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Meglumine cyclic adenosine for injecta and its preparing process

A technology for obtaining meglumine cyclophosphate and obtaining meglumine cyclophosphate is applied in the field of preparation technology of meglumine cyclophosphate for injection, and can solve the problems of easy precipitation of meglumine cyclophosphate, influence of medication safety, Problems such as poor solution stability, to achieve the effect of good curative effect, easy operation and stable quality

Inactive Publication Date: 2007-03-07
JIANGSU WANBANG BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Meglumine cyclic adenosine monophosphate is slightly soluble in water, adding meglumine can increase the solubility, but the stability of the solution is poor, and meglumine cyclic adenosine monophosphate is easy to precipitate, and the safety of the drug is affected

Method used

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  • Meglumine cyclic adenosine for injecta and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Preparation process of meglumine cyclic adenosine monophosphate freeze-dried powder for injection:

[0019] The components of adenosine cyclic monophosphate meglumine for injection include: adenosine cyclic monophosphate, meglumine and excipients, the weight ratio of each component is 1.7:1:9.26, the pH value is 5.5, and the property is white or off-white Freeze-dried block or powder, this product is dissolved by adding dilute nitric acid, adding ammonium molybdate test solution, heating and boiling for several minutes, and a yellow precipitate is precipitated. Preparation process: take 6% meglumine cyclic adenosine monophosphate solution, add excipient sterile powder into the solution, stir to dissolve, add water for injection to dilute, adjust pH value in the range of 5.5 to 7.0, turn on cooling water and freezer , turn on the plate cold work button to start pre-freezing, when the product temperature reaches -35°C for 2 hours, turn on the condenser, when the temperatu...

Embodiment 2

[0021] The preparation process of adenosine cyclic monophosphate meglumine for injection, the components of adenosine cyclic monophosphate meglumine for injection include: adenosine cyclic monophosphate, said cyclic adenosine monophosphate, meglumine and excipients are made into freeze-dried powder injection, The weight ratio of each component is 1.7:1:9.26, the pH value is 7, and the properties are white or off-white freeze-dried lumps or powders. After the product is dissolved in dilute nitric acid, add ammonium molybdate test solution and heat to boil. After a few minutes, a yellow precipitate precipitated out. Preparation process, take 6% solution of meglumine cyclic adenosine monophosphate, add excipient sterile powder into the solution, stir to dissolve, add water for injection to dilute, adjust pH value to 5.5, turn on cooling water and refrigerator, open plate to cool The working button starts pre-freezing. When the product temperature reaches -35°C for 2 hours, turn o...

Embodiment 3

[0023] The composition of meglumine cyclic adenosine monophosphate for injection includes: cyclic adenosine monophosphate, meglumine and excipients made into freeze-dried powder injection, the ratio of each component by weight and number is 1.7:1:9.26, and the pH value is 6. Its properties are white or off-white freeze-dried block or powder. After adding dilute nitric acid to dissolve this product, add ammonium molybdate test solution, heat and boil for several minutes, and a yellow precipitate will precipitate out.

[0024] This embodiment provides a preparation process for a 6% solution of adenosine cyclic monophosphate meglumine for injection: respectively weigh the prescribed amounts of adenosine cyclic monophosphate, meglumine, and mannitol in a sterile weighing room, and then operate in the following order : First, dissolve meglumine with an appropriate amount of water for injection, then pour it into a liquid mixing bucket and dilute it to a solution of about 6%, start s...

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Abstract

The invention relates to a method for preparing normal saline cosa injection. Wherein, it comprises that using 6% normal saline cosa solution, adding shaping agent germ-free powder, mixing and dissolving, adding injection water to dilute, to adjust the pH value between 5.5 and 7.0, cooling, condensing at -35Deg. C after 1-2hours, vacuuming when the temperature of condenser is -45Deg. C to -1.5*10<-2kPa, increasing temperature at 3Deg. C / hour; when the temperature is at room temperature or higher than 30Deg. C, keeping warm for 2hours, and the whole freeze process needs 24-26hours. The invention can be transmitted at normal temperature, to improve stability and safety.

Description

technical field [0001] The invention relates to a preparation process of meglumine cyclic adenosine monophosphate for injection, which belongs to chemical pharmacy. Background technique [0002] Meglumine cyclophosphate is slightly soluble in water, adding meglumine can increase the solubility, but the stability of the solution is poor, and meglumine cyclophosphate is easy to precipitate, which affects the safety of the drug. After being made into freeze-dried powder, it can be transported and stored at normal temperature, which improves the safety and stability of the medicine. [0003] In addition, the problem to be solved in the present invention is to formulate the lyophilized powder preparation into a stable solution. Contents of the invention [0004] The object of the present invention is to provide a preparation process of adenosine cyclic monophosphate meglumine freeze-dried powder for injection with simple process and safe medication. [0005] Another object of...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/08A61K31/7076A61P9/00
Inventor 李孝成李显林田海英沈洲
Owner JIANGSU WANBANG BIOPHARMLS