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A kind of adenosine triphosphate disodium composition powder injection

A technology of adenosine triphosphate disodium and its composition, which is applied in the field of medicine, can solve the problems of large increase, and achieve the effects of improved quality stability, good quality stability and long production cycle

Active Publication Date: 2020-07-07
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The best and most stable formulation 6 disclosed in this patent has a large increase in the total amount of related substances from 1.25% to 6.04% at 40°C for 15 days

Method used

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  • A kind of adenosine triphosphate disodium composition powder injection
  • A kind of adenosine triphosphate disodium composition powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] In a GMP-compliant aseptic workshop, weigh 20kg of sterile adenosine triphosphate disodium (pure) and 1.75kg of sterile anhydrous sodium carbonate (molar ratio 1:0.5) by aseptic operation, and place them in a sterilized powder mixing tank Mix the powder for 2 hours, discharge the material into barrels, transfer to the packing room, pack into sterilized glass bottles according to the specification of 20 mg, cover with sterilized rubber stoppers, tie sterilized aluminum caps, and pack after passing the light inspection.

Embodiment 2

[0026] In the aseptic workshop conforming to GMP, 20kg of sterile adenosine triphosphate disodium (pure) and 9.72kg of sterile anhydrous sodium citrate (molar ratio 1:1) were weighed by aseptic operation, and placed in a sterilized mixed Mix the powder in the powder tank for 1 hour, discharge the material into barrels, transfer to the packing room, pack into sterilized glass bottles according to the specification of 20 mg, cover with sterilized rubber stoppers, and tie sterilized aluminum caps. After passing the light inspection Package.

Embodiment 3

[0028] In the aseptic workshop complying with GMP, adopt aseptic operation to weigh aseptic disodium adenosine triphosphate (pure) 20kg, aseptic anhydrous sodium carbonate 3.5kg and aseptic anhydrous sodium citrate 9.72kg (molar ratio 1: 1:1), mix the powder in a sterilized powder mixing tank for 2.5 hours, discharge the material into barrels, transfer to the subpackaging room, dispense 20 mg into sterilized glass bottles according to the specification, and cover with sterilized rubber stoppers , tied with a sterilized aluminum cover, and packed after passing the light inspection.

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PUM

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Abstract

The invention relates to an adenosine disodium triphosphate compound powder injection, belonging to the field of the pharmaceutical industry. The adenosine disodium triphosphate compound powder injection is composed of adenosine disodium triphosphate and a stabilizing agent in a mol ratio of 1: 0.5-2, wherein the stabilizing agent is anhydrous sodium carbonate, anhydrous sodium citrate, or a mixture thereof. The adenosine disodium triphosphate compound powder injection is good in quality stability; in a validity period of the adenosine disodium triphosphate compound powder injection, the content of other impurities in related substances are smaller than 1.0%, and the total content of impurities is less than 5%; and the adenosine disodium triphosphate compound powder injection is simple toprepare and low in cost, lowers the medical cost of patients and produces good social benefits.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a disodium adenosine triphosphate composition, which can be used for preparing sterile powder injections for injection. [0002] technical background [0003] Adenosine triphosphate disodium is a coenzyme that can improve the metabolism of the body and participate in the metabolism of fat, protein, sugar, nucleic acid and nucleotide in the body. When energy is needed for absorption, secretion, muscle contraction and biochemical synthesis reactions, adenosine triphosphate That is, it is decomposed into adenosine diphosphate and phosphate groups, and at the same time releases energy. It is the center of energy source and storage in the body and plays an important role in life activities. Adenosine triphosphate disodium can also penetrate the blood-cerebrospinal fluid barrier, improve the stability and reconstruction ability of the membrane structure of nerve cells, and promote the reg...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/02A61K47/12A61P9/04A61P9/00A61P9/10A61P21/00A61P7/04A61P13/12A61P1/16A61P27/16A61P31/14
CPCA61K9/0019A61K9/19A61K31/7076A61K47/02A61K47/12
Inventor 谭胜连文青司徒小燕郭泽彬林崝方奕森
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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