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Fructose diphosphate containing novel pharmaceutical composition injection for treating circulation system diseases

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

Inactive Publication Date: 2016-02-10
邓学峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[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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  • Fructose diphosphate containing novel pharmaceutical composition injection for treating circulation system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Sodium fructose diphosphate pharmaceutical composition (injection)

[0018] Formula 1: 30 g of sodium fructose diphosphate, 0.5 g of sodium bisulfite, 0.025 g of isosorbide dinitrate, and 500 ml of water for injection.

[0019] Formula 2: 10 g of sodium fructose diphosphate, 0.1 g of sodium bisulfite, 0.01 g of isosorbide dinitrate, and 100 ml of water for injection.

[0020] Formula 3: 50 g of sodium fructose diphosphate, 1 g of sodium bisulfite, 0.05 g of isosorbide dinitrate, and 1000 ml of water for injection.

[0021] Formula 4: 20 g of sodium fructose diphosphate, 0.8 g of sodium bisulfite, 0.02 g of isosorbide dinitrate, and 200 ml of water for injection.

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

[0023] The preparation method is as follows:

[0024] Stir and dissolve sodium fructose diphosphate, sodium bisulfite, and isosorbide dinitrate successively with water for injection, add act...

Embodiment 2

[0025] Embodiment 2 blood vessel stimulation test 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.

[0026] 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

[0035] Stability test

[0036] The sample of embodiment 1 configuration 1~5 gained and the sample of contrast 1 (in embodiment 1 configuration 2, do not add isosorbide dinitrate) sample, carry out appearance, clarity according to the requirement of national drug standard WS1-(X-063)-2001Z , Detection of related substances (free phosphate) and content and other indicators and long-term stability test.

[0037] 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 carry out an accelerated test to determine the content of active ingredients. The results are shown in Table 2. Table 2 Accelerated test results

[0038]

[0039] Through six months of accelerated observation at constant temperature, the related substances and contents of each sodium fructose diphosphate injection prepared in Example 1 1 to 5 were qualified, and all other inspections were in compliance ...

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PUM

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Abstract

The invention provides an injection prepared from a novel composition which contains three medicines such as fructose diphosphate and the like, wherein the injection consists of the following components according to effective doses: 10-50g of the fructose diphosphate, 0.01-0.05g of isosorbide dinitrate and 100-1000ml of sodium hydrogen sulfite. The invention also provides preparation steps and a preparation method. The pharmaceutical composition is applicable to shock, coronary heart disease, angina, acute myocardial infarction, myocardial ischemia, cardiac failure and surrounding lesions. By adding the isosorbide dinitrate, myocardial oxygen consumption is reduced, oxygen supply is enhanced and the angina is relieved. In cooperation with and by expanding the application of the fructose diphosphate to clinical treatment, the medicine is safer and is more stable, and the medicine is capable of relieving irritant pain on a human body and enhancing a curative effect on treating circulation system related diseases. The preparation method comprises the following steps: sequentially stirring and dissolving the fructose diphosphate, the sodium hydrogen sulfite and the isosorbide dinitrate by virtue of injection water, decoloring with the addition of activated carbon, filtering and removing carbon; and filtering, sterilizing, filling and sterilizing.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition injection 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 hypoph...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7024A61K47/16A61K47/02A61K9/08A61P3/12A61P9/10
Inventor 邓学峰
Owner 邓学峰
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