Owner 罗诚
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