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A kind of caffeine citrate injection pharmaceutical composition and preparation method thereof

A technology of citric acid and caffeine, applied in the field of medicine, can solve problems such as narrow safety range, and achieve the effect of controllable quality, simple prescription and good stability

Active Publication Date: 2016-11-30
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Theophylline, the most widely used drug, has a narrow safety range, and blood drug concentration needs to be closely monitored

Method used

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  • A kind of caffeine citrate injection pharmaceutical composition and preparation method thereof
  • A kind of caffeine citrate injection pharmaceutical composition and preparation method thereof
  • A kind of caffeine citrate injection pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052]Take 900ml of water for injection, control the temperature of the water for injection at 70°C, add 10g of caffeine, 2.5g of citric acid and 4.15g of sodium citrate, stir to dissolve completely, add water for injection to 1000ml; then add 0.3 g of activated carbon, stirred and adsorbed for 20 minutes; finely filter the above prepared medicinal solution with a sterilizing filter connected in series with "0.45 μm polypropylene membrane + 0.22 μm polyethersulfone membrane + 0.22 μm polyethersulfone membrane"; Each 1.0ml of the drug solution was filled and sealed in a 1ml low borosilicate glass ampoule; sterilized by 121°C damp heat steam for 12 minutes, and inspected by light to obtain caffeine citrate injection, the specification is 1ml: 20mg.

Embodiment 2

[0054] Take 900ml of water for injection, control the temperature of the water for injection at 80°C, add 10g of caffeine, 4.0g of citric acid and 6.64g of sodium citrate, stir to dissolve completely, add water for injection to 1000ml; then add 0.3 g of activated carbon, stirred and adsorbed for 20 minutes; finely filter the above prepared medicinal solution with a sterilizing filter connected in series with "0.45 μm polypropylene membrane + 0.22 μm polyethersulfone membrane + 0.22 μm polyethersulfone membrane"; Each 1.0ml of the drug solution was filled and sealed in a 1ml low borosilicate glass ampoule; sterilized by 121°C damp heat steam for 15 minutes, and inspected by light to obtain caffeine citrate injection, the specification is 1ml: 20mg.

Embodiment 3

[0056] Take 900ml of water for injection, control the temperature of the water for injection at 60°C, add 10g of caffeine, 5.0g of citric acid and 8.3g of sodium citrate, stir to dissolve completely, add water for injection to 1000ml; then add 0.3 g of activated carbon, stirred and adsorbed for 20 minutes; finely filter the above prepared medicinal solution with a sterilizing filter connected in series with "0.45 μm polypropylene membrane + 0.22 μm polyethersulfone membrane + 0.22 μm polyethersulfone membrane"; Each 1.0ml of the drug solution was filled and sealed in a 1ml low borosilicate glass ampoule; sterilized by 121°C damp heat steam for 12 minutes, and inspected by light to obtain caffeine citrate injection, the specification is 1ml: 20mg.

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Abstract

The invention provides a novel caffeine citrate injection pharmaceutical composition and a preparation method thereof. In the formula, a citrate-sodium citrate is added as a buffer solution, so that the pH value of a liquid medicine can be kept in a certain pH range, and a buffer effect can be achieved, thereby keeping the product stable; due to the adoption of a terminal sterilization process, the pharmaceutical composition meets the aseptic security requirements very well; and a caffeine citrate injection prepared by using the formula and process disclosed by the invention is low in related matter amount, controllable in quality, good in stability, and more applicable to industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a caffeine citrate injection pharmaceutical composition and a preparation method thereof. Background technique [0002] Caffeine citrate, the English name is caffeine citrate, the structural formula is: [0003] [0004] Caffeine is a drug belonging to the class of methylxanthines. Its mechanism of action is mainly to excite the respiratory center and increase the sensitivity to carbon dioxide, so as to stimulate breathing and relieve respiratory resistance. In addition, caffeine can effectively stimulate the diaphragm of children, causing the diaphragm to contract regularly. This mechanism of action largely avoids the phenomenon of diaphragm fatigue in children. [0005] Caffeine citrate preparations, including injections and oral solutions, were approved in France on December 31, 1997, for the treatment of apnea in premature neonates. In September 1998, it was qualified a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/522A61K47/12A61P11/00
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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